IceCure Medical News
251 articles
growth-positive
IceCure's ProSense® Showcased at TME Fall Summit: "Take the Lead in Breast Cancer Care" Roundtable Highlighting Cryoablation Advances
IceCure Medical Ltd. has received FDA marketing authorization for its ProSense® cryoablation technology for the treatment of low-risk breast cancer in patients aged 70 and above. This approval follows the companys participation in the TME Fall Summit, where the technology garnered significant interest from key opinion leaders in the field of breast cancer care. The FDA authorization is expected to enhance the commercial traction of ProSense®, which offers a minimally invasive alternative to surgical tumor removal. The approval is seen as a positive development for IceCure, potentially leading to increased clinical adoption of their technology.
FDA approved/pending approval
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd. announced that the FDA granted marketing authorization for its ProSense® Cryoablation System for the treatment of low-risk breast cancer in patients aged 70 and above. This approval is expected to enhance the commercial traction of ProSense®, a minimally invasive cryosurgical tool that destroys tumors by freezing. The announcement followed IceCures participation in the TME Fall Summit, where the system received significant interest from key opinion leaders in the medical field. The ProSense® system is designed to provide a less invasive alternative to surgical tumor removal, offering benefits such as reduced pain and faster recovery. IceCure Medical markets its cryoablation therapy systems worldwide, focusing on various cancers, including breast, kidney, and lung.
FDA approved/pending approval
growth-positive
IceCure Medical to Attend the 2025 Maxim Growth Summit
IceCure Medical Ltd. has achieved a significant milestone with its ProSense® Cryoablation system receiving FDA marketing authorization for the local treatment of early-stage, low-risk breast cancer in specific patient groups. This approval marks the first new innovation in decades for treating women with low-risk early-stage breast cancer, potentially setting a new standard of care. The company is participating in Maxims Growth Summit in New York City, where its management will meet with institutional investors to discuss its latest regulatory and commercial achievements. IceCure Medical develops minimally-invasive cryoablation technology for tumor destruction, focusing on breast, kidney, bone, and lung cancer.
FDA approved/pending approvalManagement Changes
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd. has achieved a significant milestone with its ProSense® Cryoablation system receiving FDA marketing authorization for the local treatment of early-stage, low-risk breast cancer in patients aged 70 and above, as well as women not suitable for surgery. This marks the first new innovation in decades for treating low-risk early-stage breast cancer, potentially setting a new standard of care. IceCures management, including CEO Eyal Shamir, will participate in Maxims Growth Summit in New York City on October 22-23, 2025, to meet with institutional investors and discuss the companys regulatory and commercial achievements. The ProSense® system is marketed globally, focusing on breast, kidney, bone, and lung cancer.
FDA approved/pending approval
growth-positive
IceCure Receives FDA Marketing Authorization for ProSense® Cryoablation for the Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above
IceCure Medical Ltd. has received FDA marketing authorization for its ProSense® cryoablation system, marking a significant advancement in breast cancer treatment for women aged 70 and above with low-risk tumors. This minimally invasive procedure offers an alternative to traditional lumpectomy, providing safe and effective treatment with excellent cosmetic results. The FDAs approval is expected to drive demand, supported by an existing reimbursement code. IceCure plans a post-market surveillance study involving 400 patients across 30 sites to gather additional data. The company is poised to enhance womens cancer care and quality of life with this new treatment option.
FDA approved/pending approvalProduct StageCustomers
growth-positive
ProSense ® cryoablation offers the choice of a minimally invasive outpatient procedure that destroys tumors by freezing without surgical removal of breast...
IceCure Medical has received FDA marketing authorization for its ProSense® cryoablation system, a minimally invasive treatment for early-stage, low-risk breast cancer in women aged 70 and above. This marks the first FDA-approved medical device for local breast cancer treatment, offering an alternative to surgical tumor removal. The procedure is outpatient, quick, and maintains breast shape with minimal scarring. The FDAs approval is based on data from the ICE3 trial, which showed low recurrence rates. IceCure will conduct a post-market study to gather further data. This development is expected to enhance patient choice and satisfaction, positioning IceCure for growth.
FDA approved/pending approval
growth-positive
IceCure Medical's ProSense® Cryoablation Granted FDA Marketing Authorization for Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above: Significant Development in Giving Women with Breast Cancer Minimally Invasive Care
IceCure Medical Ltd. has received FDA marketing authorization for its ProSense® cryoablation system, a minimally invasive treatment for early-stage, low-risk breast cancer in women aged 70 and above. This marks the first new innovation in local breast cancer treatment in decades and offers an alternative to surgical tumor removal. The procedure is designed to destroy tumors by freezing, providing efficacy and safety comparable to lumpectomy, with excellent cosmetic results and patient satisfaction. The announcement, made on October 3, 2025, highlights the systems potential to treat an estimated 46,000 women annually in the U.S. IceCures CEO, Eyal Shamir, expressed excitement about offering this new treatment option.
FDA approved/pending approval
growth-positive
ProSense® is the first and only medical device to be granted FDA marketing authorization for the local treatment of breast cancer Major advancement and new...
IceCure Medical Ltd. has received FDA marketing authorization for its ProSense® cryoablation system, marking a significant advancement in breast cancer care. The system is approved for treating low-risk breast cancer in women aged 70 and above, offering a minimally invasive alternative to traditional surgery. The FDAs approval is expected to drive demand, supported by an existing reimbursement code and enthusiastic feedback from medical professionals. IceCure plans a post-market study to further validate the systems efficacy. The company is poised to expand its U.S. customer base, leveraging the FDA approval and reimbursement framework to enhance patient care and provider value.
FDA approved/pending approvalCustomersProduct Stage
growth-positive
IceCure's ProSense® at the European Society of Breast Imaging Congress 2025: Unlocking De-Escalation of Care in Breast Cancer, Positive Results from 5 Independent Studies Presented
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, showcased its ProSense® system at the European Society of Breast Imaging Congress 2025. The system, which offers a non-surgical alternative for early-stage breast cancer treatment, was well-received, with workshops filled to capacity. Several studies highlighted the effectiveness of cryoablation, showing promising results in tumor response and patient outcomes. The technology is already approved in the European Union, and its adoption is growing. The event emphasized the potential of cryoablation as a safe, effective, and cosmetically favorable option for breast cancer patients, particularly those unsuited for surgery.
Product StageCustomers
growth-positive
IceCure's exclusive workshop was filled to capacity – Unlocking De-Escalation of Care: Cryoablation for Breast Cancer led by Key Opinion Leaders Dr. Federica...
IceCure Medical, a developer of minimally-invasive cryoablation technology, showcased its ProSense® system at the European Society of Breast Imaging Congress 2025. The system, which offers a non-surgical option for early-stage breast cancer treatment, was well-received, with workshops filled to capacity. Several studies highlighted the efficacy of ProSense® in treating breast cancer, showing promising results in tumor response and cosmetic outcomes. The technology is already approved in the European Union, and its adoption is growing. The company aims to shift breast cancer treatment from radical surgery to more personalized, minimally invasive approaches.
Product StageCustomers
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd. showcased its ProSense® cryoablation technology at the CIRSE Annual Meeting in Barcelona, highlighting its application in treating breast cancer and endometriosis. The event featured presentations from key opinion leaders and hands-on training sessions, emphasizing ProSense® as a minimally invasive alternative to surgical tumor removal. The technology, which uses liquid nitrogen to freeze and destroy tumors, was demonstrated to be effective in various studies, including the PRECICE trial. The companys participation in the event and the positive reception of ProSense® suggest a growth-positive outlook, with increased interest from interventional radiologists and potential expansion in breast cancer care.
Product StageCustomersPartners
growth-positive
IceCure's ProSense® Featured at CIRSE 2025 Annual Meeting: Positive Clinical Results with Cryoablation from 4 Independent Studies Presented
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, showcased its ProSense® system at the CIRSE Annual Meeting in Barcelona. The event highlighted ProSense®s role in treating breast cancer, with presentations from key opinion leaders and hands-on training sessions for doctors. The system, which uses liquid nitrogen for cryoablation, is gaining interest among interventional radiologists. Dr. Franco Orsi delivered a lecture on the evolution of breast cancer treatment, emphasizing ProSense®s role in the PRECICE trial. The trial, sponsored by the Italian Ministry of Health, uses ProSense® to treat early-stage breast cancer patients.
growth-positive
IceCure Granted Notice of Allowance for U.S. Patent for its Next-Generation XSense™ Cryoprobes
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced the receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for its cryoprobe technology. The new cryoprobe, integrated into the XSense™ system, is designed to improve the extraction process during cryoablation procedures, reducing tissue trauma and enhancing patient experience. The technology has received regulatory approval in the U.S. and Israel. IceCures systems, including ProSense® and XSense™, offer a minimally invasive option for tumor destruction, utilizing liquid nitrogen to treat various types of tumors. This advancement is expected to enhance the companys market position and patient outcomes.
Product StageFDA approved/pending approval
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, has received regulatory approval for its XSense™ System with Cryoprobes in the U.S. and Israel. The company has also been granted a Notice of Allowance from the U.S. Patent and Trademark Office for its cryoprobe technology. This new technology aims to improve cryoprobe extraction, reducing tissue trauma and enhancing patient experience. IceCures systems, including the ProSense® and XSense™, offer a minimally invasive alternative to surgical tumor removal, focusing on breast, kidney, bone, and lung cancer. The approval and patent allowance are expected to positively impact the companys growth by expanding its market reach and enhancing its product offerings.
Product StageFDA approved/pending approval
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, has received regulatory approval from Israels Ministry of Health for its XSense™ System and CryoProbes. This approval extends to a broad range of indications, including gynecology, oncology, and general surgery. The system has also received FDA clearance in the U.S. for the same indications as its ProSense® system. IceCures technology offers a minimally invasive alternative to surgical tumor removal, with benefits such as reduced recovery time and treatment costs. The approval is expected to enhance the companys leadership in cryoablation technology and accelerate commercial adoption, particularly for breast cancer treatment.
FDA approved/pending approval
growth-positive
IceCure Receives Regulatory Approval in Israel for its Next-Generation XSense™ Cryoablation System for Breast Cancer and Other Indications
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced it has received regulatory approval from Israels Ministry of Health for its XSense™ System and CryoProbes. The system has also received FDA clearance in the United States for all indications previously approved for its ProSense® system. This approval reaffirms IceCures leadership in cryoablation technology, which offers a minimally invasive option for tumor destruction across various medical fields, including oncology and gynecology. The approval is expected to accelerate commercial adoption, particularly for breast cancer treatment, by providing a cost-effective and efficient alternative to traditional surgical methods.
FDA approved/pending approval
growth-positive
Two New Publications from the Independent THERMAC Trial Featuring IceCure's ProSense® in Breast Cancer Finds 95% of Patients Satisfied with Thermal Ablation; ProSense® Cryoablation Achieves Highest Complete Ablation Rate
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced positive results from two publications regarding their ProSense® cryoablation system for early-stage breast cancer. The studies, part of the THERMAC Trial in the Netherlands, demonstrated that ProSense® achieved superior cosmetic outcomes and patient satisfaction compared to alternative thermal ablation techniques. The trial, a phase II study, concluded that cryoablation is the preferred technique for comparison with surgery in a future phase III trial. ProSense® has regulatory approval for breast cancer in the European Union, and these findings further validate its clinical efficacy and safety. The research was led by Dr. Sophie Wooldrik and presented at various medical conferences.
Product StageFDA approved/pending approval
growth-positive
IceCure's ProSense® Substantially Reduces Abdominal Wall Endometriosis Pain with High Procedural Efficacy
IceCure Medical Ltd. announced positive results from an independent study on its ProSense® cryoablation technology, which is used to treat symptomatic abdominal wall endometriosis (AWE). The study, conducted at Nîmes University Hospital in France, demonstrated significant pain relief and excellent cosmetic outcomes for patients. ProSense® is FDA cleared and approved in the European Union for gynecological indications. The study highlights the potential of ProSense® as a minimally invasive alternative to traditional treatments like surgery and hormonal therapy. The findings support the commercial potential of ProSense® in multiple gynecological indications, enhancing IceCure Medicals market momentum.
Product Stage
growth-negative
IceCure Medical Second Quarter 2025 Earnings: EPS Beats Expectations, Revenues Lag
IceCure Medical reported a revenue of US$525.0k, which is a 48% decrease from the second quarter of 2024. The net loss widened by 9.2% to US$3.36 million, with a loss of US$0.057 per share. Revenue missed analyst estimates by 21%, but earnings per share exceeded estimates by 7.7%. Despite the current financial challenges, revenue is forecasted to grow by 51% annually over the next three years, significantly outpacing the 8.2% growth forecast for the US Medical Equipment industry. The companys shares have decreased by 5.3% over the past week. The article highlights risks associated with IceCure Medical, including four warning signs.
growth-negative
Icecure Medical Ltd (ICCM) (H1 2025) Earnings Call Highlights: Navigating Challenges and ...
Icecure Medical Ltd reported a decrease in revenue and gross profit for the first half of 2025 compared to the same period in 2024. Despite the financial challenges, the company successfully raised $10 million through a rights offering and $2.65 million via a market offering facility, indicating strong shareholder confidence. Icecure is optimistic about receiving FDA marketing authorization for its breast cancer treatment by the end of 2025 and is preparing for commercialization in North America. The company faces uncertainties related to the FDA-required post-market study and has experienced delays in product shipments due to the Israeli conflict.
InvestmentPIPE/POFDA approved/pending approvalExpand
growth-negative
IceCure Medical Ltd. (ICCM) Q2 Earnings Surpass Estimates
IceCure Medical Ltd. reported a quarterly earnings surprise of +200.00%, with earnings of $0.06 per share against the expected loss of $0.06 per share. However, the company missed revenue estimates, posting $0.53 million compared to the expected $0.81 million. Despite surpassing earnings estimates, the companys shares have declined by about 25.5% since the beginning of the year, underperforming the S&P 500s gain of 9.6%. The companys future stock performance will depend on managements commentary and earnings outlook. Currently, IceCure Medical holds a Zacks Rank #3 (Hold), indicating it is expected to perform in line with the market.
growth-positive
IceCure Reports Financial & Operational Results for the First Half of 2025
IceCure Medical Ltd., a developer of cryoablation technology, announced a $10 million rights offering to support its FDA marketing authorization for ProSense® in treating early-stage low-risk breast cancer in women aged 70+. The FDA has requested a Post-Market Study for additional data, and IceCure is optimistic about receiving approval by the end of 2025. The company is experiencing increased adoption of ProSense® in Europe, attributed to successful studies and growing evidence. The rights offering was oversubscribed, indicating strong shareholder support.
PIPE/POFDA approved/pending approval
growth-positive
When Will IceCure Medical Ltd (NASDAQ:ICCM) Turn A Profit?
IceCure Medical Ltd, a commercial stage medical device company, is on the verge of achieving profitability. The company, which specializes in cryoablation systems for tumor treatment, is projected to break even by 2027 with an anticipated profit of $3.9 million. Analysts predict an average annual growth rate of 59% for the company to reach this milestone. Notably, IceCure Medical operates without debt, relying solely on shareholder funding, which reduces investment risk. The company is currently in a growth phase, focusing on expanding its market presence in the United States, Japan, India, China, and Israel.
growth-negative
Viatris (VTRS) Tops Q2 Earnings and Revenue Estimates
Viatris reported quarterly earnings of $0.62 per share, surpassing the Zacks Consensus Estimate of $0.56 per share, marking a 10.71% earnings surprise. The company also reported revenues of $3.58 billion, exceeding the consensus estimate by 2.40%. Despite these positive earnings surprises, Viatris shares have declined by about 29.7% since the beginning of the year, underperforming the S&P 500s gain of 7.9%. The companys future stock performance will largely depend on managements commentary and future earnings expectations. Currently, Viatris holds a Zacks Rank #3 (Hold), indicating expected performance in line with the market.
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology for tumor destruction, announced it will release its financial and operational results for the first half of 2025 on August 13, 2025. The company will host a conference call to discuss these results and other corporate developments. IceCures ProSense® system, which uses liquid-nitrogen-based cryoablation therapy, is marketed globally for various cancer indications. The announcement includes forward-looking statements about the companys financial expectations, market strategies, and regulatory challenges. The company emphasizes its commitment to maintaining relationships with partners and protecting its intellectual property.
growth-positive
IceCure to Report First Half 2025 Financial and Operating Results on August 13, 2025
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced it will release its financial and operational results for the six months ending June 30, 2025, on August 13, 2025. The company will also host a conference call to discuss these results and other corporate developments. IceCures ProSense® system, which uses liquid-nitrogen-based cryoablation to destroy tumors, is marketed globally for various cancer indications. The press release includes forward-looking statements about the companys financial expectations and market strategies, emphasizing its commitment to advancing its technology and maintaining partnerships.
growth-positive
IceCure Announces Expiration and Results of Approximately Two Times Over-Subscribed Rights Offering for Aggregate Gross Proceeds of $10.0 Million
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology, announced the expiration of its rights offering subscription period on July 28, 2025. The company offered non-transferable subscription rights to its shareholders to purchase up to 10,000,000 units at a subscription price of $1.00 per unit. Each unit includes one ordinary share and a warrant to purchase an additional share. The rights offering was fully subscribed, with a total of 4,627,771 units expected to be issued through over-subscription privileges. The company plans to deliver the shares and warrants to the respective holders by July 30, 2025.
PIPE/PO
growth-positive
IceCure's ProSense® Featured at Japanese Breast Cancer Society Conference: Updated Positive Clinical Data Shows 99% Recurrence Free Rate with Cryoablation
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, participated in the 33rd Annual Meeting of the Japanese Breast Cancer Societys Conference. The company presented data from its ICE3 study and independent studies, highlighting the effectiveness of its ProSense® technology in treating breast cancer. The conference, held in Tokyo, featured presentations by leading breast surgeons and experts, including Professor Eisuke Fukuma and Dr. Richard Fine. IceCure is working with Terumo Corporation, Japans largest medical device company, to anticipate strong commercial adoption upon regulatory approval. The studies presented demonstrated a high recurrence-free rate, showcasing the potential of cryoablation as an alternative to surgical tumor removal.
Product StagePartners
growth-positive
IceCure Reminds Shareholders of Upcoming Expiration of Rights Offering Subscription Period
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology for tumor destruction, has announced the expiration of its rights offering on July 28, 2025. The rights offering allows holders of the companys ordinary shares as of July 9, 2025, to purchase up to 10,000,000 units at a subscription price of $1.00 per unit. Broadridge Corporate Issuer Solutions, LLC is managing the subscription process. This initiative is part of IceCures strategy to raise funds and potentially expand its operations, indicating a growth-positive impact on the company.
PIPE/PO
growth-positive
IceCure Announces Commencement of Rights Offering
IceCure Medical Ltd. has announced the commencement of a rights offering, distributing non-transferable subscription rights to its shareholders to purchase up to 10,000,000 units at a price of $1.00 per unit. The rights offering is expected to raise $10 million in gross proceeds if fully subscribed. Epoch Partner Investments Limited, IceCures largest shareholder, has committed to fully participate in the offering and may purchase additional units not subscribed by other shareholders. The proceeds will be used to repay a $2 million bridge loan from Epoch and for general corporate purposes. The rights offering will expire on July 28, 2025, unless extended.
PIPE/PO
growth-negative
IceCure Reports Preliminary Financial Results for the Three and Six Months Ended June 30, 2025
IceCure Medical Ltd., a developer of cryoablation technology, announced preliminary financial results for the first half of 2025. The company reported product sales of approximately $525,000 for Q2 2025, with total sales for the first half of the year at $1.25 million, down from $1.65 million in the same period in 2024. The decline was attributed to shipment delays caused by geopolitical tensions, although these have since been resolved. Payments for delayed shipments were received and recorded as deferred sales. The U.S. market remained unaffected due to sufficient inventory. IceCure plans to release comprehensive financial results in August 2025.
Customers
growth-positive
IceCure Medical (NASDAQ:ICCM) shareholders have earned a 51% CAGR over the last five years
IceCure Medical Ltd has experienced significant share price growth, with a 677% increase over the past five years, despite a decline in revenue by about 0.9% per year. This growth is indicative of strong market excitement and investor confidence, even as the company remains unprofitable. The companys total shareholder return over the past year was 36%, although this is lower than the 51% annual return over five years. The article suggests that while market conditions have influenced the share price, other factors such as revenue growth and potential future profitability are crucial for investors to consider.
growth-positive
IceCure Medical's Board Approves $10 Million Rights Offering
IceCure Medical announced that its board has approved a $10 million rights offering to all shareholders. This move is aimed at raising additional capital to support the companys growth and expansion plans. The rights offering allows existing shareholders to purchase additional shares at a discounted price, providing them with an opportunity to increase their investment in the company. This strategic decision is expected to bolster IceCure Medicals financial position and enable it to further develop its medical technologies. The announcement reflects a positive outlook for the companys future growth and expansion.
Investment
growth-positive
IceCure Announces Record Date for Rights Offering for Up to $10 Million
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced a rights offering to its shareholders. The offering allows shareholders to subscribe for units comprising ordinary shares and warrants. Epoch Partner Investments Limited, the companys largest shareholder, has committed to participate fully in the offering, potentially raising up to $10 million. The proceeds will be used to repay a bridge loan and for general corporate purposes. The rights offering is expected to strengthen IceCures financial position and support its commercial plans, including the expansion of its ProSense cryoablation system. The offering is contingent on the effectiveness of a registration statement filed with the SEC.
PIPE/PO
growth-positive
IceCure Announces Record Date for Rights Offering for Up to $10 Million
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced a rights offering to its shareholders, allowing them to subscribe for units comprising ordinary shares and warrants. The rights offering is expected to raise $10 million if fully subscribed, with Epoch Partner Investments Limited, the companys largest shareholder, committing to participate fully. The proceeds will be used to repay a $2 million bridge loan from Epoch and for general corporate purposes. The rights offering will expire on July 28, 2025, unless extended. This financial maneuver is seen as growth-positive for IceCure Medical, providing necessary capital for its operations.
PIPE/PO
Not specified
Sector Update: Health Care Stocks Softer Wednesday Afternoon
The article mentions that healthcare stocks were decreasing on a Wednesday afternoon, with the NYSE Health Care Index down by 0.3%. The article is part of a premium service offered by MT Newswires, which requires a Silver or Gold subscription plan to access. No specific company details, partnerships, or investment information are provided in the text.
growth-positive
IceCure Receives Notice of Patent Allowance in U.S. for a Novel Cryogen Flow Control to Optimize Patient Outcomes
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced the receipt of a Notice of Allowance from the United States Patent and Trademark Office for its Cryogen Flow Control patent application. This patent, once granted, will be effective until 2045 and aims to enhance the efficiency of cryoablation procedures. IceCure is awaiting FDA marketing approval for its ProSense® Cryoablation System, which targets early-stage breast cancer in women aged 70 and over. The ProSense® system offers a minimally invasive treatment option by freezing tumors, providing benefits such as accelerated recovery and reduced surgical risks. The company is expanding its intellectual property assets to strengthen its position in the cryoablation market.
Product StageFDA approved/pending approval
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical, a company specializing in minimally-invasive cryoablation technology, has received a Notice of Allowance from the U.S. Patent and Trademark Office for its Cryogen Flow Control patent application. This patent, once granted, will be effective until 2045 and is expected to enhance the efficiency of cryoablation procedures. IceCure is awaiting FDA marketing approval for its ProSense® system in early-stage breast cancer treatment. The company is recognized as a leader in liquid nitrogen-based cryoablation technology, offering a minimally invasive alternative to surgical tumor removal. The ProSense® system is already marketed globally for various indications, including breast, kidney, lung, and liver tumors.
Product Stage
growth-positive
Icecure Medical Ltd (ICCM) Q1 2025 Earnings Call Highlights: Strategic Advances and Market ...
Icecure Medical Ltd has submitted a postmarket study plan to the FDA, marking a significant step towards obtaining marketing authorization for its cryoablation technology. The company saw sales growth in North America and Europe, but faced declines in Asia. Despite a slight decrease in quarterly revenue and gross profit, Icecure received a $2 million loan from its largest shareholder, indicating confidence in its technology. The company is optimistic about FDA approval, which would enable commercial sales and reimbursement under a CPT code. The postmarket study will involve 400 patients across 25 sites, with recruitment expected to complete in three years.
Product StageInvestment
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a developer of cryoablation technology, is awaiting FDA marketing authorization for its ProSense® system for treating early-stage low-risk breast cancer in women aged 70 and over. The company has submitted a post-market study plan to the FDA and expects a decision soon. IceCure is experiencing increased interest in North America, with sales of ProSense® growing year-over-year. The company received a $2 million unsecured loan from its largest investor, Li Haixiang, indicating confidence in its technology. IceCure is also pursuing regulatory approvals in Japan and Israel and anticipates further data publications and presentations. Financial results show a slight decrease in revenue and gross profit, but the company remains optimistic about future growth.
Product StageInvestmentPartners
growth-positive
IceCure Medical Reports First Quarter 2025 Financial Results
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, has submitted a post-market study plan to the FDA for its ProSense® device, aimed at treating early-stage low-risk breast cancer in women aged 70 and over. The company is optimistic about receiving marketing authorization from the FDA, which would allow them to address a significant patient population in the U.S. IceCure has reported increased sales in North America and received a $2 million unsecured loan from its largest investor, Li Haixiang, indicating confidence in their technology. Additionally, IceCures partner in Japan, Terumo Corporation, plans to seek regulatory approval for ProSense® in Japan later in 2025.
Product StageInvestmentPartners
growth-positive
IceCure to Report First Quarter 2025 Financial & Operational Results on May 28, 2025
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology for tumor destruction, announced it will release its financial and operational results for the first quarter of 2025 on May 28, 2025. The company will also host a conference call to discuss these results and other corporate developments. IceCures ProSense® system, which uses liquid-nitrogen-based cryoablation therapy, is marketed globally for various cancer indications. The technology offers a safe and effective alternative to traditional surgical tumor removal. The announcement suggests a positive outlook for the company as it continues to expand its market presence.
growth-positive
Natera (NTRA) Reports Q1 Loss, Tops Revenue Estimates
Natera reported a quarterly loss of $0.50 per share, surpassing the Zacks Consensus Estimate of a $0.59 loss, marking a 15.25% earnings surprise. The companys revenue for the quarter was $501.83 million, exceeding expectations by 13.19%. Over the last four quarters, Natera has consistently surpassed consensus EPS and revenue estimates. The companys stock has risen by about 1.1% since the start of the year, outperforming the S&P 500s decline of -4.3%. The future stock performance will depend on managements commentary and earnings outlook. Currently, Natera holds a Zacks Rank #3 (Hold), indicating expected market-aligned performance.
growth-positive
IceCure Receives High Level of Interest from Breast Surgeons at ASBrS 2025 Annual Meeting Following Recent Positive FDA Development on ProSense® Cryoablation
IceCure Medical Ltd., a developer of cryoablation technology, showcased its ProSense® system at the ASBrS 2025 Annual Meeting. The company received significant interest from breast surgeons for its minimally-invasive tumor freezing technology, particularly following a positive FDA development regarding its marketing authorization. The ProSense® system was highlighted in key presentations, including the ASBrS Presidential Address, emphasizing its potential as an alternative to surgical tumor removal for early-stage breast cancer. IceCures participation included demonstrations, training sessions, and expert discussions, underscoring the growing recognition of cryoablation as a viable treatment option.
Product Stage
growth-positive
IceCure Announces Positive FDA Development: Understanding on Path Forward for Marketing Authorization of ProSense® Cryoablation in Women 70+ with Early-Stage Breast Cancer
IceCure Medical Ltd. is advancing its ProSense® cryoablation technology for early-stage breast cancer treatment. The company recently held a productive meeting with the FDAs Center for Devices and Radiological Health regarding its De Novo marketing authorization request. The FDA has requested a post-market study involving at least 400 patients across 25 sites, which IceCure is preparing to submit. This development is seen as a positive step towards offering a minimally invasive alternative to lumpectomy for women aged 70 and over. IceCure plans to engage with clinical sites and medical professionals, including at the upcoming American Society of Breast Surgeons Annual Meeting, to support the study and market adoption.
Product StageCustomers
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical, a developer of minimally-invasive cryoablation technology, participated in the Society of Breast Imaging (SBI) 2025 Breast Imaging Symposium. The company sponsored sold-out courses on breast cryoablation using its ProSense® system, highlighting its growing adoption among radiologists. IceCures ProSense® system offers a non-surgical alternative for tumor removal by freezing, and it is marketed globally for various cancer types. The event featured Dr. Robert C. Ward, who discussed the clinical data supporting cryoablation. IceCure aims for regulatory clearance for breast cancer treatment in the U.S., aligning with SBIs mission of early detection and treatment. The companys participation in the symposium is seen as a positive step towards expanding its customer base and increasing awareness of its technology.
Product StageCustomers
growth-positive
IceCure Exhibits ProSense® & Sponsors Breast Cryoablation Courses at the Society of Breast Imaging Symposium
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, participated in the Society of Breast Imaging (SBI) 2025 Breast Imaging Symposium. The company sponsored sold-out courses on breast cryoablation using its ProSense® technology, indicating growing interest among radiologists. IceCure hosted a VIP Exhibitor Hour featuring Dr. Robert Ward, a specialist in breast imaging, to discuss the techniques and clinical data supporting cryoablation. The event aligns with IceCures mission to promote early detection and treatment of breast cancer. The company is looking forward to potential regulatory clearance for its technology in the U.S.
Product StageCustomers
growth-positive
IceCure's ProSense® Featured at European Conference on Interventional Oncology with an Emphasis on Breast Cancer Cryoablation
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, participated in the European Conference on Interventional Oncology 2025 (ECIO) in Rotterdam. The companys ProSense® system was prominently featured in several sessions, highlighting its effectiveness in treating early-stage breast cancer. Independent studies, including the THERMAC trial, demonstrated high patient satisfaction and preference for cryoablation over traditional surgery. The event underscored the growing adoption of cryoablation as a preferred treatment method in Europe. IceCures CEO, Eyal Shamir, emphasized the systems leading position in the market, reflecting its commercial success and potential for further growth.
Product StageCustomers
growth-positive
Breast cancer cryoablation was a major focus at ECIO 2025 with a dedicated scientific session Independent studies of ProSense® featured in scientific sessions...
IceCure Medical participated in the European Conference on Interventional Oncology 2025, showcasing its ProSense® cryoablation system for breast cancer treatment. The system was featured in multiple scientific sessions, highlighting its efficacy and safety. Studies presented at the conference showed high patient satisfaction and effectiveness in tumor size reduction, especially when combined with hormonal therapy. The ProSense® system offers a minimally invasive alternative to traditional surgical methods, enhancing recovery and reducing complications. IceCure Medical aims for continued commercial adoption of ProSense® in Europe and globally, positioning it as a leading cryoablation system for early-stage breast cancer.
Product Stage
growth-negative
IceCure Medical Full Year 2024 Earnings: Misses Expectations
IceCure Medical reported a revenue of US$3.29 million, which is a 1.9% increase from FY 2023. However, the company experienced a net loss of US$15.3 million, widening by 4.5% from the previous fiscal year. The earnings per share (EPS) missed analyst estimates by 5.9%, and revenue missed estimates by 5.7%. Despite the current financial challenges, revenue is forecasted to grow 45% annually over the next three years, significantly outpacing the 7.8% growth forecast for the US Medical Equipment industry. The companys shares have decreased by 12% over the past week.
growth-positive
IceCure Medical Stock Dips Despite Positive ICESECRET Study Results
IceCure Medical presented interim results from its ICESECRET kidney cancer cryoablation study, showing an 88.7% recurrence-free rate. This promising data reinforces the potential of its minimally invasive technology as an alternative to traditional treatments. Despite a recent 11.2% drop in share price, the companys stock has surged 81.2% over the past six months. The studys positive results could lead to increased adoption, regulatory approvals, and potential partnerships, boosting long-term stock value. IceCures market capitalization is $63.3 million, with expected earnings growth of 10.7% in 2025. The ongoing clinical trial evaluates the efficacy and safety of cryoablation for treating small renal masses, demonstrating it as a viable alternative to surgical resection.
Product StagePublic Trading
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, reported positive financial results for 2024, with increased sales of its ProSense® system. The company is awaiting FDA marketing authorization for ProSense® in early-stage low-risk breast cancer, which could boost adoption in the U.S. and globally. IceCures partner, Terumo Corporation, is expected to file for regulatory approval in Japan. The company raised $2.6 million in early 2025 through an at-the-market offering. IceCures technology offers a minimally invasive alternative to surgical tumor removal, with applications in breast, kidney, lung, and liver cancers.
Product StageCustomersPartnersInvestment
growth-positive
IceCure Medical Reports 2024 Financial Results: 42% Growth in ProSense® Cryoablation Sales in North America
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, is awaiting a decision from the FDA regarding its De Novo marketing authorization request for ProSense® in early-stage low-risk breast cancer with endocrine therapy. Positive results for ProSense® have been reported in 33 peer-reviewed journals and medical conferences throughout 2024. The company has experienced sales momentum in North America, Europe, and Japan, indicating potential for higher adoption if FDA approval is granted. IceCures partner in Japan, Terumo Corporation, is expected to file for regulatory approval of ProSense® for breast cancer in Japan. Additionally, regulatory approval is anticipated for the next-generation XSense™ in Israel, with further data expected to be published in 2025.
Product StageCustomersPartners
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical announced interim results from its ICESECRET study, demonstrating the effectiveness of its ProSense® cryoablation system for treating small renal masses in patients ineligible for surgery. The study, presented at the European Association of Urology Conference, showed high recurrence-free rates and a favorable safety profile. ProSense® is approved for use in the U.S., Europe, and other countries for treating benign and malignant kidney tumors. The ICESECRET trial involves 114 patients and is conducted in Israel. IceCures technology offers a minimally invasive alternative to surgical tumor removal, focusing on breast, kidney, bone, and lung cancers. The positive data supports the adoption of cryoablation as a viable treatment option.
Product StageFDA approved/pending approval
growth-positive
IceCure's ICESECRET Kidney Cancer Cryoablation Study Interim Results Presented at European Association of Urology Conference in Spain: 88.7% Recurrence-Free Rate
IceCure Medical Ltd. announced interim results from its ICESECRET study, which were presented at the European Association of Urology Conference. The study focuses on the effectiveness and safety of ProSense® cryoablation technology for treating small renal masses in patients ineligible for surgery. The results showed a high recurrence-free rate and minimal adverse events, supporting cryoablation as a viable alternative to surgical tumor removal. The study is ongoing, with follow-ups planned for up to five years. ProSense® is approved for use in the U.S., Europe, and other countries, indicating a positive impact on IceCures growth.
Product Stage
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology for tumor destruction, announced it will release its financial and operational results for the year ending December 31, 2024, on March 27, 2025. The company will hold a conference call on the same day to discuss these results and other corporate developments. IceCures ProSense® system, which uses liquid-nitrogen-based cryoablation therapy, is marketed globally for various cancer indications. This announcement is seen as growth-positive, reflecting the companys ongoing commitment to transparency and innovation in tumor treatment.
growth-positive
IceCure Medical to Report 2024 Full Year Financial & Operational Results on March 27, 2025
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology for tumor destruction, announced it will release its financial and operational results for the year ending December 31, 2024. The announcement will be made before the Nasdaq Stock Market opens on March 27, 2025. The company will also host a conference call to discuss these results and other corporate developments. IceCures ProSense® system, which uses liquid-nitrogen-based cryoablation therapy, is marketed globally for various cancer indications. This technology offers a safe and effective alternative to traditional surgical tumor removal.
growth-positive
IceCure Reports Updated Timeline and Progress with FDA Regarding Marketing Authorization for ProSense® Cryoablation in Early-Stage Breast Cancer
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, is in discussions with the FDA regarding its De Novo marketing authorization request for its ProSense® system. This system is designed for treating early-stage, low-risk breast cancer with endocrine therapy. The FDAs decision is expected after the first quarter of 2025. The FDA convened a Medical Device Advisory Committee Panel in November 2024, which voted in favor of ProSense®s benefit-risk profile. IceCures technology offers a safe alternative to surgical tumor removal and is marketed globally for approved indications. The company is focused on expanding its market presence and securing FDA approval for broader use.
Product Stage
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology for tumor destruction, is in ongoing discussions with the FDA regarding its De Novo marketing authorization request for its ProSense® system. This system is intended for early-stage low-risk breast cancer treatment with endocrine therapy. The FDAs decision is expected after the first quarter of 2025. An Advisory Panel convened by the FDA in November 2024 voted in favor of ProSense®s benefit-risk profile. IceCures technology offers a safe alternative to surgical tumor removal and is marketed globally. The company is working closely with the FDA, highlighting the public health importance of breast cancer.
FDA approved/pending approval
growth-positive
IceCure's ProSense® Cryoablation Featured in Six Studies Presented at St. Gallen International Breast Cancer Conference
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, showcased its ProSense® system at the 19th Annual St. Gallen Breast Cancer Conference in Vienna. The company presented six studies on ProSense®, which were accepted as peer-reviewed abstracts and will be published in The Breast journal. The studies highlighted the efficacy and safety of cryoablation as an alternative to surgical tumor removal in breast cancer treatment. The ICE3 trial demonstrated comparable recurrence rates to lumpectomy, while other studies explored expanding cryoablation to different breast cancer subtypes and patient demographics. The conference increased interest in IceCures technology, indicating a positive growth trajectory for the company.
Product StageCustomers
/PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
growth-positive
IceCure Receives Notice of Allowance in China for Novel Cryogenic Pump for Next-Generation Cryoablation Technology
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced a significant intellectual property win with the receipt of a Notice of Allowance for its Cryogenic System Connector from the China National Intellectual Property Administration. This development enhances IceCures market presence by enabling the introduction of a new generation of cryoablation systems with improved features, such as a smaller footprint and broader clinical applications. The companys cryogenic pump, which is submersible in liquid nitrogen and works in a closed circuit, is designed for multiple procedures without needing LN2 refills. IceCures CEO, Eyal Shamir, emphasized the companys leadership in LN2-based cryoablation, supported by over 50 patents and growing regulatory approvals. The companys flagship ProSense® system is marketed globally, including in the U.S., Europe, and China.
Product StageFDA approved/pending approval
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
Independent study published in Gland Surgery and conducted at Kameda Medical Center in Japan by ProSense® users including Dr. Kizuki Matsumoto and Dr. Eisuke...
growth-positive
Breast Cancer Patients who Underwent IceCure's ProSense® Cryoablation in Japan Reported Significantly Higher Satisfaction than Patients who Underwent Standard of Care Surgery
IceCure Medical Ltd. announced the publication of an independent study in Gland Surgery, conducted at Kameda Medical Center in Japan, comparing patient satisfaction between cryoablation and breast-conserving therapy (BCT) for early-stage breast cancer. The study found that patients who underwent cryoablation reported significantly higher satisfaction than those who received BCT. This supports the trend towards non-surgical options for breast cancer treatment. IceCures CEO, Eyal Shamir, expressed optimism that these results will aid their partner, Terumo Corporation, in obtaining regulatory approval for ProSense® in Japan. The study highlights the importance of quality of life in breast cancer treatment.
Product StagePartners
growth-positive
IceCure seeks Israeli regulatory approval for XSense cryoablation system
IceCure Medical has submitted a request to Israel’s Ministry of Health’s Medical Device Division (AMAR) for approval of its XSense cryoablation system and cryoprobes. The system has already received marketing authorization from the US FDA. The company aims to expand the indications for its XSense system, which is already approved for use in dermatology, neurology, urology, and proctology. IceCures CEO, Eyal Shamir, expressed optimism about receiving regulatory clearance in Israel soon. The company also secured a European Patent Office’s Intention to Grant Notice for its cryogenic system connector and submitted a regulatory application in China for its ProSense system. IceCures technology focuses on minimally invasive tumor removal, targeting breast, bone, lung, and kidney cancers.
FDA approvedProduct StageCustomers
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
growth-positive
IceCure Submits Filing for Regulatory Approval of its Next-Generation XSense™ Cryoablation System in Israel
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, has filed for regulatory approval with Israels Ministry of Health for its next-generation XSense™ System and CryoProbes. The company has already received FDA approval for these products in the U.S. IceCures technology offers a minimally invasive alternative to surgical tumor removal, aligning with global trends towards less invasive procedures. The company is optimistic about receiving regulatory clearance in Israel soon. IceCures ProSense® system is already marketed globally, and the company is poised to benefit from the growing minimally invasive surgery market, projected to reach $174 billion by 2029.
FDA approved/pending approval
growth-positive
IceCure Medical Ltd's (NASDAQ:ICCM) Profit Outlook
IceCure Medical Ltd, a commercial stage medical device company, is on the verge of reaching a significant milestone as it approaches breakeven. The company, which specializes in cryoablation systems for tumor treatment, has reduced its losses from $15 million to $14 million. Analysts predict that IceCure will become profitable by 2027, with an expected profit of $12 million. The company is currently operating without debt, relying solely on shareholder funding, which reduces investment risk. Analysts estimate an average annual growth rate of 51% is needed for the company to achieve profitability within the next two years. This high growth rate reflects strong confidence in the companys future prospects.
growth-positive
IceCure's ProSense® in the Spotlight at Society of Interventional Oncology (SIO) Annual Meeting: Award Winning Abstract and Hands-On Training for Breast Cryoablation as Medical Community Anticipates FDA's Market Authorization Decision
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, participated in the 2025 Society of Interventional Oncology Annual Meeting, showcasing its ProSense® system for breast cancer treatment. Two independent studies on ProSense® were presented, one receiving the Highest Scoring Abstract Award. The studies demonstrated ProSense®s safety and efficacy, supporting its potential for a Phase 3 trial. IceCure sponsored a Breast Cryoablation Mini Masterclass, highlighting the growing interest in cryoablation among medical professionals. The company anticipates the FDAs decision on ProSense® market authorization for early-stage breast cancer in Q1 2025, which could significantly impact its adoption in the U.S.
Product Stage
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a developer of cryoablation technology, showcased its ProSense® system at the Society of Interventional Oncology Annual Meeting. The system, which uses liquid nitrogen to destroy tumors, is under review for FDA market authorization for early-stage breast cancer, with a decision expected in Q1 2025. Two independent studies highlighted ProSense®s efficacy and safety, with one study winning an award. The company is optimistic about increased adoption of its technology, especially in breast cryoablation, as awareness grows among medical professionals. IceCures technology offers a minimally invasive alternative to surgical tumor removal, with applications in breast, kidney, lung, and liver cancers.
Product StageFDA approved/pending approval
growth-positive
IceCure submits application to China’s NMPA for cryoablation system approval
IceCure Medical has submitted a regulatory filing to Chinas National Medical Products Administration (NMPA) for the approval of its ProSense cryoablation system. This system is designed for minimally invasive tumour destruction and is an expansion of IceCures offerings in China. The ProSense system, which uses liquid nitrogen to destroy benign and malignant lesions, is already marketed globally with approvals in Europe, China, and the US. The company aims to secure reimbursement and expand its product line in China, a potentially large market for cryoablation. The systems design simplifies surgical processes and reduces recovery times.
Product Stage
growth-positive
IceCure Files for Regulatory Approval of ProSense® Cryoablation System in China
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, has submitted a regulatory filing with Chinas National Medical Products Administration for the approval of its ProSense® Cryoablation System. The system is designed to destroy tumors by freezing and is already approved in China in its predecessor form, IceSense3. The ProSense® system aims to expand its use in various surgical fields, including oncology and urology, with enhanced features such as different cryoprobes and introducers. The company sees China as a significant market and is working on securing reimbursement to better serve this region. IceCures technology offers a safe alternative to surgical tumor removal, with applications in breast, kidney, lung, and liver tumors.
Product Stage
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ('IceCure', 'IceCure Medical' or the 'Company'), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd. has reported significant growth in sales of its ProSense® cryoablation system, particularly in North America, and anticipates further expansion pending FDA market authorization for early-stage breast cancer in 2025. The FDA Advisory Panel has already voted positively on ProSense®s benefit-risk profile. The company completed its ICE3 study with favorable results, showing high patient satisfaction and a 96.3% recurrence-free rate. IceCure has also expanded its Board of Directors, adding Vic Lee from VI Asset Management. The company is preparing for increased market penetration and regulatory submissions in Japan and China. IceCures financials show a rise in revenue to $3.29 million for 2024, with a cash balance of $7.5 million.
CustomersPartnersManagement ChangesExpand
growth-positive
IceCure Medical CEO Issues Letter to Shareholders & Reports Increase of 42% in ProSense® Sales for 2024 in North America
IceCure Medical Ltd. has reported an increase in sales of its ProSense® cryoablation technology, indicating growing adoption for treating breast tumors. The company is anticipating a decision from the FDA on market authorization for early-stage breast cancer in the first quarter of 2025. The FDA Advisory Panel has already voted positively on ProSense®s benefit-risk profile. IceCure completed its 10-year ICE3 study with excellent results and is preparing for substantial market opportunities in 2025. The company has expanded its Board of Directors to include Vic Lee, Chairman of VI Asset Management, who invests in medical technologies. This expansion is seen as a strategic move to leverage IceCures potential in minimally-invasive procedures.
CustomersManagement Changes
growth-positive
The five-year returns have been enviable for IceCure Medical (NASDAQ:ICCM) shareholders despite underlying losses increasing
IceCure Medical Ltd has seen a significant increase in its stock price, with a 491% rise over the last five years and a 134% increase in the last quarter. Despite not making a profit in the last twelve months, the company has achieved a revenue growth rate of 5.2% per year over the past half-decade. Shareholders have enjoyed an annual total shareholder return (TSR) of 43% over five years, indicating positive market reception and potential for future growth. The article suggests that while the companys growth rate isnt exceptionally high, market enthusiasm remains strong, possibly due to anticipated faster growth.
growth-positive
IceCure Medical Regains Full Nasdaq Compliance with Nasdaq Minimum Closing Bid Price Rule
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced it has regained compliance with Nasdaqs minimum bid price requirement. This compliance allows IceCure to continue its listing on the Nasdaq Capital Market. The companys technology, which focuses on freezing tumors as an alternative to surgical removal, is marketed globally, including in the U.S., Europe, and China. The announcement is a positive development for IceCure, as it ensures continued access to capital markets and investor confidence. The company remains committed to advancing its cryoablation therapy systems, which are used for treating various cancers. The press release also includes forward-looking statements about the companys future plans and potential risks.
Public Trading
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced that it has regained compliance with Nasdaqs minimum bid price requirement. The companys shares maintained a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, allowing it to meet Nasdaqs listing requirements. IceCure Medicals ProSense® system, which uses liquid-nitrogen-based cryoablation therapy for tumor treatment, is marketed globally, including in the U.S., Europe, and China. The company focuses on treating breast, kidney, bone, and lung cancer with its technology, offering a safe alternative to surgical tumor removal. The announcement is seen as growth-positive, ensuring continued trading on the Nasdaq Capital Market.
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced receiving an Intention to Grant Notice from the European Patent Office for its Cryogenic System Connector. This patent, already granted in the U.S., is expected to enhance the companys intellectual property assets and support market adoption of its ProSense® system. IceCures technology, which has FDA clearance, offers a safe alternative to surgical tumor removal and is marketed globally. The company is experiencing growth in Europe, with key distributors and ongoing clinical studies. The tumor ablation market is estimated at $1.67 billion in 2023.
Product StageFDA approvedPartners
growth-positive
European Patent Office Issues Intention to Grant Notice to IceCure for its Next-Generation Cryoablation Technology
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced receiving an Intention to Grant Notice from the European Patent Office for its Cryogenic System Connector. This follows a recent patent grant in the United States. The company is experiencing growth in its intellectual property assets, reinforcing its leadership in the cryoablation market. IceCures technology, including the XSense™ system and ProSense® system, is used globally for tumor ablation, offering a safe alternative to surgical tumor removal. The European market is significant for IceCure, with key distributors and ongoing clinical studies. The patent is expected to support market adoption and address unmet needs in the tumor ablation market, valued at $1.67 billion in 2023.
growth-positive
Data on IceCure's ProSense® Cryoablation for Low-Risk Breast Cancer Presented at Radiological Society of North America's 2024 Annual Meeting
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, presented the results of its ICE3 trial at the Radiological Society of North Americas 2024 Annual Meeting. The trial focused on ProSense® cryoablation as a primary treatment for early-stage low-risk breast cancer. The results showed a five-year recurrence rate comparable to surgical lumpectomy, with substantial benefits such as outpatient performance, minor adverse events, and high patient satisfaction. These findings support the shift towards less invasive breast cancer care and are crucial for market adoption ahead of the FDAs expected marketing authorization decision in Q1 2025. The FDA Advisory Panel has already voted in favor of ProSense®s benefit-risk profile.
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a company specializing in cryoablation technology, presented promising results from its ICE3 trial at the Radiological Society of North Americas 2024 Annual Meeting. The trial demonstrated that ProSense® cryoablation is a safe and effective alternative to surgical lumpectomy for early-stage low-risk breast cancer. The FDA Advisory Panel has voted in favor of the benefit-risk profile of ProSense®, with a marketing authorization decision expected in Q1 2025. The ICE3 trial results show a low recurrence rate and high patient satisfaction, supporting the potential market adoption of this minimally invasive procedure. The companys technology offers significant benefits, including outpatient treatment, minimal adverse events, and excellent cosmetic outcomes.
growth-positive
IceCure's ProSense® Cryoablation Safe and Effective in Destruction of Kidney Tumors with 88.7% Recurrence-Free Rate Based on Interim ICESECRET Study Results
IceCure Medical Ltd., a company specializing in cryoablation technology, presented interim results from its ICESECRET study at the Israeli Urological Association Conference on December 5, 2024. The study focuses on the effectiveness of ProSense® cryoablation for patients with small renal masses who are ineligible for kidney-preserving surgery. The results showed a high success rate, with no tumor recurrence in 82% of patients and a success rate of 88.7% in patients with tumors smaller than 3 cm. The procedure demonstrated high efficacy and safety, with minimal adverse events and preserved renal function. These findings support ProSense® as a viable alternative to surgical tumor removal, particularly in key markets like the U.S. and Europe.
growth-positive
IceCure Medical Third Quarter 2024 Earnings: EPS Beats Expectations, Revenues Lag
IceCure Medical reported a significant increase in revenue, up 102% from the previous quarter, reaching US$662.0k. Despite this growth, the company experienced a net loss of US$4.15m, which widened by 3.7% from the previous quarter. The earnings per share (EPS) exceeded analyst estimates, although revenue fell short by 6.6%. Looking forward, IceCure Medicals revenue is projected to grow at an average rate of 58% annually over the next three years, significantly outpacing the US Medical Equipment industrys forecasted growth of 8.2%. The companys shares have risen by 29% over the past week. However, there are four warning signs that investors should consider. The article provides a general analysis based on historical data and forecasts, without offering specific financial advice.
growth-negative
IceCure Medical Ltd. (ICCM) Reports Q3 Loss, Misses Revenue Estimates
IceCure Medical Ltd. reported a quarterly loss of $0.08 per share, which was below the Zacks Consensus Estimate of a $0.07 loss, marking a negative earnings surprise of -14.29%. The companys revenue for the quarter was $0.66 million, missing the consensus estimate by 5.43%, though it showed growth compared to the previous years $0.33 million. IceCure Medicals shares have declined by about 27.4% since the start of the year, underperforming the S&P 500s gain of 25.5%. The companys earnings outlook remains mixed, with a Zacks Rank of #3 (Hold), indicating expected performance in line with the market. The future stock movement will depend on managements commentary and changes in earnings estimates.
growth-positive
IceCure Medical Reports 36% Sales Growth in the First Nine Months of 2024 Driven by Global Adoption of ProSense® Cryoablation
IceCure Medical Ltd., a developer of cryoablation technology, reported a 36% increase in sales and a 41% rise in gross profits for the first nine months of 2024. The FDAs Advisory Panel voted in favor of the benefit-risk profile of IceCures ProSense® system for early-stage low-risk breast cancer. The FDAs final decision on marketing authorization is expected in Q1 2025. IceCures partner, Terumo Corporation, plans to seek regulatory approval for ProSense® in Japan in 2025. The company anticipates further data publication and conference presentations in 2025, marking a transformative year for IceCure.
CustomersPartners
growth-positive
IceCure's Next-Generation Multiprobe Cryoablation Technology Issued Notice of Allowance from Japan's Patent Office
IceCure Medical Ltd., a developer of cryoablation technology, announced receiving a Notice of Allowance from the Japan Patent Office for its new cryogenic system featuring multiple submerged pumps. This innovation is a significant advancement in treating larger tumors and enhances IceCures intellectual property portfolio. The company is active in Japan through its partner, Terumo Corporation, which plans to seek regulatory approval for IceCures ProSense® system for breast cancer by 2025. IceCures technology offers a minimally invasive alternative to surgical tumor removal, with applications in breast, kidney, bone, and lung cancer. The announcement is seen as a positive development for IceCure, expanding its market potential and technological capabilities.
Partners
growth-positive
IceCure Medical to Report Third Quarter 2024 Financial & Operational Results on November 26, 2024
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology for tumor treatment, announced it will release its financial and operational results for the nine months ending September 30, 2024. The announcement will be made before the Nasdaq Stock Market opens on November 26, 2024, followed by a conference call to discuss the results and other corporate developments. IceCures ProSense® system, which is marketed globally, offers a safe and effective alternative to traditional surgical tumor removal. The company emphasizes its commitment to advancing its technology and maintaining relationships with partners. The press release includes forward-looking statements about the companys future plans and potential risks, highlighting the importance of financial performance and regulatory developments.
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer minimally-invasive cryoablation technology that destroys tumors by...
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology for tumor treatment, announced it will release its financial and operational results for the nine months ending September 30, 2024. The announcement will be made before the Nasdaq Stock Market opens on November 26, 2024, followed by a conference call to discuss the results and other corporate developments. IceCures ProSense® system, which is marketed globally, offers a safe alternative to surgical tumor removal. The press release includes forward-looking statements about the companys future plans and potential risks, emphasizing the importance of maintaining relationships with partners and navigating regulatory environments.
growth-positive
IceCure's ProSense® Chosen for Breast Cryoablation Study Led by the Prestigious European Institute of Oncology with Sponsorship from the Italian Ministry of Health
IceCure Medical Ltd. announced the publication of an article in the European Journal of Cancer Prevention, highlighting the PRECICE study. This study, funded by the Umberto Veronesi Foundation and the Italian Ministry of Health, focuses on using IceCures ProSense® technology for cryoablation in treating early-stage breast cancer in women over 50. The study aims to evaluate the effectiveness of cryoablation as a minimally invasive alternative to surgery. It involves 233 patients and will assess various outcomes over a five-year period. The publication of this study underscores the potential of cryoablation in reducing the need for surgical interventions in breast cancer treatment.
Customers
growth-positive
IceCure’s cryoablation system for breast cancer treatment gains FDA panel support
IceCure Medical has received a favorable recommendation from the FDAs Medical Device Advisory Committee Panel for its ProSense Cryoablation System, which targets benign and malignant lesions using liquid nitrogen. The system offers a less invasive approach to treating early-stage low-risk invasive breast cancer. The positive recommendation was based on data from the ICE3 trial, which involved 194 subjects and reported a 96.7% breast cancer survival rate. The company anticipates receiving marketing authorization in the first quarter of 2025. This development is seen as a significant milestone for IceCure Medical, potentially providing an alternative to lumpectomy for women with early-stage breast cancer.
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical Ltd., a company specializing in minimally-invasive cryoablation technology, announced a favorable recommendation from the FDAs Medical Device Advisory Committee Panel for its ProSense® System. This system is designed to treat early-stage low-risk invasive breast cancer using cryoablation and adjuvant endocrine therapy. The panels vote was 9 in favor and 5 against, with some dissenters indicating that additional special controls could have swayed their opinion. This milestone is significant for IceCure as it moves closer to obtaining marketing authorization in the U.S., expected in the first quarter of 2025. The ProSense® System offers a minimally invasive alternative to traditional surgical tumor removal, enhancing patient recovery and reducing surgical risks.
growth-positive
FDA Advisory Panel Votes in Favor of IceCure's ProSense® Cryoablation Benefit-Risk Profile in Early-Stage Low Risk Breast Cancer
IceCure Medical Ltd., a company specializing in cryoablation technology for tumor treatment, received a favorable recommendation from the FDAs Medical Device Advisory Committee Panel for its ProSense® System. The panel voted 9 to 5 in favor of the benefit-risk profile of the system for treating early-stage low-risk invasive breast cancer. This recommendation is a significant step towards obtaining marketing authorization in the U.S., expected in the first quarter of 2025. The decision was based on comprehensive data, including the ICE3 study, and input from various stakeholders. IceCures CEO, Eyal Shamir, emphasized the importance of this development for women seeking alternatives to lumpectomy.
growth-positive
Upcoming FDA Advisory Panel for IceCure's ProSense® Marketing Authorization Receives Large Number of Public Comments from Stakeholders
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, has announced a significant number of public comments from key stakeholders ahead of an FDA Medical Device Advisory Committee Panel meeting. The meeting, scheduled for November 7, 2024, will discuss the potential marketing authorization of IceCures ProSense® cryoablation system for treating early-stage low-risk breast cancer. The Advisory Panel will include experts such as breast surgeons and interventional radiologists, who will provide recommendations on the benefit-risk profile of the system. IceCures CEO, Eyal Shamir, expressed optimism about the feedback received, highlighting the potential of ProSense® as a minimally-invasive treatment option. The FDAs decision is expected by early 2025.
growth-positive
IceCure Receives Notice of Allowance from U.S. Patent and Trademark Office for its Next-Generation Cryoablation System
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced it has received a Notice of Allowance for its invention titled Cryogenic System Connector from the U.S. Patent and Trademark Office. This marks the first global patent for the cryogenic system connector, a crucial component of IceCures next-generation XSense™ cryoablation system. The system has FDA clearance for all indications previously approved for IceCures ProSense® system. The patent strengthens IceCures intellectual property portfolio, which includes over 50 issued patents, and supports its position as an innovation leader in the cryoablation market. The company aims to address unmet needs in the global tumor ablation market, valued at $1.67 billion in 2023. IceCures CEO, Eyal Shamir, emphasized the companys commitment to expanding its commercial reach and fortifying its intellectual property assets.
growth-positive
Alignment HealthCare Partners With Intermountain Health in Nevada
Alignment HealthCare, Inc. is expanding its Medicare Advantage plan services in Nevada through a new partnership with Intermountain Health, effective January 1, 2025. This collaboration will provide Medicare members in Clark and Washoe counties access to over 65 clinic locations, including 35 senior primary care clinics. The partnership aims to enhance healthcare access for Nevadas senior population, offering comprehensive care services. The expansion aligns with industry trends towards telehealth, personalized medicine, and healthcare consolidation. The healthcare services market is projected to grow significantly, driven by these trends. Other industry players like IceCure Medical, Co-Diagnostics, and HealthEquity are also making notable advancements in their respective fields.
PartnersExpand
growth-positive
IceCure's ProSense® Featured in 6 Global Studies on Cryoablation of Breast Tumors at the 2024 European Society of Breast Imaging Conference
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, showcased its ProSense® system at the 2024 European Society of Breast Imaging (EUSOBI) Scientific Meeting in Lisbon, Portugal. The companys ICE3 trial and five other studies were presented, highlighting the effectiveness of cryoablation as a primary treatment for low-risk breast cancer. The ICE3 trial received the EUSOBI 2024 Abstract Award, demonstrating a 96.3% recurrence-free rate. The THERMAC trial also showed cryoablations superiority over other methods like radiofrequency and microwave ablation. The event attracted over 1700 professionals, with IceCure conducting live demonstrations and engaging in discussions with potential partners. The recognition and positive trial results are expected to enhance IceCures commercial activities globally.
growth-positive
Zacks.com featured highlights Adverum Biotechnologies, IceCure, DarioHealth, Energous and Virgin Galactic
The article discusses the potential growth of five top-ranked stocks with rising price-to-earnings (P/E) ratios, including Adverum Biotechnologies, IceCure Medical, DarioHealth, Energous, and Virgin Galactic. It highlights the strategy of investing in stocks with rising P/E ratios, which indicates investor confidence in the companys future earnings potential. The article emphasizes that a rising P/E ratio can be a useful tool for investors seeking strong returns. Each of the mentioned companies has shown positive earnings surprises over the past four quarters, suggesting robust performance and growth prospects. The article is part of a broader investment strategy discussion by Zacks Investment Research, encouraging investors to explore these stocks for potential gains.
growth-positive
IceCure's ICE3 5-Year Trial Results Published in the Peer Reviewed Annals of Surgical Oncology Journal: ProSense® Cryoablation Without Excision for Early-Stage, Low-Risk Breast Cancer Demonstrates 96.3% Recurrence Free Rate
IceCure Medical announced the publication of an article in the Annals of Surgical Oncology detailing the results of its ICE3 trial, which studied the efficacy of ProSense® cryoablation for early-stage low-risk breast cancer. The trial showed a 96.3% recurrence-free rate and high patient and physician satisfaction with cosmetic outcomes. The publication comes ahead of an FDA Advisory Panel meeting scheduled for November 7, 2024, which could lead to marketing authorization for ProSense®. The positive trial results and upcoming FDA review are expected to accelerate market adoption of ProSense® as a minimally invasive alternative to traditional surgery.
Customers
growth-positive
Study Published in the British Journal of Radiology Demonstrates IceCure's ProSense® is a Safe Procedure with 97.7% Technical Success Rate in Treating Tumors of the Lung, Bone, and Soft Tissues
IceCure Medical announced favorable results from an independent study conducted at the European Institute of Oncology, demonstrating the safety and cost-effectiveness of its ProSense® liquid nitrogen-based cryoablation system compared to argon-based systems. The study, published by Oxford University Press, highlighted ProSense®s effectiveness in treating various tumors with minimal complications. The studys findings support the growing role of cryoablation in oncology, particularly for patients seeking minimally invasive treatments. IceCures CEO, Eyal Shamir, emphasized the importance of these results in providing safe and effective cancer treatment options.
Customers
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical announced the publication of an independent study demonstrating the safety and cost-effectiveness of its ProSense® liquid nitrogen-based cryoablation system. Conducted at the European Institute of Oncology, the study found ProSense® to be safer and more manageable compared to argon-based systems. The study involved 85 patients with various tumor types and reported a 97.7% primary technical success rate. The findings highlight the growing role of cryoablation in oncology, particularly for patients seeking minimally invasive treatment options. The study also noted the logistical and cost advantages of LN2-based systems over argon-based systems.
Customers
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical announced that the FDAs Medical Device Advisory Committee Panel will evaluate its ProSense® cryoablation system as a minimally invasive alternative to lumpectomy for early-stage low-risk breast cancer. The panel meeting is scheduled for November 7, 2024, and the FDAs decision on marketing authorization is expected by early 2025. The ProSense® system uses liquid nitrogen to destroy tumors and has shown promising results in clinical trials, including a 96.3% rate of patients being free from local recurrence at a 5-year follow-up. The public forum aims to provide transparency and gather expert opinions on the technology.
Customers
growth-positive
IceCure Announces FDA Advisory Panel Meeting Date for Marketing Authorization of ProSense® in Early-Stage Low Risk Breast Cancer Scheduled for November 7, 2024
IceCure Medical announced that the FDAs Medical Device Advisory Committee Panel will evaluate its ProSense® cryoablation system as a minimally invasive alternative to lumpectomy for early-stage low-risk breast cancer. The panel meeting is scheduled for November 7, 2024, and a decision on marketing authorization is expected by early 2025. The ProSense® system uses liquid nitrogen to destroy tumors and has shown promising results in clinical trials, with a 96.3% success rate in preventing local recurrence at a 5-year follow-up. The public forum aims to provide transparency and gather input from various stakeholders.
Customers
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical, a developer of minimally-invasive cryoablation technology for treating tumors, announced that its CEO, Eyal Shamir, and CFO/COO, Ronen Tsimerman, will conduct one-on-one meetings with institutional investors at the H.C. Wainwright and Lake Street Capital Markets conferences. The events are scheduled for September 9-11, 2024, and September 12, 2024, respectively. The companys flagship ProSense® system, which is marketed globally, will be a focal point of these meetings. The company aims to attract investment and highlight upcoming regulatory and operational catalysts.
Investment
growth-positive
IceCure to Meet Institutional Investors at the H.C. Wainwright and Lake Street Capital Markets Conferences
IceCure Medical, a developer of minimally-invasive cryoablation technology for treating tumors, announced that its CEO, Eyal Shamir, and CFO/COO, Ronen Tsimerman, will engage with institutional investors at the H.C. Wainwright and Lake Street Capital Markets conferences. These meetings aim to highlight the companys ProSense® system, which offers a non-surgical alternative for tumor removal. The events will take place from September 9-12, 2024, in New York. The company is focused on expanding its market presence and securing additional investments to support its growth and regulatory milestones.
Investment
growth-positive
USPTO Grants Notice of Allowance for Additional Patent on IceCure's Novel Cryogenic Pump Technology: Reinforces IceCure's Global IP Leadership in Cryoablation Technologies
IceCure Medical announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a continuation application based on its issued patent titled Cryogen Pump. This new patent will be in effect until 2041 and is expected to support the companys potential for increasing the number of indications, procedures, and applications that can be performed with its cryoablation systems. The company is also awaiting FDA clearance for early-stage breast cancer, expected in the first quarter of 2025. IceCures cryogenic pump improves the cooling rate during procedures and is designed for multiple or longer duration procedures without needing to refill liquid nitrogen.
CustomersPartners
growth-positive
/PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology...
IceCure Medical announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a continuation application based on its issued patent titled Cryogen Pump. This new patent will be in effect until 2041 and is expected to support the companys potential for increasing the number of indications, procedures, and applications for its cryoablation systems. The company is awaiting FDA clearance for early-stage breast cancer, expected in the first quarter of 2025. IceCures cryogenic pump, integrated into its XSense™ cryoablation system, improves the cooling rate and allows for multiple or longer duration procedures without needing to refill liquid nitrogen.
Customers
growth-negative
IceCure Medical Ltd. (ICCM) Reports Q2 Loss, Tops Revenue Estimates
IceCure Medical Ltd. reported a quarterly loss of $0.06 per share, which is an improvement from the Zacks Consensus Estimate of a loss of $0.07 and the loss of $0.09 per share a year ago. The company, which belongs to the Zacks Medical Services industry, posted revenues of $1.01 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 12.33%. This compares to year-ago revenues of $0.94 million. However, IceCure Medical shares have lost about 40.3% since the beginning of the year.
Customers
growth-positive
IceCure Medical Reports 20% Growth in ProSense® System and Probe Sales for the First Half of 2024; Reflects Continued Adoption in the U.S. and Other Global Markets
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, reported financial results for the six months ended June 30, 2024. The companys sales of ProSense systems and disposable probes grew by 20% to $1,654,000 compared to the same period in 2023. The company also reported a net loss of $6,690,000 for the six months ended June 30, 2024, a decrease from the net loss of $7,657,000 reported for the same period in 2023. The company is preparing for the FDA Medical Device Advisory Committee, which is expected to be scheduled for Q4 2024.
CustomersPartnersManagement Changes
growth-positive
IceCure's ProSense® Destroyed 100% of Breast Cancer Tumors in Independent Study of Patients Who Chose Cryoablation Instead of Surgery
IceCure Medical Ltd. has announced the publication of an independent study that supports the effectiveness of its cryoablation technology, ProSense, in treating early-stage breast cancer in non-surgical patients. The study, conducted at Hospital Lucus Augusti in Spain, found that 95.6% of patients offered cryoablation with ProSense accepted the treatment. The study concluded that cryoablation is a safe, effective alternative to surgery and is well-tolerated as an outpatient procedure. IceCures CEO, Eyal Shamir, believes these factors point to increasing demand for ProSense.
Customers
Neutral
IceCure Medical to Report Second Quarter 2024 Financial & Operational Results on August 20, 2024
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology for tumor treatment, has announced that it will release its financial and operational results for the six months ended June 30, 2024, before the Nasdaq Stock Market opens on Tuesday, August 20, 2024. The company will also discuss these results and other corporate developments on a conference call at 10:00 a.m. EDT on the same day. IceCures technology offers a safe and effective alternative to surgical tumor removal and is marketed and sold worldwide.
Public Trading
growth-positive
IceCure Announces Positive Data from the Largest Multi-Institutional Study of its Kind: "Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials"
IceCure Medical Ltd. has announced the publication of an independent study on the use of its ProSense cryoablation system in treating breast cancer patients ineligible for clinical trials. The study, published in the American Journal of Roentgenology, found that cryoablation is a safe alternative to surgery with good outcomes, even in higher-risk patients. The study evaluated 112 patients with a median age of 71. The recurrence-free rates were 94.7%, 87.8%, and 81.8%, at 1, 2, and 3 years, respectively. IceCure has filed for regulatory approval of ProSense in the U.S. for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.
CustomersExpand
Growth-Negative
IceCure Medical receives Nasdaq compliance notice
IceCure Medical, a developer of cryoablation technology for tumour destruction, has received a notice from Nasdaq regarding non-compliance with its minimum bid price rule. The company’s shares have fallen below the $1 threshold required for continued listing on the Nasdaq Capital Market. IceCure Medical has 180 days to regain compliance with the minimum bid price requirement. If IceCure Medical fails to meet the requirement within the initial period, it may be granted an additional 180 days, provided it meets other Nasdaq Capital Market initial listing standards.
Public Trading
growth-negative
IceCure presents hat-trick of positive trial data for cryoablation device
IceCure Medical has reported data from three clinical trials, showcasing the efficacy of its ProSense cryoablation device in the treatment of breast cancer. The data was unveiled at the 32nd Annual Meeting of the Japanese Breast Cancer Society. The company has an ongoing partnership with Terumo Corporation, Japan’s largest medical device company. However, IceCure received a Nasdaq compliance notice after the company’s shares fell below the $1 threshold requirement. The company’s stock took a downturn in 2021 when it announced lower gross profit and smaller gross margins, along with an increase in net loss from the year before.
CustomersPartnersPublic Trading
growth-positive
99.74% Recurrence Free Rate for Women with Breast Cancer Treated with IceCure's ProSense® Cryoablation System: Key Findings Delivered at 32nd Annual Meeting of the Japanese Breast Cancer Society
IceCure Medical Ltd. announced key findings from three clinical studies of ProSense® in the treatment of breast cancer at the 32nd Annual Meeting of the Japanese Breast Cancer Society. The studies showed promising results, with one study showing a 99.74% recurrence free rate. The companys distribution partner, Terumo Corporation, plans to submit an application for regulatory clearance for breast cancer in Japan in the first quarter of 2025. IceCures CEO, Eyal Shamir, stated that Japan is a very important market for ProSense® and expects the cryoablation system to become more commercially available to doctors and patients in Japan.
PartnersExpand
growth-negative
IceCure Medical Announces Receipt of Nasdaq Minimum Bid Price Notification
IceCure Medical Ltd. has received a notice from Nasdaq Stock Market LLC indicating that the company is not in compliance with the minimum bid price requirement for continued listing. The company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. If the company does not regain compliance after the initial 180-day period, it may be eligible for an additional 180-day compliance period. The company intends to monitor the closing bid price of its ordinary shares and its continued listing on Nasdaq is a priority.
Public Trading
growth-positive
IceCure's (ICCM) ProSense Breast Cancer Study Meets Endpoint
IceCure Medical Ltd. has announced the publication of data from an independent study evaluating its ProSense cryoablation system, which is used in the treatment of high-risk breast cancer. The study found that the system is a safe and effective treatment with a low complication rate. The ProSense system is already approved for use in Europe and is currently under review by the FDA for approval in the US. The global cryoablation market is expected to reach $1.5 billion by 2032, growing at a CAGR of 8.5%. IceCures shares have fallen by 29.9% so far this year.
CustomersInvestmentExpand
growth-positive
European Study Provides More Evidence Supporting IceCure's ProSense® is Safe & Effective Cryoablation Treatment for Metastatic and Recurrent Breast Cancer
IceCure Medical Ltd. announced the publication of an independent study evaluating its cryoablation system ProSense. The study, published in the peer-reviewed oncology journal Cancers, concluded that cryoablation with ProSense is a safe, local treatment for breast cancer with a low complication rate, high complete ablation rate, and satisfactory overall survival. The study was conducted at the Institute of Radiology and Nuclear Medicine, University Hospital Frankfurt, at Goethe University, Germany. The results are valuable for ProSense users in Europe where the system is approved for general breast cancer treatment.
Customers
growth-positive
IceCure Medical (ICCM) New Cryoablation System Gets FDA Nod
IceCure Medical Ltd has received FDA clearance for its XSense Cryoablation System, a minimally invasive cryoablation system designed for general use. The system uses liquid nitrogen to destroy tumors by freezing them, offering an alternative to traditional surgical tumor removal. The FDA approval is expected to solidify IceCures position as a global leader in cryoablation solutions. The XSense system is set to address unmet medical needs with its versatility and effectiveness in treating various tissues and tumors. The global cryoablation market size was worth $691 million in 2022 and is anticipated to reach $1.6 billion in 2032.
InvestmentCustomers
growth-positive
FDA grants marketing authorisation for IceCure’s XSense Cryoablation System
The US Food and Drug Administration (FDA) has granted marketing authorisation for IceCure Medical’s XSense Cryoablation System with CryoProbes. The system is designed for minimally invasive tumour destruction through extreme cold application. It is now cleared for the same indications as its predecessor, the ProSense system, covering a wide range of medical fields. The technology behind IceCure’s offerings, including both the ProSense and XSense systems, offers a minimally invasive treatment option for tumour treatment.
Customers
growth-positive
U.S. Food and Drug Administration Grants Regulatory Clearance to IceCure for Next-Gen XSense™ Cryoablation System with CryoProbes
IceCure Medical Ltd. has received marketing authorization from the United States Food and Drug Administration (FDA) for its next-generation single probe cryoablation system, the XSense™ Cryoablation System with CryoProbes. This system is designed to destroy tissue by the application of extreme cold temperatures, including fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions and warts. The system is cleared for all of the indications for which ProSense® has already received the requisite FDA clearance.
Customers
growth-negative
We're Keeping An Eye On IceCure Medical's (NASDAQ:ICCM) Cash Burn Rate
IceCure Medical, a software-as-a-service business, is attracting investors despite being unprofitable. The companys cash burn, or the amount of money it spends each year to fund its growth, is a concern. IceCure Medical had zero debt and cash worth US$11m as of March 2024, but its cash burn was US$13m over the trailing twelve months, giving it a cash runway of roughly 10 months. Analysts predict the company will reach cashflow breakeven in 4 years. The companys cash burn relative to its market cap is also a concern, as it could lead to shareholder dilution if the company needs to raise more cash.
Investment
growth-positive
IceCure Medical to Provide Overview and Share Recent Progress at Northland Capital Markets Virtual Growth Conference on June 25, 2024
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, announced that its management will participate in the Northland Capital Markets Virtual Growth Conference on June 25, 2024. The company has achieved its primary objectives for the first half of 2024, including the completion of the ICE3 trial and data results submission to the FDA. Several members of the Board and senior executives have demonstrated their confidence in the company by purchasing tens of thousands of shares in the open market.
InvestmentManagement Changes
growth-positive
Positive Data from IceCure's Kidney Cancer Clinical Study Presented at Interventional Radiology Conference: Minimally Invasive Approach Results in Shorter Hospitalization and Minor Impact on Renal Function
IceCure Medical Ltd. has announced positive interim results from its ICESECRET kidney cancer trial. The trial is evaluating the effectiveness of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing. The interim results showed ProSense to be safe and effective in treating kidney tumors with an 89.5% recurrence-free rate. More data is expected in the fourth quarter of 2024. The global kidney cancer treatment market is expected to reach $8.78 billion by 2029. ProSense is approved for the treatment of benign and malignant kidney tumors in the U.S., Europe, and numerous other countries.
CustomersExpand
growth-positive
FDA to Convene Advisory Panel for Review of IceCure's De Novo Marketing Clearance Request for ProSense®, Decision Expected Early 2025; Aligns with Commercial Readiness Plan
IceCure Medical Ltd. has announced that the U.S. Food and Drug Administration (FDA) will convene a Medical Device Advisory Committee to assess the potential of ProSense®, a minimally-invasive cryoablation technology that destroys tumors by freezing. The Advisory Panel is expected to convene in Q4 2024, with an FDA decision on whether to approve ProSense® expected by early 2025. ProSense® is already approved for the treatment of early-stage breast cancer in numerous European countries, as well as Brazil, India, and China. IceCures CEO, Eyal Shamir, believes that the Advisory Panel will be beneficial to all stakeholders.
CustomersPartnersExpand
growth-positive
IceCure Medical (ICCM) Moves to Buy: Rationale Behind the Upgrade
IceCure Medical Ltd. has been upgraded to a Zacks Rank #2 (Buy) due to an upward trend in earnings estimates. The Zacks rating system tracks the consensus measure of EPS estimates from sell-side analysts covering the stock for the current and following years. The rating upgrade for IceCure Medical reflects positivity about its earnings outlook that could translate into buying pressure and an increase in its stock price. Over the past three months, the Zacks Consensus Estimate for the company has increased 1.8%.
Investment
growth-positive
IceCure Medical Maintains Positive Momentum and Reports Sales Growth for Cryoablation System in First Quarter of 2024
IceCure Medical Ltd. has reported its financial results for the first quarter of 2024, highlighting a 30% sales growth due to the continued adoption of its ProSense System in the U.S. and other global markets. The company also completed its landmark ICE3 trial for breast cancer and is awaiting FDA approval for marketing authorization for ProSense. The system, which destroys tumors by freezing as an alternative to surgical tumor removal, is already cleared and being used to treat early-stage breast cancer in numerous countries. The company also managed to lower its operating expenses in non-revenue generating activities.
CustomersManagement Changes
Neutral
IceCure Medical to Report First Quarter 2024 Financial & Operational Results on May 28, 2024
IceCure Medical Ltd., a developer of the ProSense® System, a minimally-invasive cryoablation technology for tumor treatment, announced that it will release its financial and operational results for the first quarter of 2024 before the Nasdaq Stock Market opens on May 28, 2024. The company will discuss these results and other corporate developments in a conference call on the same day. IceCures technology offers a safe and effective alternative to surgical tumor removal and is marketed worldwide.
Public Trading
growth-positive
IceCure Medical to Highlight Key Achievements and Provide Business Overview at A.G.P. / Alliance Global Partners' Virtual Healthcare Company Showcase
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, announced that the companys CEO, Eyal Shamir, will present at the A.G.P / Alliance Global Partners Virtual Healthcare Company Showcase on May 21, 2024. Shamir will provide an update on the latest developments and catalysts for IceCure, including the results of the ICE3 breast cancer cryoablation trial, its pending De Novo Classification Request with the FDA for marketing clearance of the ProSense Cryoablation System, and the systems increasing global commercial reach.
Management ChangesCustomersExpand
growth-negative
Here's Why It's Unlikely That IceCure Medical Ltd's (NASDAQ:ICCM) CEO Will See A Pay Rise This Year
IceCure Medical Ltd is set to hold its Annual General Meeting on 20th May, where shareholders are expected to question CEO Eyal Shamirs compensation in light of the companys disappointing performance. Over the past three years, IceCures earnings per share fell by 14% and shareholders experienced a total loss of 29%. Shamirs total compensation, which includes a salary of US$416.4k, is similar to the industry average, despite the companys poor performance. The meeting will provide an opportunity for shareholders to influence management decisions and potentially impact the firm significantly.
Management Changes
growth-positive
Independent Study Results in Japan Demonstrate Zero (0%) Breast Cancer Local Recurrence 5 Years Following Treatment with IceCure's ProSense®, Adding to Continued Positive Data Published Globally
IceCure Medical Ltd. has announced positive data from an independent study performed in Japan, which was published in the journal Breast Cancer. The study focused on the local control of cancer, safety, patient quality of life, patient satisfaction, and cosmetic outcomes of cryoablation for patients with early-stage breast cancer. The companys strategic distribution partner in Japan, Terumo Corporation, expects to submit an application for regulatory clearance for breast cancer in the second half of 2024. Terumo Corporation owns the exclusive distribution rights for ProSense® in Japan for a 5-year term following regulatory approval. IceCure is expected to receive a total of $13.2 million in proceeds from Terumo during this initial term.
PartnersInvestment
growth-positive
IceCure Medical (ICCM) Submits Final Cryoablation Data to FDA
IceCure Medical has submitted final data to the FDA for market authorization of its ProSense System, a cryoablation technique for treating breast cancer. The companys shares have seen a 41.8% increase in the past six months. The ProSense System, which already has clearance in the US for other indications, is designed to destroy tumors by freezing them, providing a minimally invasive treatment option. The FDA has responded positively to IceCures submission, offering a possible route to clearance. The global cryoablation devices market is expected to reach $1.5 billion by 2032.
CustomersInvestment
growth-positive
IceCure Medical Reports Final ICE3 Breast Cancer Cryoablation Trial Results of 100% Patient and Physician Satisfaction and 96.3% Recurrence Free Rate: Data Submitted to FDA Requesting Marketing Authorization to Treat Early-Stage Breast Cancer
IceCure Medical Ltd. has submitted final data to the U.S. Food and Drug Administration (FDA) requesting marketing authorization for ProSense, a minimally-invasive cryoablation technology that destroys tumors by freezing. The technology, which has already received the FDAs Breakthrough Designation, is seeking indication for treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. The ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors, showed promising results. The company expects rapid adoption of the technology pending FDA approval.
CustomersPartnersInvestmentExpand
growth-positive
IceCure Medical Ltd (NASDAQ:ICCM) Q4 2023 Earnings Call Transcript
IceCure Medical Ltd held its Q4 2023 earnings call on April 3, 2024. The company discussed its financial results for the year ended December 31, 2023, and provided an update on its operations. IceCures CEO, Eyal Shamir, highlighted the companys achievements in 2024 and its expectations for the coming quarters. The company has completed its ICE3 drug process for the treatment of early-stage low-risk breast cancer and is awaiting FDA approval. The company also discussed its commercial readiness plan for ProSense for early-stage breast cancer in the U.S. and its efforts to grow its distribution networks in Europe and Asia.
CustomersExpand
growth-positive
IceCure Medical Reports Full Year 2023 Financial Results: Global ProSense® and Disposables Sales Increase 26% as Company Continues Transition to Commercial Phase and Expects to Submit ICE3 Breast Cancer Study Data to FDA this Month for Marketing Clearance
IceCure Medical Ltd., a developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, reported a 26% increase in sales for the twelve months ended December 31, 2023. The company also raised $3 million in gross proceeds from the sale of ordinary shares under its At-the-Market (ATM) offering facility in the first quarter of 2024. IceCures CEO, Eyal Shamir, stated that the company is transitioning from a research and development and clinical phase company to a commercial phase company.
CustomersInvestmentExpand
growth-positive
IceCure Submits FDA Regulatory Filing for New XSense™ Cryoablation System with Cryoprobes
IceCure Medical Ltd., the developer of the ProSense System, has filed a 510(k) submission with the United States Food and Drug Administration (FDA) for clearance of its next-generation single probe cryoablation system, the XSense System. The filing includes a request for clearance for all indications for which ProSense has already received FDA clearance. The new application for IceCures XSense System is based on the current clearance of the ProSense System and is being processed separately from the companys De Novo application for the breast cancer indication.
Investment
Growth-Positive
IceCure Medical to Report 2023 Full Year Financial & Operational Results on April 3, 2024
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, announced that it will release its financial and operational results for the twelve months ended December 31, 2023, before the Nasdaq Stock Market opens on Wednesday, April 3, 2024. The companys CEO, CFO, and VP of Sales for North America will discuss the results and other corporate developments on a conference call. The VP of Sales will also provide an overview of the companys commercial strategy to drive market adoption of the ProSense System.
Management Changes
growth-positive
IceCure Medical Reports Positive Topline Results From ICE3 Cryoablation Breast Cancer Study: Achievement of 96.39% Recurrence Free Rate Brings Company One Step Closer to Providing Women a Non-Surgical Alternative to Lumpectomy
IceCure Medical Ltd. has announced positive topline results from its ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of low-risk, early-stage malignant breast tumors. The companys ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, was found to be a safe and effective alternative to surgical tumor removal. The company plans to submit the results to the U.S. Food and Drug Administration (FDA) in April 2024 for marketing authorization of ProSense for the treatment of early-stage low-risk breast cancer.
CustomersInvestment
growth-positive
IceCure Receives Notice of Patent Allowance in Japan for a Novel Cryogen Flow Control to Optimize Patient Outcomes
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, has received a Notice of Allowance from the Japan Patent Office for its patent application titled Cryogen Flow Control. The patent, which is pending approval in the European Union, the U.S., and other major markets, will be in effect until 2042. The companys cryogen flow control technology enhances the efficacy and precision of cryoablation procedures by utilizing sensor data to regulate the flow of cryogens. IceCures CEO, Eyal Shamir, believes that this technology will be instrumental in expanding cryoablation treatment to more clinical applications in the future.
Partners
Growth-Positive
IceCure Medical to Present at 34th Annual Oppenheimer Healthcare MedTech & Services Conference
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, announced that the Companys CEO, Eyal Shamir, will present at the 34th Annual Oppenheimer Healthcare MedTech & Services Conference. Shamir will provide an update on IceCures latest developments including the Companys ICE3 breast cancer trial with its pending De Novo Classification Request with the U.S. FDA for marketing clearance of ProSense for the treatment of patients with early-stage, low-risk breast cancer as well as ProSenses increasing global commercial reach.
Management ChangesExpand
growth-positive
IceCure's ProSense® a Promising Alternative Treatment for Extra-Pelvis Endometriosis: Independent Study Presented at ECR 2024
IceCure Medical Ltd. announced the results of an independent study conducted at University Hospital, Nimes, France, which demonstrated the effectiveness of its ProSense System in treating endometriosis. The study, presented at the European Congress of Radiology 2024, enrolled seven women aged 30-45 years with endometriosis in the abdominal wall and para-diaphragmatic areas. Treatment with ProSense cryoablation took about 30 minutes, and one month following treatment, all patients reported significant pain reduction. The study concluded that ProSense appears to be a promising alternative for the treatment of extra-pelvis endometriosis.
CustomersExpand
growth-positive
Fourth BRIIT Conference in India Features IceCure's ProSense® in Breast Cancer Imaging & Interventions Workshop
IceCure Medical Ltd.s ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, was featured at the fourth Breast Imaging & Interventional Techniques (BRIIT) conference in Mumbai, India. The ProSense System has regulatory approval and is marketed and sold in India through IceCures distributor, Novomed Ltd. The company reported high levels of interest in procuring ProSense systems from doctors, clinics, and hospitals. The companys CEO, Eyal Shamir, stated that IceCure has been very active in India and appreciates the initiative of Dr. Rupa Renganathan and Dr. Hania Bednarski in leading the cryoablation education section with ProSense at BRIIT.
CustomersPartnersExpand
growth-positive
Study Using IceCure's ProSense® Treatment Results in 100% Tumor Reduction in Early-Stage Breast Cancer
IceCure Medical Ltd. has announced new data from a preliminary, independent breast cancer study conducted in Italy. The study used IceCures ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, on 39 women aged 60-92 who were deemed inoperable due to advanced age and comorbidities, or who refused surgery. The study reported a median tumor reduction of 100% at 6 and 12 months following cryoablation. IceCure CEO Eyal Shamir stated that the company is working to get ProSense approved, available and affordable for as many women as possible in a number of countries.
CustomersExpand
growth-positive
IceCure's ProSense® to be Featured at Two Upcoming Medical Conferences in Japan
IceCure Medical Ltd. has announced that Eisuke Fukuma, MD, PhD, who has performed over 600 breast cryoablation procedures with IceCures ProSense System, will host events featuring ProSense at two upcoming medical conferences in Japan. The events aim to educate and share insights on the use of ProSense for non-surgical tumor ablation. The company believes that these educational events and published studies are generating momentum for the wider adoption of cryoablation globally. ProSense is currently pending regulatory approval in Japan.
CustomersExpand
growth-positive
U.S. FDA Grants IceCure Medical's Appeal: Reopens De Novo Classification Request for Marketing Authorization of ProSense® for Early-Stage Breast Cancer
IceCure Medical Ltd. has announced that the U.S. Food and Drug Administration (FDA) has agreed to reopen the De Novo file for the companys ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing. The FDA has requested IceCure to submit the full 5-year dataset from the companys ICE3 trial, which is expected to be completed by February 2024. The FDA has also asked IceCure to submit an analysis of the ICE3 results compared with data from the LUMINA study. IceCure plans to expedite data monitoring and analysis to submit the final 5-year dataset to the FDA by April 2024.
CustomersPartners
growth-positive
IceCure Medical's Breast Cryoablation Gains Prominence in the U.S., as Society of Interventional Oncology Annual Meeting Features its First Breast Cryoablation Master Class
IceCure Medical Ltd. showcased its ProSense System at the Society of Interventional Oncologys (SIO) Annual Scientific Meeting in California. The ProSense System is a minimally-invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal. The companys ICE3 breast cancer cryoablation study was also presented, showing a 96.91% recurrence free rate. The companys CEO, Eyal Shamir, expressed optimism about the growing use of their cryoablation system in the U.S.
CustomersPartners
Growth-Positive
IceCure Medical's ProSense® Featured at Indian Society of Vascular and Interventional Radiology Conference: Key Opinion Leaders Highlight Benefits of Cryoablation
IceCure Medical Ltd., the developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing, participated at the Indian Society of Vascular and Interventional Radiology (ISVIR) 24th Annual Conference in Jaipur, India. The company, along with its in-country distributor, Novomed, conducted hands-on ProSense® demonstrations and training. The ProSense® System has regulatory clearance in India for indications including general surgery and oncology for tissues of the breast, lung, kidney, liver, and bone. The system was used to perform the first breast cryoablation procedure in India in June 2023.
CustomersPartners
growth-positive
IceCure Medical's ProSense® Featured at Indian Society of Vascular and Interventional Radiology Conference: Key Opinion Leaders Highlight Benefits of Cryoablation
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology, participated at the Indian Society of Vascular and Interventional Radiology (ISVIR) 24th Annual Conference in Jaipur, India. The company, along with its distributor Novomed, exhibited and conducted hands-on ProSense demonstrations and training. The ProSense System has regulatory clearance in India and was used to perform the first breast cryoablation procedure in India in June 2023. The system was praised by key opinion leaders at the conference, including ISVIR President Dr. Suyash Kulkarni and Dr. Shuvro Roy-Choudhury.
CustomersPartners
Growth-Positive
IceCure Medical Regains Compliance with Nasdaq Minimum Closing Bid Price Rule
IceCure Medical Ltd., a developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing, has regained compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2). The Nasdaq staff made this determination of compliance after the closing bid price of the Companys ordinary shares was at $1.00 per share or greater for the 10 consecutive business days prior to the date of the notice. The companys technology is a safe and effective alternative to hospital surgical tumor removal.
Public Trading
growth-positive
IceCure Medical CEO Issues Letter to Shareholders & Reports Increase in Sales in Preliminary Unaudited 2023 Results
IceCure Medical Ltd. reported a 25% increase in U.S. sales of its ProSense system and disposable probe in 2023 over the previous year. The company also received regulatory clearances in large markets such as Brazil, Canada, and China. The companys CEO, Eyal Shamir, expressed optimism for 2024, expecting it to be a pivotal year with the completion of the ICE3 breast cancer study and continued market penetration. The company also implemented an expense reduction plan in the fourth quarter of 2023 to reduce non-revenue generating and clinical development costs.
CustomersPartnersManagement ChangesExpand
growth-positive
New Study Reports IceCure's ProSense® Boosts Immune Response Against Cancer: Enhances CD8+ T Cell Response
IceCure Medical Ltd., the developer of the ProSense System, has announced the publication of a study that supports the effectiveness of their cryoablation technology in activating the bodys natural immune response and destroying tumors. The study was conducted at Case Western Reserve University School of Medicine and published in OncoImmunology. The ProSense System, which destroys tumors by freezing them, was used in the study. The data suggests that the system enhances CD8+ T cell activation, which is crucial for immune-mediated rejection of soft tissue tumors. The CEO of IceCure, Eyal Shamir, stated that these studies pave the way for further analysis of immune response in human trials.
CustomersExpand
growth-positive
Study Using IceCure's ProSense® Finds: "Cryoablation Allows the Ultimate De-escalation of Surgical Therapy for Select Breast Cancer Patients"
IceCure Medical Ltd. announced the publication of an independent study that concludes cryoablation, a minimally invasive procedure that destroys tumors by freezing, is a safe and feasible alternative to surgery for patients with early-stage, low-risk breast cancer. The study, which analyzed IceCures ProSense System among others, was conducted at Texas Tech University Health Sciences Center. The study suggests that cryoablation provides a significantly superior alternative when it comes to financial implications, as compared to surgical resection. All patients were disease-free at the last follow-up visit, and no major complications from the procedure were reported.
CustomersInvestment
growth-positive
IceCure's ProSense® Deepens Regulatory Approval in India
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, has received approval from the Central Drugs Standard Control Organization (CDSCO) in India for the ProSense system based on updated regulatory requirements. This approval, granted in November 2023, confirms that ProSense meets all updated regulatory requirements in India. The system is marketed and sold in India through IceCures distributor, Novomed. The first breast cancer cryoablation procedure in India was conducted using ProSense in June 2023.
CustomersPartners
growth-positive
IceCure System Successfully Treated Kidney Cancer Tumor with 92% Disease-Free Survival Rate and 100% Secondary Local Control Rate
IceCure Medical Ltd. has announced the release of a study demonstrating the safety and efficacy of its ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing. The study, conducted by eight physicians in France, showed that ProSense was effective in treating malignant small renal masses. The technology was found to preserve renal function post-treatment, which is crucial for patients quality of life. The studys findings support the commercialization of ProSense, particularly in facilities that can use one device across multiple specialties.
Customers
growth-positive
IceCure System Successfully Treated Kidney Cancer Tumor with 92% Disease-Free Survival Rate and 100% Secondary Local Control Rate
IceCure Medical Ltd. has announced the results of an independent study on its ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing. The study demonstrated the safety and efficacy of ProSense in treating malignant small renal masses. It found that 92.4% of patients were discharged the day after cryoablation, and the technology was able to preserve renal function post-treatment. The study also found that the system offers significant advantage in ability to re-treat tumors that are initially resistant, achieving a subsequent local control rate of 100%. The findings will serve as a guide for medical professionals in choosing efficient, cost-effective, and patient-friendly treatment options.
CustomersExpand
growth-positive
IceCure Medical Reports Financial Results as of and for the Nine Months Ended September 30, 2023, and Provides Update on Recent Operational Highlights
IceCure Medical Ltd. reported an 11% increase in ProSense® systems and disposable probes sales to $1.7 million for the nine months ended September 30, 2023. The company also announced significant regulatory approvals in Brazil and Canada, and the appointment of Shad Good as Vice President of Sales for North America. IceCures ICE3 trial is on track to be completed in the first quarter of 2024. The company has also filed an appeal with the FDA regarding its decision on the marketing clearance application of ProSense® in the treatment of early-stage breast cancer.
CustomersPartnersManagement ChangesExpand
Growth-Negative
IceCure Medical Files Appeal with U.S. FDA Requesting a Review of its De Novo Classification for ProSense® in Early-Stage Breast Cancer
IceCure Medical Ltd. has filed an appeal with the U.S. Food and Drug Administration (FDA) following the agencys denial of the companys De Novo Classification Request for treating patients with early-stage, low-risk breast cancer using its ProSense System. The company believes the denial is due to the FDAs choice of comparator group against which the interim results of its ICE3 breast cancer study were evaluated. IceCure is committed to working with the FDA to identify a more appropriate comparator group during the appeal process. The company expects a response to its appeal by the end of January 2024.
CustomersManagement Changes
Growth-Negative
IceCure Medical Ltd. (ICCM) Reports Q3 Loss, Misses Revenue Estimates
IceCure Medical Ltd. reported a quarterly loss of $0.09 per share, in line with the Zacks Consensus Estimate, and compared to a loss of $0.11 per share a year ago. The company posted revenues of $0.33 million for the quarter ended September 2023, missing the Zacks Consensus Estimate by 65.58%. This compares to year-ago revenues of $0.63 million. The companys shares have lost about 52.3% since the beginning of the year. The companys earnings outlook and the performance of the Medical Services industry, to which it belongs, will have a material impact on the performance of the stock.
Customers
Neutral
IceCure Medical to Report Third Quarter 2023 Financial & Operational Results on November 15, 2023
IceCure Medical Ltd., a developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing, announced that it will release its financial and operational results for the nine months ended September 30, 2023, before the Nasdaq Stock Market opens on Wednesday, November 15, 2023. The company will also discuss these results and other corporate developments on a conference call at 10:00 a.m. EST on the same day. IceCure Medicals technology is a safe and effective alternative to surgical tumor removal and is marketed and sold worldwide.
Public Trading
growth-positive
Substantial Evidence-Based Data Currently Being Generated by 19 Ongoing Studies Using IceCure Medical's ProSense® Cryoablation System
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, has announced that the number of independent, non-sponsored studies of its system has significantly increased. The company expects the growing body of scientific data, including 13 breast cancer studies, to drive adoption of ProSense. The technology is approved for various indications in 15 countries including the U.S., Canada, Europe, Brazil, and China. The companys CEO, Eyal Shamir, believes that the high proportion of breast cancer studies demonstrates a desire to provide women a safe and effective alternative to the standard of care lumpectomy.
CustomersExpand
Growth-Negative
Here's Why We're Watching IceCure Medical's (NASDAQ:ICCM) Cash Burn Situation
IceCure Medical, a loss-making company, has a cash burn rate that is causing concern among its shareholders. The company had zero debt and cash worth US$17m as of June 2023, with a cash burn of US$15m over the trailing twelve months. This gives it a cash runway of approximately 14 months. Analysts predict that IceCure Medical will reach cashflow breakeven in 3 years. The company has trimmed its cash burn by 12% over the last twelve months, but a revenue dip of 10.0% in the same period is concerning. The companys cash burn relative to its market cap is high, which could lead to significant share dilution if it needs to raise more funds.
Investment
growth-negative
IceCure Medical Announces Receipt of Nasdaq Minimum Bid Price Notification
IceCure Medical Ltd., a developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing, has received a notice from Nasdaq Stock Market LLC indicating that the company is not in compliance with the minimum bid price requirement for continued listing. The company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. If the company does not regain compliance after the initial 180-day period, it may be eligible for an additional 180-day compliance period. If the company cannot demonstrate compliance by the allotted compliance period(s), Nasdaqs staff will notify the company that its ordinary shares are subject to delisting.
Public Trading
growth-positive
IceCure's ICE3 Trial Results Demonstrating 96.91% Recurrence Free Rate Featured in a Presentation at BISICON 2023 in India
IceCure Medical Ltd. participated in the 10th Annual Conference of the Breast Imaging Society of India (BISICON 2023) with its in-country distributor, Novomed. The companys ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, was featured at the event. The system was installed at Kovai Medical Center and Hospital in May 2023, where the first breast cancer cryoablation procedure in India was successfully conducted in June 2023. The companys ICE3 study of ProSense, the largest U.S. controlled multicenter clinical trial for liquid nitrogen-based cryoablation of early-stage breast cancer, is expected to be finalized in Q1 2024.
CustomersPartners
growth-positive
Independent Scientific Paper by Doctors Using IceCure's ProSense® Published in Journal of Breast Imaging Presents Advantages of Cryoablation Breast Conserving Over Surgery in Early Breast Cancer Patients
IceCure Medical Ltd. has announced that a scientific paper citing the interim results of its ICE3 clinical study has been published in the Journal of Breast Imaging. The paper highlights the safety and efficacy of the companys ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal. The papers co-authors include ProSense users, Dr. Robert C. Ward and Dr. Alexander B. Sevrukov. IceCures CEO, Eyal Shamir, expressed gratitude to the doctors who assessed the literature and published the paper.
Customers
growth-positive
Women Deemed Inoperable for Breast Cancer Benefitted from IceCure Medical's ProSense as an Independent Study Performed in Italy Showed a Tumor Reduction Rate of 93.43% to 96.81%
IceCure Medical Ltd, a developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, has announced that findings from an independent breast cancer study in Italy support the safety and efficacy of the Companys ProSense. The study was performed on 28 women who had biopsy-proven malignant lesions and were deemed inoperable. The study found that the ProSense system was effective in reducing tumor size and eliminating malignant cells, particularly in patients with Luminal-A tumors, the most common subtype of breast cancer.
Customers
growth-positive
Independent Study Validates IceCure's ProSense Cryoablation is Safe & Effective Outpatient Procedure for Breast Cancer with 96.8% Success Rate
IceCure Medical Ltd. has announced that new data was presented at the European Society of Breast Imaging Scientific Meeting in Valencia, Spain, showing the effectiveness of its ProSense System. The system uses minimally-invasive cryoablation technology to destroy tumors by freezing as an alternative to surgical tumor removal. The study was conducted with 31 patients with early-stage breast cancer who declined surgery. The results showed that cryoablation could be an effective alternative treatment to surgery for breast cancer in patients who reject surgery. The companys CEO, Eyal Shamir, stated that the data aligns with the interim results of their ICE3 study, which is expected to conclude in the first quarter of 2024.
Customers
growth-positive
Renowned Spanish Radiologist Lucía Graña-López to Present Data Using IceCure Medical's ProSense at European Society of Breast Imaging Scientific Meeting 2023
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced that Lucía Graña-López, MD, PhD, a Spain-based radiologist and user of ProSense, will be presenting data using the Companys ProSense at the European Society of Breast Imaging (EUSOBI) Scientific Meeting. The company looks forward to building more momentum with the commercialization of ProSense throughout Europe. The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
CustomersPartnersExpand
growth-negative
IceCure Medical Receives FDA Response to De Novo Classification Request for Breast Cancer
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, has announced that the U.S. Food and Drug Administration (FDA) has denied the companys De Novo Classification request for breast cancer. The request was based on interim analysis from its ICE3 study. The FDAs decision does not affect ProSenses FDA cleared authorization for other indications in the U.S. The company is pursuing all avenues to address the FDAs response as global adoption of ProSense outside of the United States continues to build.
CustomersManagement Changes
growth-positive
IceCure Medical to Join Hands-On Cryoablation Session with ProSense and Host Symposium Led by Renowned Doctors at the CIRCE 2023 Annual Congress
IceCure Medical, the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, is gaining commercial traction in Europe. The company will participate in the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) 2023 Annual Congress in Copenhagen, Denmark. IceCure will exhibit ProSense and provide hands-on demonstrations. The company is also sponsoring CIRSEs Supporting Women in IR Grant to encourage participation by women in interventional radiology.
CustomersPartnersExpand
growth-positive
IceCure Medical's ProSense Cryoablation System Receives Regulatory Approval in Brazil
IceCure Medical Ltd. has received regulatory approval from the Brazilian Health Regulatory Agency (ANVISA) for its ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal. The approval allows healthcare providers to conduct procedures with ProSense and its disposable probes, and IceCures distributor in Brazil, Ktrfios Importação e Exportação LTDA, is cleared to market and sell the products. The company expects the approval to translate into near-term revenues, with $6.6 million in sales expected in the Brazilian market over the next five years.
CustomersPartnersExpand
growth-positive
IceCure Medical Takes Next Major Initiative as it Prepares to Accelerate the Commercialization of ProSense in U.S. and Canada: Appoints VP of Sales, North America
IceCure Medical has appointed Shad Good as Vice President of Sales for North America. Good will be responsible for building out the sales infrastructure in anticipation of the broader commercialization of the companys ProSense System in the U.S. and Canada. Good brings nearly 20 years of medical device sales and leadership experience, including working with minimally invasive breast diagnostic and therapeutic systems. IceCure is awaiting the FDAs response to its regulatory filing for early-stage low-risk breast cancer and the final ICE3 results, both expected in 2024. The appointment of Good is seen as a positive step towards a well-executed go-to-market plan for ProSense.
Customers
growth-positive
IceCure Medical Continues to Experience Growing Global Interest in ProSense: Featured at the 16th Thai Breast Symposium
IceCure Medical participated in the 16th Thai Breast Symposium and exhibited the ProSense System, a minimally-invasive cryoablation technology for breast cancer treatment. The symposium highlighted cryoablation as an effective alternative to surgical tumor removal, with Professor Eisuke Fukuma leading the discussion. IceCures exclusive distributor, Terumo, showcased the ProSense System at their booth. The partnership between IceCure and Terumo Thailand was praised by Israels Ambassador to Thailand, Orna Sagiv, for its potential to improve womens health treatment. Terumo Thailands Managing Director, Panapon Chantakulchai, emphasized the growing sales momentum of ProSense in Thailand. IceCure expects to see increasing sales in the country.
Partners
growth-positive
IceCure Medical Second Quarter 2023 Earnings: EPS Misses Expectations
IceCure Medical has reported its second-quarter 2023 results, showing a 23% increase in revenue compared to the same period in 2022. The companys net loss also narrowed by 14%. However, the earnings per share (EPS) missed analyst estimates by 1.5%. IceCure Medical is forecasted to have an average annual revenue growth of 51% over the next three years, outperforming the Medical Equipment industry in the US. The companys share price has remained relatively stable. The article also mentions that there are five warning signs for IceCure Medical that investors should be aware of. The article concludes by stating that it is not intended to be financial advice and that Simply Wall St has no position in any stocks mentioned.
InvestmentManagement Changes
growth-positive
IceCure Medical Reports First Half 2023 Financial & Operational Results: Global Adoption of Cryoablation Technology Gaining Momentum
IceCure Medical Ltd. has reported a 9% increase in revenues to $1.65 million for the six months ended June 30, 2023. The company has successfully transitioned from a clinical stage to a commercial stage, receiving regulatory approvals for its ProSense System in Canada and China. IceCure has also entered into a new distribution agreement in Portugal and has seen a 92.8% efficacy in avoiding secondary surgery during a physician-sponsored cryoablation study of endometriosis. The company is awaiting FDAs response to its regulatory filing for early-stage low-risk breast cancer in patients who are at high risk for surgery.
CustomersPartnersExpand
Neutral
IceCure Medical to Report Second Quarter 2023 Financial & Operational Results on August 14, 2023
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing, announced that it will release its financial and operational results for the six months ended June 30, 2023. The results will be released with a press release prior to the market open on Monday, August 14, 2023, and a conference call will be hosted at 10:00 a.m. EDT that day to discuss the results and corporate developments. Dr. Robert Ward, a ProSense user and specialist in womens imaging and breast tumor cryoablation, will join the IceCures management team for the conference call.
Management Changes
growth-positive
IceCure Medical's (NASDAQ:ICCM) investors will be pleased with their enviable 577% return over the last three years
IceCure Medical Ltds share price has soared 577% in three years, with a 1.3% increase in the last week. Despite the company making a loss in the last twelve months, the market is more focused on revenue and revenue growth. Over the last three years, IceCure Medicals revenue has grown at 3.0% per year. The companys share price gain has been strong, at 89% per year, compound, over three years. The recent sell-off could be an opportunity if the business remains sound.
Public Trading
growth-positive
Health Canada Approves IceCure Medical's Minimally Invasive ProSense Cryoablation System
IceCure Medical Ltd. has received approval from Health Canada for its ProSense System, disposable cryoprobes, and introducers as cryosurgical tools for various indications. The approval will allow IceCure to expand its activities into Canada, creating synergies in the broader North American market. The company has already been contacted by multiple Canadian healthcare providers with requests to purchase and implement ProSense. IceCures cryoablation system currently has regulatory approval for various indications in 15 countries, including the U.S., Europe, and China.
CustomersExpand
growth-positive
IceCure Medical Expands Distribution of ProSense® into Portugal Through Agreement with Medicinália Cormédica: Upfront Systems & Probes Sales
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, has entered a non-exclusive distribution agreement with MC Medical, the largest distributor of third-party medical devices in Portugal. The agreement will expand the distribution of IceCures ProSense System in Europe. MC Medicals initial purchases include two ProSense consoles, along with disposable cryoprobes and introducers. This will enable healthcare professionals in Portugal to perform precise and minimally invasive cryoablation procedures for various indications.
PartnersExpand
growth-positive
IceCure Medical to Review Recent Progress at Maxim Group's Virtual Healthcare Conference
IceCure Medical will participate in Maxim Group LLCs Healthcare Virtual Conference to present the ProSense Cryoablation System and discuss promising interim results from the ICE3 clinical trial. The companys CEO will highlight the advantages of the technology and its successful use in treating early-stage low-risk breast cancer. IceCure aims to tap into the growing tumor ablation market, which is projected to reach $2.4 billion by 2028. The company has regulatory approvals in over 15 markets and a number of distribution agreements. The presentation will take place on June 21st.
CustomersInvestment
growth-positive
IceCure's ProSense Installation in India is the First to Offer Cryoablation for the Treatment of Breast Cancer in the Country
IceCure Medical has announced the installation of its ProSense System at Kovai Medical Center and Hospital in Coimbatore, India. This marks the first instance of cryoablation for breast cancer treatment being offered in the country. The event was attended by Tammy Ben Haim, Consulate General of Israel, and several executives and doctors from KMCH. IceCures ProSense System is a minimally-invasive cryoablation technology that destroys tumors by freezing, providing an alternative to surgical tumor removal. The company aims to make cancer treatment safer and more effective by offering minimally invasive solutions. IceCure has a productive relationship with its in-country distributor in India and plans to participate in the 10th Annual Conference of the Breast Imaging Society of India later this year.
Customers
growth-negative
IceCure Medical Ltd. (ICCM) Reports Q1 Loss, Lags Revenue Estimates
IceCure Medical Ltd. reported a quarterly loss of $0.08 per share, beating the Zacks Consensus Estimate of a loss of $0.09. However, the companys revenues of $0.71 million missed the estimate by 25.26%. The stock has underperformed the market, and the earnings outlook is unfavorable, resulting in a Zacks Rank #4 (Sell) for the stock. The industry rank for Medical Services is in the top 48%. A competitor in the same industry, HealthEquity, is expected to report positive earnings growth. IceCure Medical Ltd. is a provider of medical services.
Public Trading
growth-positive
IceCure Medical Reports First Quarter 2023 Financial & Operational Results
IceCure Medical Ltd., the developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, has reported financial results for the three months ended March 31, 2023. The company has seen increased interest in ProSense among breast surgeons, breast radiologists, and interventional oncologists globally, particularly in the U.S. The company has also received regulatory approval in China for commercial use of disposable cryoprobes. An independently conducted endometriosis study showed 92.8% efficacy in avoiding secondary surgery. The companys cash position at the end of the quarter remains strong at over $20 million.
CustomersPartnersExpand
growth-positive
IceCure to Report First Quarter 2023 Financial & Operational Results on May 22, 2023
IceCure Medical Ltd. will release its financial and operational results for the first quarter of 2023 and host a conference call to discuss the results and corporate developments. IceCure Medical develops and markets ProSense®, a cryoablation therapy for the treatment of tumors. The companys technology is a safe and effective alternative to surgical tumor removal and is marketed worldwide. The press release contains forward-looking statements regarding the scheduling of the conference call and reporting of financial results. IceCure Medical is focused on growth and market expansion in the field of tumor treatment.
Investment
growth-negative
The Beauty Health Company (SKIN) Reports Q1 Loss, Misses Revenue Estimates
The Beauty Health Company reported a quarterly loss that was worse than expected, resulting in a negative impact on the companys growth. The companys earnings per share were $0.04, compared to the estimated loss of $0.02. The companys revenues also fell short of expectations. Despite this, the companys stock has performed well compared to the overall market. The future outlook for the company will depend on managements commentary on the earnings call. The Beauty Health Company is expected to outperform the market in the near future, based on favorable estimate revisions. However, the industry outlook for Medical Services is currently weak. IceCure Medical Ltd., a competitor in the same industry, is also expected to report quarterly losses.
CustomersInvestment
growth-positive
Cryoablation Takes Center Stage at American Society of Breast Surgeons' 24th Annual Meeting
IceCure Medical participated in the American Society of Breast Surgeons 24th Annual Meeting, resulting in high levels of interest in their ProSense cryoablation system. The ASBrS leadership mentioned cryoablation favorably and a plan for a proposed ASBrS Cryoablation trial was presented during a CME course. IceCure received a high level of interest from attending surgeons and expressed optimism about the adoption of cryoablation as a minimally invasive method for breast cancer patients. The company develops and markets ProSense, a cryoablation therapy for the treatment of tumors. IceCures participation in the event indicates growth-positive impact on the company.
CustomersPartners
growth-positive
IceCure Medical to Provide Educational Support in a First-of-its-Kind Cryotherapy Course at the American Society of Breast Surgeons' 24th Annual Meeting
IceCure Medical is providing educational support for a CME course on cryotherapy at the American Society of Breast Surgeons 24th Annual Meeting. The course will feature the use of IceCures ProSense System for hands-on training. The course will highlight the previously published interim results from IceCures ICE3 trial, which demonstrated low cancer recurrence rates following treatment with ProSense. IceCure is awaiting FDA approval for marketing authorization of ProSense. The company believes that the strong interim data, combined with physician education, will lead to the accelerated adoption of ProSense as a non-surgical option for early-stage breast cancer patients.
PartnersCustomers
growth-positive
IceCure's ProSense System Used in Endometriosis Cryoablation Study That Demonstrated Efficacy Rate of 92.8% to Avoid Secondary Surgery
IceCure Medicals ProSense system was used in a study on cryoablation for endometriosis treatment. The study concluded that cryoablation is a safe and effective procedure that significantly reduces pain and obtains local control of endometriosis. The ProSense system has regulatory approval in several countries and is considered an effective minimally invasive treatment for endometriosis.
Customers
growth-negative
IceCure Medical Ordinary Shares to Trade Exclusively on Nasdaq: Company to Voluntarily Delist Shares from Trading on the Tel Aviv Stock Exchange
IceCure Medical Ltd. has announced that it will voluntarily delist its ordinary shares from the Tel Aviv Stock Exchange (TASE) and continue trading on the Nasdaq Capital Market. The delisting is expected to reduce redundant listing costs and allow the company to focus on its efforts in the U.S. capital markets. IceCure develops minimally-invasive cryoablation technology for tumor treatment and believes that its unique cryoablation technologies have the potential to provide enhanced patient outcomes in the U.S. healthcare market. The delisting from the TASE will not affect the companys continued listing on Nasdaq. IceCure values its TASE investors and expresses gratitude for their ongoing support.
Public Trading
growth-negative
IceCure Medical Ordinary Shares to Trade Exclusively on Nasdaq: Company to Voluntarily Delist Shares from Trading on the Tel Aviv Stock Exchange
IceCure Medical Ltd. has announced that it will voluntarily delist its ordinary shares from the Tel Aviv Stock Exchange (TASE) and focus on trading exclusively on the Nasdaq Capital Market. The delisting in Israel will not affect the companys continued listing on Nasdaq. IceCure develops and markets cryoablation technology for the treatment of tumors and believes that its unique cryoablation technologies have the greatest potential in the U.S. healthcare market. The company values its TASE investors and will continue to operate in Israel from an operational, developmental, and strategic perspective.
Public Trading
IceCure Medical Ltd (NASDAQ:ICCM) Q4 2022 Earnings Call Transcript
growth-positive
IceCure Medical Reports 2022 Full Year Financial Results & Recent Corporate Developments; Milestone Achievements Expected to Drive Revenue Growth in 2023
IceCure Medical Ltd. reported its financial results for the year ended December 31, 2022, highlighting a year-over-year consumable revenue growth due to the rising utilization of its ProSense system in the U.S. market. The company also received regulatory approval in China for commercial use of its IceSense3 Disposable Cryoprobes. IceCure also signed an exclusive distribution agreement with Shanghai Medtronic Zhikang Medical Devices Co. Ltd. for the sale of its cryoablation system and cryoprobes in China. The company raised $14.5 million in December 2022 to expand its global marketing footprint.
PartnersInvestment
growth-positive
IceCure Medical Receives Regulatory Approval in China for Commercial Use of its IceSense3 Disposable Cryoprobes
IceCure Medical Ltd. has received approval from the National Medical Products Administration (NMPA) of China for the commercial use of its IceSense3 disposable cryoprobes. The cryoprobes will be used in combination with the companys IceSense3 console, which was previously approved by the NMPA. IceCure and its partners in China, including Shanghai Medtronic Zhikang Medical Devices Co. Ltd. and Beijing Turing Medical Technology Co. Ltd., can now address the Chinese market with their cryoablation technology for the treatment of malignant and benign tissue in various organs. The company sees China as a prime market for its cryoablation system, especially for breast cancer cases. IceCure expects to effectively monetize its distribution agreement in China.
CustomersPartners
growth-positive
IceCure Medical to Report 2022 Full Year Financial & Operational Results on March 29, 2023
IceCure Medical Ltd. will release its full year financial and operational results for the twelve months ended December 31, 2022. The company will host a conference call to discuss the results and corporate developments. IceCure develops and markets ProSense®, a cryoablation therapy for the treatment of tumors. The therapy is a safe and effective alternative to surgical tumor removal. The system is marketed and sold worldwide. The companys forward-looking statements discuss the timing for reporting its financial and operational results.
Public Trading
7 Speculative Penny Stocks to Bet On This March
growth-negative
IceCure Medical Announces Preliminary Unaudited 2022 Year-End Financial Results & Recent Operational Highlights
IceCure Medical Ltd., a developer of cryoablation technology, announced preliminary unaudited year-end financial results for 2022. The companys revenues decreased to $3.1 million in 2022, compared to $4.1 million in 2021, due to decreased revenue recognition and a decrease in sales in most territories. However, there was a 28% increase in U.S. sales and higher sales of disposable probes. IceCure also raised $14.5 million in an equity financing funding. The company is awaiting a response from the FDA on regulatory clearance for its ProSense system in early-stage breast cancer. IceCures cash and cash equivalents totaled $23.6 million as of December 31, 2022. The company plans to report full audited financial results later.
CustomersInvestment
growth-negative
IceCure Medical Announces Preliminary Unaudited 2022 Year-End Financial Results & Recent Operational Highlights
IceCure Medical Ltd., a developer of cryoablation technology, announced preliminary unaudited year-end financial results for 2022. Revenues decreased compared to the previous year due to decreased revenue recognition and a decrease in sales in most territories. However, there was a 28% increase in U.S. sales and higher sales of disposable probes. The companys cash and cash equivalents totaled $23.6 million as of December 31, 2022. IceCure raised $14.5 million in an equity financing funding. The company is awaiting a response from the FDA on regulatory clearance for ProSense in early-stage breast cancer. IceCure plans to report full audited financial results and continues to focus on regulatory achievements, clinical results, and commercialization.
CustomersInvestment
growth-positive
IceCure's ProSense Featured in Breast Session at the Society of Interventional Oncology's Annual Scientific Meeting in Washington, D.C.
IceCure Medical Ltd. participated in the Society of Interventional Oncologys Annual Scientific Meeting, showcasing its ProSense cryoablation system. The system was featured in a panel discussion on breast cancer treatment and the ICE3 interim trial results. Doctors expressed growing interest in ProSense, which could lead to the development of new patient markets and increased accessibility to minimally invasive procedures. IceCure Medical develops and markets ProSense, a liquid-nitrogen-based cryoablation therapy for the treatment of tumors. The companys technology is a safe and effective alternative to surgical tumor removal and is used for various types of cancer.
CustomersPartners
growth-positive
IceCure's ProSense Presented in Hands-On Training Course at The American Society of Breast Surgeons Breast Follows Ultrasound Course
IceCure Medical Ltd, a developer of minimally-invasive cryoablation technology, participated in the American Society of Breast Surgeons (ASBrS) Breast Fellows Ultrasound Course in Cincinnati, Ohio, on January 13-14, 2023. The course was organized by ASBrS and moderated by investigators from the West Cancer Center, who are also involved in IceCures ICE3 ProSense trial. The companys ProSense system, which destroys tumors by freezing, was well received by course participants. IceCures CEO, Eyal Shamir, highlighted the importance of clinician training in advancing the standard of care for breast cancer and supporting the commercial rollout of cryoablation for breast procedures.
PartnersCustomers
growth-positive
U.S. Patent Office Grants Notice of Allowance to IceCure for Novel Cryogenic Pump for Next-Generation Cryoablation Systems
IceCure Medical Ltd. has received a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application titled Cryogen Pump. The patent will be in effect until February 2040 and was recently granted in the European Union and allowed in Japan. The cryogenic pump enables IceCure to bring to market a new generation of cryoablation systems with a small footprint for a wide range of clinical applications. This development is expected to have a positive impact on the companys growth. IceCures CEO stated that the patent is well-timed to protect their intellectual property as they develop new cryoablation systems for new indications. The companys ProSense system is gaining commercial traction in the U.S., particularly in breast cancer treatment. The cryogenic pump expands IceCures product portfolio and allows for improved cooling rate and longer duration procedures without the need to refill liquid nitrogen.
Customers
growth-positive
IceCure Receives Notice of Patent Allowance in Japan for a Novel Cryogenic Pump for its Next-Generation Cryoablation Systems
IceCure Medical has received a Notice of Allowance from the Japan Patent Office for its patent application titled Cryogen Pump. The patent will be in effect until 2041. The cryogenic pump developed by IceCure is submersible in liquid nitrogen and works in a closed circuit, improving the cooling rate during procedures. It enables longer duration procedures without the need to refill liquid nitrogen and allows for temperature control of the cryoprobe. The patent supports IceCures distribution agreement with Terumo for its cryoablation systems in Japan. IceCure is a global leader in cryoablation technologies and develops the ProSense System for tumor destruction through freezing.
Partners
growth-positive
IceCure Medical Ltd. Announces Proposed Public Offering
IceCure Medical Ltd. has announced the commencement of a proposed public offering of its ordinary shares. The company intends to use the net proceeds from the offering for the development of its next generation systems, collecting clinical data, adding regulatory approvals, business development, marketing and selling activities, as well as for working capital and general corporate purposes. A.G.P./Alliance Global Partners and Brookline Capital Markets are acting as placement agents for the offering. The offering is subject to market conditions and there is no assurance as to whether or when it may be completed or the actual size or terms of the offering.
Investment
growth-positive
העתיד של הטיפול בסרטן: מערכת ProSense™ של IceCure Medical - מדיקו
Israeli biomed company IceCure Medical has developed a minimally invasive medical device for the treatment of breast cancer, the most common cause of death among women. The device freezes the cancerous cell using liquid nitrogen, eliminating the need for surgery. The procedure lasts between 20 to 40 minutes, with no hospitalization or pain. The treatment is recommended for primary cancer that is still less than 2 cm. The technology is available in several hospitals in Israel and the company aims to make the treatment accessible to women with early-stage breast cancer worldwide.
CustomersExpand
growth-positive
"אייסקיור נמצאת בנקודה הכי מעניינת של חברת מכשור רפואי" - Techtime - חדשות אלקטרוניקה והייטק
IceCure, a company that developed a system for destroying cancerous growths by freezing them with liquid nitrogen, is preparing for a significant phase in the marketing of its technology. The company recently applied to the FDA for marketing approval of its system, ProSense, for treating patients diagnosed with early-stage breast cancer. IceCure has already been marketing the ProSense system for several years for different types of cancer. However, receiving FDA approval for the current application would open up the companys most significant target market: patients with breast cancer in the United States. IceCure has also recently added Gilad Glick, former CEO of Itamar Medical, to its team to help build the companys marketing and sales infrastructure in the United States and formulate its market entry strategy.
PartnersExpand
growth-positive
IceCure Medical, Shanghai Medtronic & Turing Medical Sign Distribution Agreement in Mainland China
IceCure Medical Ltd. has signed an exclusive distribution agreement with Shanghai Medtronic and Turing for its IceSense3 cryoablation systems in mainland China. Shanghai Medtronic will be the exclusive distributor for an initial period of three years, with a minimum purchase target of $3.5 million. The first systems are expected to be delivered in 2022. IceCure aims to receive regulatory approval for its disposable probes by the end of 2022. The partnership with Shanghai Medtronic and Turing is expected to help IceCure penetrate the Chinese market and provide a safe and cost-efficient treatment for early-stage breast cancer and other indications. IceCures CEO, Eyal Shamir, expressed optimism about the collaboration and the opportunity to improve outcomes for tumor patients in China.
Partners
Growth-Positive
IceCure Medical Receives Notice of Intention to Grant a European Patent Covering Its Cryogenic Pump
IceCure Medical Ltd., an Israel-based developer of minimally-invasive cryoablation technology, has received notification from the European Patent Office (EPO) of an intention to grant a patent for its cryogenic pump. The patent, which will be in effect until 2041, will protect IceCures proprietary cryogenic pump, a key component of its next-generation cryoablation systems. The pump is designed to be used for multiple or long-term procedures without the need to refill liquid nitrogen, and enables temperature control of the cryoprobe, use of a wider range of cryoprobes and catheters, and improved cooling rate during a procedure.
Investment
growth-positive
IceCure Medical Ltd. Closes $17 Million Underwritten Public Offering and Partial Exercise of Over-Allotment Option
IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology, has closed its underwritten public offering of nearly 4 million shares at $3.45 per share, raising approximately $17 million. The company plans to use the net proceeds for new product development, business development, working capital, and general corporate purposes. A.G.P./Alliance Global Partners acted as the sole book-running manager for the offering, with Brookline Capital Markets acting as a co-manager.
InvestmentPublic Trading
growth-positive
IceCure Medical Announces New Independent Data Published in the Journal of Cancer Therapy Showing that Percutaneous Cryoablation Presents a Potential Substitute for Lumpectomy for Tumors 15mm using ProSense™
IceCure Medical Ltd. has announced the publication of a peer-reviewed article that supports the use of its ProSense Cryoablation System to eliminate small malignant lesions in the breast. The independent study was conducted in Japan and enrolled eight female patients diagnosed with invasive ductal carcinoma (IDC) tumors. The procedure was performed using IceCures ProSense, under local anesthesia without the need of subsequent resection. The study concluded that cryoablation shows feasibility for the elimination of small malignant lesions in the breast, with promising safety prospects.
Customers
growth-positive
אייסקיור מדיקל תחל להיסחר ב-Nasdaq היום
IceCure Medical, an Israeli medical equipment company, has announced that its shares have been approved for trading on Nasdaq. The companys shares will begin trading for the first time on August 26, 2021, under the symbol ICCM. The companys securities will continue to be traded on the Tel Aviv Stock Exchange under the symbol ASKM. The listing on Nasdaq is expected to significantly increase the companys exposure to the global and American investor community, increase the liquidity of the companys shares, and allow access to investors and analysts specializing in the companys field of activity.
Public Trading
growth-positive
IceCure Medical Announces Exclusive $6.6M Distribution Agreement to Sell ProSense™ Cryoablation System in Brazil
IceCure Medical has entered into an exclusive distribution agreement with KTRFIOS IMPORTACAO E EXPORTACAO LTDA to sell the Companys ProSense Cryoablation System in Brazil. The agreement carries a duration of five years and guarantees at least $6.6 million in total sales. IceCure aims to bring its technology to all geographies and increase sales. Brazil, with a population of over 200 million and a high number of cancer cases and deaths, presents a significant market for minimally invasive cancer treatments. IceCure is confident that ProSense, upon regulatory approval, can provide a cost-effective and simple procedure for cancer patients in Brazil.
Partners
growth-positive
אייסקיור כבר שווה 1.2 מיליארד שקל: מי הרוויחו 900% בחודשיים?
IceCure, an Israeli medical equipment company, has seen a significant increase in its stock value, rising by more than 300% since April, and reaching a company value of 1.2 billion shekels. This has resulted in a substantial return for a group of investors who agreed to invest $15 million in the company in January. The company, which has developed a method for selectively freezing tumours, primarily cancerous ones, saw a 130% increase in revenue in 2020, despite the decrease in elective medical procedures during the pandemic. IceCure is also planning to list on NASDAQ in the third quarter of 2021.
InvestmentPublic Trading
growth-positive
IceCure Reports Positive Results In Tumor-Freezing Breast Cancer Trial
Israeli biomedical company IceCure Medical has announced positive results from a clinical trial of its ProSense system for cryoblation of small low-risk breast cancer tumors. The ProSense system uses liquid nitrogen to freeze tumors, leaving healthy tissue untouched. The trial, which began in 2014, involved 194 patients and was conducted in 19 hospitals and medical centers across the US. The company reported that 2.06% of patients experienced cancer recurrence after treatment, indicating a high rate of success. IceCure expects to have follow-up data from a significant number of patients by June 2021.
Customers
growth-positive
Israel's IceCure granted FDA Breakthrough Medical Device designation
IceCure Medical Ltd., a company that develops tumor-freezing technology, has received a breakthrough medical device designation from the U.S. FDA for its ProSense technology. This designation puts the company on the fast track for final approval. The ProSense technology uses an ultrasound imaging-guided probe to inject liquid nitrogen into a tumor, freezing its tissue in a process called cryoablation. The destroyed tumor cells are then reabsorbed in the body over time. The technology is capable of treating early detected, low risk cases of breast cancer.
CustomersExpand
growth-positive
IceCure Signs Exclusive Distribution Agreement with Rise General Trading, LCC, Expanding Market Reach Across the Middle East
IceCure Medical Ltd. has announced an exclusive distribution agreement with Rise General Trading, LLC for IceCures ProSense Cryoablation System in the United Arab Emirates and Arabian Gulf States. Under the agreement, Rise General Trading will purchase approximately $16 million USD of IceCures products over three years. The first purchase order will be executed within three months after the receipt of all regulatory licenses necessary for the sale of IceCures products in the first territory. This partnership allows IceCure to significantly expand into several new, high growth opportunities.
PartnersExpand
growth-positive
אייסקיור מדיקל גייסה 15 מיליון דולר בהנפקה פרטית ופועלת לרישום בנאסד"ק
IceCure Medical, a company that markets technology for the destruction of benign and cancerous tumors in the breast and other organs, has announced a private placement of about $15 million from three qualified investors: European investment fund Alpha Capital, Clover Wolf and Clover Alpha funds, and the companys controlling shareholder. The company also decided to register for trading on NASDAQ. The funds will be used to increase marketing efforts of the companys products in existing and new markets, to accelerate development and promote obtaining additional regulatory approvals in target markets.
InvestmentPublic Trading
growth-positive
IceCure Inks Expanded Distribution Agreement with Terumo Corporation for Thailand
IceCure Medical has signed an expanded distribution agreement with Terumo Corporation in Thailand, building on their previous successful partnership in Japan and Singapore. The agreement grants Terumo exclusive rights to distribute IceCures cryoablation products in Thailand for six years, with an option to extend for another six years. IceCure has received approval from the Thai government to market their products for the treatment of benign and malignant tumors. The agreement includes a payment of $450,000 from Terumo to IceCure. IceCure aims to expand its global activities in 2021 through strengthening business relations with strategic partners and obtaining additional regulatory approvals.
Partners
growth-positive
https://www.jpost.com/health-science/israeli-company-successfully-freezes-breast-cancer-tumors-647089
Israeli med-tech company IceCure Medical has reported promising early results from US clinical trials of its innovative breast cancer treatment. The treatment uses a liquid nitrogen technology to freeze and destroy tumours. The company is nearing the end of a major clinical trial across US hospitals, having already treated hundreds of women. The interim results of the trial, which includes 206 patients across 19 hospitals, are set to be presented in mid-2021. Despite the ongoing COVID-19 pandemic, IceCure has continued to expand into new markets, recently receiving regulatory approval in Taiwan and Russia.
CustomersExpand
growth-positive
אייסקיור קיבלה אישורים לשיווק מוצריה בטאיוון וברוסיה
IceCure Medical, a medical device company that markets technology for the destruction of benign and cancerous tumors, has received regulatory approvals in Russia and Taiwan for the marketing and use of its ProSense product. The company has distributors in these countries with whom it has signed agreements. The regulatory approvals, which are for an indefinite period, allow the use of the companys products for treatment by freezing benign and cancerous tumors in a variety of medical indications. The company also reported a gross profit of 4.1 million NIS, 8.5 times higher than the gross profit in the same period in 2019 and more than double the gross profit of all of 2019.
PartnersExpand
growth-positive
Kidney tumors destroyed by outpatient cryoablation system
Israeli company IceCure Medical has reported a 100% success rate in a trial of its non-surgical liquid nitrogen cryoablation technology on seven kidney cancer patients whose surgically removed tumors had reoccurred. The technology, which destroys benign and malignant tumors, is an alternative to surgical tumor removal and can be performed as a short outpatient procedure. IceCures ProSense cryoablation system is available worldwide after receiving FDA and CE approvals. The company recently completed a $6 million equity offering and plans to continue expanding its operations in the US, Europe, and Asia.
CustomersInvestment
growth-positive
IceCure expands Asian distribution agreement to $20m
Israeli cancer treatment company IceCure Medical Ltd. has expanded its Asian distribution agreement with Japans Terumo Corp. to $20 million. Terumo will also operate exclusively in Thailand to distribute IceCure products worth $7.2 million over six years. The new agreement will grant Terumo exclusive rights to distribute IceCure’s products in Thailand for six years, with an option to extend the agreement for an additional six years. IceCure recently reported that it tripled its revenue in the first half of 2020 compared to the same period last year.
PartnersExpand
growth-positive
IceCure raises NIS 20.7m in TASE offering
IceCure Medical Ltd., an Israeli company specializing in non-surgical tumor freezing and eradication, has completed a NIS 20.7 million equity share offering on the Tel Aviv Stock Exchange. The offering was oversubscribed, with demand reaching NIS 24 million. The capital raising was supported by several investors including Rosario Capital and Yair Capital Offerings. The company also reported strong initial results for the first half of 2020, with revenue totaling about NIS 6.5 million, three times higher than the first half of 2019 and 13% higher than total revenue in 2019.
Investment
growth-positive
Israeli ice device destroys malignant liver and kidney tumors
IceCure Medical, a Caesarea-based company, has expanded the applications of its ProSense system, a device that uses minimally invasive cryoablation to destroy tumors by freezing them. The device is currently used in Asia, Israel, and Europe to treat early-stage cancerous liver and kidney tumors. IceCure recently received US FDA approval to use the device in the United States. The company is also working towards gaining FDA approval for using ProSense to treat cancerous breast tumors. IceCure has also started registration in China and received its first order from a leading Chinese hospital.
CustomersExpand
growth-positive
IceCure Receives Additional FDA Clearance For Its Cancer Freezing Technology
Tel Aviv-listed medtech company IceCure Medical Ltd. has received clearance from the U.S. Food and Drug Administration (FDA) to use its tumor-freezing technology on additional types of cancers. The company, which was already cleared to use its technology on breast cancer patients, can now market its technology in the U.S. for the treatment of cancerous and benign tumors of the kidney, liver, ear, nose, and throat.
CustomersExpand
Israel's IceCure says gets FDA nod to treat tumors in liver, kidney
https://www.ptcommunity.com/wire/icecure-medical-appoints-medical-device-veteran-sharon-levita-its-board-directors
growth-positive
Cancer Freezing Company IceCure Signs Partnership With Oregon Hospitals
IceCure Medical Ltd., a Tel Aviv-listed cancer freezing company, has successfully used its technology in a procedure on a breast cancer patient in Oregon. This is part of a new partnership with Legacy Health Good Samaritan, a non-profit organization that operates several hospitals in Portland. IceCures device, which injects liquid nitrogen into a tumor to freeze it, was first used in Japan and has treated over 300 patients since 2013. The device is also used in several European countries, Singapore, Thailand, New York, and Israel.
PartnersExpand
growth-positive
IceCure Medical Announces Landmark Strategic Deal With Global Medical Company, Terumo Corporation
IceCure Medical Ltd. has announced an exclusive distribution agreement with Terumo Corporation. The agreement will accelerate the commercialization of IceCures ProSense cryoablation system and associated consumables to treat malignant breast tumors in Japan and Singapore. Terumo will commit up to $2 million, including a one-time, up-front payment of $1 million to IceCure 30-days after signing the agreement and the remainder in milestones. Terumo will also purchase 10 ProSense system consoles and consumables for use in clinical trials to support regulatory filing.
PartnersInvestment
growth-positive
Tokyo-Listed Terumo Signs Distribution Deal With Cancer Freezing Company IceCure
IceCure Medical Ltd. has signed a distribution agreement with Terumo Corp. for the licensing, import, marketing, and distribution of its tumor-freezing product in Japan and Singapore. The first order from Terumo is expected to be at least $13.2 million.
Partners
growth-positive
Another Success: IceCure Receives Israeli AMAR Approval for Use of its Freezing Technology in Specific Indications, Following an Earlier General Approval
IceCure Medical Ltd., an Israeli medical device company, has received Israeli AMAR authorization for the use of its minimally-invasive cryoablation technology to treat malignant and benign tumors. This approval allows the company to market its product for specific procedures, including the freezing of benign and malignant tumors in the breast, lungs, bones, liver, lymphatic tissue, lymph nodes, and endocrine glands. This follows a recent approval from the American Medical Association that enables providers to apply for reimbursement for procedures using cryoablation therapy for ablating malignant breast tumors.
CustomersExpand
growth-positive
IceCure breast tumor therapy awarded US medical code
Israeli cancer treatment company IceCure Medical Ltd. has been awarded a new Category III CPT code from the American Medical Association for its breast cryoablation therapy. The code is expected to support further adoption of minimally invasive cryoablation treatments for breast cancer. IceCures CEO Eyal Shamir said the new code is a significant milestone for the company. The company is also in discussions with the US Food and Drug Administration to expand the use of its flagship cryoablation system, ProSense.
CustomersPartners
Growth-Positive
IceCure Medical Announces New Category III CPT Code for Breast Cryoablation Therapy, Issued by the American Medical Association
IceCure Medical Ltd., an Israeli company that develops cryoablation technology for treating tumors, has received approval from the American Medical Association for a new CPT code for its cryoablation therapy for breast cancer. The new code will support better tracking of the use of these procedures and enable providers to apply for reimbursement. The company is also in discussions with the FDA to expand the use of its ProSense cryoablation system for treating cancerous breast tumors. The system is already cleared by the FDA for treating non-cancerous breast tumors.
CustomersPartners
growth-positive
Israeli Company Destroys Cancerous Tumors By Freezing Them - JOY! News
IceCure Medical, an Israeli company, has developed a non-invasive cancer treatment system called ProSense™. The system uses liquid nitrogen to freeze tumors, destroying them while leaving surrounding tissue unharmed. ProSense™ has been approved by the FDA and CE and is available in multiple countries. The treatment is quick, painless, and allows patients to go home the same day. IceCure Medical CEO Eyal Shamir stated that the treatment eliminates the entire tumor without scarring or changing the shape or size of the breast. The company has conducted successful clinical trials on breast cancer patients, and the findings were presented at a conference for surgeons and decision makers in the oncology field. ProSense™ is also being used to treat renal, lung, and bone cancer.
Customers
growth-positive
Israeli Company Destroys Cancerous Tumors by Freezing Them
Israeli company IceCure Medical is offering a new method of treating cancer by freezing tumors with liquid nitrogen. Their non-invasive ProSense system is FDA and CE approved and is available in the United States, Europe, Asia, and South America. The system works by inserting a thin probe into the tumor and injecting it with a -274 degrees Fahrenheit liquid nitrogen solution. This destroys the tumor but leaves surrounding tissue unharmed. The body then absorbs the dead tumor. The treatment can take up to an hour and the only pain medication needed is local anesthesia. Many patients can go home the same day of the procedure.
Customers
growth-positive
WATCH: Israeli technology puts cancer cells on ice World Israel News
Icecure Medical, an Israeli company, has developed a new treatment for cancer cells that freezes them to minus-240 degrees Fahrenheit, rendering the cells inactive. The treatment is so non-invasive that patients can even go home on the same day or the day after the procedure.
Customers
growth-positive
IceCure Medical touts interventional radiology cryoablation study data
IceCure Medical has released data from a study of its ProSense cryoablation system, which uses liquid nitrogen technology to treat benign and cancerous tumors. The study, presented at the Annual European Association of Urology Congress, involved 75 patients with small kidney masses. The data indicated a 93% treatment success rate, suggesting the system is a safe and effective treatment for small kidney tumors. The ProSense system offers a non-surgical alternative for treating cancer of the kidney, lung, bone, and prostate.
Customers
growth-positive
IceCure Medical Presents Promising Results from First-ever Interventional Radiology Study With Its Next Generation Liquid Nitrogen (LN2) Cryoablation System, ProSense™
IceCure Medical, a developer of cryoablation technology, announced promising results from its interventional radiology study on the ProSense system for treating kidney tumors. The study reported that the system was safe and effective, with a 93% treatment success rate at 1-year follow-up. IceCure Medical plans to expand the use of the ProSense system in interventional oncology for the treatment of various cancers. The company will provide a hands-on demonstration of the technology at an upcoming conference. IceCure Medical develops and markets minimally-invasive cryoablation therapies for womens health and the interventional oncology market.
Customers
growth-positive
Cryoablation may be promising alternative to surgery for low-risk breast cancer
Preliminary findings from the Ice 3 trial suggest that cryoablation could be an effective primary treatment for women with low-risk breast cancer. The trial, which included women aged 60 years and older across 20 centers in the U.S., showed a success rate higher than 98% with no serious adverse events reported. Kenneth R. Tomkovich, MD, radiologist at Princeton Radiology, believes that if these positive preliminary findings are maintained, it could indicate the promise of cryotherapy as an alternative treatment for a specific group of breast cancer patients.
Customers
growth-positive
Cancer Freezing Company IceCure Raises Just Third of Planned Offering
IceCure Medical Ltd., a company that develops an ultrasound imaging-guided probe for tumor treatment, has raised $980,000 in a public offering, falling short of its target of $2.43 million. The company, which was aiming to sell 10% of its securities, has a valuation of $24.3 million. Despite the shortfall, the company reported a 68% increase in revenues in 2018 and assets worth $6.2 million.
Investment
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Cancer Freeze-Blasting Company Seeks to Expand Market Foothold
IceCure Medical Ltd., a company that develops devices for freezing and destroying tumours, has seen a significant increase in device sales over the past seven months. The company, which is controlled by a founder of Tencent, is planning to expand its marketing efforts and connect with US health insurers. IceCures device uses ultrasound imaging to guide a probe that injects liquid nitrogen into a tumour. The company has raised $8m to date, with $5.3m coming from main shareholder Vic Lee in February. IceCure is now focusing on market penetration, having previously concentrated on collecting clinical data and development.
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US-guided breast cryoablation offers new treatment option
A study conducted by CentraState Medical Center is evaluating the effectiveness of ultrasound-guided cryoablation as an alternative treatment for breast cancer. Cryoablation involves freezing cancer cells to destroy them and has been used for cancer treatment in other parts of the body. The study, called the Ice3 trial, currently includes 18 centers across the U.S. and has shown promising results. Only one out of 180 patients in the trial has had a cancer recurrence, resulting in a success rate of 99.4% for ultrasound-guided cryoablation. If the positive findings continue, cryoablation could offer a less-invasive option for a specific group of breast cancer patients. Final results of the study will be published when five-year follow-up data are available.
Customers
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US surgeons back IceCure breast tumor technology
The American Society of Breast Surgeons (ASBS) has updated its guidelines to recommend surgeons participate in clinical trials for treating malignant breast tumors, which supports the use of IceCure Medicals cryoablation technology. IceCures technology treats benign and malignant cancer tumors by freezing them during treatment in a clinic, without surgery. In May 2018, IceCure published positive results from a trial involving 146 patients. The ASBSs updated guidelines specifically mention cryoablation technology and recommend participation in clinical trials and registries due to initial data on the effectiveness of cryoablation.
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Tumors to meet a frozen end at private Haifa hospital
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IceCure jumps on positive breast cancer treatment data
IceCure Ltd. reported clinical trial results with 99% effectiveness in eliminating cancerous breast tumors through freezing with liquid nitrogen without surgery. The companys share price jumped 130% on the Tel Aviv Stock Exchange following the announcement. IceCure is engaged in research, development, and marketing of medical devices for minimally invasive treatment of tumors. The clinical trial, known as ICE3, is the largest controlled trial held in the US for freezing malignant breast tumors. IceCure has FDA and CE approval to market the device in the US and Europe. The trial results showed that only one patient out of 146 experienced cancer recurrence. IceCures CEO stated that the treatment provides a safe alternative to surgical procedures for removing breast tumors.
Customers
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Israeli Startup Freezing Cancer In Its Tracks Now Tackling Kidney, Liver, Bone Tumors
IceCure Medical, an Israeli biomedical company, has been developing a technology that uses extreme cold to freeze and destroy cancer tumors. The companys IceSense3 system has been used to treat benign breast cancer tumors and is also being applied to lung, kidney, liver, and bone tumors. The treatment is minimally invasive and can be done in a doctors office within 15 minutes. IceCures system has FDA and CE approval and the company is looking to expand in the European and East Asian markets.
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How to treat breast cancer in Israel Free directory of clinics in Israel
Israeli company IceCure Medical has developed a device called IceSense3, which uses cryoablation to treat fibroadenomas, benign breast tumors. The device, which has been used by surgeons in the US, allows for a quick and painless procedure that leaves no scars, accelerating patient recovery. The company is now working on using the device to treat malignant tumors. The device was first used for this purpose in 2012, and further operations are planned. The device has received a certificate of compliance with European standards, but has not yet been used in the European Union.
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Israeli start-up freezes breast cancer in its tracks, without surgery
IceCure Medical, an Israeli startup, has developed a cryoablation system that can eliminate early-stage growths within minutes without the need for surgery. This method of treatment, which involves freezing the tumor, results in no scarring and does not require a hospital stay. However, chemotherapy or radiation treatment may still be necessary. The companys innovation provides a lesser-known alternative to traditional treatments for breast cancer, the most common malignancy among women, which typically involve mastectomy and chemotherapy or radiation therapy.
Customers
Growth-Positive
Epoch invests NIS 21.2m in IceCure Medical
Epoch Partner Investments is acquiring 57.13% of IceCure Medical Inc., a tumor treatment device developer. The investment is worth NIS 21.2 million. IceCures management sees Epoch as a strategic investor that can assist in implementing IceCures strategy and in finding additional strategic partners. The deal includes the allocation of 151,420,000 shares at NIS 0.14 per share and 22,700,000 options not listed for trading and exercisable at NIS 0.14 per option for 36 months from the deal closing date. IceCures sales have grown since it switched to a new business model in 2014, focusing on the sale of its IceSense3 systems and special disposable needles to hospitals, medical centers, and private clinics.
InvestmentAcquisition
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IceCure Medical successfully treats breast cancer patients with IceSense3 cryoablation system
IceCure Medical has successfully treated the first two patients in a multi-centred clinical trial using the IceSense3 cryoablation system to treat breast cancer without surgery. The ICE3 trial is significantly expanding data on cryoablation and may create a paradigm shift in the treatment of breast cancer. The trial is recruiting and following women aged over 65, diagnosed with luminal A breast tumours measuring less than 1.5cm in diameter. The company claims that the start of the ICE3 trial, combined with the recent evolution of its business model, establishes them as the technological leader in the field of breast cancer treatment.
Customers
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IceCure Medical Ltd. announces treatment of first breast cancer patient using its IceSense3 Cryoablation System at John Wayne Cancer Institute
IceCure Medical Ltd. has announced that the John Wayne Cancer Institute (JWCI) at Saint Johns Health Center in Santa Monica, CA, has treated its first breast cancer patient using the IceSense3 Cryoablation System. The treatment is part of a pilot study evaluating immune responses in patients with operable breast cancer. The study aims to understand how cancers evade the immune system and mechanisms to overcome this resistance. The clinical trial is supported in part by funds donated by the Fashion Footwear Association of New York Charitable Foundation.
Partners
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IceCure Medical expands to hospitals in US
IceCure Ltd. has announced the expansion of its US operations from private clinics to breast cancer institutes at large hospitals. This comes after its first year of marketing activity in the US. The company has installed its IceSense3 systems at the Cleveland Clinic, the St. Elizabeth Health Center, the Barbara Ann Karmanos Cancer Institute, and the Hoag Family Cancer Institute. These installations will give more women access to the companys cryoablation procedure for the removal of breast cancer tumors. IceCure has installed 20 IceSense3 systems at hospitals, medical centers, and private clinics in the US to date.
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Israeli ice device destroys breast tumors
Israeli company IceCure Medicals device, IceSense3, is being used by American doctors to remove benign breast lumps and is now being tested by a renowned Japanese surgeon to destroy small malignant tumors. The device, which uses cryoablation to destroy tumors, received FDA approval in December 2010. The procedure is quick, virtually painless, and leaves no scarring, making it a more attractive option than surgery. The company is also planning to conduct similar trials in the US and is developing a new generation of IceSense and a device for treating uterine fibroids.
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Israeli medical device firm IceCure picks Cleveland for U.S. headquarters
Israeli device company IceCure Medical has announced plans to establish its U.S. headquarters in Cleveland, Ohio. The company has had a business relationship with the Bridge Investment Fund, which has invested over $1 million in IceCure since 2008. The companys lead product, IceSense3, is used to freeze and destroy benign breast tumors in women. IceCure raised $10 million through an initial public offering on the Tel Aviv Stock Exchange in February. The company plans to conduct clinical trials to study using the IceSense3 to treat breast cancer.
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