InspireMD News
119 articles
Pleasing Signs As A Number Of Insiders Buy InspireMD Stock
The article discusses the insider buying activity at InspireMD, Inc., highlighting that multiple insiders, including Gary Roubin, have purchased shares, which sends a positive signal to shareholders. The largest insider purchase was worth $100k at $2.42 per share, indicating confidence in the companys future despite the current lower share price of $2.19. Insiders own 20% of the companys shares, valued at approximately $19 million, suggesting alignment with other shareholders. The article also mentions that InspireMD has three warning signs, two of which are concerning, that should be considered in further analysis.
InspireMD to Announce Third Quarter 2025 Financial Results
InspireMD, Inc., a company known for its CGuard® Prime carotid stent system, announced that it will release its third quarter 2025 financial results on November 4, 2025. The company will host a conference call and webcast to discuss these results and recent highlights. InspireMD aims to establish its proprietary MicroNet™ mesh technology as the industry standard for carotid stenting. The companys stock is listed on Nasdaq under the ticker symbol NSPR. The announcement is primarily informational, detailing the upcoming financial results release and related events.
Intuitive Surgical, Inc. (ISRG) Q3 Earnings and Revenues Top Estimates
Intuitive Surgical, Inc. reported quarterly earnings of $2.4 per share, surpassing the Zacks Consensus Estimate of $1.99 per share, marking a 20.60% earnings surprise. The company also reported revenues of $2.51 billion, exceeding the consensus estimate by 3.92%. Despite these positive results, Intuitive Surgical shares have declined by about 12.2% since the start of the year, underperforming the S&P 500s gain of 14.5%. The companys earnings outlook and estimate revisions will be crucial for future stock performance. Currently, Intuitive Surgical holds a Zacks Rank #3 (Hold), indicating expected performance in line with the market.
InspireMD Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
InspireMD Inc., a developer of the CGuard® Prime carotid stent system, announced inducement grants to three new non-executive employees, totaling 40,513 shares of restricted stock. These grants are part of InspireMDs 2024 Inducement Plan, designed to attract new employees. The restricted stock will vest over three years, contingent on continued employment. InspireMD aims to make its MicroNet™ Mesh technology the industry standard for carotid stenting. The companys stock is listed on Nasdaq under the ticker NSPR. The announcement reflects InspireMDs strategic efforts to expand its workforce and enhance its product offerings in the medical device industry.
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InspireMD Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
InspireMD Inc., a company focused on developing the CGuard™ Prime carotid stent system, announced inducement grants to five new non-executive employees. These grants, totaling 88,324 shares of restricted stock, are part of InspireMDs strategy to attract new talent. The grants were issued under the companys 2024 Inducement Plan, designed for new employees, and will vest over a three-year period. InspireMD aims to make its products the industry standard for carotid stenting, leveraging its proprietary MicroNet™ mesh technology. The company is publicly traded on Nasdaq under the ticker NSPR and is focused on expanding its U.S. commercial launch and operations.
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Parkman Healthcare Expands Stake in InspireMD Backing Carotid Innovation
InspireMD, Inc., a Florida-based medical device company, is experiencing growth due to increased investment and strategic management changes. Parkman Healthcare Partners LLC has increased its stake in the company by 37.1%, now owning 3.82% of the shares. InspireMD is focused on developing and commercializing treatments for carotid artery and other vascular diseases, with products like the CGuard carotid embolic prevention system. The company is expanding its team, highlighted by the appointment of Mike Lawless as the new CFO. Despite its potential, some investors may find AI stocks more appealing due to their perceived upside potential.
InvestmentManagement ChangesExpand
InspireMD Announces the Appointment of Dan Dearen to its Board of Directors
InspireMD Inc., a developer of the CGuard® Prime carotid stent system, has appointed Dan Dearen to its Board of Directors. Dearen brings extensive experience in the medical device and life sciences sectors, having previously co-founded Axonics, Inc., which was acquired by Boston Scientific. His appointment comes as InspireMD continues its U.S. commercial launch of the CGuard Prime system, which has received FDA approval. The company aims to lead the carotid intervention market and execute its long-term value-creation strategy. Dearens leadership and financial expertise are expected to support InspireMDs growth and market position.
Management Changes
InspireMD to Present at Upcoming H.C. Wainwright 27th Annual Global Investment Conference
InspireMD Inc., a developer of the CGuard® Prime carotid stent system, announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference scheduled for September 10th, 2025. The company aims to showcase its proprietary MicroNet™ mesh technology, which is designed to set a new industry standard for carotid stenting by delivering excellent acute results and long-term stroke-free outcomes. InspireMDs stock is publicly traded on Nasdaq under the ticker NSPR. The presentation will be available via a live audio webcast and replay on the companys website.
InspireMD Reports Second Quarter 2025 Financial Results
RxSight, Inc. Appoints Raymond W. Cohen to Its Board of Directors
RxSight, Inc., a company specializing in ophthalmic medical devices, announced the appointment of Raymond W. Cohen to its Board of Directors. Cohen, with a strong background in leading medical technology companies, is expected to contribute significantly to RxSights growth strategy. The company aims to expand the reach of its Light Adjustable Lens system, which offers customized vision solutions post-cataract surgery. Cohens experience, including his leadership at Axonics and involvement in successful acquisitions, positions him as a valuable asset to RxSights mission of accelerating revenue and profit growth. The appointment is seen as a positive step towards strengthening RxSights position in the premium intraocular lens market.
Management Changes
Investors in InspireMD (NASDAQ:NSPR) from five years ago are still down 60%, even after 11% gain this past week
InspireMD, Inc. has experienced a 20% increase in its share price over the last month, but this is overshadowed by a 60% decline over the past five years. Despite recent positive signs, the company remains unprofitable, though it has achieved an 18% annual revenue growth over five years. The share price has averaged a 10% annual loss, indicating tempered investor expectations. Significant insider buying in the last quarter is a positive indicator, but long-term shareholders have faced a 10% loss over five years. The company needs sustained improvements in key metrics to regain investor confidence.
InspireMD Announces the Appointment of Raymond W. Cohen to its Board of Directors
InspireMD Inc. announced the appointment of Raymond W. Cohen to its Board of Directors. Cohen brings over 40 years of leadership experience in medical technology, having successfully scaled commercial operations and created shareholder value. His appointment follows the recent PMA approval of InspireMDs CGuard Prime carotid stent system, which is now shifting focus to commercial launch. Cohens experience is expected to aid InspireMD in executing its strategy to capture market share and deliver long-term value. Cohens previous roles include CEO of Axonics, which was acquired by Boston Scientific, and Chairman of SoniVie Ltd., also acquired by Boston Scientific.
Management Changes
InspireMD Announces Combined Financings of $58 Million
InspireMD Inc. has raised approximately $58 million through a combination of PIPE financing and warrant exercises following the FDA approval of its CGuard Prime carotid stent system. The PIPE financing, led by OrbiMed and Marshall Wace, generated $40.1 million, while the warrant exercise contributed $17.9 million. The funds will support the commercialization of the stent in the U.S. market, enhancing InspireMDs balance sheet and enabling expansion. The company plans to use the proceeds for operations, including sales, marketing, and R&D. The closing of the PIPE is expected by August 1, 2025.
InvestmentPIPEFDA approved
InspireMD to Announce Second Quarter 2025 Financial Results
InspireMD Inc., a developer of the CGuard® Prime carotid stent system, announced it will release its second quarter 2025 financial results on August 5, 2025. The company will host a conference call and webcast to discuss these results and recent highlights. InspireMD aims to establish its proprietary MicroNet™ mesh technology as the industry standard for carotid stenting, providing excellent acute results and durable, stroke-free long-term outcomes. The companys stock is traded on Nasdaq under the ticker NSPR. The announcement is seen as growth-positive, reflecting the companys ongoing efforts to engage with investors and stakeholders.
CVRx (CVRX) Surges 19.0%: Is This an Indication of Further Gains?
CVRx shares surged by 19% to $8.45 following a proposal by the Centers for Medicare and Medicaid Services (CMS) to maintain the Barostim implant procedure under the New Technology Ambulatory Payment Classification (APC) 1580, with an associated payment of approximately $45,000. This optimism contributed to a significant increase in trading volume. CVRx is expected to report a quarterly loss of $0.52 per share, a 20% improvement year-over-year, with revenues anticipated to rise by 14% to $13.46 million. Despite the positive outlook, the consensus EPS estimate for the quarter has remained unchanged over the past 30 days. The stock holds a Zacks Rank #3 (Hold).
InspireMD Launches CGuard Prime Carotid Stent System in the U.S.
InspireMD, Inc. has launched its CGuard Prime Carotid Stent System in the U.S. after receiving FDA premarket application approval. This launch is a significant milestone for the company, as it introduces its advanced stroke prevention technology to the U.S. market. The CGuard Prime system, featuring proprietary MicroNet mesh technology, aims to provide sustained embolic protection and reduce stroke risks. Despite a recent decline in share prices, the launch is expected to drive revenue growth and expand market share. InspireMDs market capitalization stands at $74.4 million, and the company is well-positioned to capture a significant portion of the U.S. carotid stenting market.
Product StageFDA approved/pending approval
InspireMD Announces U.S. Commercial Launch of CGuard® Prime Carotid Stent System for the Prevention of Stroke
InspireMD Inc. announced the commercial launch of its CGuard Prime carotid stent system in the U.S. following FDA premarket application approval. The device is designed to minimize embolism risk and features a dual-layer design with MicroNet™ and SmartFit™ technology. This launch marks a significant milestone for InspireMD, which has already achieved a substantial market share in over 30 countries. The company has prepared for this launch by assembling a skilled commercial team. The CGuard Prime system is recognized for its innovative approach to stroke prevention, offering enhanced embolic protection. OhioHealth and Ballad Health have been key contributors to the development and trial phases of this technology.
Product StageCustomers
InspireMD Announces FDA Approval for CGuard® Prime Carotid Stent System for the Prevention of Stroke
InspireMD Inc. announced that the U.S. FDA has granted premarket application (PMA) approval for its CGuard Prime Carotid Stent System, a significant milestone for the company. The approval is based on the C-GUARDIANS pivotal trial, which demonstrated the safety and efficacy of the stent system in treating carotid artery stenosis. The trial showed the lowest major adverse event rates of any pivotal study of carotid intervention. The approval marks a breakthrough in less invasive carotid artery revascularization, with over 65,000 implants sold and studies in over 2,000 patients. InspireMD plans an immediate and aggressive U.S. launch.
FDA approved/pending approval
InspireMD Announces CE Mark Approval for CGuard® Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke
InspireMD Inc. announced that it has received CE Mark approval under the European Medical Device Regulation for its CGuard® Prime EPS, a carotid stent system designed to prevent strokes. This approval is a significant milestone for the company, allowing for the commercial launch of CGuard® Prime EPS in European markets. The stent system features a proprietary MicroNet™ mesh to reduce embolic events. InspireMD plans to launch the same platform in the United States later this year, pending FDA approval. This development marks a pivotal step in InspireMDs growth as a commercial-stage company and strengthens its position in carotid stenting innovation.
Product Stage
InspireMD Announces Appointment of Michael Lawless as Chief Financial Officer
InspireMD Inc. announced the appointment of Michael Lawless as the new Chief Financial Officer, effective by June 30, 2025. Lawless, an experienced CFO in the healthcare sector, will succeed Craig Shore, who has been with the company for nearly 15 years. The transition is part of InspireMDs strategy to accelerate growth and prepare for the U.S. market launch of its CGuard Prime carotid stent system. In connection with his appointment, Lawless will receive 465,000 shares of restricted stock and options to purchase 212,000 shares, as approved by the companys Board of Directors under NASDAQ Listing Rule 5635(c)(4).
Management Changes
InspireMD Inc (NSPR) Q1 2025 Earnings Call Highlights: Revenue Growth Amid Operational Challenges
InspireMD Inc reported a 1.2% year-over-year revenue growth for Q1 2025, reaching $1.53 million. Despite this growth, the company faced a significant net loss of $11.17 million, up from $732,000 the previous year, due to increased operating expenses and launch preparations. The company is optimistic about receiving FDA approval for its Seaguard Prime stent in Q3 2025, although the timeline has been slightly delayed due to facility site audit issues. InspireMD is advancing its clinical pipeline with strong enrollment in the Sea Guardians 2 study and plans for the Sea Guardians 3 IDE submission. Cash reserves have decreased significantly, raising concerns about financial stability.
Product StageLayoffs
InspireMD Reports First Quarter 2025 Financial Results
InspireMD Inc. announced its financial and operational results for the first quarter of 2025, highlighting progress in the development and anticipated approval of its CGuard Prime carotid stent system. The company is optimistic about receiving FDA Premarket Approval in the third quarter of 2025, which would facilitate its U.S. launch. InspireMD has been expanding its commercial infrastructure and sales force in preparation for this approval. The company reported a slight increase in revenue, driven by the adoption of its technology in existing markets, despite challenges such as foreign exchange impacts. Operating expenses rose significantly due to increased salaries and preparations for the U.S. launch. InspireMD is focused on achieving transformative milestones and expanding its market presence.
Product StageManagement ChangesExpand
InspireMD to Present at Upcoming Bank of America 2025 Healthcare Conference
InspireMD Inc., a developer of the CGuard™ Prime carotid stent system, announced that its management will present at the Bank of America 2025 Healthcare Conference on May 14, 2025. The company aims to establish its proprietary MicroNet® technology as the industry standard for carotid stenting, offering outstanding acute results and durable, stroke-free long-term outcomes. InspireMDs common stock is traded on Nasdaq under the ticker symbol NSPR. The presentation will be available via a live audio webcast and replay on the companys website.
InspireMD to Announce First Quarter 2025 Financial Results
InspireMD Inc., a developer of the CGuard™ Prime carotid stent system, announced it will release its first quarter 2025 financial results on May 9, 2025. The company will host a conference call and webcast to discuss these results and recent highlights. InspireMD aims to set industry standards in carotid stenting using its proprietary MicroNet® technology, focusing on providing outstanding acute results and long-term stroke-free outcomes. The companys stock is traded on Nasdaq under the ticker NSPR. The announcement is seen as growth-positive, highlighting the companys commitment to transparency and investor engagement.
InspireMD Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
InspireMD, Inc., a developer of the CGuard™ Prime carotid stent system, announced inducement grants of 299,398 shares of restricted stock to 11 new non-executive employees. These grants are part of InspireMDs 2024 Inducement Plan and are intended to attract new talent. The restricted stock vests over three years, contingent on continued employment. InspireMD aims to make its MicroNet® technology the industry standard for carotid stenting. The company faces various risks, including recurring losses, regulatory challenges, and intense competition. Despite these challenges, the inducement grants suggest a growth-positive outlook as the company expands its workforce.
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InspireMD to Present at Upcoming 24th Annual Needham Virtual Healthcare Conference
InspireMD Inc., a company specializing in carotid stent systems, announced that its management will present at the 24th Annual Needham Virtual Healthcare Conference on April 9, 2025. The presentation will be available via a live audio webcast and replay on the companys website. InspireMD aims to establish its MicroNet® technology as the industry standard for carotid stenting, offering superior acute results and long-term stroke-free outcomes. The companys stock is listed on Nasdaq under the ticker NSPR. This event is part of InspireMDs efforts to engage with investors and stakeholders, showcasing its advancements in healthcare technology.
InspireMD Full Year 2024 Earnings: US$0.76 loss per share (vs US$0.82 loss in FY 2023)
InspireMD reported a revenue of $7.01 million, marking a 13% increase from the previous fiscal year. However, the company also reported a net loss of $32 million, which widened by 61% from FY 2023, resulting in a loss of $0.76 per share. Despite a forecasted revenue growth of 57% annually over the next three years, InspireMDs shares have decreased by 3.1% over the past week. The article highlights two warning signs for the company, suggesting potential concerns for investors. The analysis is based on historical data and analyst forecasts and does not constitute financial advice.
InspireMD Inc (NSPR) Q4 2024 Earnings Call Highlights: Revenue Growth Amid Rising Expenses and ...
InspireMD Inc reported a 10.6% year-over-year increase in Q4 2024 revenue, reaching $1.95 million, and a full-year revenue increase of 13% to $7 million. Despite the revenue growth, the company experienced a decrease in gross profit and margin due to increased costs, resulting in a net loss of $9.1 million for Q4 2024. Operating expenses rose significantly, driven by higher salaries and share-based compensation. The company is preparing for the US launch of CGuard Prime, with anticipated FDA approval in the first half of 2025. InspireMD has relocated its headquarters to Miami and expanded its sales team to support the US market entry. Cash reserves decreased to $34.7 million by the end of 2024.
Product StageExpand
InspireMD Reports Fourth Quarter and Full Year 2024 Financial Results
InspireMD Inc. announced its financial and operating results for the fourth quarter and full year ended December 31, 2024. The company is advancing its CGuard Prime carotid stent system towards potential U.S. approval, having submitted a Premarket Approval (PMA) application to the FDA. InspireMD has also initiated the CGUARDIANS II pivotal study for the systems use in TCAR procedures. The company achieved record quarterly revenue and unit sales in its served markets. InspireMD is preparing for a potential U.S. commercial launch of CGuard Prime in the first half of 2025, pending FDA approval. The company has established a new headquarters in Miami to support this launch.
Product StageFDA approved/pending approval
InspireMD to Announce Fourth Quarter and Full Year 2024 Financial Results
InspireMD Inc., a developer of the CGuard™ Prime carotid stent system, announced it will release its fourth quarter and full year 2024 financial results on March 12, 2025. The company will host a conference call and webcast to discuss these results and recent highlights. InspireMD aims to make its products the industry standard for carotid stenting using its proprietary MicroNet® technology. The companys common stock is traded on Nasdaq under the ticker symbol NSPR. The announcement is seen as growth-positive as it indicates transparency and engagement with investors.
InspireMD Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
InspireMD Inc. announced inducement grants of 138,442 shares of restricted stock to six new non-executive employees as part of their employment inducement plan. The grants are outside of the companys 2021 Equity Compensation Plan and are in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted stock will vest over three years, encouraging employee retention. InspireMD is focused on utilizing its MicroNet technology to establish its CGuard™ Prime carotid stent system as the industry standard for stroke prevention. The company faces various risks, including financial challenges and regulatory hurdles, but remains committed to its strategic goals. InspireMDs stock is traded on Nasdaq under the ticker NSPR.
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Investors in InspireMD (NASDAQ:NSPR) have unfortunately lost 78% over the last five years
InspireMD, Inc. has seen a 13% increase in its share price over the last month, which may suggest a potential turnaround. However, long-term shareholders have experienced a 78% decline in value over the past five years. Despite being unprofitable, the company has achieved a 16% annual revenue growth over the last half-decade, which is notable for a pre-profit company. The recent short-term total shareholder return (TSR) of 25% contrasts with the five-year annualized TSR loss of 12% per year. This indicates potential short-term optimism, but long-term performance remains a concern. Investors are advised to consider future growth indicators and balance sheet risks before investing.
InspireMD and NAMSA to Partner on CGUARDIANS II Pivotal Clinical Trial of the CGuard Prime™ 80 cm Carotid Stent System for Use in TCAR procedures
InspireMD, Inc., a developer of the CGuard™ Prime Carotid Stent System, has partnered with NAMSA to conduct the CGUARDIANS II pivotal study. This study aims to evaluate the safety and effectiveness of the CGuard Prime stent platform in Transcarotid Artery Revascularization (TCAR) procedures. The collaboration leverages NAMSAs expertise in vascular clinical and regulatory processes. The study, which began enrolling patients on December 9, 2024, is a prospective, multi-center, single-arm pivotal study targeting a minimum of 50 evaluable patients. The objective is to assess the acute and technical success of the CGuard Prime when used with an FDA-cleared TCAR neuro-protection system. This partnership and study represent a significant growth opportunity for InspireMD in the expanding TCAR market.
Product StagePartners
InspireMD Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
InspireMD, Inc., a developer of the CGuard™ Prime carotid stent system, announced inducement grants of 18,000 shares of restricted stock to a new non-executive employee. This grant, outside of the companys 2021 Equity Compensation Plan, is intended to attract new talent, in line with Nasdaq Listing Rule 5635(c)(4). The stock vests over three years, contingent on continued employment. InspireMD aims to establish its MicroNet® technology as the industry standard for carotid stenting. The company faces various challenges, including financial sustainability, regulatory approvals, and competitive pressures. Despite these challenges, the inducement grant reflects a positive growth strategy to strengthen its workforce.
Management Changes
InspireMD Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
InspireMD, Inc., a company focused on developing the CGuard™ Prime carotid stent system, announced inducement grants to nine new non-executive employees. These grants, totaling 372,135 shares of restricted stock, are intended to attract new talent to the company. The grants are outside of InspireMD’s 2021 Equity Compensation Plan and are in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted stock will vest over three years, contingent on continued employment. InspireMD aims to make its MicroNet® technology the industry standard for carotid stenting. The company faces various risks, including recurring losses, regulatory challenges, and intense competition, but remains committed to its growth and innovation strategies.
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Here's Why We're Watching InspireMD's (NASDAQ:NSPR) Cash Burn Situation
The article discusses InspireMDs financial situation, focusing on its cash burn and cash reserves. As of September 2024, InspireMD had $40 million in cash and no debt, with a cash burn of $21 million over the last year. This gives the company a cash runway of 2 years. Despite a 32% increase in cash burn, the company saw a 25% increase in operating revenue, suggesting some business traction. However, the cash burn represents 29% of its $72 million market capitalization, indicating potential shareholder dilution if new shares are issued to raise funds. The article suggests that while InspireMD is in a stable position, it should consider future funding strategies.
InspireMD Announces Expected Retirement of its CFO Craig Shore and CFO Transition in 2025
InspireMD, Inc., a developer of the CGuard™ Embolic Prevention Stent System, announced the upcoming retirement of its Chief Financial Officer, Craig Shore. Shore will remain in his role until a successor is appointed, ensuring a smooth transition. His departure marks a significant change in the companys management as it prepares for potential U.S. FDA approval of its products in 2025. CEO Marvin Slosman praised Shores 15-year contribution to the company, highlighting his role in transforming InspireMD into a leader in carotid interventions. The company is actively searching for a new CFO to continue its growth trajectory. InspireMD aims to establish its MicroNet® technology as the industry standard for carotid stenting, despite facing challenges such as regulatory approvals and market competition.
Management Changes
InspireMD Announces First Patient Enrolled in the CGUARDIANS II Pivotal Study of the CGuard Prime Carotid Stent System in Transcarotid Artery Revascularization Procedures (TCAR)
InspireMD, Inc. has announced the enrollment of the first patient in its CGUARDIANS II clinical trial, which evaluates the CGuard Prime Carotid Stent System for carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach. The trial, led by Dr. Patrick Muck at Good Samaritan Hospital, aims to enroll a minimum of 50 patients and is a significant step towards potential FDA approval. The studys success could expand InspireMDs market presence in the TCAR procedure space, which sees approximately 30,000 procedures annually in the U.S. The CGuard Prime system has shown promising clinical outcomes, with over 60,000 devices sold to date. This development is expected to enhance patient care and broaden the application of InspireMDs stenting platform.
InspireMD Announces Appointment of Accomplished Medical Technology Executive Scott R. Ward to its Board of Directors
InspireMD, Inc. announced the appointment of Scott R. Ward to its Board of Directors. Ward, with extensive experience in the cardiovascular sector, is expected to contribute significantly as the company approaches potential U.S. approval of its CGuard Prime stent system. His appointment is seen as a strategic move to guide InspireMD through its next growth phase, focusing on innovation and market expansion. Wards background includes leadership roles at Medtronic and founding Raymond Holdings, a firm involved in venture capital and advisory services. InspireMD views this addition as a key step in establishing its stent system as a new standard-of-care for carotid intervention and stroke prevention.
Management Changes
InspireMD Third Quarter 2024 Earnings: US$0.16 loss per share (vs US$0.15 loss in 3Q 2023)
InspireMD reported a revenue increase of 16% from the third quarter of 2023, reaching US$1.81 million. However, the net loss widened by 52% to US$7.89 million, with a loss per share of US$0.16. Despite these losses, the companys shares rose by 2.5% over the past week. Looking forward, InspireMDs revenue is expected to grow at an average rate of 63% annually over the next three years, significantly outpacing the 8.3% growth forecast for the US Medical Equipment industry. The article highlights three warning signs in InspireMDs investment analysis, with one being notably concerning.
InspireMD Inc (NSPR) Q3 2024 Earnings Call Highlights: Revenue Growth Amid Rising Costs and ...
InspireMD Inc reported a 16% increase in revenue for Q3 2024, reaching $1.81 million, driven by a 14% growth in CGUARD implants sold. Despite this growth, the company faced a decrease in gross profit and an increase in operating expenses, resulting in a net loss of $7.9 million. The company is expanding its operations with a new headquarters in Miami, Florida, and plans to launch CGUARD Prime in the US in 2025, pending FDA approval. This expansion includes hiring a new commercial leadership team. However, the company faces challenges in managing costs and achieving profitability, with regulatory risks potentially delaying US market entry.
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InspireMD Reports Third Quarter 2024 Financial Results and Provides Business Update
InspireMD, Inc. has made significant strides in advancing its CGuard Prime carotid stent system, aiming for U.S. market entry in the first half of 2025. The company submitted a Premarket Approval (PMA) application to the FDA and received approval for an Investigational Device Exemption (IDE) to initiate a pivotal study. InspireMD also established a new headquarters in Miami, Florida, to support its anticipated U.S. commercial launch. The company reported record quarterly revenue of $1.81 million, marking a 16.3% increase over the previous year. These developments indicate a positive trajectory for InspireMD as it seeks to expand its presence in the U.S. market.
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InspireMD Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
InspireMD, Inc., a developer of the CGuard™ Prime carotid stent system, announced inducement grants to five new non-executive employees, totaling 197,167 shares of restricted stock. These grants are part of an inducement plan outside of the companys 2021 Equity Compensation Plan, aimed at attracting new talent. The restricted stock will vest over three years, contingent on continued employment. This move is seen as a growth-positive step, indicating InspireMDs efforts to expand its workforce and strengthen its position in the carotid stenting market. The announcement also highlights the companys focus on utilizing its MicroNet® technology to set industry standards. The event took place on October 24, 2024.
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InspireMD to Report Third Quarter 2024 Financial Results and Provide Corporate Business Update on Tuesday, November 12th
InspireMD, Inc., a developer of the CGuard™ Embolic Prevention Stent System, announced that it will report its third quarter 2024 financial results on November 12, 2024. The company will host a conference call and webcast to discuss these results and provide updates on corporate developments. InspireMD aims to make its MicroNet® technology the industry standard for carotid stenting, focusing on stroke prevention and improved patient outcomes. The announcement includes forward-looking statements about the companys plans and potential risks, such as market acceptance, regulatory approvals, and competition. The webcast will be available on the companys website, and a replay will be accessible after the live broadcast.
One InspireMD Insider Raised Stake By 13% In Previous Year
The article discusses insider transactions at InspireMD, Inc., highlighting that insiders have been net buyers of the companys stock over the past year. The most significant purchase was made by insider Gary Roubin, who bought $127,000 worth of shares at a price of $2.53 per share. This indicates confidence in the companys future, as the purchase was made at a price higher than the current share price of $2.49. InspireMD insiders own 21% of the company, valued at approximately $13 million, suggesting a reasonable degree of alignment with shareholders. The article emphasizes the importance of insider transactions as a potential indicator of a companys prospects.
InspireMD Announces Establishment of Global Headquarters in Miami, Florida to Support Anticipated U.S. Launch and Commercialization of the CGuard Prime Carotid Stent System
InspireMD, Inc. has announced the establishment of its global headquarters in Miami, Florida, positioning itself for the anticipated U.S. launch of its CGuard Prime carotid stent system in 2025, pending FDA approval. The new headquarters will support the companys expansion into the U.S. market, leveraging South Floridas resources and talent pool. InspireMD is building its marketing, training, and sales operations teams to form a strong U.S. commercial organization. The company recently submitted the final module of its Premarket Authorization application to the FDA for the CGuard Prime system. This move is part of InspireMDs strategy to drive long-term growth and create sustained shareholder value.
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InspireMD Advances with FDA Study Approval and Global Goals
InspireMD, Inc. announced on October 7, 2024, that it received FDA approval to commence the CGUARDIANS II pivotal study for its CGuard Prime 80cm Carotid Stent System. This approval marks a significant milestone for the company as it seeks to enhance stroke prevention and carotid disease management. The study will be led by renowned vascular surgeons Dr. Patrick Geraghty and Dr. Patrick Muck and will assess the devices application in transcarotid revascularization procedures. This development is a crucial step towards InspireMDs ambition of achieving market leadership in the U.S. and expanding globally, alongside the development of their next-generation TCAR Neuroprotection System, SwitchGuard NPS.
InspireMD Announces Approval of Investigational Device Exemption (IDE) Application for CGUARDIANS II Pivotal Study of the CGuard Prime 80cm Carotid Stent System
InspireMD, Inc. announced that the FDA has approved its Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System. This approval marks a significant milestone for the company, as it aims to expand its market presence in the U.S. with its advanced carotid stent system designed for stroke prevention. The study will be led by Dr. Patrick Geraghty and Dr. Patrick Muck, with the goal of facilitating the approval of CGuard Prime for transcarotid revascularization (TCAR) procedures. InspireMD continues to develop its next-generation TCAR Neuroprotection System, SwitchGuard NPS, to further enhance its product offerings. The company is focused on achieving market leadership in the U.S. and improving stroke prevention and carotid disease management.
Customers
InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard™ Prime Carotid Stent System
InspireMD, Inc. has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system, based on positive results from the C-GUARDIANS clinical trial. The trial, which included 316 patients across 24 sites in the U.S. and Europe, showed a major adverse event rate of 1.95% through twelve months post-procedure, the lowest reported for any carotid stent or embolic protection device trial. The company anticipates a U.S. commercial launch in the first half of 2025, pending approval. InspireMD is building its U.S. commercial and operational infrastructure to support the launch.
Customers
Investors in InspireMD (NASDAQ:NSPR) have unfortunately lost 88% over the last five years
InspireMD, Inc. (NASDAQ:NSPR) has experienced a significant decline in its share price over the past five years, with an 88% drop. Despite a 16% annual revenue growth, the companys stock has fallen by an average of 13% each year. The past year alone saw a 16% loss, contrasting with a market gain of 26%. The article suggests that the stock may have been over-hyped initially and recommends caution. Insider purchases in the last year are noted as a positive sign, but the overall sentiment remains cautious due to the companys lack of profitability and sustained losses.
Companies Like InspireMD (NASDAQ:NSPR) Are In A Position To Invest In Growth
The article discusses the financial situation of InspireMD, a company listed on NASDAQ. It highlights the companys cash burn rate, which is the amount of cash the company is spending each year to fund its growth. As of June 2024, InspireMD had US$47m in cash and was debt-free. Its cash burn was US$19m over the trailing twelve months, giving it a cash runway of about 2.5 years. The companys cash burn is increasing by 11% in the last year, but its revenue was up 23%, indicating growth. The article suggests that if the company had to sell enough shares to fund another years growth at the current share price, it could result in costly dilution.
Investment
InspireMD Reports Second Quarter 2024 Financial Results and Provides Business Update
InspireMD, Inc. has announced positive results from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system, with a one-year primary endpoint event rate of 1.95%. The company is on track to submit a Premarket Approval (PMA) application to the FDA this quarter. It has also raised $17.9 million from the full exercise of Series H warrants. The companys Q2 2024 revenue was $1.74 million, a 5.4% increase over Q2 2023. InspireMD is also preparing to initiate the CGUARDIANS II clinical trial in the latter half of 2024.
Investment
InspireMD Congratulates CREST-2 Investigators on Completion of Trial Enrollment
InspireMD, Inc., a developer of the CGuard Embolic Prevention Stent System for stroke prevention, has completed enrollment in the CREST-2 clinical trials. The CGuard carotid stent, which uses proprietary MicroNet mesh, was included as a device option for stenting in the CREST-2 trials following FDA approval of InspireMDs Investigational Device Exemption supplement application in February 2022. The trials included 23 cases implanted with CGuard. The companys CEO, Marvin Slosman, expressed pride in being the only second-generation investigational device option approved by the FDA for inclusion in the stenting arm of the trial.
Investment
InspireMD to Report Second Quarter 2024 Financial Results and Provide Corporate Business Update on Tuesday, August 6th
InspireMD, Inc., a developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced it will report its second quarter 2024 financial results on Tuesday, August 6th, before the financial markets open. The management will host a conference call and webcast with the investment community at 8:30 am (EDT) that same day to review financial results and provide an update on corporate developments.
Investment
InspireMD Announces Full Exercise of Series H Warrant Tranche for Gross Proceeds of $17.9 Million
InspireMD, Inc. has announced the full exercise of 12.9 million Series H warrants, which were converted primarily into pre-funded warrants. This move has generated gross proceeds of $17.9 million for the company. The warrants were issued as part of a private placement financing of up to $113.6 million that was announced in May 2023. The warrant holders include Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members. The funds will be used to strengthen the business and fuel growth, including advancing the CGuard Prime Carotid Stent System.
Investment
InspireMD Announces Presentation of Positive One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at LINC 2024
InspireMD, Inc. has announced positive one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard Carotid Stent System for the treatment of carotid artery stenosis. The trial demonstrated a primary endpoint event rate of 1.95% through twelve months post-procedure, the lowest reported for any carotid stent or embolic protection device pivotal trial. The results will support a Premarket Approval (PMA) application to the FDA in H2 2024, with a U.S. commercial launch of the CGuard Prime Carotid Stent System anticipated in H1 2025, if approved.
InvestmentExpand
InspireMD Insider Ups Holding By 13% During Year
Over the past year, insiders at InspireMD, Inc. have been net buyers of the companys stock. The largest insider purchase was made by Gary Roubin, who bought $127k worth of shares at about $2.53 per share. This suggests that insiders view the stock as good value, even at a higher price. InspireMD insiders own 22% of the company, worth about $12m, indicating some alignment between management and smaller shareholders. No insider has traded InspireMD shares in the last quarter, but insiders have shown more of an appetite for the stock over the last year.
Investment
InspireMD Reports First Quarter 2024 Financial Results and Provides Business Update
InspireMD, Inc. reported a 22.0% increase in Q1 2024 CGuard EPS revenue, reaching $1.51 million. The company also announced that an abstract detailing one-year outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime has been accepted for presentation at LINC 2024. Additionally, Patrick Geraghty, M.D. and Patrick Muck, M.D. have been named as lead principal investigators for the Company’s CGUARDIANS II clinical trial. The company also announced the appointment of Pete Ligotti as Executive Vice President and General Manager of North America. The companys total revenue for Q1 2024 increased by 22.0%, reaching $1,511,000.
InvestmentManagement Changes
InspireMD to Report First Quarter 2024 Financial Results and Provide Corporate Business Update on Tuesday, May 14th
InspireMD, Inc., the developer of the CGuard Embolic Prevention Stent System for the treatment of Carotid Artery Disease and stroke prevention, has announced that it will report its first quarter 2024 financial results on Tuesday, May 14th, before the financial markets open. Management will host a conference call and webcast with the investment community at 8:30 am (EDT) that same day to review the financial results and provide an update on corporate developments.
Investment
InspireMD to Present at the 23rd Annual Needham Virtual Healthcare Conference
InspireMD, Inc., a developer of the CGuard Embolic Prevention Stent System for stroke prevention, announced that its CEO, Marvin Slosman, will present a company update at the 23rd Annual Needham Virtual Healthcare Conference held from April 8-11, 2024. The company aims to make its products the industry standard for carotid stenting by providing excellent acute results and durable, stroke-free long-term outcomes using its proprietary MicroNet technology.
Management Changes
InspireMD's (NASDAQ:NSPR) investors will be pleased with their solid 110% return over the last year
InspireMD, Inc. has seen its share price fall by 16% over the last quarter, despite impressive returns over the last year, with the share price increasing by 110%. The company is not currently profitable, but has seen revenue growth of 20% over the last year. The companys share price performance has outshone its revenue growth. However, the companys five-year annualised TSR loss of 14% per year compares unfavourably with the recent share price performance.
Public Trading
InspireMD Announces Abstract of One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at LINC 2024
InspireMD, Inc. has announced that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig Interventional Course (LINC) 2024. The trial demonstrated positive 30-day follow-up data and the company is optimistic that the 12-month outcomes data will show a similar level of neuroprotection. This could support a Premarket Approval Application (PMA) later this year and allow for a commercial launch of CGuard Prime in the U.S. in the first half of 2025.
InvestmentExpand
InspireMD, Inc. (NASDAQ:NSPR) Q4 2023 Earnings Call Transcript
InspireMD, Inc. reported its Q4 2023 earnings, beating expectations with a reported EPS of $-0.16 against expected $-0.2. The company experienced a productive fourth quarter, ending 2023 on a high note. The companys CGuard carotid stent platform continues to lead the carotid revascularization market. InspireMD generated record total CGuard revenue of $1.76 million, representing a growth of 71.6% compared to Q4 2022. The company also announced a strategic agreement with the Jacobs Institute at the State University of New York and Buffalo to conduct an early feasibility study of CGuard Prime. The company also welcomed Pete Ligotti as Executive Vice President and General Manager of North America.
CustomersInvestmentExpand
InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update
InspireMD, Inc. has reported a record revenue of $1.76 million for Q4 2023, a 71.6% increase from Q4 2022. The company also announced positive data from its ongoing U.S. clinical trial, C-GUARDIANS, and named Patrick Geraghty, M.D. and Patrick Muck, M.D. as lead principal investigators for the Company’s C-GUARDIANS II clinical trial. The company also announced a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo. InspireMD also appointed medical technology executive Pete Ligotti as Executive Vice President and General Manager of North America.
CustomersManagement ChangesPartners
InspireMD to Report Fourth Quarter and Full-Year 2023 Financial Results and Provide Corporate Business Update on Wednesday, March 6th
InspireMD, Inc., a developer of the CGuard Embolic Prevention Stent System device for the treatment of Carotid Artery Disease and stroke prevention, announced that it will report its fourth quarter and full-year 2023 financial results on March 6th, 2024. The company will host a conference call and webcast with the investment community at 8:30 am (EST) that same day to review financial results and provide an update on corporate developments.
InspireMD Appoints Principal Investigators for C-GUARDIANS II Clinical Trial of the SwitchGuard™ Neuroprotection System
InspireMD, Inc., a developer of the CGuard™ Embolic Prevention Carotid Stent System, has announced the appointment of principal investigators for its upcoming C-GUARDIANS II clinical trial of the SwitchGuard™ Neuroprotection System. The trial is a significant milestone for the company and is planned to start later in the year. The companys mission is to develop solutions that support both Carotid Artery Stenting (CAS) and Transcarotid Artery Revascularization (TCAR) procedures with a best-in-class implant. The C-GUARDIANS II study aims to advance clearance of SwitchGuard™ NPS and associated tools.
Management ChangesExpand
InspireMD Receives CE Mark Recertification Under EU’s New Medical Device Regulation (MDR) Regulatory Framework
InspireMD, Inc., the developer of the CGuard Embolic Prevention Carotid Stent System (EPS) for stroke prevention, has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) framework. The recertification allows the company to continue its work in existing commercial territories and advance its new product pipeline. The company is also working on the Premarket Approval Application (PMA) for the C-GUARDIANS U.S. IDE trial, with results expected in mid-2024.
Customers
We're Hopeful That InspireMD (NASDAQ:NSPR) Will Use Its Cash Wisely
InspireMD, a company listed on NASDAQ, has seen its share price rise by 170% over the last year. Despite being unprofitable, the companys cash burn rate is steady and it had a cash runway of about 2.7 years as of September 2023. The company had US$43m in cash and was debt-free. Its cash burn was US$16m in the last year. InspireMDs market capitalisation is US$66m and it burnt through 24% of the companys market value last year. Despite the cash burn relative to its market cap being a concern, the companys cash runway is considered promising.
Investment
InspireMD Announces Appointment of Medical Technology Executive Pete Ligotti as Executive Vice President and General Manager of North America
InspireMD, a developer of the CGuard Embolic Prevention Stent System for stroke prevention, has appointed Pete Ligotti as Executive Vice President and General Manager of North America. Ligotti brings over 30 years of experience in medical technology management and commercial leadership. The appointment comes as InspireMD scales its U.S. infrastructure ahead of potential approval of the CGuard EPS carotid stent platform. Ligotti previously served as Vice President and General Manager of NuVasive Specialized Orthopedics and held various roles at Integra LifeSciences and Smith+Nephew.
Management Changes
InspireMD Announces Issuance of Key U.S. Patent Covering Its SwitchGuard™ Neuroprotection System
InspireMD, a developer of the CGuard Embolic Prevention Stent System for stroke prevention, has announced the issuance of a U.S. patent for its SwitchGuard Neuroprotection System. The patent covers key aspects of the system and future features in development that are expected to enable physicians to visualize flow through the system. The SwitchGuard system is designed to prevent embolic debris generated during a carotid artery stenting procedure from traveling to the brain. The company expects to submit an Investigational Device Exemption to the FDA in 2024, which, if approved, would allow it to initiate a clinical trial.
Investment
InspireMD's Gary Roubin Acquires 13% More Stock
Insiders at InspireMD, Inc., including Gary Roubin and Michael Berman, have recently made significant purchases of the companys stock. Roubin bought $127k worth of shares at $2.53 per share, increasing his holding by 13%. Berman, an independent director, bought $200k worth of shares at $1.63 per share. These purchases suggest that the insiders consider the stock undervalued at lower prices. InspireMD insiders own 18% of the company, indicating some alignment between management and smaller shareholders. Despite the company making a loss in the last year, the insider transactions suggest confidence in a bright future.
Investment
InspireMD Announces Strategic Agreement with Jacobs Institute to Execute Early Feasibility Study of CGuard EPS for the Treatment of Acute Stroke Patients with Tandem Lesions
InspireMD, Inc. has announced a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo, and Dr. Adnan Siddiqui, to conduct an Early Feasibility Study (EFS) evaluating the CGuard EPS carotid stent for treating severe carotid stenosis or occlusion in patients with acute ischemic stroke and tandem lesions. The study will enroll 15 patients across three U.S. sites. The company views this study as a critical part of its long-term growth strategy for the CGuard stent platform.
PartnersInvestment
InspireMD, Inc. (NASDAQ:NSPR) Q3 2023 Earnings Call Transcript
InspireMD, Inc. reported its Q3 2023 earnings, beating expectations with a reported EPS of $-0.15 against expected $-0.17. The company generated total revenue of $1.556 million on 2,734 devices sold, representing nearly a 9% revenue growth over the comparable period in 2022. The company also announced management changes with the hiring of Dr. Patrick Verta as Executive VP of Clinical and Medical Affairs, Cheryl Tal to lead quality assurance and regulatory affairs, and the promotion of Shane Gleason to Chief Commercial Officer.
CustomersManagement Changes
InspireMD Inc (NSPR) Reports Q3 2023 Financial Results: CGuard EPS Revenue Increases by 9% ...
InspireMD Inc has reported Q3 2023 CGuard EPS revenue of $1.56 million, a nearly 9% increase over Q3 2022. The company also presented positive 30-day results from the C-GUARDIANS U.S. IDE clinical trial at the VIVA23 meeting. Furthermore, InspireMD announced support for CMS decision to expand CAS coverage to include both asymptomatic and standard risk patients, significantly expanding the U.S. CAS addressable market. The company sold 2,734 CGuard EPS stent systems in the third quarter of 2023, a 4.2% increase compared to the same period in 2022.
CustomersExpand
InspireMD Reports Third Quarter 2023 Financial Results and Provides Business Update
InspireMD, Inc. has announced positive 30-day follow-up results from its C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial. The company also announced support for CMS’ decision to expand coverage of CAS to include both asymptomatic and standard risk patients, significantly expanding the U.S. CAS addressable market. InspireMD reported Q3 2023 CGuard EPS revenue of $1.56 million, a nearly 9% increase over Q3 2022. The company also made senior leadership changes to support its commercial growth initiatives.
Management Changes
InspireMD to Participate in Upcoming November Investor Conferences
InspireMD, Inc., a developer of the CGuard Embolic Prevention Stent System for the treatment of carotid artery disease and prevention of stroke, announced that CEO Marvin Slosman will participate in three investor conferences in November 2023. The conferences include the Wolfe Research Healthcare Conference, the Canaccord Genuity MedTech, Diagnostics, Digital Health & Services Forum, and the Piper 35th Annual Healthcare Conference. The presentations will be webcast live and replays will be available on the companys website for 30 days.
Investment
InspireMD Presents Positive 30-Day Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial at VIVA23
InspireMD, Inc. has presented 30-day results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial at the Vascular InterVentional Advances (VIVA) meeting. The trial is designed to evaluate the safety and efficacy of the CGuard™ Carotid Stent System in treating symptomatic and asymptomatic carotid artery stenosis in patients at high risk for carotid endarterectomy. The results showed a low major adverse event rate of 0.95% through 30 days post-procedure. The company anticipates reporting primary endpoint results from C-GUARDIANS in the second half of 2024 and potential FDA approval in the first half of 2025.
Customers
InspireMD to Report Third Quarter 2023 Financial Results and Provide Corporate Business Update on Monday, November 6th
InspireMD, Inc., the developer of the CGuard Embolic Prevention Stent System for the treatment of Carotid Artery Disease and stroke prevention, has announced that it will report its third quarter 2023 financial results on November 6th, 2023. The company will host a conference call and webcast with the investment community to review the financial results and provide an update on corporate developments. The conference call will be webcast live from the companys website.
Investment
InspireMD's (NASDAQ:NSPR) investors will be pleased with their impressive 179% return over the last year
InspireMD, Inc.s share price has more than doubled in just one year, up 179%, despite the company not being profitable in the last twelve months. Over the last twelve months, InspireMDs revenue grew by 3.5%, which is not considered great considering the company is losing money. However, its positive that insiders have made significant purchases in the last year. The five-year annualised TSR loss of 15% per year compares very unfavourably with the recent share price performance.
Investment
InspireMD Supports CMS’ Final National Coverage Determination (NCD) Expanding Coverage of Carotid Stenting (CAS) to Include Both Asymptomatic and Standard Risk Patients
InspireMD, Inc., a developer of the CGuard Embolic Prevention Stent System for stroke prevention, has announced its support for the Centers for Medicare and Medicaid Services (CMS) decision to expand coverage of carotid artery stenting (CAS) and transcarotid artery revascularization (TCAR) to include both asymptomatic and standard risk patients. The company believes this decision will accelerate the shift towards less invasive endovascular procedures. InspireMD is advancing its CAS and TCAR stent delivery platforms along U.S. and E.U. regulatory pathways. The company completed enrollment in the C-GUARDIANS clinical trial of its CGuard EPS stent system in June 2023 and anticipates filing for Premarket Approval in the second half of 2024.
CustomersExpand
InspireMD Announces Senior Leadership Changes to Support Commercial Growth Initiatives
InspireMD, Inc. has announced changes to its senior leadership team to support its commercial growth initiatives. The company has hired Patrick Verta, MD, as Executive Vice President of Clinical and Medical Affairs and Cheryl Tal as Vice President of Quality Assurance and Regulatory Affairs. Shane Gleason, who previously served as InspireMD’s General Manager of North America and VP of Global Marketing, has been promoted to Chief Commercial Officer. The changes are part of the companys strategy to prepare for the potential approval of the CGuard Prime carotid stent platform in the U.S., and to support growth in existing approved territories outside of the U.S.
Management ChangesExpand
Favourable Signals For InspireMD: Numerous Insiders Acquired Stock
Multiple insiders at InspireMD, Inc. have purchased stock in the company, a move that is generally seen as good news for shareholders. The biggest insider purchase in the last 12 months was made by Independent Director Michael Berman, who bought US$200k worth of shares. While the shares were purchased at a lower price than the current share price, insiders were buying shares but not selling over the last year. Insiders own 17% of InspireMD shares, worth about US$12m. The transactions over the last year suggest that InspireMD insiders are not doubting the company.
Investment
InspireMD Announces Abstract of 30-Day Results from the C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at VIVA23
InspireMD, Inc. announced that an abstract detailing upcoming 30-day results from its C-Guardians U.S. IDE clinical trial has been accepted for presentation at the Vascular InterVentional Advances Annual Meeting. The company believes that its CGuard™ EPS offers superior patient outcomes and aims to demonstrate this with the trial. The company also plans to share one-year data from the trial in the second half of next year, which may support a Premarket Approval Application and potential launch of the CGuard Prime EPS stent system in the U.S. in the first half of 2025.
PartnersInvestment
InspireMD Reports Second Quarter 2023 Financial Results and Provides Business Update
InspireMD, Inc. has completed a private placement for up to $113.6 million, including $42.2 million upfront. The company has also completed enrollment in the C-Guardians US IDE trial and is on track to announce primary and secondary endpoints and, if successful, submit a PMA application in H2 2024. The company generated Q2 2023 CGuard EPS revenue of $1.6 million, a nearly 10% increase over Q2 2022. The company also sold 2,804 CGuard EPS stent systems in the second quarter of 2023, an increase of 7.8% compared to the second quarter of 2022.
Investment
InspireMD to Report Second Quarter 2023 Financial Results and Provide Corporate Business Update on Tuesday, August 8th
InspireMD, Inc., a developer of the CGuard Embolic Prevention Stent System for the treatment of Carotid Artery Disease and stroke prevention, announced it will report its second quarter 2023 financial results on August 8, 2023. The company will host a conference call and webcast with the investment community to review the financial results and provide an update on corporate developments. The conference call will be webcast live from the company’s website.
Investment
InspireMD Announces Completion of Enrollment in C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial
InspireMD has completed enrollment of its C-Guardians U.S. Investigational Device Exemption (IDE) clinical trial, which supports potential U.S. marketing approval of the CGuard Prime EPS stent system. The trial, which enrolled 315 patients across 25 trial sites in the U.S. and Europe, is evaluating the safety and efficacy of the CGuard Carotid Stent System for the treatment of carotid artery stenosis. The company anticipates study results and a Premarket Approval (PMA) submission in the second half of 2024, with potential U.S. approval in the first half of 2025. InspireMD aims to be the only company developing comprehensive next-generation delivery and neuroprotection platforms for carotid disease and stroke prevention.
CustomersInvestment
Israeli stent co InspireMD raises up to $113m
Israeli stent company InspireMD has completed a private placement of up to $113.6 million, led by the LifeSci investment bank and with participation from various investors. The financing will allow InspireMD to advance its business, obtain potential regulatory approval, launch its CGuard stent in the US, and develop new products. The company aims to make its products the industry standard for carotid stenting using its proprietary MicroNet technology. InspireMDs share price initially jumped but then fell back, and the company currently has a market cap of $15 million. The CEO expressed satisfaction with the financing and highlighted the companys growing product pipeline and mission of delivering implant-focused patient outcomes.
Investment
InspireMD Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)
InspireMD, Inc. has announced the appointment of Shane Gleason as General Manager of North America and VP of Global Marketing. As an inducement for joining the company, InspireMD granted Gleason 256,450 shares of restricted stock and stock options to purchase 85,480 shares of common stock. The grant was approved by the Compensation Committee and is subject to vesting conditions. InspireMD utilizes its proprietary MicroNet® technology in its products and aims to become the industry standard for carotid stenting. The companys common stock is listed on the Nasdaq under the ticker symbol NSPR.
Management Changes
InspireMD Reports First Quarter 2023 Financial Results and Provides Business Update
InspireMD, Inc. has announced its Q1 2023 financial results, revealing a 6.7% increase in CGuard EPS revenue over Q1 2022. The company also completed a transformational private placement for up to $113.6 million, including $42.2 million upfront. The funds will be used to advance the companys business, including obtaining potential regulatory approval and launch of CGuard in the U.S., initiating new regulatory pathways for advanced applications of its CGuard stent platform, and developing new products. The company also announced management changes, including the hiring of Shane Gleason as General Manager of North America and Vice President of Global Marketing, and the promotion of Andrea Tommasoli to Chief Operating Officer.
InvestmentManagement Changes
InspireMD Announces Private Placement of Up to $113.6 Million
InspireMD, Inc. has signed a securities purchase agreement with certain healthcare-focused institutional investors for a private placement that will provide up to $113.6 million in gross proceeds to the company. The financing, led by Marshall Wace with participation from OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members, includes an upfront funding of $42.2 million. The funds will be used for product and clinical development, obtaining regulatory approvals, expanding manufacturing capabilities, and other general corporate purposes. The private placement is expected to close on May 15, 2023.
Investment
InspireMD Announces May 16, 2023 as New Date for First Quarter 2023 Results Conference Call and Webcast
InspireMD, Inc. will host a conference call and webcast to review its first quarter 2023 financial and operating results. The company is the developer of the CGuard™ Embolic Prevention Stent System for the treatment of Carotid Artery Disease and stroke prevention. The conference call will be held on May 16th, 2023, and will be accessible via toll-free and international numbers. The webcast will be available on the companys website. InspireMD seeks to utilize its proprietary MicroNet® technology to become the industry standard for carotid stenting.
Public Trading
InspireMD Announces May 15th as New Date for First Quarter 2023 Financial Results and Corporate Business Update
InspireMD Announces Successful First-in-Human Procedure Utilizing CGuard Prime, its Next Generation Carotid Artery Stent (CAS) Platform
InspireMD, Inc. has announced the successful treatment of the first carotid artery disease patient using its next-generation CAS stent platform, CGuard Prime. The procedure was performed as part of the companys ongoing CGuardians U.S. Investigational Device Exemption (IDE) trial. InspireMD anticipates completing enrollment in the trial by the end of Q2 2023. The company aims to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. The advanced features of CGuard Prime, including its innovative handle design and catheter and tip construction, are expected to accelerate its uptake among interventionalists and surgeons. The company plans to provide further updates on recent developments during its Q1 2023 earnings conference call.
CustomersInvestment
InspireMD Announces Successful First-in-Human Procedure Utilizing CGuard Prime, its Next Generation Carotid Artery Stent (CAS) Platform
InspireMD to Report First Quarter 2023 Financial Results on May 9, 2023, and Provide Corporate Business Update
InspireMD, Inc. will report its first quarter 2023 financial results on May 9th, 2023. The company will host a conference call and webcast to review financial results and provide an update on corporate developments. InspireMD is the developer of the CGuard™ Embolic Prevention Stent System for the treatment of Carotid Artery Disease and stroke prevention. The company aims to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting. The forward-looking statements in the press release discuss the expansion of the companys portfolio and potential indications for its products. InspireMD faces risks and uncertainties, including market acceptance, regulatory approvals, competition, product liability claims, and the need for additional capital.
InvestmentManagement Changes
InspireMD Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Business Update
InspireMD Announces Promotion of Andrea Tommasoli to Chief Operating Officer
InspireMD to Report Fourth Quarter and Full-Year 2022 Financial Results on March 30, 2023, and Provide a Corporate Business Update
InspireMD Announces Hiring of Medical Device Commercial Veteran Shane Gleason as General Manager of North America and VP of Global Marketing
InspireMD Announces Hiring of Medical Device Commercial Veteran Shane Gleason as General Manager of North America and VP of Global Marketing
InspireMD, Inc. has hired Shane Gleason as General Manager of North America and Vice President of Global Marketing. This hiring is seen as a positive move for the companys growth and expansion. Gleason brings significant expertise in vascular interventions and a successful track record in go-to-market execution. He will lead the critical transition as InspireMD nears completion of enrollment in its C-Guardian U.S. investigational device exemption (IDE) clinical trial and shifts focus to U.S. market readiness. Gleasons knowledge of the carotid market and reputation with key opinion leader (KOL) partners will be valuable in this role. InspireMD is positioned to enable the shift to a carotid endovascular standard of care with its CGuard EPS stent platform.
Management Changes
InspireMD Announces “12 Days of Carotid Stenting” Video Series Featuring Fireside Chats with Top Multidisciplinary Vascular Specialists
InspireMD, Inc., a developer of the CGuard™ Embolic Prevention Stent System for stroke prevention, has announced a video series titled “12 Days of Carotid Stenting”. The series will feature leading multidisciplinary vascular specialists discussing current and future trends in the carotid treatment market. The series will also highlight the distinct advantages of CGuard™ versus competing stent platforms for carotid revascularization and stroke prevention. The video series will be available for viewing from November 28, 2022.
Customers
InspireMD Announces Multiple Presentations Featuring CGuard EPS and its Novel MicroNet Mesh Covering at the 2022 VEITH Symposium
InspireMD Reports Third Quarter 2022 Financial Results and Provides Business Update
InspireMD to Report Third Quarter 2022 Financial Results on November 8, 2022, and Provide Corporate Business Update
InspireMD Announces Presentation at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) Conference
NAMSA and InspireMD Announce Strategic Outsourcing Partnership to Accelerate New Product Development
InspireMD Reports Second Quarter 2022 Financial Results and Provides Business Update
InspireMD to Report Second Quarter 2022 Financial Results on August 9, 2022, and Provide Corporate Business Update
InspireMD Announces Appointment of Endovascular Pioneer Dr. Juan Parodi as Strategic Advisor
InspireMD Announces Successful Live Clinical Case Transmissions Featuring CGuard™ EPS at the Leipzig Interventional Course (LINC) 2020
InspireMD, Inc. announced a successful live case featuring their CGuard EPS at the LINC conference. The live case showcased the ease of use and patient safety features of the device. The procedure was performed on an 82-year-old male patient with symptomatic high-risk carotid artery disease and had an excellent angiographic result. The doctors involved in the case commented that CGuard EPS is a game changer in the plaque-stent interaction paradigm. InspireMD seeks to make their products the industry standard for the treatment of carotid artery disease.
Customers
InspireMD's CGuard™ Embolic Prevention System to be Prominently Featured in Live Case Transmission at LINC, 28th to the 31st January 2020, in Leipzig, Germany
InspireMD, Inc. announced that its CGuard Carotid Embolic Prevention System (EPS) will be featured in a live case transmission and several presentations at the Leipzig Interventional Course (LINC) 2020. The company will also have a booth at the event. LINC is a global forum for new methods in vascular medicine. InspireMD aims to make its products the industry standard for embolic protection and provide a superior solution to current stenting issues. The companys stock is quoted on the NYSE American.
PartnersCustomers
InspireMD Announces Publication of Meta-Analysis Citing Benefits of Next Generation Mesh-Covered Carotid Stent Systems
InspireMD, Inc. has announced the publication of a meta-analysis of four clinical studies involving dual layered and mesh-covered stents. The analysis concluded that carotid artery disease (CAD) patients treated with mesh-covered stents experienced a lower 30-day minor stroke rate compared to other studies. The results support the positive findings from InspireMDs own studies with MicroNet-covered products. The company aims to expand the commercial availability of its MicroNet-covered product, CGuard EPS. The article also features a discussion with a leading European interventional cardiologist who praises the mesh-covered stents for achieving low complication rates even in high-risk patients. InspireMD seeks to make its products the industry standard for the treatment of carotid artery disease.
Customers
InspireMD Announces Positive Long-Term Safety and Efficacy Data from Ongoing CGuard™ EPS Registries at the Recent 45th Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (VEITHsymposium)
InspireMD, Inc. announced the positive results of several presentations on the CGuard EPS at the recent VEITHsymposium. The presentations showcased the long-term benefits of CGuard EPS in preventing embolic events in patients with carotid artery disease. The results from three separate registries demonstrated excellent safety and efficacy of CGuard EPS, with no major stroke or restenosis observed. The presentations highlighted the significant advancement in the treatment of carotid artery disease that CGuard EPS represents. InspireMD seeks to make its products the industry standard for carotid artery disease treatment using its proprietary MicroNet technology.
Customers
InspireMD Announces Regulatory and Reimbursement Approval of CGuard™ Embolic Prevention System in Australia
InspireMD, Inc. has received regulatory approval from the Therapeutic Goods Administration in Australia for its CGuard™ Embolic Prevention System (EPS). The approval allows for commercial sale and reimbursement in Australia, and the company will immediately begin launching the product in collaboration with its local distribution partner, Diverse Devices Pty Ltd. The approval represents an important step for InspireMD in expanding its commercial availability into new territories, particularly in the Asia-Pacific region. Australias Therapeutic Goods Administration is known for its high standards in regulatory and reimbursement approval of new medical devices. The company believes that the approval reflects the agencys recognition of CGuards unique features and the need for safer treatments for carotid artery disease. InspireMD aims to make its products the industry standard for the treatment of carotid artery disease by utilizing its proprietary MicroNet® technology.
Customers
InspireMD Announces Regulatory Approval of CGuard Embolic Prevention System in Mexico
InspireMD Inc. has received regulatory approval from COFEPRIS for the commercial sale of its CGuard Embolic Prevention System (EPS) in Mexico. The companys CEO, James Barry, stated that expanding into new geographies is a key part of their growth strategy. InspireMDs distribution partner, LevBeth Medical, played a crucial role in the approval process. The company aims to make its products the industry standard for treating carotid artery disease by utilizing its proprietary MicroNet technology. InspireMDs common stock is quoted on the NYSE American under the ticker symbol NSPR.
Customers
https://markets.businessinsider.com/news/stocks/inspiremd-announces-issuance-of-two-new-u-s-patents-covering-proprietary-micronet-stent-jacket-and-related-drug-eluting-technology-1027539364
InspireMD, Inc. has been issued two US patents for its proprietary MicroNet stent jacket technology and related drug eluting technologies. The patents strengthen the companys intellectual property and product portfolio, particularly for its lead product, CGuard EPS, which is used for the prevention of stroke in patients with carotid artery disease. The MicroNet technology acts as a safety net, preventing debris from passing through the stent struts and reducing the risk of complications. The patents also cover the companys coronary stent product, MGuard Prime EPS, and potential applications in the coronary drug eluting stent market. InspireMD plans to expand its commercial footprint and submit an Investigational Device Exception (IDE) with the FDA in mid-2019.
CustomersPartners
InspireMD Receives Regulatory Approval for both CGuard™ EPS and MGuard Prime™ in Ecuador - InspireMD
InspireMD has received regulatory approval for its CGuard Embolic Prevention System and MGuard Prime from the Ministry of Health in Ecuador. The company has an exclusive distribution agreement with CARDIOBENE S.A., a leading medical device distributor in Ecuador, and sales for both products will commence immediately. The approval enhances InspireMDs footprint across Latin America.
Partners
http://www.marketwired.com/press-release/inspiremd-announces-planned-recapitalization-2242135.htm
AIM ImmunoTech will participate in the Virtual Investor Summer Spotlight Series.
Investment
InspireMD closes $15m offering
InspireMD has raised $14.6 million in a stock offering to boost sales of its anti-stroke devices. The offering consisted of Series B stock convertible into common stock and warrants for common stock. The funds will be used to grow sales of CGuard MGuard Prime devices and develop new products. Dawson James Securities served as the sole placement agent.
Investment