Ark Surgical News
6 articles
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/PRNewswire/ -- Ark Surgical, a women's health-focused medical device innovator, has received FDA 510(k) clearance for LapBox® POWER, a breakthrough tissue...
Ark Surgical, a company focused on womens health, has received FDA 510(k) clearance for its LapBox® POWER, a tissue containment system for use with power morcellators in minimally invasive gynecologic surgery. This clearance expands on their 2023 approval for manual morcellation, making LapBox® the first FDA-cleared dual-wall containment system for both manual and power tissue extraction. The system, designed in collaboration with OB/GYNs, aims to prevent the spread of undiagnosed cancer and other harmful tissues during laparoscopic procedures. The FDA has emphasized the importance of using cleared containment systems to mitigate risks associated with uncontained morcellation. With a large number of gynecologic procedures performed annually, Ark Surgicals innovation supports safer surgeries, benefiting both patients and providers.
FDA approved/pending approval
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Ark Surgical Secures $1.1M in Funding to Advance Safer Surgical Solutions for Women's Health -
Ark Surgical, a medical device company focused on womens health, has secured an additional $1.1 million in funding between December 2023 and January 2024. The investment will support the U.S. market expansion of its FDA-cleared tissue containment system, the LapBox. The funding round included participation from Intempo Ventures, NGT3, the Israel Innovation Authority, and the Israel Ministry of Economy and Industry, as well as a U.S.-based medical device group. The LapBox is designed to facilitate safer surgical procedures for women, particularly hysterectomies, by preventing the dispersion of cancerous tissues. Ark Surgical is now preparing to scale its commercial activities in the U.S. and is seeking strategic distribution partners.
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Ark Surgical Performs First Hysterectomies in the USA with its FDA-Cleared LapBox for Manual Morcellation |
Ark Surgical, an Israeli medical device company, has announced the successful completion of its first hysterectomy procedures in the US using the LapBox tissue containment system for manual morcellation. The LapBox system is designed to improve patient outcomes and lower the risk of cancer cell spread during minimally invasive hysterectomies. The FDA-cleared device is now available in the US. The Arizona Gynecology Consultants were among the first to use the LapBox system.
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Novel Tissue Containment System for Manual Morcellation Lowers Risk of Cancer Cell Spread
Ark Surgical, based in Nazareth, Israel, has received FDA clearance for its LapBox containment removal system, designed to facilitate safe tissue removal during laparoscopic surgeries. The LapBox aims to reduce the risks associated with open surgeries and uncontained morcellation, particularly for procedures like hysterectomies and myomectomies. The device features a double-walled design that minimizes the spread of cancerous cells and enhances surgical precision. This development is expected to positively impact Ark Surgical by providing gynecologists with a safer and more efficient tool for tissue removal.
Customers
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Israeli Femtech Start-up, Ark Surgical, secures $2.1 Million in Funding for LapBox Tissue Containment System for Laparoscopic GYN Surgery
Ark Surgical Ltd., an Israeli Femtech start-up, has secured $2.1 million in funding for its LapBox containment system, which is used for the secure removal of large internal organs during laparoscopic GYN surgery. The funding was raised from investors of the Together equity crowdfunding platform, the Israeli Innovation Authority, and NGT. The company has completed the first-in-human study demonstrating the safety and functionality of the LapBox. The current funding will enable Ark Surgical to submit for FDA regulatory and marketing clearance.
Investment
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Ark Surgical Gives Peace of Mind for Women Undergoing Gynecological Procedures
Ark Surgical is developing a device called LapBox, designed to facilitate the removal of large internal organs through a laparoscopic incision. The device is intended to replace the use of power morcellators, which have seen a decrease in use due to the risk of spreading cancerous tissue. The LapBox is designed to be user-friendly, with a rapid setup, operation, and removal process. The company has filed three US patents for the device. The market potential for the device is estimated at over $500M annually, with approximately 500,000 laparoscopic procedures involving large organ removal performed in the US each year.
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