Israeli Medical Company Receives FDA Approval For Tumor Treatment
A medical device company in Israel is making major strides in an effort to treat cancer patients around the world and it just received U.S. regulatory approval to expand the use of its cryoablation technology. According to Reuters it will be used to to treat benign and cancerous tumors in livers and kidneys.
Moreover, after the U.S. Food and Drug Administration gave Icecure Medical further approval its share prices rose 30 percent.
According to IceCure’s vice president of business development and global marketing, Tlalit Bussi Tel Tzure, the corporation first received FDA approval for its tumor-treating cryoablation technology in 2010 after undergoing a series of tests.
“The cryoablation system only became commercial in 2014,” Tel Tzure told The Jerusalem Post. “We had already general FDA approval to treat benign and cancerous tissues, but we didn’t have a specific application, meaning which organ we are treating with the cryoablation system.”
IceCure, founded in 2006 and headquartered in Tel Aviv, uses its high-tech cryoablation abilities to enable rapid minimally-invasive, safe, and effective treatment of breast lesions in-office or ambulatory hospital settings.
“The additional FDA clearance is a pivotal milestone for IceCure and we now plan to expand our operational capabilities in the addressable markets for labels with existing CPT codes and reimbursement, while driving further revenues,” Eyal Shamir, CEO of IceCure Medical, said in a statement. “Receipt of this bundled approval is a significant step in our ability to commercialize our products in the U.S., and we believe this along with the other achievements, allow us to enter 2020 with plenty of momentum and revenue generation opportunities.”
According to IceCure, The ProSense™ system provides physicians full control over these procedures, ensuring that the treated zone is destroyed while leaving surrounding tissue undamaged. This method has successfully been used for the treatment of benign and malignant breast tumors, as well as renal, lung, and bone cancer.
Back home, IceCure has earned Israeli AMAR authorization for ‘use of its freezing technology in specific indications.’
“This specific approval in Israel is an important achievement that will support IceCure to expand our technology use,” stated Shamir in August. “Doctors can now more easily destroy benign and malignant tumors for a wide range of indications that will help save and improve the lives of many patients.”
The AMAR authorization allows doctors in Israel to use the company’s technology to freeze tumors in ‘specific medical indications’, including for breast and lung cancer.