By Yakir Benzion, United With Israel -
The Israeli medical device company IceCure received a huge boost after American authorities approved the company’s revolutionary ProSense system for treating cancerous tumors by freezing them, Globes reported Sunday.
The U.S. Food and Drug Administration (FDA) gave marketing approval to ProSense as part of the FDA’s Breakthrough Devices Program that fast-tracks new devices to the market.
Based in Caesarea, north of Tel Aviv, and with offices in America, IceCure Medical developed a system that uses liquid nitrogen-based technology to freeze tumors so they can be removed without the need for surgery.
“Using ProSense, oncologists provide better quality patient care, achieve superior outcomes, and reduce the cost of care,” the company says.
ProSense, which can be used for several types of cancer, was proven effective and much less intrusive for removing breast cancer growths.
The FDA announcement was also great for business, with IceCure stock shares soaring 35% in value.
“We are delighted about the FDA’s recognition of our innovative cryoablation (freezing) technology as a breakthrough device, which meets the major needs for treating benign and cancerous tumors for a range of indications, including early stage and low risk breast cancer,” said IceCure CEO Eyal Shamir. “Receiving breakthrough device status allows the company direct access to the FDA team examining the product.”
Founded in 2006, IceCure bases its technology on the science of cryoablation – the use of the super-cold temperature of liquid nitrogen at −195°C (−320°F) – to destroy tumors safely, quickly and painlessly without the need for surgery.
The ProSense system provides physicians with full control over the procedure, ensuring that the treated zone is destroyed while leaving surrounding tissue undamaged.
