Israeli biomedical company IceCure Medical, the developer of technology that freezes cancerous tumors, announced this week that its flagship system, ProSense, was granted a designation as a Breakthrough Device from the US Food and Drug Administration (FDA). The status is granted for certain medical devices and device-led products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The ProSense is a liquid-nitrogen-based cryoablation system used in the treatment of patients with T1 invasive breast cancer or patients who are not suited for surgical alternatives for the treatment of breast cancer.
The system is one of two cryoablation systems developed by IceCure for treating malignant and benign tumors. The treatments involve streaming liquid nitrogen in a closed circuit and then freezing the tumor with a unique needle developed by IceCure. The company says the healthy tissue remains untouched.
In 2018, IceCure reported great success rates following clinical trials across the US using the IceSense3 system (ICE3). IceCure said doctors performed the procedures on 146 patients affected by early-stage breast cancer, a majority (103) of whom were under monitoring for almost two years. The company reported that out of the 146 women, one saw the cancer recur.
IceCure touts its procedures as non-invasive, safe, and a viable alternative to surgery. The procedure can be performed in a clinic in about an hour, without the need for general anesthesia or hospitalization.
“We are thrilled to receive the Breakthrough Device Designation from the FDA for our lead asset, ProSense, based on promising clinical outcomes in multiple clinical studies to date,” said IceCure CEO Eyal Shamir. “ProSense has successfully demonstrated the potential to be an exceptionally safe and effective minimally-invasive cryoablation approach to tumor destruction. We believe receipt of this designation is a testimony to the potential of ProSense to become the new gold standard for cryoablation tumor therapy.”
Shamir said the designation builds on a series of successful regulatory milestones for ProSense which already has FDA approval for general minimally-invasive cryoablation applications, including for kidney, liver, and benign breast tumors.
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IceCure, he said, is now pursuing FDA-specific approval for breast cancer with its ongoing ICE3 clinical trial, “the largest controlled multilocation clinical trial in the US for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors.”
Shamir indicated that the company will present updated interim results of the ICE3 trial at the upcoming American Society of Breast Surgeons Annual Meeting at the end of the month.
IceCure was founded in 2006 as part of an incubator hosted by the Israel Innovation Authority (then the Israel Chief Scientist Office) to find a minimally invasive alternative to treat cancer. It became a private company in 2008 before going public three years later.
As of 2011, IceCure is a publicly-traded company on the Tel Aviv stock exchange, with a market cap of almost NIS 31.5 million ($9.5 million). A majority of its shares (70 percent) are owned by Chinese investor Haixiang Lee, founder and managing partner at VI Ventures.