IceCure Medical has sought approval from Israel’s Ministry of Health’s Medical Device Division (AMAR) for its XSense cryoablation system and cryoprobes.
Both components have already gained marketing authorisation from the US Food and Drug Administration (FDA).
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The cryogenic connector technology of the system is claimed to be tailored for enhancing “safety” and maintaining cryogen integrity during cryoablation procedures.
IceCure’s submission to AMAR includes a request to approve the XSense system for all indications currently authorised for its ProSense system, which include dermatology, neurology, urology, and proctology.
IceCure Medical CEO Eyal Shamir said: “While de-escalation of surgery is a trend specific to the treatment of breast cancer, we see growing opportunities for our cryoablation systems to offer minimally invasive solutions in a wide range and expanding number of indications. We are optimistic about receiving regulatory clearance for XSense in Israel in the coming months.”
IceCure secured the European Patent Office’s Intention to Grant Notice for its invention, the Cryogenic system connector, last month.
Additionally, the company made a regulatory submission to China’s National Medical Products Administration for the ProSense cryoablation system in January. The company’s previous system, IceSense3, is already approved in the country.
IceCure Medical focuses on liquid-nitrogen-based cryoablation therapy solutions for tumour destruction.
The company’s minimally invasive technology is claimed as an effective and safe hospital surgical alternative for removing the tumour, with a focus on breast, bone, lung, and kidney cancers.
The ProSense system, the company’s flagship product, is sold for approved indications in various regions, including Europe, China, and the US.
Last November, the FDA Medical Device Advisory Committee Panel issued a favourable recommendation for ProSense.
