IceCure Medical, a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has submitted a regulatory filing with China’s National Medical Products Administration (“NMPA”) for the approval of its ProSense Cryoablation System. IceCure’s IceSense3, its predecessor cryoablation system, already has regulatory approval in China.
The indicated use for ProSense in China, per the Company’s regulatory filing application, is as a cryosurgical tool in the fields of general surgery including breast tissue, dermatology, thoracic surgery including lung tissue, gynecology, oncology, proctology, and urology including kidney tissue. The ProSense application with the NMPA expands upon the current IceSense3 clearance to include a total of five different cryoprobes of varying length, diameter, and ice ball shape, as well as the use of introducers, which provide increased accessibility to the targeted tissue in certain indications.
“China is potentially a very large market for cryoablation and we are moving forward with an expanded line of available products, as well as securing reimbursement, so that IceCure can be ideally positioned to serve this important geography,” stated IceCure CEO, Eyal Shamir.
