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Seeks to expand regulatory approval in China where IceSense3 has already been approved
CAESAREA, Israel, Jan. 27, 2025 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), 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.
About ProSense®
The ProSense® Cryoablation System is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedures for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and China.