IceCure Medical announces regulatory strategy for the IceSense3 System

IceCure Medical Ltd., developer of the next generation minimally invasive cryoablation technology that destroys tumors by freezing, today announced the advancement of its regulatory strategy in China with the submission of an amendment to the registration certificate for the IceSense3® system, which was granted by China’s National Medical Products Administration (“NMPA”). The amendment, if approved, will allow the Company to sell its disposable IceSense3 Cryoprobes for commercial procedures. The Company expects the NMPA to complete its evaluation of the amendment by the end of 2022. If the amendment is approved, the Company expects to then launch its commercial sales program for the IceSense3 system in China in early 2023.

“We are excited to announce the advancement of our regulatory strategy for the IceSense3 system in China, as we look to bring our minimally-invasive therapy to more cancer patients around the world. With more than 400,000 new breast cancer cases diagnosed in China in 2020, according to the World Health Organization, breast cancer continues to be a significant health concern in China,” commented Eyal Shamir, Chief Executive Officer of IceCure. “As Chinese health providers continue to look for advanced technologies, we expect early adopters in China to provide a base for our commercial launch once the IceSense3 Cryoprobes receive NMPA regulatory clearance. As part of our strategy to gain greater awareness of our systems and cryotherapy as a cancer treatment more broadly with healthcare providers in the region, we have been supportive of an ongoing independent clinical trial with a site in Hong Kong and a site in Shenzhen. Also, we expect another independent trial to start soon in a leading hospital in Shanghai.” PR Newswire