IceCure submitted an amendment to the registration certificate granted for the IceSense3 system by China’s national medical products administration (NMPA), which will allow IceCure to sell the IceSense3 and cryoprobes for commercial procedures in China.
IceCure Medical recently announced the advancement of the regulatory strategy in China with the submission of an amendment to the registration certificate for the IceSense3 system, which was granted by China’s NMPA. The amendment, if approved, will allow the company to sell the disposable IceSense3 cryoprobes for commercial procedures. The company expects the NMPA to evaluate the amendment by the end of 2022 and providing the amendment is approved, the company expects to then launch the 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, the 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” said Shamir, illustrating ongoing trail plans.