IceCure Medical Wins NMPA Approval to Market ProSense Cryoablation System in China
核心洞察
China's National Medical Products Administration (搜索) has granted Class III medical device approval to IceCure Medical's ProSense (搜索) cryoablation system and associated cryoprobes.
ProSense (搜索) uses liquid nitrogen-based cryoablation to destroy benign and malignant tumors in breast, kidney, bone and lung under imaging guidance.
The approval was supported by clinical data demonstrating safety and efficacy, particularly in breast tumors, and expands ProSense (搜索)'s reach beyond the U.S., Europe and Asia.
IceCure Medical Ltd. (NASDAQ: ICCM) announced on Sept. 10, 2026 that China's National Medical Products Administration (搜索) (NMPA) has granted approval, as a Class III medical device, for its ProSense (搜索) system and associated cryoprobes. The authorization enables the company's flagship cryoablation platform to be marketed in China in accordance with the approved registration, extending the device's commercial footprint into one of the world's largest healthcare markets.
A Minimally Invasive Alternative to Surgical Tumor Removal
ProSense (搜索) is a liquid-nitrogen-based cryoablation system that destroys benign and malignant tumors by freezing them, positioning the technology as a non-surgical option to tumor removal. The system targets tumors in the breast, kidney, bone and lung. Cryoablation is performed under imaging guidance, allowing physicians to target tumors precisely while sparing surrounding healthy tissue, and the procedure can be completed in a relatively short session.
According to IceCure, the NMPA approval was supported by clinical data demonstrating ProSense (搜索)'s safety and efficacy, particularly in breast tumors. The company also highlighted that cryoablation can be performed in outpatient settings, reducing recovery time and healthcare costs compared with traditional surgery.
Regulatory and Commercial Implications
The approval represents an important regulatory milestone for IceCure, whose ProSense (搜索) system is already cleared and marketed in the U.S., Europe and other parts of Asia. The new Chinese registration significantly expands the device's global reach.
"We are pleased to receive NMPA approval for ProSense (搜索) in China, marking an important step in expanding access to IceCure's minimally invasive cryoablation technology," said Eyal Shamir, Chief Executive Officer of IceCure Medical. "The approval further strengthens our global regulatory position and expands the markets in which ProSense may be commercialized."
In a separate statement, Shamir described the NMPA decision as "a major milestone in our mission to make ProSense (搜索) available to patients worldwide," noting that China represents one of the largest healthcare markets globally.
Commercialization Strategy in China
With the authorization in hand, IceCure said it plans to accelerate commercialization efforts in China through local partnerships, aiming to provide physicians and patients with access to advanced cryoablation technology. The company has not disclosed specific timelines or partner identities for the Chinese launch.
Corporate Developments
IceCure recently implemented a 1-for-30 reverse stock split on June 4, 2026. Shares of ICCM were trading at $2.14, up 1.42%, according to market data cited in coverage of the announcement.
IceCure Medical develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of benign and cancerous tumors, with primary focus areas in breast, kidney, bone and lung cancer (搜索). The company's ProSense (搜索) system is marketed and sold worldwide for the indications cleared and approved to date, including in the U.S., Europe and Asia.