On January 27, 2025, IceCure Medical Ltd. announced the submission of a regulatory filing with China's National Medical Products Administration (NMPA) for the approval of its ProSense® Cryoablation System. This filing aims to expand the company's presence in the Chinese market, where its predecessor system, IceSense3, already holds regulatory approval. The application seeks to broaden the available product line and secure reimbursement in this important geography.
The indicated use for ProSense® in China, as per the regulatory filing, encompasses a wide range of surgical fields including general surgery (breast tissue), dermatology, thoracic surgery (lung tissue), gynecology, oncology, proctology, and urology (kidney tissue). The application specifically expands upon the current IceSense3 clearance by including a total of five different cryoprobes of varying length, diameter, and ice ball shape, as well as the use of introducers to increase accessibility to targeted tissue.
IceCure's CEO, Eyal Shamir, emphasized that China represents a potentially very large market for cryoablation. The company is strategically positioning itself with an expanded product line and efforts to secure reimbursement to effectively serve this market. This regulatory initiative is a key step in IceCure's global commercialization strategy.
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