ProSense® is already marketed and sold in India based on previous regulatory requirements and now has been re-classified due to new regulationsBreast cancer cryoablation is already performed in India with ProSense®IceCure Medical Ltd. developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that the Central Drugs Standard Control Organization ("CDSCO") in India has granted approval for the ProSense® system based on the CDSCO's updated regulatory requirements. This is in addition to existing approvals, including disposables and cryoprobes, already approved for indications covering general surgery and oncology for tissues of the breast, lung, bone, kidney, liver and more. ProSense® was previously marketed and sold in India in accordance with prior regulatory requirements. This latest approval, granted in November 2023, confirms that ProSense® meets all updated regulatory requirements in India. ProSense® is marketed and sold in India through IceCure's distributor, Novomed. The first breast cancer cryoablation procedure in India was conducted using ProSense® in June of 2023, at the Kovai Medical Center and Hospital in Coimbatore. Along with Novomed, IceCure recently presented ProSense® at the 10th Annual Conference of the Breast Imaging Society of India, where the cryoablation system was enthusiastically received by doctors, who attended a presentation of the ICE3 clinical study results and participated in hands-on demonstrations."India is a very important market for us because we see the potential for significant growth with safe, effective, and cost-efficient technologies rapidly adopted. We have a highly productive partnership with our in-country distributor, Novomed, and anticipate increasing market traction," stated IceCure's Chief Executive Officer, Eyal Shamir. "Obtaining and maintaining regulatory approvals across the world supports our continued commercial traction worldwide." About IceCure MedicalIceCure Medical (NASDAQ: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment 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 system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.
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