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FDA Panel Backs IceCure's ProSense for Early-Stage Breast Cancer

  • An FDA advisory panel has favorably recommended IceCure Medical's ProSense cryoablation system for treating early-stage, low-risk breast cancer.
  • The panel voted 9-5 that the benefits of ProSense outweigh the risks when used with adjuvant endocrine therapy, offering a potential alternative to lumpectomy.
  • The FDA's final decision on marketing authorization for ProSense is expected in the first quarter of 2025.
  • ProSense uses liquid nitrogen to freeze and destroy tumors, providing a minimally invasive treatment option.
An FDA Medical Device Advisory Committee has given a favorable recommendation to IceCure Medical's ProSense cryoablation system for the treatment of early-stage, low-risk invasive breast cancer. The panel voted 9-5 in favor of the benefit-risk profile of ProSense when used with cryoablation and adjuvant endocrine therapy, marking a significant step toward potential FDA marketing authorization. The FDA's final decision is anticipated in the first quarter of 2025.
The positive vote was based on a comprehensive review of data, including results from IceCure's ICE3 study, which compared ProSense to the current standard of care, lumpectomy. The panel also considered testimonies from patients, advocacy groups, doctors, nurses, and researchers.
Eyal Shamir, CEO of IceCure, stated, "This is a significant milestone on the path towards the marketing authorization of ProSense cryoablation in the U.S. for early-stage low risk breast cancer and I believe a critically important development for women seeking an alternative to lumpectomy." Shamir also noted that the company's U.S. sales and distribution team is prepared to support doctors and patients if marketing authorization is granted.

How ProSense Works

The ProSense Cryoablation System offers a minimally invasive approach to tumor destruction by freezing. Utilizing liquid nitrogen, the system creates large lethal zones, maximizing its effectiveness in treating both benign and cancerous lesions in the breast, kidney, lung, and liver.
ProSense aims to improve patient and provider experiences by accelerating recovery and reducing pain, surgical risks, and complications. Its design allows for convenient office-based procedures for breast tumors.

About IceCure Medical

IceCure Medical (Nasdaq: ICCM) develops and markets cryoablation therapy systems that use liquid nitrogen to freeze and destroy tumors. The company focuses primarily on breast, kidney, bone, and lung cancer treatments. ProSense, IceCure's flagship system, is currently marketed and sold worldwide for approved indications, including in the U.S., Europe, India, Brazil, and China.
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Reference News

[1]
IceCure Medical's ProSense® Gains FDA Panel Support
tipranks.com · Nov 8, 2024

IceCure Medical's ProSense® cryoablation system received a favorable FDA Advisory Panel recommendation for treating earl...

[2]
IceCure's ProSense Cancer Treatment Wins Crucial FDA Panel Vote, Shares Surge
stocktitan.net · Nov 8, 2024

FDA Advisory Panel recommends IceCure's ProSense® cryoablation for early-stage low risk breast cancer, with 9 in favor a...

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