IceCure Medical Gains FDA Advisory Panel's Positive Vote

IceCure Medical Gains FDA Advisory Panel's Positive Vote

FDA decision on marketing authorization expected soon

IceCure Medical Ltd. (NASDAQ: ICCM), a developer known for its innovative cryoablation technology, has recently achieved a significant milestone. This comes as the U.S. Food and Drug Administration's Medical Device Advisory Committee Panel has provided a favorable recommendation concerning IceCure's ProSense® System for treating early-stage low risk breast cancer. The panel's vote saw 9 approving the system's benefit-risk profile, while 5 voted against it.

The Advisory Panel concluded that the advantages of using IceCure’s ProSense® system outweigh the risks for patients undergoing cryoablation combined with adjuvant endocrine therapy. Among the panelists who were not in favor, several commented that adequate special controls might have altered their stance positively.

"This is a significant achievement for IceCure," stated Eyal Shamir, the Chief Executive Officer of IceCure Medical. "We are optimistic about the FDA's forthcoming decision based on this recommendation, which we anticipate will occur in the near future. Our team is fully prepared to support healthcare professionals and patients should the marketing authorization for ProSense® be granted, enabling an alternative to traditional lumpectomy for women diagnosed with early-stage low risk breast cancer."

The favorable recommendations by the Advisory Panel were grounded in extensive data regarding the efficacy of the ProSense® system for early-stage low risk breast cancer treatment. This included insights from the ICE3 study and contributions from key stakeholders, amongst them patients, medical professionals, and advocacy groups dedicated to cancer awareness.

The advisory role of the panel was to provide independent expert perspectives on the potential marketing authorization of the ProSense® system for treating early-stage low risk breast cancer. The panel comprised specialists including breast surgeons, interventional radiologists, and oncologists, as well as representatives from patient advocacy groups and regulatory bodies.

Understanding ProSense® Cryoablation Technology

About ProSense®
IceCure's ProSense® Cryoablation System provides a cutting-edge, minimally invasive method to effectively destroy tumors through a freezing technique. This innovative system leverages liquid nitrogen to create extensive lethal zones essential for maximum treatment efficacy on both benign and malignant tumors, covering a range of types including breast, kidney, lung, and liver cancers.

ProSense® serves to enhance the experience for both patients and providers by facilitating quicker recovery periods, diminishing pain, and reducing the risks associated with surgery. Its unique design, which utilizes liquid nitrogen, allows for efficient office-based procedures for breast tumors, paving the way for more accessible and convenient treatment options for patients.

About IceCure Medical

IceCure Medical (NASDAQ: ICCM) is committed to advancing the field of cryoablation therapy. The company develops and markets state-of-the-art liquid-nitrogen-based systems aimed at treating various tumors by freezing. The main focus lies in addressing breast, kidney, lung, and bone cancers.

Unlike traditional surgical approaches, IceCure’s minimally invasive technology offers a safe and effective alternative that can be performed in a fraction of the time, making it a preferred choice for many patients globally. The ProSense® system is already marketed and sold across several countries including the U.S., Europe, India, Brazil, and China, demonstrating its worldwide applicability and efficacy.

Looking Ahead

With the FDA’s anticipated decision on the marketing authorization of ProSense® for the treatment of early-stage low risk breast cancer on the horizon, IceCure is positioned to potentially transform how this condition is managed in clinical settings. The outcome of this decision may significantly impact treatment paradigms for patients seeking alternatives to more invasive surgical options.

Frequently Asked Questions

What is the ProSense® System?

The ProSense® System by IceCure Medical is a minimally invasive cryoablation technology used to destroy tumors by freezing them.

What did the FDA Advisory Panel recommend?

The panel voted in favor of the ProSense® System's benefit-risk profile for treating early-stage low risk breast cancer, indicating a favorable outlook for its approval.

When is the FDA expected to make a decision?

The FDA's decision regarding the marketing authorization for ProSense® is expected soon.

How does cryoablation compare to traditional surgery?

Cryoablation offers a less invasive alternative to surgery, which may result in quicker recovery times and reduced complications for patients.

In what markets is IceCure's ProSense® available?

The ProSense® system is marketed in several locations worldwide, including the U.S., Europe, India, Brazil, and China.

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