IceCure Medical Set to Present ProSense® Cryoablation Progress

IceCure Medical Prepares for FDA Advisory Panel Meeting

IceCure Medical Ltd (NASDAQ: ICCM) has announced an important meeting involving the U.S. Food and Drug Administration (FDA). The FDA's Medical Device Advisory Committee Panel will convene to discuss ProSense®, a cryoablation technology aimed at providing an alternative solution for patients with early-stage low-risk breast cancer.

Understanding ProSense® and Its Significance

The ProSense® Cryoablation System is designed to treat tumors by utilizing extreme cold to effectively freeze and destroy tissue. This innovative approach is particularly relevant for the approximately 70,000 women diagnosed annually in the U.S. with early-stage low-risk breast cancer. IceCure aims to demonstrate that ProSense® is a viable alternative to traditional surgical options, such as lumpectomy.

Public Forum to Gain Insights for Stakeholders

The upcoming panel meeting serves as a platform for stakeholders, including patients, physicians, and payors, to engage in discussions. IceCure's CEO, Eyal Shamir, expressed the importance of this forum, stating it allows diverse perspectives to assess the potential benefits of ProSense® cryoablation.

Anticipated Outcomes and Next Steps

Following the Advisory Panel, the FDA is expected to render a decision regarding the marketing clearance of ProSense® by early 2025. This timeline is critical as it could pave the way for broader implementation of the technology in clinical settings.

Composition of the Advisory Panel

The panel will consist of professionals including breast surgeons and interventional radiologists. They will review extensive data from various clinical trials, such as the ICE3 study—significant as it represents the largest controlled multicenter trial examining liquid nitrogen-based cryoablation.

Clinical Study Results Highlighting ProSense® Efficacy

Preliminary findings from the ICE3 study illustrate promising results: 96.3% of patients treated with the ProSense® cryoablation followed by adjuvant endocrine therapy remained free from local recurrence over a five-year period, with total satisfaction from both patients and healthcare providers.

The Role of IceCure Medical in Advancing Cancer Treatment

IceCure Medical is on the forefront of cancer treatment technologies, specializing in cryoablation. Their method utilizes liquid nitrogen to create effective and large lethal zones that enhance the destruction of both benign and malignant tumors. The technology is not limited to breast cancer; it encompasses applications in various cancers, including those affecting the kidney, lung, and liver.

Concluding Thoughts on the Upcoming Advisory Panel Meeting

As the FDA prepares for the Advisory Panel proceedings, IceCure will ensure transparency by releasing meeting materials to the public shortly before the event. This open approach reinforces IceCure's commitment to keeping shareholders and interested parties informed.

Frequently Asked Questions

What is the purpose of the FDA Advisory Panel meeting?

The meeting is intended to gather expert opinions on ProSense® cryoablation technology and discuss its potential as a treatment for early-stage low-risk breast cancer.

What outcomes does IceCure Medical anticipate?

IceCure expects the FDA to make a marketing clearance decision regarding ProSense® by early 2025.

Who will be part of the Advisory Panel?

The panel will include breast surgeons, interventional radiologists, and regulatory experts who will review clinical data.

How effective is ProSense® based on clinical studies?

Clinical studies indicate that over 96% of patients treated with ProSense® remained free from local tumor recurrence five years post-treatment.

What are the main advantages of using ProSense®?

The ProSense® System is minimally invasive, leads to quicker recovery times, and reduces pain and surgical risks compared to traditional surgery.

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