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IceCure's ProSense® Cryoablation Receives FDA Marketing Authorization

In a groundbreaking achievement for women's health, IceCure Medical has announced that its ProSense® cryoablation system has been granted marketing authorization by the U.S. Food and Drug Administration (FDA) for the treatment of low-risk breast cancer in women aged 70 and older. This marks a significant advancement in the medical field, offering the first and only FDA-approved device for this specific indication.

Understanding ProSense®

ProSense® utilizes a minimally invasive cryoablation technique that aims to destroy tumors by freezing them, eliminating the need for traditional surgical procedures. This method is particularly beneficial for older women suffering from biologically low-risk tumors that are 1.5 cm or smaller. With this new FDA approval, IceCure opens the door to a safer and more accessible treatment option for approximately 46,000 women in the U.S. annually who fall into this demographic and may not be eligible for surgery.

Eyal Shamir, IceCure's Chief Executive Officer, expressed pride in this advancement, emphasizing how it enhances women's cancer care, significantly improves their quality of life, and offers a compelling alternative to the conventional lumpectomy procedure. The enthusiastic response from leading U.S. breast surgeons and radiologists further supports this innovation’s potential impact on the field.

The Reimbursement Landscape

One of the tremendous benefits accompanying the FDA authorization is the initial reimbursement under the CPT III code. This code provides coverage of $3,800 for facility costs, with expectations for additional reimbursement provisions as the technology becomes more accepted in the medical community. These financial aspects are crucial in ensuring that this pathologically innovative treatment remains viable for patients who could greatly benefit from its advantages.

Expanding Access Through Research

The FDA’s approval is coupled with a requirement for IceCure to conduct a post-market surveillance study. This study will assess the efficacy and safety of the ProSense® system among approximately 400 patients across 30 sites. Significantly, while this post-market study is underway, IceCure is poised to begin immediately rolling out the ProSense® system at clinical sites, demonstrating their readiness to provide this essential care to women who need it most.

In fact, Shad Good, Vice President of Sales North America, underlined the commitment of IceCure's team to expand their U.S. customer base and drive the adoption of this innovative procedure outside of traditional surgical interventions. This launch aims to empower physicians and patients alike to opt for a less invasive treatment option that can be performed in an outpatient setting.

Clinical Backing and Future Implications

The foundation for the FDA’s authorization is built upon an extensive body of data, particularly from IceCure's ICE3 trial — the largest multi-center clinical trial to evaluate liquid-nitrogen (LN2) based cryoablation for patients with early-stage, low-risk breast cancer. This trial has set benchmarks using ProSense®, offering results comparable to those achieved from traditional lumpectomy procedures but with significantly lower associated risks, reduced recovery times, and higher patient satisfaction rates.

Dr. Richard Fine, an investigator for the ICE3 study, highlighted the safety and efficacy of cryoablation as proven through clinical trials, reinforcing ProSense® as an excellent non-surgical option for carefully selected patients. The expectation of expanding clinical data from the post-market study promises to further validate ProSense®'s unparalleled approach to treating breast cancer.

Conclusion: A New Era in Breast Cancer Treatment

With its innovative design and approach, ProSense® marks a pivotal shift in how breast cancer can be treated, particularly among older women who may face constraints with traditional surgical methods. By minimizing risks and promoting faster recovery times, IceCure's ProSense® promises to leave a lasting imprint on the landscape of cancer treatment options. As the company prepares for a formal conference call to discuss these developments, the anticipation for the adoption of this revolutionary technology heightens, paving the way for improved healthcare outcomes for women across the nation.

For more details regarding the ProSense® system and its benefits, please visit IceCure’s website or join the upcoming live webcast for an in-depth discussion.