IceCure Medical Announces Key Steps for ProSense System Approval
IceCure Medical's Advancement in Breast Cancer Treatment Authorization
IceCure Medical Ltd. (NASDAQ: ICCM) is making significant strides toward gaining marketing authorization for its innovative ProSense® cryoablation system, specifically tailored for women aged 70 and over diagnosed with early-stage breast cancer. The final marketing authorization decision hinges on the FDA's approval of IceCure's post-market study plan, emphasizing the importance of clinical studies in gaining trust and evidence of effectiveness.
Preparation for FDA Submission
Recently, IceCure engaged in a constructive dialogue with leaders from the FDA's Center for Devices and Radiological Health (CDRH) regarding its De Novo marketing authorization request for ProSense®. The proposed cryoablation solution seeks to offer a non-invasive alternative to traditional surgical tumor removal, targeting a patient demographic that represents around 46,000 women annually in the United States.
Next Steps in Research and Engagement
Following the FDA meeting, IceCure has been tasked with conducting a post-market study designed to gather more data and information on the effectiveness of the ProSense® device. With plans to recruit at least 400 patients across 25 clinical sites, IceCure hopes to solidify the evidence needed to forecast the system's impact on breast cancer treatment. This recruitment process will be bolstered at prominent medical events, including the upcoming American Society of Breast Surgeons (ASBrS) Annual Meeting.
Strategic Communication and Target Demographic
“We are confident that this development will enhance access to minimally invasive options for women facing early-stage breast cancer,” says Eyal Shamir, CEO of IceCure Medical. The commitment to expedite the preparation of the post-market study plan reflects IceCure's dedication to engaging with leading breast surgeons and radiologists, putting patient welfare at the forefront of their efforts.
ProSense®: A Pioneering Solution for Breast Cancer
The ProSense® cryoablation system stands out as a groundbreaking technology in women's health, aiming to revolutionize breast cancer care. By utilizing liquid nitrogen to create extensive lethal zones, the system can effectively destroy tumors while being minimally invasive. This innovative method expedites recovery times, minimizes pain, and lowers the overall risks often associated with more invasive surgical procedures.
Easing Financial Barriers for Patients
As part of its commitment to support both medical professionals and patients, IceCure expects that procedures conducted under this post-market study will be covered by a CPT III code, allowing for facility cost reimbursements. This financial support is critical for ensuring widespread adoption and accessibility, especially for patients seeking alternatives to traditional lumpectomy.
About IceCure Medical and Future Prospects
IceCure Medical specializes in developing advanced cryoablation therapy systems targeting benign and cancerous tumors. With a strong focus on non-invasiveness, their technology presents a compelling alternative to traditional surgical techniques, with the flagship ProSense® system showing promise worldwide, including markets in the U.S., Europe, and Asia.
With a clear roadmap ahead, IceCure is well-positioned to bring ProSense® to market, engaging actively with the medical community while ensuring that patients receive the most cutting-edge treatment available. The excitement surrounding this innovative approach marks a pivotal moment for how breast cancer is managed in older women—a demographic that deserves comprehensive and compassionate care.
Frequently Asked Questions
1. What is ProSense® and how does it work?
ProSense® is a cryoablation system that uses liquid nitrogen to freeze and destroy tumors, presenting a minimally invasive alternative to surgical procedures.
2. Who is eligible for treatment with ProSense®?
The system is specifically designed for women aged 70 and older diagnosed with early-stage breast cancer.
3. What steps is IceCure taking to gain FDA approval?
IceCure is conducting a post-market study with plans to gather data from at least 400 patients across multiple clinical sites.
4. What financial support is available for patients?
Procedures performed as part of the post-market study are expected to receive reimbursement under a CPT III code, making it more accessible financially for patients.
5. What are the future implications of this treatment?
ProSense® aims to offer a new standard in breast cancer care with significant benefits, improving recovery times and minimizing surgical risks for patients.
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