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IceCure Medical Advances FDA Approval Process for ProSense®

IceCure Medical Ltd. has recently achieved a significant milestone in its journey toward the marketing authorization of its innovative ProSense® Cryoablation system. This cutting-edge technology offers a minimally invasive approach to treating early-stage low-risk breast cancer in women aged 70 and older. As the company's leadership engages with the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), the path looks promising for bringing this important new option to thousands of patients across the country.

Understanding ProSense®

The ProSense® Cryoablation system utilizes advanced cryosurgical technology to destroy tumors by freezing them, thus providing an alternative to traditional surgical removals. This outpatient procedure is particularly noteworthy as it becomes the first of its kind designed specifically for the female demographic of older adults facing breast cancer diagnoses, which affects approximately 46,000 women in the U.S. each year.

During a recent meeting with FDA officials, IceCure's team discussed the necessary next steps for gaining final marketing authorization. Among these was the initiation of a post-market study aimed at gathering additional data on the effectiveness and patient outcomes of the ProSense® system. The company plans to implement this study across a minimum of 25 clinical sites, engaging healthcare professionals including breast surgeons and radiologists to ensure comprehensive analysis.

The Importance of FDA Engagement

Eyal Shamir, IceCure's CEO, expressed optimism following the productive meeting with the FDA. He emphasized the company’s commitment to facilitating access to innovative treatment options for women aged 70 and above, aiming for a smoother and less invasive alternative compared to conventional lumpectomy procedures. With the FDA’s approval of the proposed post-market study plan, IceCure anticipates advancing toward the final marketing authorization.

As part of their strategic plan, IceCure will showcase the ProSense® system at the upcoming American Society of Breast Surgeons (ASBrS) Annual Meeting, which gathers leading experts in the field. This event serves as a crucial platform for recruitment and networking with potential clinical sites necessary for the impending post-market study. The collaboration with medical professionals is a vital component, paving the way for the broader acceptance and utilization of ProSense® in clinical practice.

Looking Ahead

The post-market study comes with significant financial implications as procedures conducted under this study will be eligible for reimbursement under CPT III codes, potentially covering up to $3,800 in facility costs. This financial backing indicates a strong commitment from the medical community to support innovative treatments and enhance patient care options.

IceCure Medical doesn’t solely focus on breast cancer; its cryoablation technology is also applicable for various tumor types, including those found in the kidneys, lungs, and bones. This versatility enhances the technology's value proposition and its potential impact on healthcare delivery.

In addition to this major FDA development, IceCure Medical remains focused on expanding its sales and distribution efforts in the U.S. With the groundwork laid out for successful commercialization, their team is fully prepared to market ProSense® and its disposable probes, further supporting medical professionals who seek effective, minimally invasive treatment solutions.

In summary, the developments surrounding IceCure’s ProSense® Cryoablation system mark a significant advancement in women's health care, not only serving as a groundbreaking treatment for early-stage breast cancer but also paving the way for innovative practices in oncology. As IceCure collaborates with various stakeholders, the momentum gained from ongoing discussions with the FDA will be pivotal in transforming the treatment landscape for older women facing breast cancer.