The IceCure ChoICE Study has reached an important milestone following the selection of West Cancer Center & Research Institute in Germantown, Tennessee, as the first U.S. clinical site to participate in the company’s post-marketing study evaluating the ProSense® cryoablation system. The announcement marks the next phase in IceCure Medical’s commercialization strategy after receiving U.S. Food and Drug Administration (FDA) marketing authorization for ProSense in October 2025.
The study is expected to play a central role in expanding clinical evidence for minimally invasive breast cancer treatment while supporting broader physician confidence and patient access. Unlike pivotal regulatory studies designed primarily to obtain product approval, the IceCure ChoICE Study will focus on collecting real-world clinical data from routine hospital settings, offering valuable insights into patient outcomes following commercial adoption.
The initiative is expected to enroll up to 400 patients across approximately 30 healthcare institutions throughout the United States. As additional hospitals join the program, IceCure aims to strengthen the clinical evidence supporting cryoablation as a treatment option for eligible women diagnosed with early-stage, low-risk breast cancer.
The first participating institution, West Cancer Center & Research Institute, has been recognized for its extensive oncology services and clinical research capabilities. The study at the site will be led by breast surgical oncologist Dr. Richard Gilmore through the Margaret West Comprehensive Breast Center, providing the company with an experienced clinical team to support patient enrollment and long-term outcome assessment.
For IceCure, the launch of the IceCure ChoICE Study represents more than the addition of another research program. It signals the company’s transition from regulatory achievement toward commercial execution in one of the world’s largest healthcare markets.
IceCure ChoICE Study Strengthens Real-World Evidence for ProSense Cryoablation
Healthcare systems are increasingly looking beyond traditional clinical trials when evaluating new medical technologies. While regulatory approval establishes the safety and effectiveness of a product, physicians, hospitals, and healthcare payers often rely on real-world clinical evidence before integrating new treatment options into routine practice.
The IceCure ChoICE Study has been designed with this objective in mind. The study will evaluate the use of ProSense cryoablation alongside endocrine therapy in women aged 70 years and older diagnosed with biologically low-risk, early-stage breast cancer. These patients represent a population that may benefit from less invasive treatment approaches, particularly when conventional surgery may not be the preferred option because of age, underlying health conditions, or personal treatment preferences.
ProSense uses liquid nitrogen-based cryoablation technology to destroy tumors through controlled freezing rather than surgical removal. The procedure is performed using a minimally invasive approach that seeks to eliminate cancerous tissue while reducing the physical impact commonly associated with traditional breast surgery.
Following FDA marketing authorization, ProSense is indicated for the local treatment of biologically low-risk breast tumors measuring up to 1.5 centimeters in patients receiving adjuvant endocrine therapy. The indication also includes patients who are considered unsuitable candidates for surgery.
One of the distinguishing features of the IceCure ChoICE Study is its dual-purpose design. Participating hospitals will not only enroll patients into the clinical study but will also function as active commercial treatment centers. This approach allows physicians to offer ProSense to eligible patients outside the formal study while simultaneously contributing to the collection of long-term clinical evidence.
The model is expected to accelerate physician familiarity with cryoablation while providing broader patient access to a treatment option that has already received regulatory authorization.
As healthcare providers continue to explore alternatives that improve patient experience without compromising treatment quality, studies evaluating commercial performance in real-world environments are becoming increasingly valuable for both clinical decision-making and healthcare policy development.
Commercial Expansion Reflects Growing Interest in Minimally Invasive Breast Cancer Care
The launch of the IceCure ChoICE Study comes at a time when healthcare providers are placing greater emphasis on personalized and minimally invasive cancer treatments. Advances in imaging technologies, tumor characterization, and targeted therapies have created opportunities to tailor treatment strategies according to disease stage, patient age, and overall health status.
Breast cancer remains the most frequently diagnosed cancer among women globally, creating continuous demand for treatment approaches that balance clinical effectiveness with quality of life. For selected patient groups, minimally invasive technologies are attracting growing attention because they may reduce procedural complexity, shorten recovery periods, and lessen the physical burden associated with surgery.
IceCure has positioned ProSense within this evolving treatment landscape by focusing on cryoablation technology that offers an alternative to conventional surgical tumor removal for eligible patients. The company’s technology platform has already secured regulatory approvals and commercial availability across multiple international markets, including the United States, Europe, and parts of Asia.
The expansion of the IceCure ChoICE Study also reflects the company’s broader commercial strategy of generating post-market evidence that supports wider physician adoption. As additional U.S. hospitals begin participating in the study, IceCure expects to build a larger body of clinical data demonstrating treatment outcomes across diverse healthcare settings.
From a business perspective, post-marketing studies have become increasingly important for medical technology companies seeking long-term market expansion. While regulatory clearance provides initial access to the market, sustained commercial growth often depends on physician confidence, published clinical evidence, reimbursement support, and hospital adoption. Real-world studies such as ChoICE help address these requirements by documenting product performance under routine clinical practice rather than controlled trial conditions.
The participation of West Cancer Center & Research Institute also strengthens the credibility of the study because of the institution’s longstanding experience in oncology care, cancer research, and clinical trials. Established nearly five decades ago, the center has developed a reputation for integrating advanced technologies with multidisciplinary cancer treatment, making it an appropriate launch site for a study focused on expanding access to innovative breast cancer therapies.
Looking ahead, IceCure’s ability to successfully enroll patients across all planned U.S. sites will be closely monitored by clinicians, investors, and healthcare stakeholders. The findings generated through the IceCure ChoICE Study could influence future treatment discussions for older patients with low-risk breast cancer while supporting broader commercial adoption of cryoablation technology in oncology practice.
As healthcare increasingly moves toward less invasive treatment strategies supported by real-world clinical evidence, the IceCure ChoICE Study represents an important step in evaluating how cryoablation can contribute to the evolving management of early-stage breast cancer in routine clinical care.
