Icecure Medical Ltd. Stock Price, News & Analysis

IceCure Medical (NASDAQ: ICCM) reported strong interest from breast surgeons at the ASBrS 2025 Annual Meeting following recent positive FDA developments for their ProSense® cryoablation system. The company's ICE3 study was recognized as one of the "Best Papers of 2024" and received favorable mention during the ASBrS Presidential Address.

The FDA has requested a post-market study for ProSense® in treating early-stage low-risk breast cancer in women aged 70+ when combined with adjuvant endocrine therapy. The planned study will include 400 patients across 25 sites. The company's participation at ASBrS included system demonstrations, ultrasound course training, and an expert booth meeting featuring former ASBrS President Dr. Nathalie Johnson.

IceCure Medical has made significant progress with the FDA regarding its ProSense® cryoablation system for treating early-stage breast cancer in women aged 70 and over. Following a productive meeting with the FDA's Center for Devices and Radiological Health, the company is preparing for a post-market study as part of its De Novo marketing authorization process.

The planned study will involve 400 patients across 25 sites in the U.S., targeting approximately 46,000 potential patients annually. ProSense® aims to become the first minimally invasive alternative to lumpectomy, offering treatment as an outpatient procedure. The company will submit its post-market study plan within weeks and is actively recruiting clinical sites and doctors at the American Society of Breast Surgeons Annual Meeting.

Procedures will be eligible for reimbursement under the CPT III code, covering $3,800 in facility costs. IceCure's U.S. sales team is prepared for commercialization once final marketing authorization is granted, pending FDA approval of the post-market study plan.

IceCure Medical (Nasdaq: ICCM) participated in the Society of Breast Imaging (SBI) 2025 Breast Imaging Symposium in Colorado Springs, showcasing their ProSense® cryoablation technology. The company sponsored two sold-out breast cryoablation courses featuring hands-on training with ProSense® on April 24 and 26, 2025.

The event included a VIP Exhibitor Hour featuring Dr. Robert Ward, Assistant Professor at Brown University and Program Director for Breast Imaging Fellowship, who has published research on breast cancer cryoablation using ProSense®. The strong attendance demonstrates growing interest from radiologists in integrating ProSense® into their clinics, with medical societies increasingly incorporating cryoablation into their curriculum.

IceCure Medical's ProSense® cryoablation system was prominently featured at ECIO 2025 in Rotterdam, with a major focus on breast cancer treatment. The conference highlighted several key studies demonstrating ProSense®'s effectiveness:

The THERMAC trial showed 94% efficacy rate, 0% complications, and 95% of patients preferring cryoablation over traditional surgery. A study by Prof. Vogl demonstrated 2.9 years mean progression-free survival in 45 patients with 56 tumors.

Another significant study comparing treatment methods revealed that cryoablation combined with hormonal therapy achieved 94% tumor size reduction, outperforming both standalone treatments. The conference included hands-on device training sessions and expert exchanges, highlighting ProSense®'s growing adoption in European markets.

IceCure Medical (ICCM) reported its 2024 financial results, highlighting a 42% growth in ProSense® cryoablation sales in North America. Total revenue increased to $3.29M from $3.23M in 2023, with product sales reaching $3.19M. Gross profit grew 12% to $1.45M with a 44% margin.

The company awaits FDA marketing authorization for ProSense® in early-stage low-risk breast cancer with endocrine therapy, following a favorable Advisory Panel decision in November 2024. ProSense® demonstrated increased adoption globally, with 33 peer-reviewed studies published in 2024.

Financial highlights include a 14% decrease in R&D expenses to $7.10M, a 42% increase in sales and marketing expenses to $6.30M, and a 10% decrease in general administrative expenses to $3.76M. The company reported a net loss of $15.32M ($0.30 per share) and held cash and equivalents of $7.6M as of December 2024.

IceCure Medical (NASDAQ: ICCM) has presented interim results from its ICESECRET study on ProSense® cryoablation for small renal masses at the European Association of Urology Conference in Madrid. The study demonstrated an 88.7% recurrence-free rate in patients with tumors ≤3 cm at a mean follow-up of 3.4 years.

The study evaluated 111 patients with a mean age of 69, of whom 84.2% had comorbidities. Safety results showed 17 mild adverse events, 3 moderate events, and 1 severe complication. The data supports cryoablation as a viable alternative for patients ineligible for kidney-preserving surgery, particularly for tumors ≤3 cm.

ProSense®, which uses liquid nitrogen-based cryoablation technology to destroy tumors by freezing, is currently approved for benign and malignant kidney tumors in the U.S., Europe, and other countries.

IceCure Medical (Nasdaq: ICCM), a developer of minimally-invasive cryoablation technology for tumor treatment, has scheduled its 2024 full year financial and operational results announcement for March 27, 2025. The company will release its results before the Nasdaq market opens, followed by a conference call at 10:00 AM EDT.

The conference call will be accessible via US dial-in (1-888-407-2553) and International dial-in (+972-3-918-0696). A live webcast will be available, with a recording subsequently posted on the company's investor relations website.