Icecure Medical Ltd. - ICCM STOCK NEWS

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.

IceCure Medical (Nasdaq: ICCM) provided an update on its FDA marketing authorization timeline for ProSense® cryoablation system in early-stage breast cancer treatment. The company now expects the FDA's decision after Q1 2025, extending beyond the initial timeline.

The FDA process has involved extensive stakeholder engagement due to the product's novelty and breast cancer's public health significance. In November 2024, an FDA Medical Device Advisory Committee Panel, comprising breast surgeons, interventional radiologists, oncologists, and patient representatives, voted favorably on ProSense®'s benefit-risk profile for treating early-stage low-risk breast cancer with endocrine therapy.

ProSense® uses minimally-invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal. The company continues to work closely with the FDA towards a De Novo marketing authorization decision.

IceCure Medical (NASDAQ: ICCM) showcased its ProSense® cryoablation technology at the 19th Annual St. Gallen Breast Cancer Conference, with six peer-reviewed studies presented and to be published in The Breast journal. The studies demonstrate ProSense®'s efficacy in treating breast cancer through tumor freezing.

Key findings include the ICE3 trial showing a 3.61% recurrence rate at 5 years (7/194 patients), with patients receiving endocrine therapy showing a 3.22% recurrence rate. An independent study in Hong Kong successfully expanded treatment to include triple negative breast cancer and younger patients.

The THERMAC trial compared different ablation methods, with ProSense® achieving 94% complete ablation rate and 0% adverse events, outperforming other techniques. Additional studies demonstrated success in treating inoperable patients, with 81.7% complete tumoral necrosis in 60 treated tumors, and showed particular effectiveness in luminal cancers up to 2.5cm.

IceCure Medical (Nasdaq: ICCM) has received a Notice of Allowance from China for its novel 'Cryogenic System Connector' invention, completing patent protection in major global markets including the U.S., Europe, and Japan. The company, which develops minimally-invasive cryoablation technology for tumor destruction, has created an innovative cryogenic pump with several key features:

• Submersible in liquid nitrogen (LN2)
• Operates in a closed circuit
• Enables cryoprobe temperature control
• Improves cooling rate during procedures
• Designed for multiple or longer procedures without LN2 refills

This technological advancement allows IceCure to develop a new generation of compact cryoablation systems and expand their product portfolio to include thinner cryoprobes and catheters. The company currently holds over 50 granted patents for cryoablation systems and cryoprobes.

IceCure Medical (NASDAQ: ICCM) announced significant findings from an independent study published in Gland Surgery, comparing patient satisfaction between their ProSense® cryoablation technology and traditional breast-conserving therapy (BCT) for breast cancer treatment.

The study, conducted at Kameda Medical Center in Japan, revealed that patients who underwent cryoablation reported significantly higher satisfaction scores (71.0±18.6) compared to BCT patients (56.3±16.5), with mean follow-up periods of 4.2 and 4.0 years respectively. The research included 147 Asian female breast cancer patients, with 76 meeting the final analysis criteria (35 cryoablation, 41 BCT).

The study utilized the BREAST-Q questionnaire to assess health-related quality of life and satisfaction. Researchers attributed the higher satisfaction in cryoablation patients to the preservation of breast volume and symmetry, as the procedure doesn't require tissue excision. This data supports the ongoing trend toward de-escalation of breast cancer treatment from surgical to nonsurgical options in Japan.

IceCure Medical (Nasdaq: ICCM) has submitted a regulatory approval filing to Israel's Ministry of Health for its next-generation XSense™ System and CryoProbes. The application covers multiple indications already approved for ProSense®, including general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology.

The company has already secured FDA marketing authorization for the XSense™ System. The filing aligns with growing trends in surgical de-escalation and increasing adoption of minimally invasive cryoablation procedures. The global minimally invasive surgery market is projected to grow at a 17% CAGR between 2022-2029, reaching $174 billion by 2029.