Icecure Medical Ltd. Stock Price, News & Analysis

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.

IceCure Medical (NASDAQ: ICCM) showcased its ProSense® cryoablation technology at the 2025 Society of Interventional Oncology Annual Meeting in Las Vegas. Two independent studies demonstrated ProSense®'s safety and efficacy in breast cancer, with one study from the Netherlands winning the 'Highest Scoring Abstract' award. This study concluded that cryoablation was the only thermal ablative technique warranting a Phase 3 trial versus surgery.

The company sponsored a Breast Cryoablation Mini Master Class, featuring leading experts in the field. The FDA's decision on ProSense® market authorization for early-stage breast cancer is expected in Q1 2025. The Dutch study showed 94% complete ablation rate for cryoablation with 0% adverse events, while a Romanian study reported 100% technical success for tumors ≤35 mm with high physician and patient satisfaction.

IceCure Medical (Nasdaq: ICCM) has submitted a regulatory filing to China's National Medical Products Administration (NMPA) for its ProSense® Cryoablation System. The company, which already has approval for its IceSense3 system in China, is seeking to expand its presence in the Chinese market.

The ProSense® application includes expanded capabilities compared to IceSense3, featuring five different cryoprobes with varying specifications and introducers for better tissue accessibility. The system's indicated uses cover multiple medical fields including general surgery, breast tissue, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology.

IceCure Medical reported preliminary unaudited results for 2024, showing a 42% increase in ProSense® sales in North America. Total revenue grew to $3.29 million from $3.23 million in 2023, with ProSense® system and probe sales reaching $3.19 million. The company ended 2024 with $7.5 million in cash.

Key developments include the FDA Advisory Panel's favorable vote for ProSense®'s benefit-risk profile in early-stage low-risk breast cancer, with a decision expected in Q1 2025. The ICE3 study showed a 96.3% recurrence-free rate and 100% patient satisfaction. The ICESECRET kidney cancer study demonstrated an 88.7% recurrence-free rate.

The company strengthened its intellectual property with four new patents and received FDA clearance for its XSense™ Cryoablation System. For 2025, IceCure plans to expand in the U.S. market pending FDA authorization and pursue regulatory approvals in Japan and China.

IceCure Medical (NASDAQ: ICCM), a developer of minimally-invasive cryoablation technology for tumor treatment, has announced its return to full compliance with Nasdaq's listing requirements. The company received confirmation from Nasdaq that it has successfully met the minimum bid price requirement under Rule 5550(a)(2), having maintained a closing bid price of $1.00 or higher for at least 10 consecutive business days.

This development resolves the previous bid price deficiency matter, and IceCure will continue to be listed and traded on The Nasdaq Capital Market, now being in full compliance with all Nasdaq continued listing requirements.

IceCure Medical (Nasdaq: ICCM) announced receiving an Intention to Grant Notice from the European Patent Office for its 'Cryogenic System Connector' invention, which is already patented in the United States. The technology is part of the company's XSense™ system, designed to improve safety and maintain cryogen integrity during cryoablation procedures.

The XSense™ system and its cryoprobes have FDA clearance for all indications currently approved for IceCure's flagship ProSense® system. The company aims to address additional indications in the global tumor ablation market, which was valued at $1.67 billion in 2023 according to Grand View Research. The company sees Europe as a major market, with multiple distributors selling ProSense® and various independent clinical studies being conducted across different medical indications.