Icecure Medical Ltd. Stock Price, News & Analysis

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.

IceCure Medical (NASDAQ: ICCM) presented data from its ICE3 trial of ProSense® cryoablation technology at the Radiological Society of North America's 2024 Annual Meeting. The study, presented by ICE3 Co-Principal Investigator Dr. Kenneth Tomkovich, demonstrated promising results for treating early-stage low-risk breast cancer.

Key findings include a five-year recurrence rate of 3.7% with adjuvant endocrine therapy and 4.3% in the eligible trial population, comparable to surgical lumpectomy outcomes. The procedure offers significant advantages over surgery, including outpatient treatment with local anesthesia, minor adverse events, and 100% patient satisfaction with cosmetic outcomes.

Following a favorable FDA Advisory Panel vote in November 2024, the FDA's marketing authorization decision is expected in Q1 2025. The ICE3 trial, being the largest of its kind, supports the transition towards less invasive breast cancer treatment options.

IceCure Medical (NASDAQ: ICCM) announced promising interim results from their ICESECRET study evaluating ProSense® cryoablation for small renal masses. The study, involving 111 patients with 117 lesions over a mean follow-up of 36 months, showed:

- 82% of patients remained tumor-free
- 88.7% success rate in patients with single tumors <3 cm without prior kidney cancer
- 95.6% successful freezing achievement including safety margins
- Preserved renal function across patient cohort
- Short procedure time of approximately 25 minutes

The technology is currently approved for benign and malignant kidney tumors in the U.S., Europe, and other countries, addressing a significant market with an estimated 81,610 new kidney cancer cases expected in the U.S. in 2024.

IceCure Medical reported strong financial results for the first nine months of 2024, with 36% growth in ProSense® system and probe sales to $2.3M. Gross profits increased 41%, with non-GAAP gross profits up 104%. Gross margins improved to 43% from 37% year-over-year. The FDA Advisory Panel voted favorably for ProSense®'s benefit-risk profile in early-stage low risk breast cancer, with a final FDA marketing authorization decision expected in Q1 2025. The company maintained $10.7M in cash as of September 30, 2024, and raised $8.1M through share offerings. Research and development expenses decreased 15%, while sales and marketing expenses increased to support growth.