IceCure Medical Ltd. highlighted a newly published peer-reviewed article in the International Journal of Surgery that presents key clinical advantages of cryoablation over radiofrequency ablation (RFA) for early-stage breast cancer. The publication, globally ranked in the top three among surgery journals, emphasizes the growing body of evidence supporting cryoablation as a minimally invasive treatment option, noting procedural benefits such as shorter recovery times and improved cosmetic outcomes compared to breast-conserving surgery (BCS). The announcement comes as the company prepares for the 34th Annual Meeting of the Japanese Breast Cancer Society (JBCS) scheduled for June 25-27, 2026, in Kyoto, Japan.

The article, titled "Thermal Ablation as a Minimally Invasive Alternative to Surgery for Primary Breast Cancer," was authored by Drs. Masato Takahashi, Takayuki Kinoshita, and Eisuke Fukuma. Professor Fukuma, a ProSense user at Kameda Medical Center, has performed an estimated 680 breast cancer cryoablation procedures. The publication evaluates current clinical evidence for cryoablation and RFA as alternatives to BCS, indicating that thermal ablation technologies offer local tumor control rates comparable to surgery for selected patients with small tumors.

Clinical Data Comparison

The study provides a comparative analysis of recurrence-free survival rates between cryoablation and RFA. Data presented at the 2025 JBCS Conference showed a recurrence-free rate of 99.02% from over 600 breast cancer patients treated with cryoablation, with follow-up extending up to 17 years. In contrast, the RAFAELO study on RFA reported a 5-year ipsilateral breast tumor-free survival rate of 98.6% in 353 patients.

Procedural Advantages

The authors outlined several key advantages of cryoablation over RFA. Cryoablation can be performed under local anesthesia, whereas RFA requires general anesthesia. During the procedure, cryoablation allows for flexible adjustment of the ice ball size, and the ice ball margin is visible. RFA is described as harder to control due to tissue resistance, with micro-bubbles only vaguely visible. Multiple studies reviewed found no significant differences in local recurrence or overall survival between thermal ablation and BCS for patients with tumors measuring 2 cm or less.

Regulatory Developments in Japan

Terumo Corporation, IceCure's exclusive distributor in Japan and one of the world's top 20 medical device companies, is expected to submit ProSense for regulatory approval for breast cancer to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026. The submission will leverage international clinical data and Japanese physician experience. Eyal Shamir, Chief Executive Officer of IceCure, stated that the growing clinical evidence is accelerating physician interest worldwide, particularly following the FDA marketing authorization of ProSense for early-stage breast cancer in October 2025. Japan is identified as a key market for the company's expansion efforts.

IceCure Medical Ltd. has entered into securities purchase agreements with a single healthcare-focused institutional investor for a private placement priced at a premium to the previous Nasdaq closing price. The offering consists of 1,833,334 ordinary shares, Series D Warrants to purchase up to 1,833,334 ordinary shares, and Series E Warrants to purchase up to 1,833,334 ordinary shares. The combined purchase price is set at $3.00 per share and accompanying Warrants, with gross proceeds expected to be approximately $5.5 million before deducting placement agent commissions and other estimated offering expenses.

Offering Details

The Warrants will have an exercise price of $3.00 per share and will be exercisable immediately upon issuance. The Series D Warrants will expire five years following the date of issuance, while the Series E Warrants will expire one year following the date of issuance. The closing of the offering is expected to occur on or about June 18, 2026, subject to the satisfaction of customary closing conditions.

Use of Proceeds and Amendments

IceCure Medical currently intends to use the net proceeds from the offering for working capital and other general corporate purposes. Additionally, the company has agreed to amend certain Series B and Series C warrants issued to the investor in March 2026 to purchase up to an aggregate of 266,666 ordinary shares. Subject to shareholder approval, the exercise price of these March 2026 Warrants will be reduced from $16.50 per share to $3.00 per share. The Series B Warrants will expire in June 2031 and the Series C Warrants will expire in June 2027.

Regulatory and Placement Details

A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering. The offer and sale of the securities are being made in reliance on an exemption from the registration requirement under Section 4(a)(2) of the Securities Act of 1933, as amended, and/or Regulation D. The company has agreed to file a registration statement with the U.S. Securities and Exchange Commission covering the resale of the ordinary shares and ordinary shares underlying warrants sold in the offering.