Shares of IceCure Medical Ltd. (ICCM) skyrocketed more than 300% in late-morning Nasdaq trading Wednesday, driven by the company's announcement of a sharp increase in U.S. commercial adoption of its ProSense cryoablation system for breast cancer.
The stock surged $5.04 to $7.17, after hitting an intraday high of $9.45. Trading volume was exceptionally high, with approximately 86.7 million shares changing hands. The move stood out against a relatively flat market, as the Dow Jones Industrial Average gained 0.15%, the S&P 500 edged up 0.11%, and the Nasdaq Composite rose 0.35% at 9:41 a.m. ET.
IceCure reported that its active U.S. commercial install base for ProSense has grown 70% since receiving FDA marketing authorization in October 2025. The FDA cleared the device for use in low-risk breast cancer patients aged 70 and older who are receiving adjuvant endocrine therapy, a common hormone treatment combined with local therapy. The company estimates this clearance covers approximately 46,000 women annually.
The surge in installations follows the company's recent 1-for-30 reverse stock split, which began trading on a split-adjusted basis June 4. The reverse split was implemented to help IceCure regain compliance with Nasdaq's minimum $1.00 bid price requirement. The company faces a compliance deadline of November 9, 2026.
CEO Eyal Shamir commented, 'With growing physician interest, expanding clinical acceptance, and increased patient awareness, we believe we remain in the early stages' of the U.S. commercial opportunity. The company noted that ProSense procedures have been performed in major cities including Los Angeles, New York, Atlanta, Dallas, Detroit, Philadelphia, Phoenix, and Memphis. IceCure also reported a rise in sales leads from this year's Society of Breast Imaging symposium and American Society of Breast Surgeons annual meeting compared to the same events in 2025.
However, the company did not disclose the exact number of new systems added to its install base in Wednesday's release. The stock's rally suggests investors view the 70% growth as evidence that FDA clearance is beginning to translate into meaningful commercial adoption.
Despite the positive news, IceCure faces significant challenges. Competition remains a key risk, with other cryoablation systems already used for indications outside of breast cancer. Fierce Biotech highlighted systems from Varian/Siemens Healthineers and Boston Scientific's ICEfx system, which is cleared for cryoablation in oncology and other tissue destruction.
As a small-cap company, IceCure carries substantial risk. The company reported first-quarter revenue of $911,000 and a net loss of $4.27 million. In May, it flagged risks related to its cash levels, the need for additional funding, and its ability to sell devices. Regulatory changes and instability in the Middle East, particularly in Israel, were also cited as potential headwinds.
The key question now is whether higher installations will translate into stronger sales, more procedures, and improved reimbursement. Wednesday's stock move indicates that at least some investors are betting on that outcome.
