IceCure Medical jumps on U.S. ProSense install base growth after FDA clearance

IceCure Medical jumps on U.S. ProSense install base growth after FDA clearance

New York, June 17, 2026, 11:08 EDT

  • IceCure Medical shares last traded at $7.17, $5.04 higher than Tuesday’s close. The stock hit $9.45 earlier, with around 86.7 million shares changing hands.
  • IceCure Medical Ltd. said its active U.S. commercial install base for ProSense cryoablation in breast cancer is up 70% since FDA marketing approval in October 2025.
  • Shares rallied after a 1-for-30 reverse split started trading on a split-adjusted basis June 4. IceCure is trying to get back to Nasdaq minimum-bid compliance.

IceCure Medical shares surged more than threefold late Wednesday morning on Nasdaq. The Israeli medical-device company said U.S. commercial adoption of its ProSense cryoablation system for breast cancer climbed sharply since it received FDA clearance last year. Cryoablation is a method that destroys tissue by freezing.

The stock climbed $5.04 to $7.17, after touching $9.45 earlier in the session. That jump stood out as Wall Street stayed mostly quiet with small gains; Reuters said the Dow added 0.15%, the S&P 500 edged up 0.11%, and the Nasdaq gained 0.35% at 9:41 a.m. ET.

This update comes after IceCure got U.S. Food and Drug Administration marketing authorization in October 2025 for its ProSense device. The FDA cleared ProSense for use in low-risk breast cancer patients age 70 and older who get adjuvant endocrine therapy, a common hormone treatment with local therapy. IceCure said that U.S. clearance covers about 46,000 women a year.

IceCure said Wednesday its ProSense procedures have taken place in big cities across the U.S., with Los Angeles, New York, Atlanta, Dallas, Detroit, Philadelphia, Phoenix and Memphis among them. The company also reported a rise in sales leads from this year’s Society of Breast Imaging symposium and American Society of Breast Surgeons annual meeting versus the same meetings in 2025.

Chief Executive Eyal Shamir said, “With growing physician interest, expanding clinical acceptance, and increased patient awareness, we believe we remain in the early stages,” as he talked about the U.S. commercial opportunity. But the company didn’t say how many new systems made up the updated install base in Wednesday’s release. IceCure Medical Ltd.

IceCure shares jumped two weeks after the company finished a 1-for-30 reverse split. The move lumps shares together and boosts the share price, but doesn’t change how much of the company each investor owns, aside from minor fractional-share impacts. IceCure said it did the split to try to get back in line with Nasdaq’s $1.00 minimum bid rule. The company faces a compliance deadline of Nov. 9, 2026.

Competition is still an issue here. After the FDA cleared IceCure, Fierce Biotech pointed out that other cryoablation systems are already used for indications outside of breast cancer. The report named the Varian/Siemens Healthineers systems and Boston Scientific’s ICEfx system. Boston Scientific says ICEfx is cleared for cryoablation in oncology and for other tissue destruction.

This is a small-cap play with a lot of risk unless growth in adoption brings in revenue. IceCure posted first-quarter revenue of $911,000 and a net loss of $4.27 million. In May, the company flagged risks tied to its cash levels, getting new funding, and the ability to sell its devices. Regulatory changes and instability in the Middle East—Israel in particular—were also cited.

The question now is if higher installs will turn into stronger sales, more procedures and better reimbursement. On Wednesday, the move in the stock suggests investors see the 70% install-base as evidence that FDA clearance is beginning to translate into commercial use.

Shan Ahmed Khan

Shan Ahmed Khan is a senior markets reporter at TS2.tech. His coverage ranges from stocks and technology to economic developments across global markets. He worked in investment research and market analysis before becoming a financial journalist and is a graduate of the Lahore University of Management Sciences (LUMS).

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