IceCure Medical (ICCM) Company Report

For the nine months ended September 30, 2025, IceCure Medical reported revenue of $2.1 million, a decrease from $2.4 million in the same period of 2024, with gross profit falling to $626,000 from $1,034,000.
In October 2025, the company received FDA marketing authorization for its ProSense cryoablation system to treat low-risk breast cancer, targeting an addressable market of over 200,000 patients annually in the U.S..
IceCure's cash, cash equivalents, and short-term deposits increased to $10 million as of September 30, 2025, from $7.6 million at December 31, 2024, significantly bolstered by $10 million from a rights offering and $5.87 million from an at-the-market offering.
ProSense received approval in Switzerland, and the company's Japanese partner, Terumo Corporation, plans to submit a regulatory application for breast cancer treatment in H1 2026.
The company expects to receive final FDA approval for its post-market study protocol by end of 2025 or early 2026, with the first patient recruitment anticipated by summer 2026.

Nov 19, 2025, 3:00 PM

Transcript

IceCure Medical Announces Q3 2025 Results and FDA Marketing Authorization for ProSense

ICCM

Earnings

Product Launch

New Projects/Investments

IceCure Medical received FDA marketing authorization in October 2025 for its ProSense cryoablation system to treat low-risk breast cancer.
The company estimates a significant U.S. addressable market of approximately 200,000 patients annually for ProSense, including women aged 70 and older with specific tumor characteristics, patients not eligible for surgery, and those with benign breast tumors.
For the nine months ended September 30, 2025, revenue was $2.1 million and net loss was $10.8 million ($0.18 per share).
As of October 31, 2025, IceCure Medical held $11.8 million in cash, cash equivalents, and short-term deposits, bolstered by a $10 million rights offering in July 2025 and $5.87 million from an at-the-market offering.

Nov 19, 2025, 3:00 PM

Transcript

IceCure Medical Receives FDA Authorization for ProSense and Reports Q3 2025 Financials

ICCM

Product Launch

Earnings

Revenue Acceleration/Inflection

IceCure Medical received FDA marketing authorization in October 2025 for its ProSense cryoablation system to treat low-risk breast cancer, which the company considers its most significant milestone to date.
The FDA authorization targets a U.S. addressable market of approximately 200,000 patients annually, including women aged 70 and older with small tumors, those not eligible for surgery, and patients with benign breast tumors.
For the nine months ended September 30, 2025, revenue was $2.1 million, a decrease from $2.4 million in the prior year, and the company reported a net loss of $10.8 million or $0.18 per share.
As of September 30, 2025, cash, cash equivalents, and short-term deposits totaled $10 million, increasing to $11.8 million by October 31, 2025, following a $10 million rights offering and $5.87 million from an at-the-market offering.

Nov 19, 2025, 3:00 PM

Transcript

IceCure Medical Reports Q3 2025 Financial and Operational Results, Highlights FDA Marketing Authorization

ICCM

Earnings

Product Launch

Revenue Acceleration/Inflection

IceCure Medical Ltd. reported revenue of $2.1 million for the nine months ended September 30, 2025, a decrease from $2.416 million in the prior year, primarily due to reduced sales in Japan, other Asian territories, and North America.
The net loss for the nine months ended September 30, 2025, was $10.811 million, or $0.18 per share, which was relatively consistent with the $10.839 million, or $0.22 per share, reported for the same period in 2024.
In October 2025, the U.S. FDA granted marketing authorization for IceCure's ProSense® cryoablation system for the local treatment of low-risk breast cancer in specific patient populations, a "landmark achievement" expected to accelerate commercial momentum.
As of September 30, 2025, the company held approximately $10.0 million in cash, cash equivalents, and short-term deposits. This was supplemented by $10 million in gross proceeds from a July 2025 rights offering and $5.87 million net proceeds from an at-the-market offering through October 2025, bringing the cash balance to $11.8 million as of October 31, 2025.

Nov 19, 2025, 2:05 PM

6-K

IceCure Medical Reports Nine-Month Financials and Landmark FDA Authorization

ICCM

Earnings

Product Launch

Revenue Acceleration/Inflection

IceCure Medical received FDA marketing authorization in October 2025 for its ProSense® cryoablation system for the local treatment of low-risk breast cancer in patients aged 70 and above, a landmark achievement expected to accelerate commercial momentum in the U.S. and globally starting in 2026.
For the nine months ended September 30, 2025, revenue decreased to $2.1 million from $2.416 million in the prior year, with gross profit also declining to $0.626 million from $1.034 million.
The net loss for the nine months ended September 30, 2025, was $10.811 million, relatively unchanged from $10.839 million for the same period in 2024.
The company significantly improved its cash position, reporting approximately $10.0 million in cash, cash equivalents, and short-term deposits as of September 30, 2025, up from $7.6 million at December 31, 2024, following a $10 million rights offering and $5.87 million from an at-the-market offering.

Nov 19, 2025, 1:54 PM

Press Release

IceCure Medical's ProSense System Approved in Switzerland

ICCM

Product Launch

New Projects/Investments

IceCure Medical Ltd. announced on November 18, 2025, that its ProSense® Cryoablation System received regulatory approval in Switzerland.
The approval covers indications for malignant or benign tissue in the breast, lung, liver, kidney, and musculoskeletal (bone), including palliative interventions, consistent with its European Union approvals.
This regulatory milestone is expected to broaden global access for ProSense® and support the company's commercial momentum, following the U.S. FDA's recent marketing authorization for ProSense® in low-risk breast cancer.
Switzerland's healthcare market is projected to reach $120 billion in 2023, with 12% of its GDP spent on healthcare.

Nov 18, 2025, 1:45 PM

6-K

IceCure's ProSense® Cryoablation System Receives Swiss Regulatory Approval

ICCM

Product Launch

New Projects/Investments

IceCure Medical's ProSense® system and cryoprobes received official registration and approval for distribution by Swissmedic (the Swiss Agency for Therapeutic Products) on November 18, 2025.
The approval covers indications for the treatment of malignant or benign tissue in the breast, lung, liver, kidney, and musculoskeletal (bone), including palliative interventions, which are the same as its European Union approvals.
This regulatory milestone is expected to broaden global access to ProSense® and supports IceCure's commercial momentum, following the FDA's recent marketing authorization for ProSense® in low-risk breast cancer.
The Swiss healthcare market is projected to reach $120 billion in 2023, with the country spending 12% of its GDP on healthcare.

Nov 18, 2025, 1:30 PM

Press Release

IceCure Medical announces Nasdaq minimum bid price notification

ICCM

Delisting/Listing Issues

IceCure Medical Ltd. (ICCM) received a Nasdaq minimum bid price notification on November 14, 2025, for not meeting the $1.00 per share requirement.
The company has 180 calendar days, until May 11, 2026, to regain compliance by maintaining a closing bid price of at least $1.00 for ten consecutive business days.
This notification has no immediate effect on ICCM's Nasdaq listing or the trading of its ordinary shares.
IceCure Medical states that continued listing on Nasdaq is a priority and it intends to monitor its share price and consider options to cure the deficiency.

Nov 14, 2025, 10:00 PM

6-K

IceCure Medical Receives Nasdaq Minimum Bid Price Non-Compliance Notice

ICCM

Delisting/Listing Issues

IceCure Medical (ICCM) received a Nasdaq notice on November 14, 2025, indicating non-compliance with the $1.00 minimum bid price requirement.
The company has been granted 180 calendar days, until May 11, 2026, to regain compliance.
To regain compliance, ICCM's ordinary shares must maintain a closing bid price of at least $1.00 for a minimum of ten consecutive business days.
The notice has no immediate effect on the company's Nasdaq listing or the trading of its ordinary shares.

Nov 14, 2025, 9:30 PM

Press Release

IceCure Medical Ltd. promotes Shay Levav to Chief Operating Officer

ICCM

Management Change

Product Launch

Revenue Acceleration/Inflection

IceCure Medical Ltd. (ICCM) announced the promotion of Shay Levav to Chief Operating Officer on November 5, 2025.
Mr. Levav, who previously served as Vice President of Regulatory and Quality Assurance and Clinical Applications since September 2020, will continue to lead these functions in his new role.
This appointment is intended to support the company's anticipated accelerating commercial momentum and expansion in the U.S. market.
The company expects increased commercial traction following the FDA marketing authorization in October 2025 for ProSense® for the local treatment of early-stage, low-risk breast cancer.