IceCure Announces Shero Imaging is First to Offer Breast Cancer Cryoablation Procedures in Missouri with ProSense®

Rhea-AI Summary

IceCure Medical (NASDAQ: ICCM) announced that Shero Imaging in St. Louis, Missouri is the first clinic in the state to offer breast cancer cryoablation using the ProSense® system. The release notes FDA marketing authorization for ProSense® for low-risk breast cancer and inclusion in proposed medical society guidelines for the approved population. Procedures at Shero Imaging will be performed by founder and board-certified breast radiologist Dr. Tish Singer, expanding local patient access to a minimally invasive alternative to surgical tumor removal.

Positive

• ProSense received FDA marketing authorization for treatment of low-risk breast cancer
• ProSense included in proposed medical society guidelines for the approved patient population
• First Missouri clinic (Shero Imaging) to offer ProSense breast cryoablation
• Procedures to be performed by board-certified breast radiologist Dr. Tish Singer

Negative

• None.

Key Figures

2025 ProSense® sales: $3.4 million Cash & equivalents: $8.9 million ATM program size: $13,960,500 +5 more

8 metrics

2025 ProSense® sales $3.4 million Preliminary full-year 2025 sales reported Jan 12, 2026 6-K

Cash & equivalents $8.9 million Balance as of Dec 31, 2025 from Jan 12, 2026 6-K

ATM program size $13,960,500 Equity distribution agreement capacity per Jan 9, 2026 6-K

CPT III reimbursement $4,049 Reimbursement level effective January 2026 for ProSense® procedures

Addressable patients 200,000 women annually U.S. low-risk breast cancer cryoablation population cited in 6-K

Current share price $0.602 Pre-news trading level vs 52-week range

Market capitalization $40,764,153 Equity value based on pre-news price

52-week high $1.66 Upper end of 52-week trading range

Market Reality Check

Price: $0.5911 Vol: Volume 93,661 is below 20...

low vol

$0.5911 Last Close

Volume Volume 93,661 is below 20-day average of 216,970, indicating subdued pre-news trading. low

Technical Shares at $0.602 are trading below the 200-day MA of $0.88 and well under the $1.66 52-week high.

Peers on Argus

ICCM was up 1.84% pre-news while several medical device peers (LUNG, VNRX, APYX,...

ICCM was up 1.84% pre-news while several medical device peers (LUNG, VNRX, APYX, BDMD) showed declines and TELA was modestly positive, pointing to a stock-specific move rather than a sector-wide rotation.

Historical Context

4 past events · Latest: Jan 28 (Positive)

Pattern 4 events

Date	Event	Sentiment	Move	Catalyst
Jan 28	Guideline inclusion	Positive	+0.0%	ASBrS draft guidelines include cryoablation for low-risk breast cancer patients.
Jan 12	Operational update	Positive	-5.5%	Record ProSense® sales and cash update alongside recent FDA authorization.
Dec 17	Sales outlook	Positive	+8.7%	Company expects record Q4 North American sales after FDA authorization.
Dec 10	Clinical data	Positive	+3.1%	Four independent RSNA studies report strong ProSense® cryoablation outcomes.

Pattern Detected

Recent positive ProSense® and regulatory milestones have produced mixed reactions, with some strong gains but also at least one notable selloff on good news.

Recent Company History

Over the past few months, IceCure highlighted key milestones around its ProSense® cryoablation platform. An Oct 2025 FDA marketing authorization and expectations for record Q4 North American sales on Dec 17 coincided with a 8.68% gain. Scientific validation at RSNA 2025 on Dec 10 saw a 3.11% rise. However, a shareholder letter on Jan 12 reporting record $3.4M sales and $8.9M cash led to a -5.46% move. The Jan 28 guidelines news had a flat reaction, underscoring inconsistent trading responses to otherwise positive developments.

Market Pulse Summary

This announcement underscores continued U.S. uptake of IceCure’s ProSense® system following FDA mark...

Analysis

This announcement underscores continued U.S. uptake of IceCure’s ProSense® system following FDA marketing authorization for low-risk breast cancer, with Shero Imaging becoming the first Missouri clinic to offer breast cryoablation. In recent months, the company reported record ProSense® sales of about $3.4M, cash of roughly $8.9M, and supportive draft treatment guidelines. Investors may watch how additional site installations, reimbursement at $4,049, and evolving guidelines translate into system placements and procedure volumes over time.

Key Terms

cryoablation, fda marketing authorization, fibroadenomas

3 terms

cryoablation medical

"a developer of minimally-invasive cryoablation technology that destroys tumors by freezing"

A medical treatment that uses extreme cold to freeze and destroy unwanted tissue, such as small tumors or heart tissue causing irregular rhythms; think of it like applying a focused freezer to stop a problem spot without cutting it out. It matters to investors because devices, tools, and drugs tied to cryoablation, plus clinical results, approval status and insurance coverage, can drive sales, shape market adoption and affect the financial outlook of healthcare companies.

fda marketing authorization regulatory

"ProSense® system recently received FDA marketing authorization for the treatment of low-risk breast cancer"

Permission from the U.S. Food and Drug Administration that allows a medical product—such as a drug, device, or biologic—to be legally sold and promoted after the agency reviews data showing it meets safety and effectiveness standards. For investors this milestone matters because it clears the main regulatory hurdle to generate sales, reduces uncertainty about future revenue, and can materially change a company’s market value, similar to obtaining a license that lets a business open to customers.

fibroadenomas medical

"our minimally invasive treatment option for low-risk breast cancer and fibroadenomas to women in Missouri"

Fibroadenomas are common, non-cancerous lumps in breast tissue made of gland and fibrous tissue; they feel like a firm, movable knot under the skin, similar to finding a harmless bump in fabric. They matter to investors because their prevalence and management influence demand for diagnostic imaging, biopsy tools, surgical procedures and follow-up care, and can affect clinical trial design, regulatory attention and revenue for companies selling breast-health products.

AI-generated analysis. Not financial advice.

ProSense® system recently received FDA marketing authorization for the treatment of low-risk breast cancer
Cryoablation for breast cancer is now included in proposed medical society guidelines for the approved patient population

CAESAREA, Israel, Feb. 11, 2026 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced the most recent purchase and installation of the ProSense® system in the U.S. at St. Louis, Missouri based Shero Imaging, the first clinic in the state of Missouri to offer breast cancer cryoablation with ProSense®. Shero Imaging is dedicated to delivering exceptional care by providing their patients with the choice of a minimally invasive treatment. ProSense® procedures will be conducted by Shero Imaging's founder and board-certified breast radiologist, Dr. Tish Singer.

Dr. Singer commented, "Shero Imaging is bringing IceCure breast cryoablation out of the ivory towers and making it accessible to patients across the country. From our St. Louis facility, we are thrilled to announce the addition of breast cryoablation services—an advanced, minimally invasive treatment option for women seeking cutting-edge care. This system perfectly complements our philosophy of delivering the highest level of care with state-of-the-art techniques in a comfortable, patient-centered environment. We're proud to bring this innovative technology to our community and provide our patients with expanded access to cutting-edge breast cancer treatment options."

"It is highly encouraging to see innovative breast care centers like Shero Imaging be in a position to grow beyond diagnostics and imaging into treatment with ProSense®. Breast radiologists are uniquely well qualified to adopt ProSense® to immediately freeze cancer in its tracks for the indicated patient population," stated IceCure's VP of Sales, North America, Shad Good. "We applaud Shero for being the first to bring our minimally invasive treatment option for low-risk breast cancer and fibroadenomas to women in Missouri."

About ProSense®

The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.

ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.

ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.

About IceCure Medical

IceCure Medical (NASDAQ: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses the proposed inclusion of ProSense® cryoablation in medical society treatment guidelines. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on March 27, 2025, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

IR Contact:

Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914

Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg

 

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SOURCE IceCure Medical

FAQ

What did IceCure (ICCM) announce about ProSense® availability in Missouri on Feb 11, 2026?

IceCure announced that Shero Imaging in St. Louis is the first Missouri clinic offering ProSense® for breast cryoablation. According to the company, the installation expands access to a minimally invasive treatment option for the FDA-authorized low-risk breast cancer population.

Does ProSense® have FDA authorization for breast cancer treatment and what does ICCM say?

Yes. ProSense® received FDA marketing authorization for treating low-risk breast cancer. According to the company, this authorization supports offering cryoablation as an alternative to surgical tumor removal for the approved patient group.

Who will perform ProSense® breast cryoablation procedures at Shero Imaging (ICCM news)?

Procedures will be conducted by Dr. Tish Singer, Shero Imaging founder and a board-certified breast radiologist. According to the company, Dr. Singer will provide minimally invasive cryoablation care from the St. Louis facility to local patients.

How does IceCure (ICCM) describe ProSense® inclusion in medical guidelines?

IceCure said cryoablation for breast cancer is now included in proposed medical society guidelines for the approved population. According to the company, that inclusion reinforces clinical acceptance for using ProSense® in the authorized low-risk indication.

What patient access changes does the ICCM announcement signal for ProSense® in the U.S.?

The announcement signals expanded local access by adding a new U.S. treatment site in Missouri offering ProSense®. According to the company, centers like Shero Imaging can move beyond diagnostics into delivering minimally invasive cryoablation care.