IceCure Receives Notice of Patent Allowance in U.S. for a Novel Cryogen Flow Control to Optimize Patient Outcomes

Rhea-AI Summary

IceCure Medical (NASDAQ: ICCM) has received a Notice of Allowance from the USPTO for its 'Cryogen Flow Control' patent, extending protection until 2045. The patent, already granted in Japan and pending in EU and other markets, enhances the company's cryoablation technology that destroys tumors through freezing. The innovation focuses on precise temperature control using sensor data to regulate cryogen flow, improving treatment effectiveness. IceCure, with over 20 patents in the U.S., is currently awaiting FDA marketing approval for ProSense® in early-stage breast cancer treatment for women over 70 when combined with adjuvant endocrine therapy. CEO Eyal Shamir emphasizes this patent's importance in expanding treatment indications and strengthening their position as a global leader in liquid nitrogen-based cryoablation technology.

Positive

• Patent protection secured until 2045 for novel cryogen flow control technology
• Patent already granted in Japan with pending approvals in EU and other major markets
• Technology enables precise temperature control for improved treatment effectiveness
• Awaiting FDA marketing approval for ProSense in early-stage breast cancer treatment
• Strong IP portfolio with 20+ patents in the U.S.

Negative

• FDA approval for early-stage breast cancer treatment still pending
• Commercial success depends on regulatory approvals and market adoption

Insights

Medical Technology Patent Expert

IceCure strengthens its IP position with new cryogen flow control patent, enhancing technology value while awaiting critical FDA decision.

IceCure's new patent allowance represents a significant enhancement to their intellectual property portfolio in the cryoablation space. The 'Cryogen Flow Control' patent, which will remain in effect until 2045, addresses a fundamental challenge in cryoablation technology: precise temperature control for optimal tissue treatment.

The technology utilizes sensor data to regulate cryogen flow, ensuring targeted temperatures are maintained at catheter and probe tips. This precision is crucial for both treatment efficacy and patient safety. The patent's long protection period (until 2045) provides IceCure substantial competitive advantage in this specialized medical technology segment.

This patent approval in the U.S. complements their existing approval in Japan, with pending applications in the EU and other markets, indicating a comprehensive global IP strategy. With over 20 patents already secured in the U.S., IceCure is building a formidable barrier to competition.

The timing is particularly strategic as the company awaits the FDA's decision on marketing authorization for ProSense® in early-stage breast cancer treatment for women over 70 when used with adjuvant endocrine therapy. This pending regulatory decision represents a potential inflection point for the company's commercial trajectory.

The patent's scope extends beyond current applications, potentially enabling navigation and mapping functionalities within a patient's anatomy. This suggests IceCure is positioning its technology platform for expanded clinical applications beyond their current focus areas, creating multiple pathways for future growth in minimally-invasive tumor treatment.

IceCure has 20+ patents in the U.S. and the Company anticipates further market traction upon FDA's marketing authorization decision in early-stage breast cancer

CAESAREA, Israel, June 9, 2025 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has received a Notice of Allowance from the United States Patent and Trademark Office for its patent application titled 'Cryogen Flow Control'. Once granted, the patent will be in effect until 2045. A patent has already been granted for this invention in Japan and is pending approval in European Union and other major markets.

"This invention is designed to further improve cryoablation's efficiency and to expand the number of indications we can deliver in the future," stated Eyal Shamir, IceCure's Chief Executive Officer. "As we await the U.S. Food and Drug Administration's ("FDA") decision on marketing approval for ProSense® in early-stage breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over, expanding our intellectual property assets around our platform cryoablation technology is more important than ever. We believe IceCure is the global leader in liquid nitrogen-based cryoablation technology as we continue to innovate and roll out our systems commercially."  

Precise temperature control is crucial for efficacy and tissue safety in cryoablation procedures. Cryogenic flow control, as covered in this patent, achieves this by utilizing sensor data to regulate the flow of cryogens, ensuring the desired temperature is reached and maintained at the distal tip of catheters and probes. This optimized cryogenic delivery enhances treatment effectiveness in cryoablation procedures. Advanced cryogen flow control systems may also offer functionalities, such as navigation and mapping support within the patient's anatomy, and be incorporated into a wide range of cryosurgical tools.

About ProSense®

The ProSense® Cryoablation System provides a minimally invasive treatment 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 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 that 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 alternative to hospital 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 Statements
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 prospective grant of its patent application titled "Cryogen Flow Control"; the prospective effective period of the prospective patent should it be granted; the purposes of the underlying invention; the FDA's prospective decision on marketing approval for ProSense in early-stage breast cancer; the belief that the Company is the global leader in liquid nitrogen-based cryoablation technology; and the potential benefits and uses of advanced cryogen flow control systems. 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

Todd Kehrli
Phone: 310-625-4462

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

 

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SOURCE IceCure Medical

FAQ

What is the new patent IceCure Medical received approval for?

IceCure received a Notice of Allowance from the USPTO for its 'Cryogen Flow Control' patent, which improves cryoablation efficiency through precise temperature control using sensor data.

How long will IceCure's new cryogen flow control patent be valid?

The patent will be valid until 2045 once granted in the United States.

What is IceCure Medical (ICCM) waiting for from the FDA?

IceCure is awaiting FDA marketing approval for ProSense in early-stage breast cancer treatment when combined with adjuvant endocrine therapy for women aged 70 and over.

How many patents does IceCure Medical have in the United States?

IceCure Medical has more than 20 patents in the United States.

In which countries is IceCure's cryogen flow control patent approved or pending?

The patent is already granted in Japan and is pending approval in the European Union and other major markets.