European Patent Office Issues Intention to Grant Notice to IceCure for its Next-Generation Cryoablation Technology

Rhea-AI Summary

IceCure Medical (Nasdaq: ICCM) announced receiving an Intention to Grant Notice from the European Patent Office for its 'Cryogenic System Connector' invention, which is already patented in the United States. The technology is part of the company's XSense™ system, designed to improve safety and maintain cryogen integrity during cryoablation procedures.

The XSense™ system and its cryoprobes have FDA clearance for all indications currently approved for IceCure's flagship ProSense® system. The company aims to address additional indications in the global tumor ablation market, which was valued at $1.67 billion in 2023 according to Grand View Research. The company sees Europe as a major market, with multiple distributors selling ProSense® and various independent clinical studies being conducted across different medical indications.

Positive

• Received European Patent Office Intention to Grant Notice for cryogenic connector technology
• XSense™ system already has FDA clearance for all ProSense® approved indications
• Company operates in a $1.67 billion global tumor ablation market (2023)
• Strong presence in European market with established distribution network

Negative

• None.

Insights

Medical Device Patent Analyst

The European Patent Office's intention to grant notice for IceCure's cryogenic connector technology represents a strategic IP expansion that strengthens the company's position in the $1.67 billion tumor ablation market. The XSense™ system's improved safety features and cryogen integrity maintenance capabilities could provide IceCure with a significant competitive advantage. However, the market impact is as this is a procedural step in patent granting, not final approval and commercialization timelines remain unclear. The existing FDA clearance for XSense™ across ProSense®'s indications provides a foundation for market penetration, but revenue impact will depend on successful market adoption and expansion into additional indications.

For investors, this patent development should be viewed as a long-term value driver rather than an immediate catalyst. The European market opportunity is substantial, but market penetration typically requires significant time and resources in the medical device sector.

Market Research Analyst

The tumor ablation market's current valuation at $1.67 billion presents a substantial opportunity, but IceCure's ability to capture market share faces several challenges. The company's dual-system strategy with ProSense® and XSense™ could enhance its competitive positioning, particularly in Europe where established distribution networks exist.

The patent protection, once granted, will provide important market exclusivity in Europe, complementing the existing U.S. patent. However, given IceCure's current market cap of $66.6 million, significant execution risks remain in translating intellectual property advantages into meaningful market share gains. The ongoing independent clinical studies across multiple indications could provide validation for the technology, but the timeline for meaningful revenue impact remains uncertain.

XSense™ system's innovative cryogenic connector technology designed to improve safety and maintain the integrity of cryogen used in the cryoablation procedure

CAESAREA, Israel, Jan. 3, 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 an Intention to Grant Notice from the European Patent Office for its invention titled "Cryogenic System Connector". This invention was recently granted a patent in the United States.

 

 

"We are experiencing increased momentum in the growth of our intellectual property assets, further demonstrating our global leadership in cryoablation. Europe is a major market for us, with several key distributors selling ProSense® and numerous new and ongoing independent clinical studies initiated by doctors who are using our cryoablation technology across many indications," stated IceCure's CEO, Eyal Shamir.

XSense™ and its cryoprobes, which have U.S. Food and Drug Administration clearance for all of the indications for which IceCure's flagship ProSense® has already received clearance, has the potential to address additional indications and significant unmet needs in the global tumor ablation market, estimated at $1.67 billion in 2023 according to Grand View Research.

About IceCure Medical

IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the treatment 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 China.

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 belief that the Intention to Grant Notice from the European Patent Office will increase momentum in the growth of its intellectual property assets, its global leadership in cryoablation and its new and ongoing independent clinical studies, and the belief that the Intention to Grant to Notice will support and accelerate the market adoption of ProSense®. 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, 2023 filed with the SEC on April 3, 2024, 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

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SOURCE IceCure Medical

FAQ

What patent approval did IceCure Medical (ICCM) receive from the European Patent Office in January 2024?

IceCure Medical received an Intention to Grant Notice from the European Patent Office for its 'Cryogenic System Connector' invention, which is already patented in the United States.

What is the market size for tumor ablation where ICCM's XSense™ system competes?

According to Grand View Research, the global tumor ablation market was estimated at $1.67 billion in 2023.

What regulatory clearances does ICCM's XSense™ system have?

XSense™ and its cryoprobes have FDA clearance for all indications that are currently approved for IceCure's ProSense® system.

How does ICCM's new cryogenic connector technology benefit medical procedures?

The technology is designed to improve safety and maintain the integrity of cryogen used in the cryoablation procedure for tumor removal.