#Israel #Caesarea #IceCure Medical #Cryoablation #ProSense

IceCure Medical Reports Impressive Financial Growth for 2024

IceCure Medical Ltd. (Nasdaq: ICCM), a leader in minimally-invasive cryoablation technology, recently announced its financial results for the year ending December 31, 2024. This report highlights a remarkable 42% increase in sales for its ProSense® cryoablation system within North America. This growth is indicative of the growing acceptance and potential market for cryoablation technology as a humane alternative to traditional surgical procedures.

Overview of Financial Performance

The financial results reveal that IceCure’s ProSense® systems and disposable probes generated total sales of $3,191,000, compared to $2,955,000 the previous year. This considerable growth is primarily seen in North America while also benefiting from increased sales in Japan and various other regions in Europe and Asia. Notably, sales in China and Latin America experienced a decline, which presents a challenge that the company acknowledges.

Total revenue saw a slight increase, from $3,229,000 in 2023 to $3,291,000 in 2024, due largely to the momentum in product sales despite reduced revenues from other service areas, particularly in Japan.

Gross profit also rose, totaling $1,451,000 with a gross margin of 44%, compared to 40% from the previous year. This upturn can be attributed to an 8% increase in product sales revenue, providing a strong foundation for the company as it navigates the dynamic medical device landscape.

Strategic Direction and Future Potential

One focal point of IceCure’s strategy is its quest for FDA marketing authorization for ProSense® in treating early-stage low-risk breast cancer in conjunction with endocrine therapy. Such approval would position ProSense® as a pioneering option for minimally invasive treatment, potentially correcting the surgical approach typically used. CEO Eyal Shamir emphasizes that there is a growing interest in U.S. breast cancer cryoablation treatments following positive recommendations from the FDA Medical Device Advisory Panel late last year.

The company announced that ongoing studies and favorable outcomes are critical to boosting awareness and adoption rates for ProSense®. Throughout 2024, 33 peer-reviewed studies and presentations showcased the benefits and efficacy of this alternative treatment, underscoring a concentrated effort to validate its technology through evidence-based research.

Resources and Upcoming Developments

As 2025 unfolds, IceCure is poised for several crucial developments, including the anticipated FDA decision regarding ProSense® marketing authorization. If granted, this milestone, coupled with the final results from the ICE3 trial, is expected to enhance market traction significantly. Moreover, Terumo Corporation, a key partner in Japan, is set to pursue regulatory approval for ProSense® in their market, which could expand its use further.

The introduction of next-generation technology, the XSense™ system, also awaits approval in Israel, promising advancements in tumor treatment. The ongoing commitment to research and innovation places IceCure Medical at the forefront of the medical technology industry.

Fiscal Challenges and Future Outlook

Despite the revenue growth, IceCure reported a net loss of $15,318,000 for 2024, which is a slight increase from $14,652,000 in 2023. The loss per share stood at $0.30 against $0.32 the year prior, reflecting the challenges that continue to accompany rapid growth and expansive marketing initiatives.

Looking forward, IceCure is not only focusing on internal efficiencies but also on maximizing partnerships and utilizing its advancements in cryoablation technology to maintain its competitive edge. As of March 2025, IceCure maintains about $6.0 million in cash reserves, bolstered by a recent capital raise of $2.6 million, indicating a prudent approach to finance amidst expenses incurred during product development and marketing expansion.

In conclusion, IceCure Medical's 2024 performance marks a significant period of growth and transformation. The company's commitment to innovation and strategic market entry aligns it for success in the evolving world of medical treatments, particularly within the growing sector of minimally invasive procedures.