#None #IceCure Medical #Cryoablation #ProSense

IceCure Medical's Remarkable Sales Surge in 2024

IceCure Medical Ltd. (Nasdaq: ICCM), the pioneering developer of minimally-invasive cryoablation technology, has introduced impressive financial results for the first three quarters of 2024. With a remarkable 36% increase in sales, largely fueled by the global adoption of its ProSense® Cryoablation system, the company is reshaping the landscape of non-surgical cancer treatments.

A Look at Financial Performance

The data presented by the company indicates that sales from both ProSense® consoles and disposable probes have surged, totaling approximately $2.3 million. Alongside this, the gross profits have also seen a substantial increase of 41%, while non-GAAP gross profits show a striking growth rate of 104%. This growth is a clear reflection of their commitment to expanding market access and improving the utilization rates of ProSense®.

Eyal Shamir, CEO of IceCure Medical, underscored the importance of this growth, stating, "Our initiatives to collaborate with global partners have allowed us to increase the adoption of ProSense® effectively." The rise to a gross margin of 43% in 2024, compared to 27% in 2023, highlights the efficiency and market readiness of their pioneering technology, which utilizes cryoablation as an alternative to surgical tumor removal.

Anticipating FDA Marketing Authorization

On November 7, 2024, IceCure received a positive recommendation from the FDA Medical Device Advisory Committee for ProSense®'s application to treat early-stage low-risk breast cancer, which opens avenues for marketing authorization expected in Q1 2025. Shamir emphasized the company's commitment to making this innovative treatment broadly available, stating that it could become an indispensable tool for medical professionals treating breast cancer patients.

As IceCure Medical prepares for the FDA's official decision, the company's future looks promising. The expected clearance could potentially make ProSense® a game-changing non-surgical option for women requiring treatment for early-stage breast cancer.

Growth Beyond the U.S.

IceCure is not solely focusing on the United States; its partnership with Terumo Corporation in Japan is generating excitement. The company anticipates Terumo will seek regulatory approval for ProSense® to treat breast cancer in Japan in 2025. This highlights IceCure's strategy to position itself favorably in international markets.

Positive Clinical Trial Results

In addition to revenue growth and regulatory prospects, IceCure's ICE3 trial results have recently been published, indicating a 96.3% recurrence-free rate for patients receiving ProSense® treatment for early-stage low-risk breast cancer. Multiple studies in peer-reviewed journals support these findings, showcasing the system's efficacy and safety across a variety of cancer types, including lung and kidney cancers.

Further, the company is embarking on the PRECICE study, a prospective observational study in Italy that will exclusively utilize ProSense®. The study will involve 233 women aged 50 and older with specific types of breast cancer, marking an innovative step in enhancing the credibility and data supporting the cryoablation approach.

Concluding Thoughts

IceCure Medical is on the cusp of a transformative period. With impressive financial growth driven by innovative technology advancements and expanding global partnerships, the company is rapidly becoming a leader in the field of minimally invasive cancer treatments. As they navigate through potential marketing authorizations and continue to invest in research and data development, IceCure is poised for remarkable growth in both sales and reputation in the medical community. The advancements and successes in 2024 not only elevate IceCure's market position but also promise to deliver enhanced medical options for cancer patients worldwide, illustrating the potential of cryoablation technology in modern medicine.