Icecure Medical Ltd. ((ICCM)) has held its Q2 earnings call. Read on for the main highlights of the call.
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IceCure Medical Ltd. recently held an earnings call that painted a mixed picture of the company’s current standing and future prospects. The sentiment was largely positive regarding regulatory and clinical advancements, particularly with the ProSense system, which is on track for FDA approval and has seen increased adoption in Europe and Japan. However, these advancements were overshadowed by financial difficulties, including reduced revenue and gross profit, as well as ongoing net losses, exacerbated by geopolitical tensions.
Regulatory Progress for ProSense
IceCure Medical has made significant strides in regulatory progress for its ProSense system. The company concluded a productive meeting with the FDA concerning de novo marketing authorization, expressing optimism for approval by the end of 2025. The FDA has requested a post-market study, which IceCure has already submitted, and they are now awaiting feedback.
Increased Adoption in Europe
The ProSense system has seen a notable increase in adoption across Europe, particularly for breast cancer cryoablation. This surge is attributed to the positive results from the ICE3 study and growing clinical evidence, which have been highlighted in several high-impact medical forums.
Successful $10 Million Rights Offering
In a move to bolster its financial position, IceCure successfully completed a $10 million rights offering. The offering was significantly oversubscribed, providing the company with a sufficient cash runway to support its operations until the anticipated FDA decision.
Strong Clinical Results in Japan
IceCure reported impressive clinical results from Japan, where 17 years of data from over 600 breast cancer patients showed a 99% recurrence-free rate with cryoablation. This underscores the clinical success and potential of the ProSense technology.
Decrease in Revenue and Gross Profit
Despite the clinical and regulatory successes, IceCure faced financial challenges with a decrease in revenue and gross profit. Revenue for the first half of 2025 was $1.25 million, down from $1.75 million in 2024. Gross profit also fell to $349,000 from $799,000, with gross margins declining from 46% to 28%.
Impact of Geopolitical Conflict
The Israel-Iran conflict in June led to delays in product shipments worth over $200,000, affecting IceCure’s revenue recognition. This geopolitical issue has added to the financial strain the company is experiencing.
Continued Net Loss
IceCure reported a net loss of $6.95 million for the first half of 2025, slightly higher than the $6.69 million net loss in the same period last year. This continued net loss highlights the financial hurdles the company is facing despite its clinical and regulatory achievements.
Forward-Looking Guidance
Looking ahead, IceCure remains optimistic about obtaining FDA approval for ProSense by the end of 2025. The company emphasized the transformative potential of ProSense in breast cancer care for approximately 46,000 women in the U.S. annually. Despite financial setbacks, IceCure’s recent rights offering and cost optimization efforts are expected to support ongoing regulatory, clinical, and commercial initiatives, with hopes of accelerated growth following the FDA’s decision.
In summary, IceCure Medical’s earnings call presented a dual narrative of promising regulatory and clinical advancements tempered by financial challenges. While the company is making significant progress with its ProSense system, the financial difficulties and geopolitical issues it faces cannot be overlooked. Investors and stakeholders will be keenly watching for the FDA’s decision and its impact on IceCure’s future trajectory.