Icecure Medical Ltd. ((ICCM)) has held its Q3 earnings call. Read on for the main highlights of the call.
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The recent earnings call from IceCure Medical Ltd. conveyed a positive sentiment, driven by the significant milestone of obtaining FDA marketing authorization for their ProSense system. This achievement has opened up substantial market opportunities and sparked global interest, positioning the company as a leader in minimally invasive breast cancer care. Despite facing challenges with declining revenue and gross margins, the strategic accomplishments and market potential were emphasized as outweighing the current financial hurdles.
FDA Marketing Authorization for ProSense
IceCure Medical’s ProSense system received FDA marketing authorization to treat low-risk breast cancer, marking a pivotal moment for the company. This approval positions IceCure at the forefront of minimally invasive breast cancer treatment, enhancing its reputation and opening doors to new market opportunities.
Significant Addressable Market
The ProSense system addresses a significant market potential, targeting approximately 200,000 patients annually in the U.S. This includes 46,000 women over 70 diagnosed with low-risk breast cancer, 88,000 patients not eligible for surgery, and 63,000 women with benign breast tumors, highlighting the expansive reach of IceCure’s technology.
International Expansion and Interest
Following the FDA approval, IceCure has witnessed growing global interest. The company recently secured regulatory approval in Switzerland and is planning further expansion in Japan through collaboration with Terumo Corporation, indicating a robust international growth strategy.
Financial Position Strengthened
IceCure Medical has bolstered its financial position by raising $10 million from a rights offering and $5.87 million from a market offering, resulting in a cash balance of $11.8 million as of October 31, 2025. This financial strengthening supports the company’s commercialization and strategic initiatives.
Operational Cost Optimization
The company has successfully reduced its total operating expenses to $11.5 million from $12.2 million, demonstrating effective cost optimization while continuing to execute its commercial and regulatory strategies.
Decrease in Revenue
Revenue for the first nine months of 2025 was reported at $2.1 million, a decline from $2.4 million in 2024. This decrease is attributed to reduced sales in Japan, other Asian territories, and North America, posing a challenge for the company’s financial performance.
Decline in Gross Margin
Despite an increase in gross profit to $626,000, IceCure experienced a decline in gross margin to 30% from 43% the previous year. This indicates a need for strategic adjustments to improve profitability.
Forward-Looking Guidance
IceCure Medical outlined a strategic growth trajectory following the FDA’s marketing authorization for ProSense. The company plans to expand its U.S. commercial footprint with a post-market study involving 30 clinical sites, expecting to enroll the first patient by summer 2026. Additionally, an anticipated CPT code reimbursement increase to over $4,000 in early 2026 is expected to bolster financial performance. Globally, IceCure aims to leverage FDA approval to drive international adoption, with recent approval in Switzerland and ongoing efforts in Japan.
In summary, IceCure Medical’s earnings call highlighted a positive outlook, driven by strategic achievements and market potential. Despite current financial challenges, the company’s strengthened financial position and international expansion plans underscore its commitment to growth and innovation in minimally invasive breast cancer care.