The following is a summary of the IceCure Medical Ltd (ICCM) Q3 2024 Earnings Call Transcript:

Financial Performance:

• ProSense systems and disposable probe sales increased by 36% to $2.32 million for the nine months ending September 30, 2024, compared to the previous year.

• Total revenue grew by 22% to $2.42 million in the same period, driven by higher sales in Europe, the US, and Japan.

• Gross profit increased by 41% to $1.03 million, and gross margin improved to 43% from the previous year's 37%.

Business Progress:

• Completed the ICE3 trial with positive outcomes, potentially leading to FDA marketing authorization for ProSense.

• Engaged in the PRECISE study, financed by the Umberto Veronesi Foundation and the Italian Ministry of Health, using ProSense in a larger patient population.

• Partnered with Terumo Corporation in Japan to file for regulatory approval of ProSense for breast cancer in 2025.

Opportunities:

• The potential FDA authorization of ProSense in Q1 2025 could significantly boost the U.S. market presence.

• Upcoming catalysts in 2025 include interim results from the ICESECRET study and additional regulatory approvals in Japan.

Risks:

• There remains uncertainty regarding the exact timing for FDA marketing authorization and the approach of the FDA in terms of special controls and post-marketing requirements.

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