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Pay attention to upcoming possible catalysts! Make a note to keep on your mind! That is if you’re looking for a possible ST! NFA
$Icecure Medical (ICCM.US)$ 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.
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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