[Management View]
Revenue: $725,000 for Q1 2025, driven by North America and Europe, offset by lower sales in Asia. Gross profit: $218,000 with a gross margin of 30%, down from 36% YoY. Operating expenses: $3.88 million, nearly unchanged YoY. Net loss: $3.59 million, or $0.06 per share, versus $3.61 million, or $0.08 per share, in Q1 2024. Cash position: $4.0 million as of March 31, 2025, and $6.2 million as of May 27, 2025, including a $2 million unsecured bridge loan from Epoch Partner Investments.

[Outlook]
IceCure plans for immediate U.S. commercial launch of ProSense for early-stage, low-risk breast cancer in women aged 70 and older, pending FDA approval. The company aims to complete patient recruitment for the post-market study within three years. Geographic expansion includes regulatory filings in Japan and Israel in 2H 2025.

[Financial Performance]
Revenue decreased slightly from $743,000 in Q1 2024 to $725,000 in Q1 2025. Gross margin declined from 36% to 30% YoY. Operating expenses remained stable at $3.88 million compared to $3.92 million YoY. Net loss slightly improved from $3.61 million to $3.59 million YoY.

[Q&A Highlights]

Question 1: Is the post-market study still expected to be a minimum of 400 patients over 25 sites? Any indication from the FDA on the response timeline?
Answer: Yes, the post-market study will require 400 patients at a minimum of 25 sites. The FDA's top management will continue to review it, but no specific timeline for the response was provided. The submitted package is extensive, and continuous discussions with the FDA are expected.

Question 2: How long is the post-market study expected to take?
Answer: The recruitment time for the post-market study is expected to be within three years, pending finalization with the FDA.

Question 3: Can you provide more details on the potential for expanded reimbursement?
Answer: With more records and claims on the CPT3 code for breast cancer, the company believes it can increase the CPT record. After FDA marketing authorization, IceCure will apply to the AMA to move from CPT3 to CPT1, which includes physician fees.

Question 4: What is the size of the market opportunity in Japan?
Answer: Japan has over 100,000 new breast cancer cases annually, with nearly two-thirds being low-risk early-stage breast cancer. Terumo's assumption is that the indication will not be limited by age or tumor size, similar to other regulatory approvals.

Question 5: Can you give more details on the geographic breakdown of revenue this quarter?
Answer: North America saw an 11% YoY increase, Europe saw a 60% YoY increase, while Japan experienced a 60% decline, and other parts of Asia saw a 40% decline. The numbers fluctuate between quarters.

Question 6: Is ProSense subject to any new tariffs for the US market?
Answer: Yes, the company has been affected by US tariffs, but future presidential decisions may alter the impact.

Question 7: Do you plan to expand your sales team after the post-market study approval?
Answer: Yes, the company plans to increase the sales team after marketing authorization, starting with North America, led by experienced management.

Question 8: What are your strategies for pricing and sales?
Answer: The commercial model will be a mix of placement and selling consoles, with a commitment to a monthly number of probes over two to three years for placements. There will also be a separate business model for selling consoles and single-use probes.

[Sentiment Analysis]
Analysts showed a positive tone, focusing on the FDA engagement and potential market expansion. Management expressed optimism about FDA approval and commercial readiness.

[Quarterly Comparison]
| Metric | Q1 2025 | Q1 2024 |
|-----------------------|---------------|---------------|
| Revenue | $725,000 | $743,000 |
| Gross Profit | $218,000 | $269,000 |
| Gross Margin | 30% | 36% |
| Operating Expenses | $3.88 million | $3.92 million |
| Net Loss | $3.59 million | $3.61 million |
| Cash Position | $4.0 million | N/A |

[Risks and Concerns]
- Dependence on FDA approval for commercial launch.
- Revenue fluctuations due to low revenue base.
- Impact of US tariffs on financial performance.

[Final Takeaway]
IceCure's Q1 2025 earnings call highlighted stable financial performance and ongoing FDA engagement for ProSense marketing authorization. The company is poised for commercial expansion in the US and other markets, contingent on regulatory approvals. The management's strategic focus on reimbursement and geographic diversification aims to drive future growth.