Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $896,000, up 39% compared to $647,000 in Q1 2024 [26] - Unit sales increased approximately 46% due to growth from patients with full insurance reimbursement coverage and the company's financial assistance program [26] - Gross margin in Q1 2025 was 84.4%, down from 88.4% in Q4 2024, attributed to a higher growth rate of discounted financial assistance patients [27][28] - Operating loss for Q1 2025 was $2,300,000, an increase of 25% compared to a $1,800,000 loss in Q1 2024 [30] Business Line Data and Key Metrics Changes - Significant growth of 40% in Q3 2024, 43% in Q4 2024, and 39% in Q1 2025 for IV stem technology [9] - 300 patients were treated in Q1 2025, an annualized rate of 1,200 patients, representing only 0.2% of the 600,000 severely affected children in the U.S. [18] - The rectal expulsion device (RED) received FDA clearance and is currently in a soft launch phase [16][21] Market Data and Key Metrics Changes - Total covered lives increased from 4 million a year ago to approximately 51 million today [11] - The company expects to see increased orders following the publication of independent guidelines by the academic society [33][34] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven and profitability through increased insurance coverage and the effective date of the category one CPT code on January 1, 2026 [25][20] - The strategy includes leveraging strong published data to drive insurance expansion and sustainable revenues [8][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding continued revenue growth due to the expected increase in insurance policy coverage and the category one CPT code [21][25] - The company is cautiously optimistic about the timeline for receiving guidelines and subsequent policy coverage from payers [33][35] Other Important Information - The company settled a lawsuit for $750,000, which will be paid in equal monthly installments starting January 2026 [42] - The legal settlement is viewed positively as it mitigates further risks and legal fees [42][43] Q&A Session Summary Question: When do you expect the guidelines to be published? - Guidelines are expected to be published by the end of the month, with orders anticipated to increase based on policy coverage from those guidelines [33][34] Question: How do you see your operating expenses in the near and medium term? - Operating expenses are expected to increase as investments in sales and marketing are necessary, but as a percentage of sales, they are expected to decrease [36][37] Question: Can you provide more color on RED and its launch? - The response to the RED soft launch has been stronger than expected, with a significant need for the technology noted [38][40] Question: Can you provide details on the legal settlement? - The legal settlement from 2019 will be paid in installments starting January 2026, and it is seen as a positive step for the company [41][42]