Merit Medical Systems (MMSI) FDA Announcement Transcript

Summary of Merit Medical Systems (MMSI) Conference Call Company Overview - Company: Merit Medical Systems (MMSI) - Event: Rhapsody Investor Conference Call - Date: January 28, 2025 - Key Participants: Fred Lampropoulos (CEO), Brian Lloyd (CLO), John Hall (EVP R&D), Daniel Patel (Medical Director), Caleb Konstanski (VP Sales & Marketing), Raul Parra (CFO) Core Industry and Product Insights - Industry: Medical Device Industry, specifically focusing on dialysis access solutions - Product: Rhapsody Cell and Permeable Endoprosthesis (CIE) - FDA Approval: Received pre-market approval from the FDA in December 2024, with commercial launch initiated in January 2025 [9][10] Key Points Discussed 1. Strategic Initiative: The Rhapsody CIE is part of a long-term strategic initiative that began in 2010, aimed at transitioning Merit towards higher-value therapeutic medical devices [11][12][13] 2. Market Opportunity: - Over 660,000 people in the U.S. live with end-stage renal disease, with approximately 560,000 undergoing in-center hemodialysis [38] - The addressable market for Rhapsody CIE includes over 420,000 U.S. patients using AV fistulas or AV grafts [39][40] - In 2023, there were 665,000 dialysis access maintenance procedures, with 95,000 stent units implanted [41][42] 3. Clinical Validation: - Rhapsody CIE demonstrated 84.6% target lesion primary patency at 12 months and 65.9% access circuit primary patency at 12 months in clinical trials [22][25] - A total of 423 patients were studied in the U.S. and international markets, with plans to enroll up to 500 patients in a post-market study [25][26] 4. Innovative Features: - The Rhapsody CIE includes a cell impermeable membrane to prevent tissue growth, a modified biocompatible PTFE to reduce thrombosis, optimized compression resistance, and a user-friendly catheter delivery system [20][21][22] 5. Commercial Strategy: - The U.S. commercialization strategy includes intensive training for sales teams, marketing plans, and engagement with physician advocates [44][46][48] - Targeted average selling price (ASP) for Rhapsody CIE is set at $5,800, positioned as a premium product [84][86] Financial Expectations - Revenue Forecast: Projected U.S. revenue from Rhapsody CIE in 2025 is estimated to be between $7 million and $9 million [63] - Reimbursement Strategy: Applications for new technology add-on payments (NTAP) and transitional pass-through payments (TPT) are underway, with decisions expected in June 2025 [55][57] Additional Considerations - Challenges: Pricing sensitivity in outpatient settings and the need for larger diameter sheets for Rhapsody CIE may impact adoption [35][36] - Future Outlook: The Rhapsody CIE is expected to be featured in multiple medical meetings and publications throughout 2025, enhancing awareness and credibility [58][61] Conclusion - Merit Medical Systems is positioned to leverage the Rhapsody CIE as a significant advancement in dialysis access technology, with a comprehensive strategy for market entry and growth, supported by clinical validation and a focus on improving patient outcomes.