Financial Data and Key Metrics Changes - In Q4 2024, bio envelope sales reached $2.7 million, representing an 18% growth year-over-year [56] - For the full year, bio envelope sales totaled $9.9 million, showing a solid growth of approximately 5% [56] - Simpliderm sales in Q4 were $2.3 million, down year-over-year, but for the full year, it was $11.6 million, up 12% [58] - Overall revenue for Q4 was $5.5 million, down about 7% year-over-year, while total revenue for the year was $24.4 million, down about 1% [60] - GAAP gross margin improved to 43% for Q4 compared to 36% in the prior year, and adjusted gross margin was 58% versus 51% year-over-year [61] Business Line Data and Key Metrics Changes - EluPro accounted for approximately 30% of bio envelope sales in Q4, marking a significant initial uptake [44] - The bio envelope sales rate, including Kangaroo and EluPro, increased by 18% in Q4, indicating a strong market response [43] - The company reported a 65% increase in sales at centers that switched from Kangaroo to EluPro, driven by repeat orders [45] Market Data and Key Metrics Changes - The U.S. market sees about 600,000 pacemakers and internal defibrillators implanted annually, with Medtronic holding a 40% market share [13][14] - Elutia's EluPro is positioned to capture a significant portion of the remaining 60% of the market, which is currently not served by antibiotic-eluting envelopes [15][16] Company Strategy and Development Direction - The company aims to prove the commercial value of EluPro, drive growth with Simpliderm, and expand drug-eluting biologics into other product lines [10][11] - Elutia is focused on operational excellence, obtaining hospital and GPO approvals, and driving clinical uptake of EluPro [24][25][26] - The company plans to initiate a rollout of EluPro with Boston Scientific, leveraging their distribution network to enhance market penetration [52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong initial uptake of EluPro and the potential for significant growth in 2025 [56][58] - The company is actively engaged in strategic discussions with multiple partners to enhance its market position [27] - Management acknowledged the challenges faced in the Simpliderm product line due to the bankruptcy of a distribution partner but remains hopeful for recovery [93][96] Other Important Information - The company ended Q4 with $13.2 million in cash, with a significant cash usage attributed to settling outstanding lawsuits [64] - A registered direct offering raised $15 million in gross proceeds after the end of the quarter, bolstering the cash position [65] Q&A Session Summary Question: Can you discuss Boston's involvement with EluPro? - The agreement with Boston Scientific involves leveraging their 900 reps for distribution in the U.S., focusing on hospital access and product awareness [68][69] Question: When will Boston commence distribution? - Distribution will commence shortly [79] Question: How should we think about utilization at accounts? - High volume accounts are expected to have annual usage in the hundreds, with significant growth anticipated in Q1 [84][85] Question: What occurred during Q4 regarding Simpliderm's growth deceleration? - Simpliderm faced challenges due to the bankruptcy of Sientra, but the product still grew 12% year-over-year [96] Question: Can you discuss the structure of distribution agreements? - The agreement with Boston allows for potential future agreements with other pacemaker manufacturers, but current demand is being met with Boston [101][105] Question: What is the cadence of new account additions expected in 2025? - The current pace is about 15 new accounts per month, but this may slow due to varying VAC approval times [107][110] Question: Can you break down the cash burn in Q4? - Cash burn included operational expenses and litigation settlements, with a significant reduction in outstanding litigation liabilities [111][115]