Financial Data and Key Metrics Changes - Elutia reported Q3 2025 revenue of $3.3 million, down from $3.6 million in the same quarter last year, but gross margin improved to 55.8% from 49% a year ago [39][40] - Adjusted gross margin, excluding non-cash amortization, was 64% compared to 56% in the prior year [40] - Operating expenses decreased to $7.1 million from $11 million a year ago, resulting in a loss from operations of $5.2 million, down from $9 million [40] Business Line Data and Key Metrics Changes - SimpliDerm revenue increased by 18% from Q2 2025 to $2.4 million, although it was down from the previous year due to various factors [35] - Cardiovascular product sales reached $900,000 in Q3 2025, up 68% year-over-year and 28% sequentially [38] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion, with 162,000 procedures performed annually in the U.S. [11][12] - Post-operative infection rates in breast reconstruction are reported to be between 15%-20%, highlighting a significant unmet medical need [10][11] Company Strategy and Development Direction - Elutia aims to leverage its validated technology platform to address the unmet medical need in breast reconstruction through the development of NXT 41 and NXT 41X products [10][29] - The company plans to utilize its existing commercial infrastructure from SimpliDerm to support the launch of NXT 41 and NXT 41X [49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, emphasizing the importance of the recent sale of the bio-envelope business to Boston Scientific for $88 million, which strengthens the balance sheet and operational efficiency [32][33] - The company is focused on resolving legacy litigation issues, with only six cases remaining from an initial 110, indicating a move towards a cleaner operational slate [42] Other Important Information - The company has a robust manufacturing facility in Gaithersburg, Maryland, which is expected to support the production of NXT 41 and NXT 41X without delays [55] - Elutia has resolved seven legacy litigation cases in the quarter, reducing the total to six remaining cases with an estimated liability of $700,000 [42] Q&A Session Summary Question: Insights from Eliupro's development to commercial rollout - Management highlighted the importance of having a strong team and commercial infrastructure in place, which contributed to Eliupro's successful market entry [46][47] Question: Leveraging SimpliDerm for NXT - The existing relationships and commercial presence from SimpliDerm will be utilized to facilitate the adoption of NXT 41X, as both products target the same customer base [49] Question: Clinical evidence and data generation for NXT - While there is no requirement for clinical data for the 510(k) pathway, the company plans to generate strong clinical evidence to support the product's market adoption [51][53] Question: Manufacturing plans for NXT and 41X - The manufacturing of NXT and 41X will occur in a separate GMP facility, ensuring compliance with regulations and readiness for production [54][55] Question: Current run rate and growth sustainability for cardiovascular business - The cardiovascular business is expected to achieve steady growth, with a current run rate of approximately $1 million per quarter, benefiting from high gross margins [57]