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]

Core Insights - Elutia Inc. is advancing its NXT-41x biomatrix technology to address a significant unmet medical need in plastic and reconstructive surgery, targeting a market opportunity estimated at $1.5 billion in the U.S. [1][5] Business Highlights - The CEO emphasized the importance of addressing infection in breast reconstruction, which affects 15-20% of cases, and highlighted the company's antibiotic-eluting technology aimed at preventing such infections [4]. - Elutia sold its BioEnvelope business to Boston Scientific for $88 million, with proceeds allocated to eliminate debt and fund the NXT-41x development program [5]. - The company is progressing with the NXT-41x biomatrix, which is expected to receive FDA clearance for the base matrix in the second half of 2026 and for the drug-eluting version in the first half of 2027 [5]. - Elutia's balance sheet has been strengthened through the sale of the BioEnvelope business, allowing for the full funding of the NXT-41x platform development without shareholder dilution [5]. - Guido J. Neels has been appointed to the Board of Directors, bringing experience from his previous role as COO of Guidant Corporation [5]. Financial Results - For Q3 2025, Elutia reported net sales of $3.3 million, a decrease from $3.7 million in Q3 2024, with SimpliDerm sales at $2.4 million and cardiovascular products at $0.9 million [6]. - The gross margin on a GAAP basis improved to 55.8% from 48.9% year-over-year, while the adjusted gross margin rose to 63.9% from 56.3% [6][20]. - Total operating expenses decreased to $7.1 million from $11.0 million, resulting in a loss from operations of $5.2 million, down from $9.2 million in the prior year [6]. - The net loss from continuing operations was $0.4 million, compared to a net income of $3.3 million in Q3 2024 [6]. - As of September 30, 2025, the cash balance was $4.7 million, bolstered by $80.3 million received from the BioEnvelope business sale [7]. Market Opportunity - The NXT-41x biomatrix is positioned to tackle serious complications faced by one in three patients undergoing breast reconstruction, addressing a critical need in the $1.5 billion U.S. market [5].

Financial Data and Key Metrics Changes - The company reported a 33% year-over-year increase in bioenvelope revenue for the quarter, reaching a run rate of approximately $14 million [10] - Elupro revenue grew 49% sequentially, now accounting for 68% of total bioenvelope revenue [10][12] - Adjusted gross margin improved to 62.4%, up over four percentage points from the previous year [34] - The company ended Q2 with $8.5 million in cash, indicating a stable financial position [36] Business Line Data and Key Metrics Changes - Elupro's sales per account are 130% higher than the previous product, Kangaroo, reflecting greater utilization [13] - The cardiovascular patch products generated over $700,000 in revenue for a partial quarter, more than double the previous distributor's revenue [32] - SimpliDerm revenue decreased to $2 million, indicating potential for improvement in that product line [33] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion in the U.S., with biologics accounting for 65% of device-related spending [20] - Approximately 317,000 women are diagnosed with invasive breast cancer annually, leading to significant market potential for reconstruction products [19] Company Strategy and Development Direction - The company aims to scale Elupro by increasing the number of VAC approvals and GPO coverage [38] - The NXT 41 platform is positioned to address significant unmet medical needs in breast reconstruction, with anticipated market launch in 2026 [25][40] - The company is exploring strategic opportunities that may positively impact cash position in the near future [36][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Elupro, citing predictable ordering patterns and strong hospital partnerships [46][50] - The company is focused on addressing the high complication rates in breast reconstruction procedures, emphasizing the need for innovative solutions [22][23] Other Important Information - The company has settled 97 out of 110 lawsuits related to a past product recall, significantly reducing future expenses and legal overhang [29][30] - The company is actively working on business development transactions, with expectations for announcements in the near future [41] Q&A Session Summary Question: What are the bottlenecks in the Elupro launch? - Management noted initial production challenges but emphasized that operations have now stabilized, allowing for efficient scaling [45][46] Question: Can you clarify the NXT 41 launch timeline? - The base matrix is expected to launch in 2026, followed by the drug-eluting version in 2027, with a focus on regulatory strategy [52][56] Question: How can gross margins be maintained or expanded? - Management highlighted opportunities for margin improvement across all business segments, particularly in Elupro and cardiovascular products [64] Question: What level of clinical evidence is needed for NXT 41? - The company plans to follow a similar regulatory pathway as Elupro, focusing on generating clinical data for marketing purposes [67]

Core Insights - Elutia Inc. reported a significant revenue increase for its EluPro product, with a 49% sequential growth in Q2 2025 and a 33% year-over-year increase in total BioEnvelope sales, reaching $3.5 million [2][5][6] - The company is advancing its next-generation drug-eluting biomatrix, NXT-41, targeting a $1.5 billion market for breast reconstruction, with initial product launch planned for the second half of 2026 [2][4] Business Highlights - EluPro has become the preferred choice in cardiac implantable electronic device procedures, expanding into over 160 VAC-approved hospitals and growing its customer base more than 15 times since launch [4][6] - The average sales per EluPro customer were 130% higher than those for the legacy CanGaroo platform, indicating stronger market penetration [6] - Elutia has received two awards for innovation and product launches, and has published five peer-reviewed articles on EluPro, showcasing its scientific leadership [6] Financial Performance - For Q2 2025, Elutia's overall net sales were $6.3 million, nearly unchanged from Q2 2024, with a gross margin of 48.8%, up from 44.5% [9][15] - The company reported a net loss of $9.6 million for Q2 2025, a significant improvement compared to a net loss of $28.2 million in the same period of the previous year [9][15] - Adjusted EBITDA for Q2 2025 was a loss of $3.8 million, compared to a loss of $2.6 million in Q2 2024 [9][18] Market Access and Growth Strategy - Elutia's distribution strategy includes a partnership with Boston Scientific and a focus on expanding access through national GPO contracts and VAC approvals [2][4] - The company regained direct control of its cardiovascular product sales, generating $736K in revenue in the first partial quarter of direct sales [6] Litigation and Financial Position - Elutia has resolved 97 out of 110 cases related to FiberCel litigation, significantly reducing expected litigation expenses [6] - As of June 30, 2025, the company had a cash balance of $8.5 million, down from $13.2 million a year earlier [9][13]

Core Insights - Elutia Inc. reported strong first-quarter results for 2025, highlighting the successful launch and adoption of its EluPro™ product, which has established itself as a significant solution for cardiac implantable electronic device (CIED) procedures [1][4]. Business Highlights - EluPro experienced an 84% sequential sales increase, contributing to a 31% year-over-year growth in BioEnvelope revenue, totaling $3.1 million, with EluPro accounting for approximately 52% of BioEnvelope sales [4][5]. - The partnership with Boston Scientific is expected to enhance the adoption of EluPro, with over 900 sales professionals involved and initial training completed, leading to sales generation in over 50 hospitals [3][4]. - EluPro's marketing efforts include a prominent presence at the Heart Rhythm Society 2025 and a new national campaign aimed at increasing awareness [4]. - EluPro received a 2025 Edison Award for innovation, and new peer-reviewed data has validated its antibacterial efficacy [4]. Financial Performance - Total net sales decreased by 10% to $6.0 million compared to $6.7 million in Q1 2024, with BioEnvelope products showing a 31% increase [5][9]. - Gross margin on a GAAP basis was 40.7%, down from 42.5%, while adjusted gross margin was 54.8%, slightly down from 55.2% [9][17]. - The company reported a loss from operations of $7.9 million, an improvement from a loss of $8.5 million in the previous year [9][16]. Strategic Developments - Elutia regained full commercial rights to its ProxiCor™, Tyke™, and VasCure™ products, which are now sold through a contractor-based model expected to enhance cash flow [4]. - The company raised $15 million through a registered direct offering and amended loan terms to improve financial flexibility [4].