Core Insights - Elutia Inc. reported a 16% year-over-year increase in fourth quarter revenue, reaching approximately $3.3 million, and eliminated $26.9 million of secured debt, ending the year with total cash and escrowed proceeds of $44.3 million [1][8]. Company Developments - The company is advancing its NXT-41x antibiotic-eluting biomatrix program, which is expected to improve outcomes in breast reconstruction, a market valued at $1.5 billion with a post-operative infection rate of 15-25% [2][5]. - Elutia plans to submit an FDA filing for NXT-41 in the first half of 2026, with anticipated FDA clearance in the second half of 2026, followed by FDA clearance for NXT-41x in the first half of 2027 [3]. Financial Position - As of December 31, 2025, Elutia had approximately $36.3 million in cash, with an additional $8.0 million from the BioEnvelope divestiture held in escrow, expected to be released in 2026 [8]. - The company has a strong balance sheet, having repaid its outstanding debt, which will significantly reduce interest expenses moving forward [8].

Core Insights - Elutia Inc. is participating in the inaugural Global BioInnovation Forum during the JP Morgan Healthcare Conference on January 13, 2026, to present its advancements in drug-eluting biomatrix technologies [1][5] Company Overview - Elutia is focused on developing and commercializing drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients [6] - The company aims to address the growing need for implantable technologies, emphasizing its mission to humanize medicine [6] Product Development - Elutia will showcase its NXT-41x program, a next-generation antibiotic-eluting biomatrix designed for plastic and reconstructive surgery, which builds on its established biomatrix technology platform [2] - The NXT-41x program is positioned to meet significant unmet needs in breast reconstruction, where postoperative infection rates can reach up to 25% and serious complications affect one in three patients [4] Expert Involvement - Randy Mills, CEO of Elutia, will present alongside Dr. Christopher Reid, a plastic surgeon with expertise in microsurgery and breast reconstruction, who will discuss strategies to mitigate postoperative complications [3] Industry Context - The Global BioInnovation Forum aims to bring together leaders in biotechnology, digital health, and life sciences to discuss innovations that are shaping the future of healthcare [5]

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].

Core Insights - Elutia Inc. has been recognized with two awards in the 2025 Medical Device Network Excellence Awards for its innovations in drug-eluting biomatrix technologies and the successful launch of EluPro [3][4] - EluPro has shown strong commercial performance since its pilot launch in September 2024, with a sequential sales increase of 84% in Q1 2025 and a year-over-year revenue increase of 31% in BioEnvelope sales [4][6] - The product is cleared for use with all major cardiac implantable electronic devices (CIEDs) and neurostimulation devices, addressing complications such as infection and migration [5][6] Company Performance - EluPro was commercially launched in January 2025 and has received approvals from 150 hospital value analysis committees, indicating strong clinical demand [4][6] - The product has established partnerships with seven major group purchasing organizations, reflecting its acceptance within the healthcare procurement ecosystem [4] Product Details - EluPro combines a soft, regenerative biomatrix with antibiotics rifampin and minocycline to enhance healing and reduce complications associated with CIEDs [5][6] - With over 600,000 CIEDs implanted annually in the U.S. and complications occurring in 5-7% of cases, EluPro aims to improve patient outcomes significantly [6] Industry Recognition - The Medical Device Network Excellence Awards analyze over 1 billion datasets annually to recognize top-tier companies in the medical device industry [8] - The awards honor innovative companies that drive positive change, highlighting Elutia's commitment to advancing medical technology [8]