SILVER SPRING, Md., April 14, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today confirmed that the ongoing global tariff environment has had no material impact on its commercial or operational performance. Elutia sources, manufactures, and distributes 100% of its products within the United States, primarily from its Roswell, Georgia production facility and U.S.-based suppliers. These products include EluPro™, CanGaroo®, Simpl ...

Core Insights - Elutia Inc. has developed EluPro™, the first FDA-cleared antibiotic-eluting bioenvelope, which has won a 2025 Bronze Edison Award for its innovative approach to reducing post-surgical complications [1][2] - EluPro™ is designed for use with major cardiac implanted electronic devices (CIEDs) and neurostimulation devices, addressing complications such as infection and skin erosion, which occur in 5-7% of cases [2] Company Overview - Elutia focuses on drug-eluting biomatrix technologies to enhance compatibility between medical devices and patients, aiming to humanize medicine [4] - The company launched EluPro™ in January 2025, targeting a market with over 600,000 CIEDs implanted annually in the U.S. [2] Industry Context - The Edison Awards recognize excellence in innovation, with the 2025 awards highlighting significant advancements in product and service development [5] - The need for improved outcomes in post-surgical recovery solutions is underscored by the prevalence of complications associated with CIEDs [2]

Core Insights - Elutia Inc. is launching its EluPro™ Antibiotic-Eluting BioEnvelope for cardiac implantable electronic devices (CIEDs) and neurostimulators at the Heart Rhythm Society's annual meeting in San Diego from April 25-27, 2025 [1][3] - The EluPro product features a proprietary biomatrix that enhances performance and handling, providing a soft and conforming feel compared to synthetic alternatives, while delivering a dual-antibiotic combination for effective bacterial colonization reduction [2][3] Company Overview - Elutia focuses on developing and commercializing drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients, with a mission to humanize medicine [5] - The company is positioned to address the growing demand for implantable technologies as the population requiring such devices increases [5]

Seventh GPO Agreement Signed Since EluPro’s Launch SILVER SPRING, Md., March 27, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, announced that it has entered into an agreement with Advantus Health Partners (“Advantus”), to provide access of Elutia’s EluPro™ Antibiotic Eluting BioEnvelope to Advantus’ core group purchasing organizations (GPO) solutions portfolio. “Teaming up with Advantus is another major step forward in meeting ...

— Rigorous testing demonstrates robust antimicrobial performance against bacterial strains relevant to cardiac implanted electronic device (CIED) infections — SILVER SPRING, Md., March 25, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the publication of new preclinical data in the current issue of Antibiotics, further demonstrating the antimicrobial performance of its antibiotic-eluting biologic envelope de ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2024 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For transition period from to Commission File Number: 001-39577 Elutia Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

Elutia (ELUT) Q4 2024 Earnings Call March 07, 2025 01:31 AM ET Company Participants David Carey - Senior PartnerRandy Mills - President & CEOMatthew Ferguson - CFO Conference Call Participants Ross Osborn - Director, Lead Research Analyst - MedTech and DiagnosticsFrank Takkinen - Senior Research Analyst Operator I would now like to hand the conference call over to David Carey, Fin FIN Partners. Please go ahead. David Carey Thank you, operator, and thank you all for participating in today's call. Earlier tod ...

C. Randal Mills PhD Chief Executive Officer Matt Ferguson Chief Financial Officer March 6, 2025 Forward-Looking Statements This presentation of Elutia Inc. ("Elutia," "we," "us," "our" or the "Company") (together with any other statements or information that we may make or discuss in connection herewith) contains forward-looking statements. All statements other than statements of historical facts, including but not limited to statements regarding the launch and market reception of EluPro®, including the tim ...

Sales Performance - Overall BioEnvelope sales increased by 18%, with same-center sales rising by 65% following the commercialization of EluPro[1] - EluPro accounted for over 30% of BioEnvelope sales in the fourth quarter, indicating strong initial market uptake[4] - Net sales for BioEnvelope products, including EluPro and CanGaroo, totaled $9.9 million for the full year 2024, a 5% increase from $9.4 million in 2023[5] - Net sales of SimpliDerm increased by 12% to $11.6 million, compared to $10.3 million in 2023[5] - Net sales for Q4 2024 were $5,468 million, a decrease of 6.9% compared to $5,875 million in Q4 2023[15] Financial Performance - Net loss from continuing operations was $54.1 million for the full year 2024, compared to a loss of $41.2 million in 2023[8] - Cash balance as of December 31, 2024, was $13.2 million, following a registered direct offering that raised approximately $15 million[8] - Gross margin on a GAAP basis was 43.9% for the full year 2024, down from 44.7% in 2023[8] - Net loss for Q4 2024 was $9,061 million, compared to a net loss of $9,316 million in Q4 2023, showing a 2.7% improvement[15] Operating Expenses - Total operating expenses for the fourth quarter were $10.8 million, compared to $10.6 million in the same period of 2023[8] - Total operating expenses for Q4 2024 were $10,756 million, an increase of 1.2% from $10,631 million in Q4 2023[15] - Research and development expenses for Q4 2024 were $834 million, down 39.5% from $1,381 million in Q4 2023[15] - FiberCel litigation costs for Q4 2024 were $2,611 million, slightly down from $2,711 million in Q4 2023[15] Profitability Metrics - Adjusted EBITDA for the fourth quarter was a loss of $3.8 million, an improvement from a loss of $4.5 million in the same period of 2023[8] - Adjusted gross profit (Non-GAAP) for Q4 2024 was $3,175 million, up 6.7% from $2,975 million in Q4 2023[16] - Adjusted gross margin percentage (Non-GAAP) for Q4 2024 was 58.1%, compared to 50.6% in Q4 2023[16] - EBITDA (Non-GAAP) for Q4 2024 was $(7,126) million, a decline from $(6,922) million in Q4 2023[18] - Adjusted EBITDA (Non-GAAP) for Q4 2024 was $(3,751) million, an improvement from $(4,453) million in Q4 2023[18] Product Development - The company had 67 approved EluPro accounts by the end of 2024, averaging more than 15 new approvals per month[4] - Gross profit for Q4 2024 increased to $2,324 million, up 9.4% from $2,124 million in Q4 2023[15]

Core Viewpoint - Elutia Inc. reported strong sales growth driven by the successful pilot launch of EluPro, an FDA-cleared antibiotic-eluting biomatrix, which has gained significant traction in the market [3][4]. Business Highlights - EluPro accounted for over 30% of BioEnvelope sales in the fourth quarter, indicating robust initial market uptake [5]. - The company ended 2024 with 67 approved EluPro accounts, averaging more than 15 new approvals per month [5]. - Sales growth is supported by agreements with major national group purchasing organizations (GPOs) [5]. - Independent sales agents contributed 45% of BioEnvelope sales from EluPro, showcasing the scalability of the sales model [5]. - Elutia raised approximately $15 million in a registered direct offering, enhancing its financial position [5]. Financial Results - For the full year 2024, net sales for BioEnvelope products increased by 5% to $9.9 million compared to $9.4 million in 2023 [6]. - SimpliDerm net sales rose by 12% to $11.6 million, while cardiovascular product sales decreased by 42% to $2.9 million [6]. - Overall net sales decreased by 1.5% to $24.4 million, driven by changes in the cardiovascular sales model [6]. - Gross margin on a GAAP basis was 43.9%, down from 44.7% [6]. - Total operating expenses increased to $46.4 million from $41.6 million, with a net loss from continuing operations of $54.1 million compared to a loss of $41.2 million in 2023 [6]. Quarterly Performance - In Q4 2024, net sales for BioEnvelope products increased by 18% to $2.7 million compared to $2.3 million in Q4 2023 [10]. - SimpliDerm sales decreased by 23% to $2.3 million, while cardiovascular product sales fell by 20% to $0.5 million [10]. - Overall net sales for the quarter decreased by 7% to $5.5 million [10]. - Gross margin on a GAAP basis improved to 42.5% from 36.2% [10]. - Adjusted EBITDA for Q4 was a loss of $3.8 million, an improvement from a loss of $4.5 million in the same period last year [10].