Financial Data and Key Metrics Changes - The company reported Q1 2025 revenue of $6,000,000, down from $7,000,000 in Q1 2024 but up 10% sequentially from Q4 2024 [33][34][36] - Adjusted gross margin for Q1 2025 was 54.8%, slightly down from 55.2% in the previous year, with expectations for improvement as efficiencies are realized [35][36] - Adjusted EBITDA for Q1 2025 was $3,300,000, an improvement from $4,500,000 in the previous year [37] Business Line Data and Key Metrics Changes - The BioEnvelope division generated $3,100,000 in revenue, representing a 31% year-over-year growth and a 16% sequential increase [10][33] - Simploderm revenue was $2,600,000, down from $3,600,000 year-over-year but up 13% from Q4 2024 [34] - Cardiovascular products division reported $300,000 in sales, with expectations for significant growth as the company takes back control of sales [35][36] Market Data and Key Metrics Changes - The company has secured contracts with 125 hospitals actively ordering Elupro, with an additional 130 Value Analysis Committees (VACs) in process [12][13] - The partnership with Boston Scientific has expanded the sales force to 900 representatives, enhancing market penetration [18][20] Company Strategy and Development Direction - The primary focus is on driving top-line growth for Elupro through expanding VAC and Group Purchasing Organization (GPO) coverage [41] - The company plans to explore strategic alternatives for its Simploderm product line and advance its drug-eluting biologic pipeline for reconstructive surgery [42][44] - The new Gaithersburg facility will enhance production capacity and reduce costs by manufacturing critical components in-house [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about a strong second half of 2025, driven by the successful launch of Elupro and the partnership with Boston Scientific [14][41] - The company is focused on increasing production capacity and lowering costs to achieve gross margins in the mid-seventy percent range [42] Other Important Information - The company received an Edison Award for innovation in post-surgical recovery for Elupro [27] - A real-world clinical study has commenced, with the first patients enrolled at UCSD, aimed at gathering clinical outcome data [27][60] Q&A Session Summary Question: How have relationships with physicians gone in those cases with Boston Scientific? - Adoption patterns for Elupro show that initial orders are often followed by higher subsequent orders, indicating strong physician interest and usage [48][50] Question: What is the current manufacturing capacity without the Gaithersburg facility? - Current manufacturing capacity allows for approximately $140,000,000 in Elupro revenue, but without the antibiotic disc expansion, it is limited to $25,000,000 to $30,000,000 [53] Question: What should be expected regarding cash burn going forward? - Cash flow from operations is expected to stabilize around $4,000,000 to $5,000,000 as litigation settlements conclude [55][56]

Financial Performance - EluPro sales experienced significant sequential growth of 84%, now representing 52% of BioEnvelope revenue[8, 11] - BioEnvelope revenue increased by 31% year-over-year, reaching $3.1 million[11] - The company's cash balance as of March 31, 2025, was $17.4 million[29] - A registered direct offering generated gross proceeds of $15.0 million on February 4, 2025[29] Strategic Initiatives - A strategic partnership with Boston Scientific aims to accelerate EluPro adoption, leveraging a combined commercial footprint of over 900 sales professionals[8, 15, 16] - The company reacquired distribution rights for its cardiovascular portfolio from LeMaitre, expecting it to contribute to cash flow with approximately 80% gross margin[8, 24, 27] Operational Improvements - The company is focused on increasing production capacity and reducing COGS for EluPro[17, 33] - The Roswell, GA facility has scalable capacity to support approximately $140 million in EluPro sales at over 70% gross margin[20] Market Expansion - Elutia is targeting approximately 1,000 hospitals with Cardiac Implantable Electronic Devices (CIED) volumes exceeding 100 cases per year[14] - Elutia is actively engaging with hospitals, with 125 institutions actively ordering and 130 Value Analysis Committees (VACs) in process, adding 10-12 institutions per month[11, 14]

Exhibit 99.1 Elutia Announces Strong First Quarter 2025 Financial Results Driven by 84% Sequential Growth in EluPro™ Sales - New Boston Scientific distribution partnership now underway - - Conference call today at 5:00 p.m. ET / 2:00 p.m. PT - SILVER SPRING, Md., May 8, 2025 — Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix technologies, today reported strong first-quarter results for 2025 and highlighted key developments driving the adoption of EluPro™. In its fi ...

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].

Core Insights - Elutia Inc. is reclaiming U.S. sales and distribution responsibilities for its cardiovascular portfolio, which includes ProxiCor®, VasCure®, and Tyke®, after ending its distribution agreement with LeMaitre Vascular, Inc. This strategic move is expected to enhance top-line revenue and improve gross margins and profitability for this product segment [1][4] Company Developments - Dwayne Montgomery has been appointed as Head of Cardiovascular to lead the newly established business unit, bringing extensive experience from previous roles at Osiris Therapeutics, Smith & Nephew, Guidant, and C.R. Bard [2] - Under Montgomery's leadership, Elutia has assembled a team of 26 independent sales representatives dedicated to the cardiovascular line, allowing for focused operations separate from the EluPro™ commercial organization [3] Financial Expectations - The cardiovascular portfolio is projected to deliver approximately 80% gross margins and maintain a premium price position in the market. In 2024, sales from cardiovascular products accounted for $2.9 million, representing about 12% of total revenue [4]

Core Points - Elutia Inc. will release its first quarter 2025 financial results on May 8, 2025, after market close [1] - A conference call and webcast will be hosted by the management team at 5:00 p.m. Eastern Time on the same day [1] - The conference call can be accessed by U.S. investors at 877-407-8029 and international investors at 201-689-8029, with a Conference ID of 13753035 [1] Company Overview - Elutia develops and commercializes drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients [2] - The company focuses on addressing the needs of a growing population requiring implantable technologies [2] - Elutia's mission is to humanize medicine, enabling patients to thrive without compromise [2]

Core Insights - Elutia Inc. is participating in Chardan's Trending Issues in Drug Development Conference Series on April 29, 2025, with Dr. Michelle LeRoux Williams as the Chief Scientific Officer [1] - The conference will be held in a virtual format, featuring a fireside chat at 11:00 a.m. ET, and a webcast will be available on Elutia's investor website [2] - Elutia focuses on developing and commercializing drug-eluting biomatrix products aimed at enhancing the compatibility of medical devices with patients [3] Company Overview - Elutia is dedicated to improving medical technology for a growing population that requires implantable devices, with a mission to humanize medicine [3] - The company emphasizes the importance of patient compatibility and aims to ensure that patients can thrive without compromise [3]

Core Insights - Elutia Inc. has initiated a clinical study for its EluPro™ product, aimed at collecting real-world patient outcome data in cardiac implantable electronic device (CIED) procedures [1][2] - EluPro is the first FDA-cleared antibiotic-eluting bioenvelope for use with CIEDs and neurostimulators, launched commercially earlier this year [1][3] - The study will enroll 100 patients and follow them for 12 months to assess clinical and patient-reported outcomes, focusing on complications such as infection and device migration [2][3] Company Overview - Elutia specializes in drug-eluting biomatrix technologies, aiming to improve compatibility between medical devices and patients [5] - The company’s mission is to humanize medicine, allowing patients to thrive without compromise [5] - The CIED protection market in the U.S. is valued at $600 million, with over 600,000 CIEDs implanted annually, and complication rates ranging from 5-7% [3] Product Details - EluPro combines antibiotics rifampin and minocycline with a soft, regenerative biomatrix, addressing critical needs in CIED procedures [3] - The product is cleared for use with all major CIED brands, including pacemakers and implantable defibrillators, as well as various neurostimulation devices [3]

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]