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]

Core Viewpoint - Elutia Inc. has confirmed that the ongoing global tariff environment has not materially impacted its commercial or operational performance, thanks to its U.S.-based operations and vertically integrated manufacturing strategy [1][3]. Company Operations - Elutia sources, manufactures, and distributes 100% of its products within the United States, primarily from its Roswell, Georgia production facility [2]. - The company's product offerings include EluPro™, CanGaroo, SimpliDerm, and a full Cardiovascular portfolio, with all sales occurring domestically [2]. Management Statements - Dr. Randy Mills, CEO of Elutia, emphasized the company's pride in being U.S.-based and highlighted that their operations remain insulated from tariff uncertainties, allowing for reliable production and delivery of medical products [3]. - The Roswell facility is FDA-registered and has not faced delays, cost increases, or supplier issues related to tariffs, positioning the company well to serve the U.S. market without affecting pricing or margins [3]. Company Mission - Elutia develops and commercializes drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients, with a mission to humanize medicine [4].

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 ...