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]

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 ...

Company Mission and Market Opportunity - Elutia's mission is to humanize medicine by improving the interaction between implanted medical devices and patients, aiming to reduce complications such as infection and device migration [29]. - The company estimates a market opportunity exceeding $1 billion in the Device Protection, Women's Health, and Cardiovascular markets, with significant growth potential [46]. - Over 700,000 surgical procedures involving medical device implantation are performed annually in the U.S., driven by advances in technology and an aging population [30]. Product Offerings and Innovations - Elutia's product EluPro is the only drug-eluting biomatrix in the U.S. for implantable electronic device protection, addressing complications like infection and erosion [34][35]. - The company has developed SimpliDerm, a novel biological matrix aimed at improving healing in various applications, including breast reconstruction and sports medicine [36]. - SimpliDerm, a new product, is designed to improve biocompatibility and tissue integration, utilizing patented cell removal technology to maintain the extracellular matrix's integrity [92]. - SimpliDermRM, a next-generation biomatrix for breast reconstruction, aims to address post-operative infections, which affect more than 10% of patients, and is expected to enter clinical studies by the end of 2025 [93]. Clinical Data and Outcomes - Clinical data indicates a complication rate of 7% to 11% for cardiac implantable electronic device placements, highlighting the need for improved solutions [56]. - The overall rate of adverse events in the CARE Plus Study was 9.2%, with low rates of pocket infection (0.4%) and hematoma (2.6%) observed [77]. - EluPro demonstrated complete eradication of MRSA in a rabbit model, highlighting its potential to reduce infection risk in CIED procedures [71]. - The CanGaroo Envelope showed a threefold reduction in infection risk when gentamicin was used, with a major contributing factor being the use of preoperative intravenous antibiotics [75]. Sales and Marketing Strategy - Elutia's growth strategy focuses on increasing market penetration through direct sales and partnerships with major medical device companies, including Boston Scientific and LeMaitre Vascular [51][48]. - CanGaroo and EluPro are marketed in the U.S. through a direct sales force and a partnership with Boston Scientific, leveraging approximately 900 sales representatives [66]. - The agreement with Tiger provides access to approximately 50 sales representatives to expand the distribution of SimpliDerm in the U.S. [95]. - The company has established a multi-faceted sales and marketing organization, including partnerships with Boston Scientific and Tiger, to enhance market penetration [110][111]. Financial Performance and Challenges - The company reported net losses of $53.9 million and $37.7 million for the years ended December 31, 2024, and 2023, respectively [190]. - The accumulated deficit as of December 31, 2024, was $229.6 million, raising substantial doubt regarding the company's ability to continue as a going concern [191]. - The company has incurred operating losses since its inception in 2015 and expects to continue incurring losses in the foreseeable future [190]. - The company is facing challenges in navigating reimbursement complexities and uncertainties in coverage policies [169]. Regulatory and Compliance Issues - The company’s products are subject to extensive FDA regulations, with medical devices classified into three categories based on risk, impacting the marketing and approval processes [131][132]. - The FDA's 510(k) clearance process for certain ECM products typically takes three to twelve months, but can extend longer depending on the need for additional information [136]. - The company requires approval and oversight from an Institutional Review Board (IRB) for clinical studies, which includes initial and ongoing reviews of the Investigational Device Exemption (IDE) application [141]. - The company no longer maintains its CE mark for cardiovascular products in the EU, which expired on May 23, 2024, and does not market products in the EU [148]. Litigation and Liability Risks - The company is subject to significant litigation risks related to product recalls, with 66 lawsuits outstanding for FiberCel and 15 for VBM as of December 31, 2024 [208]. - The company recorded a total estimated contingent liability of $20.4 million related to FiberCel and VBM lawsuits, with $15.9 million attributed to FiberCel and $4.5 million to VBM as of December 31, 2024 [204]. - As of December 31, 2024, the company has exhausted its insurance coverage for FiberCel liability, making the entire estimated liability of $15.9 million its financial responsibility [213]. Future Outlook and Strategic Initiatives - Long-term growth depends on enhancing products, expanding product indications, and developing or commercializing additional offerings in a highly competitive and rapidly changing industry [226]. - The company must adequately protect intellectual property and comply with FDA regulations to successfully commercialize new products and enhancements [227]. - Developing and commercializing new products is expensive and time-consuming, potentially diverting management's attention from core business [226]. - The company faces challenges in distinguishing its products from competitors and requires effective sales and marketing strategies to succeed [227].

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 ...

Financial Data and Key Metrics Changes - In Q4 2024, bio envelope sales reached $2.7 million, representing an 18% growth year-over-year [56] - For the full year, bio envelope sales totaled $9.9 million, showing a solid growth of approximately 5% [56] - Simpliderm sales in Q4 were $2.3 million, down year-over-year, but for the full year, it was $11.6 million, up 12% [58] - Overall revenue for Q4 was $5.5 million, down about 7% year-over-year, while total revenue for the year was $24.4 million, down about 1% [60] - GAAP gross margin improved to 43% for Q4 compared to 36% in the prior year, and adjusted gross margin was 58% versus 51% year-over-year [61] Business Line Data and Key Metrics Changes - EluPro accounted for approximately 30% of bio envelope sales in Q4, marking a significant initial uptake [44] - The bio envelope sales rate, including Kangaroo and EluPro, increased by 18% in Q4, indicating a strong market response [43] - The company reported a 65% increase in sales at centers that switched from Kangaroo to EluPro, driven by repeat orders [45] Market Data and Key Metrics Changes - The U.S. market sees about 600,000 pacemakers and internal defibrillators implanted annually, with Medtronic holding a 40% market share [13][14] - Elutia's EluPro is positioned to capture a significant portion of the remaining 60% of the market, which is currently not served by antibiotic-eluting envelopes [15][16] Company Strategy and Development Direction - The company aims to prove the commercial value of EluPro, drive growth with Simpliderm, and expand drug-eluting biologics into other product lines [10][11] - Elutia is focused on operational excellence, obtaining hospital and GPO approvals, and driving clinical uptake of EluPro [24][25][26] - The company plans to initiate a rollout of EluPro with Boston Scientific, leveraging their distribution network to enhance market penetration [52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong initial uptake of EluPro and the potential for significant growth in 2025 [56][58] - The company is actively engaged in strategic discussions with multiple partners to enhance its market position [27] - Management acknowledged the challenges faced in the Simpliderm product line due to the bankruptcy of a distribution partner but remains hopeful for recovery [93][96] Other Important Information - The company ended Q4 with $13.2 million in cash, with a significant cash usage attributed to settling outstanding lawsuits [64] - A registered direct offering raised $15 million in gross proceeds after the end of the quarter, bolstering the cash position [65] Q&A Session Summary Question: Can you discuss Boston's involvement with EluPro? - The agreement with Boston Scientific involves leveraging their 900 reps for distribution in the U.S., focusing on hospital access and product awareness [68][69] Question: When will Boston commence distribution? - Distribution will commence shortly [79] Question: How should we think about utilization at accounts? - High volume accounts are expected to have annual usage in the hundreds, with significant growth anticipated in Q1 [84][85] Question: What occurred during Q4 regarding Simpliderm's growth deceleration? - Simpliderm faced challenges due to the bankruptcy of Sientra, but the product still grew 12% year-over-year [96] Question: Can you discuss the structure of distribution agreements? - The agreement with Boston allows for potential future agreements with other pacemaker manufacturers, but current demand is being met with Boston [101][105] Question: What is the cadence of new account additions expected in 2025? - The current pace is about 15 new accounts per month, but this may slow due to varying VAC approval times [107][110] Question: Can you break down the cash burn in Q4? - Cash burn included operational expenses and litigation settlements, with a significant reduction in outstanding litigation liabilities [111][115]

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 ...