EluPro Commercial Progress - EluPro实现了显著的商业成功，同比增长49%[12] - EluPro的增长现在占BioEnvelope收入的68%[14] - 已经获得了7个国家GPO合同[12, 21, 22] - 161家医院积极订购EluPro[12, 23] - 预计年底销售额将接近2000万美元[17] - 通过波士顿科学公司销售的EluPro案例占30%[18] Reconstruction Pipeline - 生物制剂代表着15亿美元的美国市场，占重建支出的65%[28] - 每年大约有151,000例乳房切除术，其中三分之二是双侧乳房切除术，导致200,000-225,000个乳房重建[30] - 生物网在80%的重建案例中使用，每个乳房的成本为7,500-9,500美元[30] - 1/3的患者在乳房重建后会出现严重的并发症[31] Litigation Update - 在FiberCel诉讼方面取得了重大进展，自2025年第一季度以来已解决了27起案件[42] - 总共解决了110起案件中的97起[42] Financial Review - BioEnvelope（EluPro和CanGaroo）的净销售额为350万美元，而去年同期为260万美元[45] - 调整后的毛利率为62.4%，而去年同期为58.0%[45] - 截至2025年6月30日，现金余额为850万美元[45]

Core Insights - Elutia Inc. has published a study demonstrating the bioactive properties of its EluPro BioEnvelope, which shows superior healing responses compared to synthetic materials for cardiac implantable electronic devices (CIEDs) [1][4] - The study indicates that EluPro controls inflammation and supports vascularization, which are crucial for reducing scarring and infection risks associated with CIED implantation [1][2] Group 1: Study Findings - The preclinical study revealed that EluPro stimulates early proangiogenic signals and reduces fibrosis over time, addressing precursors to pocket infection [2] - Mechanistic studies showed that fibroblasts in the biomatrix environment released significantly higher levels of growth and wound healing factors compared to controls (p<0.001) [3] - Long-term animal studies indicated that the biomatrix promoted blood vessel formation (angiogenesis) and reduced inflammation and scarring over a 26-week period, while synthetic materials exhibited persistent inflammation and fibrosis [3] Group 2: Product and Market Position - EluPro is the first and only FDA-cleared antibiotic-eluting bioenvelope designed for use with CIEDs and neurostimulators, launched commercially in the U.S. in January 2025 [4] - The company aims to expand its proprietary drug-eluting biomaterial platform to address other high-impact medical indications, focusing on improving patient outcomes through biologic solutions [4][6] Group 3: Company Overview - Elutia develops and commercializes drug-eluting biomatrix products to enhance compatibility between medical devices and patients, with a mission to humanize medicine [6]

Core Insights - Elutia Inc. has developed a validated method for measuring antibiotic release from a biologic envelope, which accelerates product development and testing [1][2] - The new method provides reliable data in 30 hours, significantly faster than the traditional 14-day in vivo protocols, enhancing efficiency in drug release testing [2][3] - EluPro, the first FDA-cleared antibiotic-eluting bioenvelope, was launched in January 2025 and is designed for use with cardiac implantable electronic devices and neurostimulators [3] Company Overview - Elutia focuses on drug-eluting biomatrix products to improve compatibility between medical devices and patients, aiming to humanize medicine for those needing implantable technologies [5] - The company emphasizes the importance of drug elution performance for manufacturing consistency and regulatory evaluation, as recognized by the FDA [2][3] - Elutia's innovative approach supports the product lifecycle of EluPro and future drug-eluting biologic matrices, showcasing its leadership in the field [3]

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]

— Integration of clinical and patient-reported outcomes expected to further differentiate EluPro's utility in cardiac implantable electronic device (CIED) procedures — SILVER SPRING, Md., April 21, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix technologies, today announced the initiation of an EluPro™ clinical study designed to collect patient outcome data in real-world clinical practice. EluPro, the first and only FDA-cleared antibiotic ...

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]