Financial Data and Key Metrics Changes - The company reported a 33% year-over-year increase in bioenvelope revenue for the quarter, reaching a run rate of approximately $14 million [10] - Elupro revenue grew 49% sequentially, now accounting for 68% of total bioenvelope revenue [10][12] - Adjusted gross margin improved to 62.4%, up over four percentage points from the previous year [34] - The company ended Q2 with $8.5 million in cash, indicating a stable financial position [36] Business Line Data and Key Metrics Changes - Elupro's sales per account are 130% higher than the previous product, Kangaroo, reflecting greater utilization [13] - The cardiovascular patch products generated over $700,000 in revenue for a partial quarter, more than double the previous distributor's revenue [32] - SimpliDerm revenue decreased to $2 million, indicating potential for improvement in that product line [33] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion in the U.S., with biologics accounting for 65% of device-related spending [20] - Approximately 317,000 women are diagnosed with invasive breast cancer annually, leading to significant market potential for reconstruction products [19] Company Strategy and Development Direction - The company aims to scale Elupro by increasing the number of VAC approvals and GPO coverage [38] - The NXT 41 platform is positioned to address significant unmet medical needs in breast reconstruction, with anticipated market launch in 2026 [25][40] - The company is exploring strategic opportunities that may positively impact cash position in the near future [36][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Elupro, citing predictable ordering patterns and strong hospital partnerships [46][50] - The company is focused on addressing the high complication rates in breast reconstruction procedures, emphasizing the need for innovative solutions [22][23] Other Important Information - The company has settled 97 out of 110 lawsuits related to a past product recall, significantly reducing future expenses and legal overhang [29][30] - The company is actively working on business development transactions, with expectations for announcements in the near future [41] Q&A Session Summary Question: What are the bottlenecks in the Elupro launch? - Management noted initial production challenges but emphasized that operations have now stabilized, allowing for efficient scaling [45][46] Question: Can you clarify the NXT 41 launch timeline? - The base matrix is expected to launch in 2026, followed by the drug-eluting version in 2027, with a focus on regulatory strategy [52][56] Question: How can gross margins be maintained or expanded? - Management highlighted opportunities for margin improvement across all business segments, particularly in Elupro and cardiovascular products [64] Question: What level of clinical evidence is needed for NXT 41? - The company plans to follow a similar regulatory pathway as Elupro, focusing on generating clinical data for marketing purposes [67]

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=8&type=section&id=Item%201.%20Financial%20Statements) The unaudited financial statements show a net loss of $13.5 million for H1 2025 and a significant 'going concern' uncertainty [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of $33.8 million and a stockholders' deficit of $41.8 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $8,500 | $13,239 | | Total current assets | $22,280 | $26,172 | | Total assets | $33,849 | $36,127 | | Total current liabilities | $37,948 | $37,795 | | Total liabilities | $75,692 | $82,387 | | Total stockholders' deficit | $(41,843) | $(46,260) | [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of $13.5 million for H1 2025, an improvement from $46.2 million in H1 2024 due to warrant liability revaluation Q2 Statement of Operations Highlights (in thousands) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net sales | $6,263 | $6,291 | | Gross profit | $3,058 | $2,799 | | Loss from operations | $(9,875) | $(8,510) | | (Gain) loss on revaluation of warrant liability | $(2,233) | $18,337 | | Net loss from continuing operations | $(9,610) | $(28,360) | Six-Month Statement of Operations Highlights (in thousands) | Metric | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net sales | $12,293 | $12,985 | | Gross profit | $5,515 | $5,642 | | Loss from operations | $(17,797) | $(16,989) | | (Gain) loss on revaluation of warrant liability | $(7,420) | $27,974 | | Net loss from continuing operations | $(13,543) | $(46,354) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash used in operations increased to $17.1 million in H1 2025, leading to a net decrease in cash of $4.7 million Six-Month Cash Flow Summary (in thousands) | Cash Flow Activity | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,109) | $(6,973) | | Net cash provided by (used in) investing activities | $(392) | $167 | | Net cash provided by financing activities | $12,762 | $5,718 | | **Net decrease in cash and cash equivalents** | **$(4,739)** | **$(1,088)** | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes disclose substantial 'going concern' doubt, a $17.0 million contingent liability for product recalls, and debt amendments - The company has substantial doubt about its ability to continue as a going concern due to a **net loss of $13.5 million** and **$17.1 million of cash used in operations** for the six months ended June 30, 2025, along with an accumulated deficit of $243.1 million[43](index=43&type=chunk) - The company has accrued a **contingent liability of $17.0 million** for legal proceedings as of June 30, 2025, related to the FiberCel and VBM product recalls[27](index=27&type=chunk)[127](index=127&type=chunk)[129](index=129&type=chunk) - In May 2025, the company amended its SWK Loan Facility to, among other things, fix the minimum liquidity covenant at **$8.0 million** and allow the May 2025 interest payment to be paid-in-kind (PIK)[99](index=99&type=chunk) Net Sales by Segment - Q2 2025 (in thousands) | Segment | Net Sales | | :--- | :--- | | Device Protection | $3,516 | | Women's Health | $2,011 | | Cardiovascular | $736 | | **Total** | **$6,263** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=47&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the EluPro launch driving Device Protection sales, offset by declines in other segments and ongoing liquidity challenges [Overview](index=47&type=section&id=Overview) The company focuses on Device Protection and Women's Health markets, with success highly dependent on the new EluPro product - The company's mission is to reduce complications associated with implanted medical devices, focusing on Device Protection and Women's Health markets[148](index=148&type=chunk)[150](index=150&type=chunk) - The company's success is highly dependent on the successful commercialization, marketing, and sale of its **EluPro product**, which was cleared by the FDA in June 2024[159](index=159&type=chunk) - The company divested its Orthobiologics Business in November 2023 but retained liabilities from the **FiberCel and VBM product recalls**, which are subject to ongoing litigation[160](index=160&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) [Results of Operations](index=54&type=section&id=Results%20of%20Operations) Q2 2025 net sales were flat as Device Protection growth was offset by declines elsewhere, while litigation costs rose significantly Net Sales by Segment: Q2 2025 vs Q2 2024 (in thousands) | Segment | Q2 2025 | Q2 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Device Protection | $3,516 | $2,639 | $877 | 33.2% | | Women's Health | $2,011 | $2,571 | $(560) | (21.8)% | | Cardiovascular | $736 | $1,081 | $(345) | (31.9)% | | **Total Net Sales** | **$6,263** | **$6,291** | **$(28)** | **(0.4)%** | - Gross margin, excluding intangible asset amortization, **improved to 62.4%** in Q2 2025 from 58.0% in Q2 2024, primarily due to production efficiencies in the Device Protection segment[177](index=177&type=chunk) - Litigation costs **increased to $4.0 million** in Q2 2025 from $2.3 million in Q2 2024, as the company has no more insurance to cover the cost of the FiberCel Litigation[182](index=182&type=chunk) [Liquidity and Capital Resources](index=63&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity concerns with only $8.5 million in cash and substantial doubt about its 'going concern' status - As of June 30, 2025, the company had **cash of $8.5 million** and an **accumulated deficit of $243.1 million**[199](index=199&type=chunk) - The company raised gross proceeds of approximately **$15.0 million** in a registered direct offering in February 2025 and **$13.3 million** in June 2024 to fund operations[200](index=200&type=chunk)[201](index=201&type=chunk) - Management has **substantial doubt** about the company's ability to continue as a going concern due to expected continued losses and uncertainty about its ability to raise sufficient capital[205](index=205&type=chunk)[227](index=227&type=chunk) - The company has **$24.3 million of indebtedness outstanding** as of June 30, 2025, primarily under its SWK Loan Facility, with principal payments scheduled to begin in November 2025[212](index=212&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=75&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rate fluctuations on its variable-rate debt and credit risk from cash deposits - The company's main market risk is **interest rate risk** from its variable-rate SWK Loan Facility[235](index=235&type=chunk) - **Credit risk** exists as cash balances are maintained at two financial institutions and may exceed federally insured limits[236](index=236&type=chunk) [Item 4. Controls and Procedures](index=77&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period - Management concluded that **disclosure controls and procedures were effective** as of June 30, 2025[241](index=241&type=chunk) - **No material changes** to internal control over financial reporting occurred during the six months ended June 30, 2025[242](index=242&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=77&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 9 of the financial statements for details on legal proceedings related to product recalls - For information about legal proceedings, the report refers to **Note 9** of the condensed consolidated financial statements[244](index=244&type=chunk) [Item 1A. Risk Factors](index=77&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's previously disclosed risk factors were reported during the period - There have been **no material changes** in risk factors from those included in the company's Annual Report[245](index=245&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not conduct any unregistered sales of equity securities during the reporting period - None[246](index=246&type=chunk) [Item 5. Other Information](index=79&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading plans during the six-month period - No directors or officers adopted or terminated any **Rule 10b5-1 trading plans** during the six-month period[250](index=250&type=chunk) [Item 6. Exhibits](index=79&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including credit agreement amendments and officer certifications - Lists various agreements and certifications filed as exhibits, such as amendments to the Royalty Agreement with Ligand and the Credit Agreement with SWK Funding[251](index=251&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk)

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]

[Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) Elutia reported robust Q2 2025 growth, driven by strong EluPro™ adoption and expanded hospital access, while advancing its NXT-41 platform and resolving FiberCel litigation [EluPro™ Performance and Market Adoption](index=1&type=section&id=EluPro%E2%84%A2%20Performance%20and%20Market%20Adoption) EluPro™ demonstrated strong Q2 2025 commercial momentum with 49% sequential revenue growth, rapid market penetration, and higher average sales per customer | Metric | Q2 2025 Performance | | :--- | :--- | | **EluPro™ Revenue Growth** | Up 49% sequentially | | **Total BioEnvelope Revenue** | $3.5 million (Up 33% YoY) | | **EluPro™ Sales Contribution** | ~66% of total BioEnvelope sales | - Market access for EluPro™ has expanded significantly, achieving Value Analysis Committee (VAC) approvals in over 160 centers, with the customer base growing more than **15 times** since launch[4](index=4&type=chunk)[5](index=5&type=chunk) - EluPro demonstrates strong clinical demand, with average sales per customer being **130% higher** than the legacy CanGaroo product, indicating deeper procedure penetration[5](index=5&type=chunk) - The company utilizes an efficient selling model with both direct and distributor channels, with distributor-led growth now accounting for approximately **33% of EluPro sales**[5](index=5&type=chunk) [Pipeline and Portfolio Update](index=1&type=section&id=Pipeline%20and%20Portfolio%20Update) Elutia is advancing its NXT-41x platform for breast reconstruction, targeting FDA clearance in 2026-2027, and regained direct control of its Cardiovascular portfolio, generating $736K in Q2 2025 - The company is progressing its NXT-41x platform for breast reconstruction, targeting a **$1.5 billion market** with high complication rates[4](index=4&type=chunk)[5](index=5&type=chunk) | Pipeline Product | Target Indication | FDA Clearance Timeline | | :--- | :--- | :--- | | **NXT-41x (Base Matrix)** | Breast Reconstruction | 2H 2026 | | **NXT-41x (Drug-eluting)** | Breast Reconstruction | 1H 2027 | - Elutia regained direct sales control of its Cardiovascular portfolio in May 2025, generating **$736K in revenue** in its first partial quarter[5](index=5&type=chunk) [Corporate and Legal Updates](index=1&type=section&id=Corporate%20and%20Legal%20Updates) The company has substantially resolved its legacy FiberCel litigation, settling 97 out of 110 cases, which is expected to significantly reduce future legal expenses - Elutia has settled an additional **27 FiberCel cases**, bringing the total number of settlements to **97 out of 110**, which is expected to significantly lower future litigation expenses[5](index=5&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Elutia's Q2 2025 net sales remained stable at $6.3 million, with a significantly improved net loss of $9.6 million, though adjusted EBITDA loss widened to $3.8 million | Financial Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change | | :--- | :--- | :--- | :--- | | **Overall Net Sales** | $6.3M | $6.3M | ~0% | | **GAAP Gross Margin** | 48.8% | 44.5% | +4.3 p.p. | | **Adjusted Gross Margin** | 62.4% | 58.0% | +4.4 p.p. | | **Loss from Operations** | ($9.9M) | ($8.5M) | +16.5% | | **Net Loss** | ($9.6M) | ($28.2M) | -66% | | **Adjusted EBITDA** | ($3.8M) | ($2.6M) | +45.3% | | **Cash Balance (as of 6/30)** | $8.5M | N/A | N/A | | Net Sales by Product | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :--- | :--- | :--- | :--- | | **BioEnvelope** | $3.5M | $2.6M | +33% | | **SimpliDerm** | $2.0M | $2.6M | -23% | | **Cardiovascular** | $0.7M | $1.1M | -36% | [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents Elutia's unaudited consolidated financial statements as of June 30, 2025, including the Balance Sheet and Statement of Operations [Consolidated Balance Sheet](index=5&type=section&id=Consolidated%20Balance%20Sheet) As of June 30, 2025, Elutia reported $8.5 million in cash, $33.8 million in total assets, $75.7 million in total liabilities, and a $41.8 million stockholders' deficit | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash** | $8,500 | $13,239 | | **Total Current Assets** | $22,280 | $26,172 | | **Total Assets** | $33,849 | $36,127 | | **Total Current Liabilities** | $37,948 | $37,795 | | **Total Liabilities** | $75,692 | $82,387 | | **Total Stockholders' Deficit** | ($41,843) | ($46,260) | [Consolidated Statement of Operations](index=6&type=section&id=Consolidated%20Statement%20of%20Operations) For Q2 2025, Elutia reported $6.3 million net sales, $3.1 million gross profit, a $9.9 million operating loss, and a $9.6 million net loss, or ($0.23) per share | Statement of Operations (in thousands) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Net sales** | $6,263 | $6,291 | | **Gross profit** | $3,058 | $2,799 | | **Total operating expenses** | $12,933 | $11,309 | | **Loss from operations** | ($9,875) | ($8,510) | | **Net loss** | ($9,610) | ($28,180) | | **Net loss per share - basic** | ($0.23) | ($1.13) | [Non-GAAP Financial Measures](index=3&type=section&id=Non-GAAP%20Financial%20Measures) Elutia provides non-GAAP measures like adjusted gross margin and EBITDA to supplement GAAP results, excluding non-cash items and litigation costs for core performance evaluation - The company presents non-GAAP financial measures such as adjusted EBITDA and adjusted gross margin to provide supplemental information to investors, excluding items like stock-based compensation, litigation costs, and amortization of acquired intangible assets[9](index=9&type=chunk) [Non-GAAP Gross Profit and Gross Margin Reconciliation](index=7&type=section&id=Non-GAAP%20Gross%20Profit%20and%20Gross%20Margin%20Reconciliation) In Q2 2025, Elutia's adjusted gross profit was $3.9 million, with an adjusted gross margin of 62.4%, reflecting an improvement from the prior year | Gross Profit/Margin (in thousands) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Gross profit (GAAP)** | $3,058 | $2,799 | | **Adjusted gross profit (Non-GAAP)** | $3,907 | $3,648 | | **Gross margin (GAAP)** | 48.8% | 44.5% | | **Adjusted gross margin (Non-GAAP)** | 62.4% | 58.0% | [EBITDA and Adjusted EBITDA Reconciliation](index=7&type=section&id=EBITDA%20and%20Adjusted%20EBITDA%20Reconciliation) Elutia's Q2 2025 adjusted EBITDA was a loss of $3.8 million, calculated by adjusting net loss for non-cash gains and litigation costs | EBITDA Reconciliation (in thousands) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Net loss** | ($9,610) | ($28,180) | | **EBITDA (Non-GAAP)** | ($8,191) | ($26,062) | | **Adjusted EBITDA (Non-GAAP)** | ($3,829) | ($2,648) |

Core Insights - Elutia Inc. reported a significant revenue increase for its EluPro product, with a 49% sequential growth in Q2 2025 and a 33% year-over-year increase in total BioEnvelope sales, reaching $3.5 million [2][5][6] - The company is advancing its next-generation drug-eluting biomatrix, NXT-41, targeting a $1.5 billion market for breast reconstruction, with initial product launch planned for the second half of 2026 [2][4] Business Highlights - EluPro has become the preferred choice in cardiac implantable electronic device procedures, expanding into over 160 VAC-approved hospitals and growing its customer base more than 15 times since launch [4][6] - The average sales per EluPro customer were 130% higher than those for the legacy CanGaroo platform, indicating stronger market penetration [6] - Elutia has received two awards for innovation and product launches, and has published five peer-reviewed articles on EluPro, showcasing its scientific leadership [6] Financial Performance - For Q2 2025, Elutia's overall net sales were $6.3 million, nearly unchanged from Q2 2024, with a gross margin of 48.8%, up from 44.5% [9][15] - The company reported a net loss of $9.6 million for Q2 2025, a significant improvement compared to a net loss of $28.2 million in the same period of the previous year [9][15] - Adjusted EBITDA for Q2 2025 was a loss of $3.8 million, compared to a loss of $2.6 million in Q2 2024 [9][18] Market Access and Growth Strategy - Elutia's distribution strategy includes a partnership with Boston Scientific and a focus on expanding access through national GPO contracts and VAC approvals [2][4] - The company regained direct control of its cardiovascular product sales, generating $736K in revenue in the first partial quarter of direct sales [6] Litigation and Financial Position - Elutia has resolved 97 out of 110 cases related to FiberCel litigation, significantly reducing expected litigation expenses [6] - As of June 30, 2025, the company had a cash balance of $8.5 million, down from $13.2 million a year earlier [9][13]

Group 1 - Elutia Inc. will release its second quarter 2025 financial results after market close on August 14, 2025 [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 13754773 [1] Group 2 - Elutia develops 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, allowing patients to thrive without compromise [2]

Core Insights - Elutia Inc. has announced that Dr. Michelle LeRoux Williams, the Chief Scientific Officer, received the Medical Device Innovator Award for her contributions to the medical device industry, particularly for the development of EluPro™ [1][2] - EluPro™ is recognized as the world's first FDA-cleared antibiotic-eluting bioenvelope for cardiac implantable electronic devices (CIEDs), addressing significant complications associated with these devices [1][2][3] Company Overview - Elutia specializes in developing and commercializing drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients [4] - The company focuses on humanizing medicine to enhance patient outcomes, particularly for those requiring implantable technologies [4] Product Details - EluPro™ combines a soft, regenerative biomatrix with antibiotics rifampin and minocycline to mitigate complications such as infection, migration, and skin erosion, which occur in 5-7% of the over 600,000 CIEDs implanted annually in the U.S. [3] - The product has received FDA clearance for use across all major CIED products, including pacemakers and implantable defibrillators, as well as neurostimulation devices [2][3]

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 been recognized with two awards in the 2025 Medical Device Network Excellence Awards for its innovations in drug-eluting biomatrix technologies and the successful launch of EluPro [3][4] - EluPro has shown strong commercial performance since its pilot launch in September 2024, with a sequential sales increase of 84% in Q1 2025 and a year-over-year revenue increase of 31% in BioEnvelope sales [4][6] - The product is cleared for use with all major cardiac implantable electronic devices (CIEDs) and neurostimulation devices, addressing complications such as infection and migration [5][6] Company Performance - EluPro was commercially launched in January 2025 and has received approvals from 150 hospital value analysis committees, indicating strong clinical demand [4][6] - The product has established partnerships with seven major group purchasing organizations, reflecting its acceptance within the healthcare procurement ecosystem [4] Product Details - EluPro combines a soft, regenerative biomatrix with antibiotics rifampin and minocycline to enhance healing and reduce complications associated with CIEDs [5][6] - With over 600,000 CIEDs implanted annually in the U.S. and complications occurring in 5-7% of cases, EluPro aims to improve patient outcomes significantly [6] Industry Recognition - The Medical Device Network Excellence Awards analyze over 1 billion datasets annually to recognize top-tier companies in the medical device industry [8] - The awards honor innovative companies that drive positive change, highlighting Elutia's commitment to advancing medical technology [8]

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]