Elutia Inc. Stock Price, News & Analysis

Elutia (Nasdaq: ELUT) announced that its Chief Scientific Officer, Dr. Michelle LeRoux Williams, has received the Medical Device Innovator Award from the Washington Business Journal. The recognition highlights her leadership in developing EluPro™, the first FDA-cleared antibiotic-eluting bioenvelope for cardiac implantable electronic devices (CIEDs).

EluPro, which received FDA clearance and launched commercially in January 2025, combines a regenerative biomatrix with antibiotics rifampin and minocycline. The technology addresses complications in CIEDs, with the market potential of over 600,000 annual CIED implants in the U.S., where complications occur in 5-7% of cases.

Elutia (NASDAQ: ELUT) announced new study results supporting the effectiveness of its EluPro BioEnvelope, an antibiotic-eluting device for cardiac implantable electronic devices (CIEDs). The study, published in the Journal of Functional Biomaterials, demonstrated that EluPro's biomatrix effectively controls inflammation and supports vascularization.

Research from the Cumming School of Medicine showed that EluPro stimulates early proangiogenic signals and reduces fibrosis over time. The study revealed significantly higher levels of growth and wound healing factors compared to controls (p<0.001), with long-term animal studies demonstrating improved blood vessel formation and reduced inflammation over a 26-week period.

EluPro, which received FDA clearance and was commercially launched in the United States in January 2025, is the first and only antibiotic-eluting bioenvelope approved for use with CIEDs and neurostimulators.

Elutia (Nasdaq: ELUT) has received dual honors at the 2025 Medical Device Network Excellence Awards for Innovation and Product Launches, recognizing their EluPro™ Antibiotic-Eluting BioEnvelope technology. EluPro, launched in January 2025, is designed to protect cardiac implantable electronic devices and neurostimulators.

The product has shown strong commercial performance with 84% sequential sales growth in Q1 2025 and drove a 31% year-over-year increase in BioEnvelope sales. EluPro has secured approvals from 150 hospital value analysis committees and partnerships with seven major group purchasing organizations.

The technology addresses a significant market need, with over 600,000 CIEDs implanted annually in the U.S. and complications occurring in 5-7% of cases.

Elutia (NASDAQ: ELUT) has published a groundbreaking peer-reviewed article in Dissolution Technologies, introducing a validated method for measuring antibiotic release from biologic envelopes. The innovative testing approach delivers results in just 30 hours compared to traditional 14-day in vivo protocols, significantly accelerating product development while reducing costs. The method specifically supports EluPro™, the company's FDA-cleared antibiotic-eluting bioenvelope designed for cardiac implantable electronic devices and neurostimulators, which was launched in January 2025. The testing protocol effectively captures the biphasic release profile of minocycline and rifampin, measuring both immediate and sustained release phases. This advancement strengthens Elutia's drug-eluting biomatrix platform and facilitates faster development of future products in their pipeline.

Elutia (NASDAQ: ELUT) reported strong Q1 2025 results, highlighted by an 84% sequential growth in EluPro™ sales. The company's BioEnvelope revenue grew 31% year-over-year to $3.1 million, with EluPro accounting for 52% of BioEnvelope sales. Overall net sales decreased 10% to $6.0 million. Key developments include a new strategic partnership with Boston Scientific to accelerate EluPro adoption, with a combined sales force of over 900 professionals. The company secured over 125 value analysis committee approvals and signed two new GPO contracts. Elutia strengthened its financial position by raising $15.0 million through a registered direct offering and amending loan terms. The company's gross margin was 40.7%, and adjusted EBITDA showed a loss of $3.3 million. Cash balance as of March 31, 2025, stood at $17.4 million.

Elutia (NASDAQ: ELUT) announced the transition to direct distribution of its cardiovascular product portfolio, ending its distribution agreement with LeMaitre Vascular. The company has appointed Dwayne Montgomery as Head of Cardiovascular and recruited 26 independent sales representatives dedicated to the cardiovascular line.

The cardiovascular portfolio, which includes ProxiCor®, VasCure®, and Tyke®, generated $2.9 million in revenue (12% of total) in 2024 and is expected to achieve 80% gross margins. These regenerative biomatrix products are designed for various cardiac and vascular repairs, offering advantages over synthetic alternatives by promoting healthy immune responses.

The strategic move aims to enhance top-line growth, improve gross margins and profitability, and provide greater strategic control over sales operations.

Elutia (Nasdaq: ELUT), a company specializing in drug-eluting biomatrix technologies, has scheduled the release of its Q1 2025 financial results for Thursday, May 8, 2025, after market close. The management team will host a conference call and webcast at 5:00 p.m. Eastern Time on the same day. U.S. investors can join via 877-407-8029, while international investors can dial 201-689-8029 using Conference ID 13753035. A live and archived webcast will be available on the company's investor relations website.

Elutia (Nasdaq: ELUT), a leader in drug-eluting biomatrix technologies, has announced its participation in Chardan's Trending Issues in Drug Development Conference Series. The company's Chief Scientific Officer, Dr. Michelle LeRoux Williams, will join a fireside chat discussion focused on 'Data & Regulatory Catalysts – Navigating an Evolving Landscape' on Tuesday, April 29, 2025, at 11:00 a.m. ET.

The virtual event will be accessible to investors and interested parties through a live webcast, with an archived version available afterward on the company's investor relations website at investors.elutia.com.

Elutia (NASDAQ: ELUT) has launched a real-world clinical study for EluPro™, their FDA-cleared antibiotic-eluting bioenvelope designed for cardiac implantable electronic devices (CIEDs) and neurostimulators. The first patient enrollment occurred at UC San Diego Health.

The prospective, post-market study aims to evaluate EluPro's performance in standard clinical practice across diverse CIED implantation patients. The study will track 100 patients for 12 months, monitoring complications like infection, hematoma, lead dislodgement, and device migration.

EluPro combines rifampin and minocycline antibiotics with a regenerative biomatrix, addressing the U.S. market where over 600,000 CIEDs are implanted annually with 5-7% complication rates. The CIED protection market is valued at $600 million in the U.S.