Elutia Awarded Cardiac Rhythm Management Devices Agreement with Premier, Inc.

Rhea-AI Summary

Elutia (Nasdaq: ELUT) has secured a national group purchasing agreement with Premier, Inc. for Cardiac Rhythm Management Devices, effective November 15, 2024. The agreement enables Premier members to access special pricing for the EluPro™ Antibiotic-Eluting BioEnvelope. EluPro is the first FDA-cleared antibiotic-eluting biologic envelope that combines antibiotics with natural extracellular matrix to provide stability for implantable electronic devices. The technology delivers antibiotics directly to surgical sites and transforms into vascularized tissue, reducing inflammation and simplifying device upgrades. Premier serves two-thirds of U.S. healthcare providers, offering data analytics, supply chain solutions, and consulting services.

Positive

• Secured national purchasing agreement with Premier, Inc., reaching two-thirds of U.S. healthcare providers
• Special pricing terms negotiated for EluPro product through Premier network
• First-mover advantage with FDA-cleared antibiotic-eluting biologic envelope

Negative

• None.

Insights

Market Research Analyst

This Premier agreement marks a significant commercial milestone for Elutia's EluPro product. Premier's network encompasses roughly two-thirds of U.S. healthcare providers, representing massive market access potential. The agreement structure, offering special pricing terms to Premier members, creates a strong incentive for adoption while maintaining pricing power.

The cardiac rhythm management devices market is substantial, with over 1 million pacemaker and defibrillator procedures performed annually in the U.S. As the only FDA-cleared antibiotic-eluting biologic envelope, EluPro has a unique competitive position. The agreement should accelerate market penetration by streamlining procurement processes and reducing barriers to adoption for Premier's extensive hospital network.

Medical Research Analyst

EluPro represents a significant technological advancement in cardiac device implantation. The dual-action mechanism - combining localized antibiotic delivery with a tissue-integrating matrix - addresses two critical challenges: infection prevention and device stability. The remodeling capability that transforms into vascularized tissue is particularly valuable for potential future device upgrades, a common occurrence in cardiac rhythm management.

Clinical evidence supporting infection reduction in cardiac device implants is crucial, as infections can lead to serious complications, extended hospitalizations and increased healthcare costs. The FDA clearance validates the technology's safety and efficacy profile, while Premier's agreement signals confidence in the clinical value proposition.

SILVER SPRING, Md., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, announced it has been awarded a national group purchasing agreement for Cardiac Rhythm Management Devices with Premier, Inc. Effective November 15, 2024, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the EluPro™ Antibiotic-Eluting BioEnvelope.

“We are thrilled to bring EluPro to a broader audience through this new agreement with Premier,” said Dr. Randy Mills, Elutia’s Chief Executive Officer. “EluPro reflects Elutia’s dedication to providing electrophysiologists and their patients with cutting-edge solutions that address the leading causes of post-surgical complications in pacemaker and defibrillator implants and improve quality of life. This agreement underscores our shared vision of advancing healthcare through innovation and collaboration.”

EluPro, the world’s first and only antibiotic-eluting biologic envelope cleared by the U.S. Food and Drug Administration, represents a breakthrough for cardiac rhythm management. Through advanced tissue engineering, EluPro integrates clinically proven antibiotics with natural extracellular matrix (ECM) to create a soft, conforming bioenvelope that provides optimal stability for implantable electronic devices. It delivers powerful antibiotics directly to the surgical site, extending protection well beyond closure. Over time, EluPro remodels into a healthy, vascularized pocket of the patient’s own tissue, reducing inflammation, scar formation, and foreign body response, which promotes better healing and simplifies potential device upgrades. By setting a new standard in device protection, EluPro redefines patient outcomes and procedural success.

Premier is a leading technology-driven healthcare improvement company, providing solutions to two-thirds of all healthcare providers in the U.S. Playing a critical role in the rapidly evolving healthcare industry, Premier unites providers, suppliers, payers and policymakers to make healthcare better with national scale, smarter with actionable intelligence and faster with novel technologies. With integrated data and analytics, collaboratives, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost. 

About Elutia

Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning the launch of EluPro, including the timing and anticipated success thereof. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to successfully commercialize, market and sell our newly approved EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; and our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2023, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

FAQ

What is the new agreement between Elutia (ELUT) and Premier Inc. announced in December 2024?

Elutia secured a national group purchasing agreement with Premier Inc. for Cardiac Rhythm Management Devices, specifically for their EluPro™ Antibiotic-Eluting BioEnvelope, effective November 15, 2024.

What are the key features of Elutia's (ELUT) EluPro BioEnvelope product?

EluPro is the first FDA-cleared antibiotic-eluting biologic envelope that combines antibiotics with natural extracellular matrix, provides device stability, delivers antibiotics to surgical sites, and remodels into healthy tissue while reducing inflammation.

When does Elutia's (ELUT) Premier agreement take effect?

The agreement takes effect on November 15, 2024.