Dr. Michelle LeRoux Williams Earns Washington Business Journal’s Medical Device Innovator Award
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) ha annunciato che la sua Chief Scientific Officer, la Dott.ssa Michelle LeRoux Williams, ha ricevuto il Medical Device Innovator Award dal Washington Business Journal. Il riconoscimento evidenzia la sua leadership nello sviluppo di EluPro™, il primo bioinvolucro antibiotico approvato dalla FDA per dispositivi elettronici impiantabili cardiaci (CIED).
EluPro, che ha ottenuto l'autorizzazione FDA e il lancio commerciale a gennaio 2025, combina una biomatrice rigenerativa con gli antibiotici rifampicina e minociclina. Questa tecnologia affronta le complicazioni nei CIED, con un potenziale di mercato superiore a 600.000 impianti CIED annuali negli Stati Uniti, dove le complicazioni si verificano nel 5-7% dei casi.
Elutia (Nasdaq: ELUT) anunció que su Directora Científica, la Dra. Michelle LeRoux Williams, ha recibido el Medical Device Innovator Award otorgado por el Washington Business Journal. Este reconocimiento destaca su liderazgo en el desarrollo de EluPro™, el primer bioenvoltorio liberador de antibióticos aprobado por la FDA para dispositivos electrónicos implantables cardíacos (CIED).
EluPro, que recibió la aprobación de la FDA y se lanzó comercialmente en enero de 2025, combina una biomatriz regenerativa con los antibióticos rifampicina y minociclina. Esta tecnología aborda las complicaciones en los CIED, con un potencial de mercado de más de 600,000 implantes CIED anuales en EE.UU., donde las complicaciones ocurren en el 5-7% de los casos.
Elutia (나스닥: ELUT)는 최고 과학 책임자인 미셸 르루 윌리엄스 박사가 워싱턴 비즈니스 저널로부터 의료기기 혁신가 상을 수상했다고 발표했습니다. 이 상은 심장 이식형 전자기기(CIED)를 위한 최초의 FDA 승인 항생제 방출 바이오엔벨로프인 EluPro™ 개발에 대한 그녀의 리더십을 강조합니다.
EluPro는 2025년 1월 FDA 승인을 받고 상업적으로 출시되었으며, 재생 바이오매트릭스와 항생제 리팜핀 및 미노사이클린을 결합합니다. 이 기술은 CIED의 합병증 문제를 해결하며, 미국 내 연간 600,000건 이상의 CIED 이식 시장에서 5-7%의 합병증 발생률을 보입니다.
Elutia (Nasdaq : ELUT) a annoncé que sa directrice scientifique, le Dr Michelle LeRoux Williams, a reçu le Medical Device Innovator Award décerné par le Washington Business Journal. Cette distinction met en lumière son leadership dans le développement de EluPro™, la première bioenveloppe antibiotique approuvée par la FDA pour les dispositifs électroniques implantables cardiaques (CIED).
EluPro, qui a obtenu l'autorisation de la FDA et a été commercialisé en janvier 2025, combine une biomatrice régénérative avec les antibiotiques rifampicine et minocycline. Cette technologie répond aux complications liées aux CIED, avec un potentiel de marché de plus de 600 000 implants CIED annuels aux États-Unis, où les complications surviennent dans 5 à 7 % des cas.
Elutia (Nasdaq: ELUT) gab bekannt, dass seine Chief Scientific Officer, Dr. Michelle LeRoux Williams, den Medical Device Innovator Award vom Washington Business Journal erhalten hat. Die Auszeichnung würdigt ihre Führungsrolle bei der Entwicklung von EluPro™, der ersten von der FDA zugelassenen antibiotikafreisetzenden Biohülle für implantierbare kardiale elektronische Geräte (CIEDs).
EluPro, das im Januar 2025 die FDA-Zulassung erhielt und kommerziell eingeführt wurde, kombiniert eine regenerative Biomatrix mit den Antibiotika Rifampicin und Minocyclin. Die Technologie adressiert Komplikationen bei CIEDs und hat ein Marktpotenzial von über 600.000 CIED-Implantationen jährlich in den USA, wo Komplikationen in 5-7 % der Fälle auftreten.
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GAITHERSBURG, Md., July 31, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced that Dr. Michelle LeRoux Williams, Chief Scientific Officer, has been awarded the Medical Device Innovator Award by the Washington Business Journal. This award recognizes Dr. Williams’ groundbreaking contributions to the medical device industry, particularly her leadership in the development and successful commercialization of EluPro™, the world's first FDA-cleared antibiotic-eluting bioenvelope for cardiac implantable electronic devices (CIEDs).
“I am incredibly honored and humbled to receive this prestigious award,” said Dr. Williams. “This award is a testament to the tireless dedication and brilliance of the entire Elutia CRU. The journey of bringing EluPro to patients, from its initial concept to achieving FDA clearance and then its full commercial launch in January 2025, has been a monumental team effort. It’s been a privilege to work alongside such passionate and talented individuals who share a common vision: humanizing medicine so patients can thrive without compromise.”
A leader in the field of regenerative medicine, Dr. Williams demonstrated exceptional leadership and dedication for patients with serious problems from implantable devices that are not addressed by current technology. Under her leadership, she helped solve these unmet patient needs in leading the research to successfully attain FDA clearance for EluPro for use across all major CIED products including pacemakers and implantable defibrillators, as well as for neurostimulation devices.
Unlike synthetic alternatives, EluPro combines a soft, regenerative biomatrix with the antibiotics rifampin and minocycline to address CIED complications and support healthy healing. With more than 600,000 CIEDs implanted annually in the U.S. and complications—such as infection, migration, and skin erosion—occurring in up to 5
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. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding the future success of EluPro and its future impact on device protection for cardiac implantable electronic devices (CIEDs) and neurostimulators. 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: the risk that clinical research data may not match preclinical study data; our ability to successfully commercialize, market and sell our 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; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; 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 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; 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, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, 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
This press release was published by a CLEAR® Verified individual.
FAQ
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