Elutia Initiates EluPro™ Registry Study Designed to Generate Evidence Supporting the Use of EluPro in Real-World Clinical Practice
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.
Elutia (NASDAQ: ELUT) ha avviato uno studio clinico nel mondo reale per EluPro™, il loro bioinvolucro antibiotico approvato dalla FDA, progettato per dispositivi elettronici impiantabili cardiaci (CIED) e neurostimolatori. Il primo paziente è stato arruolato presso UC San Diego Health.
Lo studio prospettico post-commercializzazione mira a valutare le prestazioni di EluPro nella pratica clinica standard su pazienti con impianto di CIED diversi. Verranno monitorati 100 pazienti per 12 mesi, osservando complicazioni come infezioni, ematomi, dislocazione dei fili e migrazione del dispositivo.
EluPro combina gli antibiotici rifampicina e minociclina con una biomatrice rigenerativa, rispondendo al mercato statunitense dove vengono impiantati oltre 600.000 CIED all’anno con tassi di complicazione tra il 5 e il 7%. Il mercato della protezione dei CIED negli USA vale 600 milioni di dollari.
Elutia (NASDAQ: ELUT) ha lanzado un estudio clínico en condiciones reales para EluPro™, su bioenvoltura liberadora de antibióticos aprobada por la FDA, diseñada para dispositivos electrónicos implantables cardíacos (CIED) y neuroestimuladores. La primera inscripción de pacientes se realizó en UC San Diego Health.
El estudio prospectivo post-comercialización tiene como objetivo evaluar el desempeño de EluPro en la práctica clínica estándar en pacientes con implantes CIED diversos. Se hará seguimiento a 100 pacientes durante 12 meses, monitoreando complicaciones como infecciones, hematomas, desplazamiento de cables y migración del dispositivo.
EluPro combina los antibióticos rifampicina y minociclina con una biomatriz regenerativa, atendiendo el mercado estadounidense donde se implantan más de 600,000 CIED anualmente con tasas de complicación del 5 al 7%. El mercado de protección para CIED en EE.UU. está valorado en 600 millones de dólares.
Elutia (NASDAQ: ELUT)가 FDA 승인을 받은 항생제 방출 바이오엔벨로프인 EluPro™에 대한 실제 임상 연구를 시작했습니다. 이 제품은 심장 이식형 전자기기(CIED) 및 신경자극기를 위해 설계되었습니다. 첫 환자 등록은 UC San Diego Health에서 이루어졌습니다.
이 전향적 시판 후 연구는 다양한 CIED 이식 환자들을 대상으로 표준 임상 실무에서 EluPro의 성능을 평가하는 것을 목표로 합니다. 100명의 환자를 12개월 동안 추적 관찰하며 감염, 혈종, 리드 이탈, 기기 이동과 같은 합병증을 모니터링합니다.
EluPro는 리팜핀과 미노사이클린 항생제를 재생 바이오매트릭스와 결합하여 미국 시장의 요구를 충족합니다. 미국에서는 연간 60만 건 이상의 CIED 이식이 이루어지며 합병증 발생률은 5~7%입니다. 미국의 CIED 보호 시장 가치는 6억 달러에 달합니다.
Elutia (NASDAQ : ELUT) a lancé une étude clinique en conditions réelles pour EluPro™, leur bioenveloppe libérant des antibiotiques, approuvée par la FDA, conçue pour les dispositifs électroniques implantables cardiaques (CIED) et les neurostimulateurs. Le premier patient a été recruté à UC San Diego Health.
Cette étude prospective post-commercialisation vise à évaluer la performance d’EluPro dans la pratique clinique standard chez des patients divers implantés de CIED. L’étude suivra 100 patients pendant 12 mois, en surveillant les complications telles que les infections, les hématomes, le déplacement des électrodes et la migration du dispositif.
EluPro associe les antibiotiques rifampicine et minocycline à une biomatrice régénérative, répondant au marché américain où plus de 600 000 CIED sont implantés chaque année avec un taux de complications de 5 à 7 %. Le marché de la protection des CIED aux États-Unis est évalué à 600 millions de dollars.
Elutia (NASDAQ: ELUT) hat eine Real-World-Studie für EluPro™ gestartet, ihre von der FDA zugelassene antibiotika-freisetzende Biohülle, die für implantierbare kardiale elektronische Geräte (CIEDs) und Neurostimulatoren entwickelt wurde. Die erste Patienteneinschreibung erfolgte am UC San Diego Health.
Die prospektive Post-Market-Studie zielt darauf ab, die Leistung von EluPro in der klinischen Standardpraxis bei unterschiedlichen CIED-Implantationspatienten zu bewerten. Es werden 100 Patienten über 12 Monate verfolgt, wobei Komplikationen wie Infektionen, Hämatome, Elektrodenverlagerungen und Gerätewanderungen überwacht werden.
EluPro kombiniert die Antibiotika Rifampicin und Minocyclin mit einer regenerativen Biomatrix und adressiert damit den US-Markt, auf dem jährlich über 600.000 CIEDs mit Komplikationsraten von 5-7 % implantiert werden. Der Markt für CIED-Schutz in den USA wird auf 600 Millionen US-Dollar geschätzt.
- First and only FDA-cleared antibiotic-eluting bioenvelope for CIEDs
- Addresses large market of 600,000 annual CIED implantations in U.S.
- Target market valued at $600 million in U.S.
- Compatible with all major CIED brands and neurostimulation devices
- Study results won't be available for at least 12 months
- initial study size of only 100 patients
Insights
Elutia's EluPro registry study will generate real-world evidence potentially supporting broader clinical adoption in the $600M CIED protection market.
Elutia's newly initiated registry study for EluPro represents a methodical approach to building the clinical evidence base for their FDA-cleared product. The study design focused on both clinical and patient-reported outcomes demonstrates a comprehensive approach to validating EluPro's value proposition.
This multi-center, prospective study will track 100 patients for 12 months, examining key complications including infection, hematoma, lead dislodgement, and device migration. These endpoints directly address the 5-7
From a technical perspective, EluPro's combination of rifampin and minocycline antibiotics with a regenerative biomatrix represents a differentiated approach compared to synthetic alternatives. The biomatrix material potentially offers advantages beyond infection prevention, addressing migration and erosion complications.
The registry study's real-world setting will provide data that complements the initial FDA clearance evidence, potentially strengthening EluPro's clinical adoption case. Post-market studies like this are standard practice for medical device companies seeking to establish their products in competitive markets.
The $600 million US market for CIED protection represents a focused opportunity where EluPro's "first and only" status could be commercially significant if the registry data supports its differentiated benefits.
— 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-eluting bioenvelope designed for use with cardiac implantable electronic devices (CIEDs) and neurostimulators, was commercially launched earlier this year. The first patient was enrolled at UC San Diego Health.
“Every innovation we pursue is driven by a commitment to improving patient care,” said Kimberly Mulligan, PhD, Vice President and General Manager of Cardiovascular at Elutia. “With EluPro, we combined trusted antibiotics with a soft, regenerative biomatrix to protect the implant, facilitate implantation, and support healing. This study will allow us to collect data on these differentiating characteristics in real-world practice.”
The multi-center clinical study is a prospective, post-market study designed to evaluate the use of EluPro in standard clinical practice and its performance across a diverse population of patients undergoing CIED implantation. Data on clinical and patient-reported outcomes will be collected, which will include assessments of key complications of interest following CIED implantation - such as infection, hematoma, lead dislodgement, device migration or erosion, and implant site complications. The study plans to enroll 100 patients, who will be followed for 12 months after device implantation.
Each year, more than 600,000 CIEDs are implanted in the U.S., with overall complication rates up to 5
To learn more, visit www.elutia.com/products/elupro/.
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 EluPro Registry Study, including the timing and anticipated data, and the value of the CIED protection market. 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, 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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