Elutia Announces Newly Published Clinical Data Demonstrating that Biologic Envelopes Support CIED Stabilization and Ease of Reoperation
Elutia (Nasdaq: ELUT) has published significant clinical and preclinical data demonstrating the effectiveness of their biologic envelopes for cardiac implantable electronic devices (CIEDs). The HEAL study revealed that patients with ECM envelopes experienced 43% lower overall procedural difficulty, including 46% easier generator mobilization and 41% easier lead mobilization during reoperations.
The research also showed complete eradication of bacterial pathogens, including MRSA, with sustained local antibiotic concentrations for up to two weeks. The company's drug-eluting biomatrix technology combines regenerative ECM with broad-spectrum antibiotics to address both infection control and tissue remodeling, with potential applications in higher-risk procedures like breast reconstruction.
Elutia (Nasdaq: ELUT) ha pubblicato dati clinici e preclinici significativi che dimostrano l'efficacia dei loro involucri biologici per dispositivi medici impiantabili cardiaci (CIED). Lo studio HEAL ha rivelato che i pazienti con involucri ECM hanno sperimentato una minore difficoltà procedurale complessiva del 43%, inclusa una mobilizzazione del generatore più facile del 46% e una mobilizzazione del cavo del 41% più facile durante le rianalisi. La ricerca ha anche mostrato l'eliminazione completa di patogeni batterici, compreso MRSA, con concentrazioni locali di antibiotici sostenute fino a due settimane. La tecnologia biomatrix rilasciatrice di farmaci dell'azienda combina ECM rigenerativo con antibiotici a largo spettro per affrontare sia il controllo delle infezioni che la rimodellazione dei tessuti, con potenziali applicazioni in procedure ad alto rischio come la ricostruzione del seno.
Elutia (Nasdaq: ELUT) ha publicado datos clínicos y preclínicos significativos que demuestran la efectividad de sus envolturas biológicas para dispositivos electrónicos implantables cardíacos (CIEDs). El estudio HEAL reveló que los pacientes con envolturas de ECM experimentaron una menor dificultad global del procedimiento en un 43%, incluyendo una movilización del generador más fácil en un 46% y una movilización de cables más fácil en un 41% durante las reoperaciones. La investigación también mostró la erradicación completa de patógenos bacterianos, incluido MRSA, con concentraciones locales de antibióticos sostenidas hasta dos semanas. La tecnología biomatriz liberadora de fármacos de la empresa combina ECM regenerativo con antibióticos de amplio espectro para abordar tanto el control de infecciones como la remodelación tisular, con posibles aplicaciones en procedimientos de mayor riesgo como la reconstrucción mamaria.
Elutia(나스닥: ELUT)는 심장 삽입형 전자장치(CIED)에 사용되는 생물학적 엔벨로프의 효과를 입증하는 임상 및 전임상 데이터를 발표했습니다. HEAL 연구에 따르면 ECM 엔벨로프를 사용한 환자는 전반적인 시술 난이도가 43% 낮았고, 제너레이터 이동이 46%, 리드 이동이 41% 더 쉬웠다고 합니다. 연구는 MRSA를 포함한 박테리아 병원체의 완전한 박멸과 최대 2주간 지속되는 국소 항생제 농도를 보여주었습니다. 이 회사의 약물 방출 바이오매트릭스 기술은 재생 ECM과 광범위 항생제를 결합하여 감염 관리와 조직 재형성 모두를 다루며, 유방 재건과 같은 고위험 절차에 대한 적용 가능성이 있습니다.
Elutia (Nasdaq: ELUT) a publié des données cliniques et précliniques significatives démontrant l'efficacité de leurs enveloppes biologiques pour dispositifs électroniques implantables cardiaques (CIED). L'étude HEAL a révélé que les patients équipés d'enveloppements ECM ont connu une difficulté procédurale globale réduite de 43 %, notamment une mobilisation du générateur plus facile de 46 % et une mobilisation des câbles 41 % plus facile lors des réopérations. La recherche a également montré une éradication complète des agents pathogènes bactériens, y compris le MRSA, avec des concentrations locales d'antibiotiques soutenues jusqu'à deux semaines. La technologie biomatrice à libération de médicament de l'entreprise associe ECM régénératif et antibiotiques à large spectre pour aborder à la fois le contrôle des infections et le remodelage tissulaire, avec des applications potentielles dans des procédures à haut risque comme la reconstruction mammaire.
Elutia (Nasdaq: ELUT) hat signifikante klinische und präklinische Daten veröffentlicht, die die Wirksamkeit ihrer biologischen Umschläge für kardioimplantierbare elektronische Geräte (CIEDs) belegen. Die HEAL-Studie zeigte, dass Patienten mit ECM-Umschlägen eine insgesamt geringere prozedurale Schwierigkeit von 43 % hatten, einschließlich einer 46 %-igen einfacheren Generatormobilisierung und einer 41 %-igen einfacheren Leadmobilisierung bei Reoperationen. Die Forschung zeigte auch eine vollständige Ausrottung bakterieller Erreger, einschließlich MRSA, mit lokalen Antibiotikakonzentrationen, die bis zu zwei Wochen anhalten. Die antibiotikaelutierende Biomatrix-Technologie des Unternehmens kombiniert regeneratives ECM mit Breitbandantibiotika, um sowohl Infektionskontrolle als auch Geweberemodellierung anzugehen, mit potenziellen Anwendungen in Hochrisikoverfahren wie Brustrekonstruktion.
أعلنت شركة Elutia (بورصة ناسداك: ELUT) عن بيانات سريرية وما قبل سريرية ذات أهمية تُظهر فعالية أغلفتها البيولوجية للأجهزة الإلكترونية المزروعة القلبية (CIEDs). أظهر بحث HEAL أن المرضى الذين لديهم أغلفة ECM شهدوا انخفاضاً في صعوبة الإجراءات الإجمالية بنسبة 43%، بما في ذلك تسهيل تحريك المولد بنسبة 46% وتسهيل تحريك الأسلاك بنسبة 41% خلال عمليات إعادة التدخل. كما أظهرت الأبحاث القضاء التام على مسببات الأمراض البكتيرية، بما في ذلك MRSA، مع تركيزات محلية من المضادات الحيوية مستدامة حتى أسبوعين. تجمع تقنية المصفوفة الحيوية المطلاقة للأدوية للشركة بين ECM المتجدد ومضادات حيوية واسعة النطاق لمعالجة كل من السيطرة على العدوى وإعادة تشكيل الأنسجة، مع تطبيقات محتملة في إجراءات عالية المخاطر مثل إعادة التكوين الثدييّة.
Elutia（纳斯达克股票代码：ELUT）公布了重要的临床和前临床数据，证明其生物包膜在心脏植入式电子设备（CIEDs）上的有效性。HEAL研究显示，使用ECM包膜的患者总体手术难度下降了43%，其中发电机移动更容易46%，导线移动更容易41%，在再次手术中。研究还显示对包括 MRSA 在内的细菌病原体的完全根除，局部抗生素浓度可持续高达两周。该公司的药物释放生物基质技术将再生ECM与广谱抗生素结合起来，既解决感染控制又促进组织重塑，且在如乳房重建等高风险手术中具有潜在应用。
- Clinical data showed 43% lower procedural difficulty with ECM envelopes
- Complete eradication of bacterial pathogens including MRSA demonstrated in preclinical studies
- Technology maintains sustained local antibiotic concentrations for up to 2 weeks
- Potential expansion into higher-risk procedures like breast reconstruction
- One in three patients currently suffer serious complications after breast reconstruction, indicating significant challenges in target market
Insights
Elutia's biologic envelope demonstrates significant clinical benefits for CIED procedures, supporting the company's drug-eluting technology platform.
The newly published data from Elutia represents meaningful clinical validation for their drug-eluting biomatrix technology. The HEAL study findings are particularly significant, demonstrating
From a technical perspective, what makes this technology compelling is its dual-functionality approach. The biologic envelope serves both as a stabilization mechanism for the device and as a drug-delivery system for antibiotics. The preclinical data showing complete eradication of common pathogens including MRSA, with sustained local antibiotic delivery for up to two weeks, addresses a critical need in CIED procedures where infection remains a serious complication.
This publication validates Elutia's core technological platform at the intersection of tissue engineering and controlled drug delivery. The company appears to be leveraging this foundation to expand into higher-value applications, particularly breast reconstruction - a market with significant unmet needs given the reported one-in-three serious complication rate. The ability to simultaneously promote tissue regeneration while preventing infection represents a differentiated technological approach that could potentially establish Elutia as a leader in this specialized biomaterials niche.
- Findings highlight the potential of antibiotic-eluting bioenvelopes to transform cardiac implantable electronic device (CIED) pocket management -
GAITHERSBURG, Md., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the publication of clinical and preclinical data supporting the clinical utility of a biologic envelope that secures cardiac implantable electronic devices (CIEDs), promotes tissue remodeling, and addresses bacterial colonization through localized antibiotic delivery. The data are published in the current issue of Frontiers in Cardiovascular Medicine.
The publication includes data from the HEAL study (NCT04645173), a multicenter observational clinical evaluation of patients undergoing CIED reoperations. This study found that patients previously implanted with an engineered extracellular matrix (ECM) envelope had
“These results suggest that biologic envelopes not only facilitate placement and stabilize the device initially but also preserve surgical access to the pocket over time,” said Dr. Benjamin D’Souza, Associate Professor of Medicine at the University of Pennsylvania and Section Chief of Cardiac Electrophysiology at Penn Presbyterian Medical Center. “That is especially relevant for patients likely to undergo future reinterventions.”
The publication also details preclinical studies showing complete eradication of bacterial inoculates commonly implicated in CIED-related complications. The antibiotic-eluting envelope eliminated pathogens, such as MRSA, while maintaining regenerative function. Pharmacokinetic assessments confirmed sustained local antibiotic concentrations for up to two weeks.
“The drug-eluting biomatrix technology developed by Elutia is an effective solution for two long-standing CIED procedural challenges — eliminating the bacteria that can cause near-term, post-operative complications and reducing long-term procedural difficulties,” said Dr. Michelle LeRoux Williams, PhD, Chief Scientific Officer at Elutia. “Elutia is committed to transforming our drug-eluting biomatrix technologies into innovative products that address real-world clinical needs and improve patient outcomes.”
The combination of regenerative ECM and broad-spectrum, synergistic antibiotics, like rifampin and minocycline, is a powerful platform for future drug-eluting biologics—particularly in surgical settings where tissue remodeling and infection control intersect. Building on this foundation, Elutia is advancing a next-generation pipeline targeting higher-risk procedures, such as breast reconstruction where one in three patients suffer serious complications after reconstruction. This research lays the groundwork for a future in which the body’s healing response is managed as carefully as the device itself.
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 Elutia’s next-generation drug-eluting biomatrix pipeline, including anticipated timing and success thereof, and the potential for ECM envelopes to facilitate medical device implantation, stabilization and future reintervention. 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, or the risk that early clinical data may not be predictive of longer-term experience with a medical device, including Elutia’s biologic envelope products; risks associated with shifting focus to our drug-eluting biomatrix solutions in the breast reconstruction area and away from our CIED business; risks regarding delays in completing the proposed disposition of the CIED business, or to meet any of the other closing conditions to the proposed transaction on a timely basis or at all; our ability to successfully execute or achieve expected benefits from the divestiture of our CIED business; our ability to continue as a going concern; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates, including our next-generation drug-eluting biomatrix pipeline; our ability to raise capital in the amounts and at the times needed, and on acceptable terms; our ability to manage our substantial indebtedness and other obligations, such as our revenue interest obligation to Ligand Pharmaceuticals, including our ability to negotiate waivers or similar accommodations as needed; 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 previous 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 that could adversely affect our sales and profitability; 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, 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
This press release was published by a CLEAR® Verified individual.
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