Elutia Inc (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today announced that its Antibiotic-Eluting BioEnvelope, EluPro® (referred to as CanGaroo®RM during development), has received clearance from the U.S. Food and Drug Administration (FDA). Specifically designed to prevent post-operative complications for devices such as pacemakers and defibrillators, EluPro incorporates powerful antibiotic therapy combined with advanced tissue engineering to create a BioEnvelope that over time regenerates into a protective pocket of the patient's own tissue.

Elutia Inc（纳斯达克：ELUT）（“Elutia”或“公司”）是药物洗脱生物基质产品的先驱，今天宣布其抗生素洗脱生物包膜EluPro®（在开发过程中称为CanGaroo®RM）已获得美国食品和药物管理局（FDA）的许可。EluPro专门为防止起搏器和除颤器等设备的术后并发症而设计，它结合了强大的抗生素疗法和先进的组织工程，创建了一种生物包膜，随着时间的推移，它会再生到患者自身组织的保护袋中。

Infection, migration, and skin erosion are some of the most frequently encountered complications of pacemaker surgery, occurring in up to five to seven percent of cases. These cause significant patient morbidity and mortality, increase the length of hospitalization, and can add more than $50,000 to healthcare costs per event.

感染、迁移和皮肤糜烂是起搏器手术中最常见的并发症，发生率高达5%至7%。这些会导致严重的患者发病率和死亡率，延长住院时间，并可能为每次事件增加超过50000美元的医疗保健费用。

In development since 2019 and protected by intellectual property extending beyond 2032, EluPro is the only biologic offering in the $600 million U.S. implantable electronic device protection market. The Company also announced that EluPro was granted clearance for indications beyond the cardiac implantable electronic devices (CIEDs), including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea.

自2019年开始开发，受2032年以后的知识产权保护，EluPro是美国6亿美元植入式电子设备保护市场上唯一的生物产品。该公司还宣布，EluPro被批准用于心脏植入式电子设备（CIED）以外的适应症，包括用于疼痛管理，癫痫，尿失禁和睡眠呼吸暂停的神经刺激剂和神经调节剂。

These additional markets, estimated to be $8.

这些额外的市场，估计为8美元。