Aziyo Biologics, Inc. announced that positive data from the HEAL Study will be presented at Heart Rhythm Society (HRS 2023) on May 21, 2023, at 12:30 PM CT at the Morial Convention Center in New Orleans, LA. HEAL is a national multi-center study evaluating patients who previously underwent implantation of a cardiac implantable electronic device (CIED) with either an Aziyo CanGaroo® Envelope, Medtronic's Tyrx™ non-biologic envelope, or no envelope, and are returning for a revision procedure at least four months after initial placement. The CanGaroo Envelope is made of an acellular biologic matrix that is designed to promote a natural healing response, resulting in a healthy, vascularized tissue capsule.

The poster to be presented at HRS 2023 comprises data from 43 patients (CanGaroo, n=11, Tyrx, n=15, or no envelope, n=17) used with their initial CIED implantation. This interim analysis includes the evaluation of medical and clinical profiles, procedural notes and physician subjective scoring of the pocket, and histology. Key findings from the interim analysis include: Physicians scored CanGaroo reoperations as having 46% easier generator mobilization (p=.02), 41% easier lead mobilization (p=.01), and 43% less overall procedural difficulty (p=.04) compared to no envelope.

Lead adhesion classification was scored as significantly less severe in the CanGaroo group compared to no envelope (p=.003). Significantly fewer capsulectomy procedures were required in the CanGaroo vs. Tyrx group (83% less, p=.04).

Independent, blinded histologic evaluation of pocket biopsies showed 30% thinner capsules in CanGaroo implant pockets vs. no envelope (p=0.12) and 32% thinner capsules vs. Tyrx (p=.09).

No significant group differences were observed in mean age, gender, race, or prior implant history. Abstract and presentation details: Abstract Title: Biologic Cardiovascular Electronic Device Envelopes Enhance Pocket Healing and Simplify Reoperative Procedures; Presenter: Dr. John N. Catanzaro, MD, MBA, FACC, FESC, FHRS, Department of Cardiology, University of Florida Health, Jacksonville, FL; Date: May 21, 2023 at 12:30 PM – 2:30 PM Central Time; Location: Abstract Pavilion - Morial Convention Center; During the event, Aziyo Biologics will be exhibiting at Booth 319.