Study Presented at Heart Rhythm Society Supports Wound-Healing Benefits in Patients Receiving Cardiac Implantable Electronic Devices

SILVER SPRING, Md., May 19, 2023 — Aziyo Biologics, Inc., a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, 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 HEAL data further support the potential of biologic envelopes to enhance pocket healing during CIED implantation and simplify reoperative procedures,” said John N. Catanzaro, MD, Associate Professor of Medicine with the University of Florida and lead investigator of the study. “This study demonstrates that biologic envelopes, such as CanGaroo, can improve patient care and decrease complications following device implantation.”

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: Sunday, 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.

About Aziyo Biologics

Aziyo develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Aziyo’s mission is to humanize medical devices to improve patient outcomes. For more information, visit www.Aziyo.com.