Benzinga | Feb 17, 2021 04:08PM EST

Aziyo Biologics Announces First Patient Enrolled In HEAL Study

SILVER SPRING, Md., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (NASDAQ:AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, announced today the first patient enrolled in the HEAL Study, investigating the biologic and clinical effects of device envelopes which are placed around cardiovascular implantable electronic devices ("CIEDs") at the time of implantation surgery.



HEAL is a national multi-center study that will evaluate approximately 100 patients who previously underwent implantation of CIEDs with either an Aziyo CanGaroo(r) Envelope, Medtronic's Tyrx(tm), or no envelope, who have had their implants for at least a year and are returning for a CIED change-out or revision procedure.

The study focuses on identifying characteristics of soft tissue healing surrounding the CIED implant using tissue biopsies taken at the time of the change-out/revision procedure for patients treated with or without an envelope at the time of device implantation. Additional visual, structural and clinical assessments will provide insight into the clinical impact that the implant pocket healing has on the subsequent surgical procedure challenges and risks. Additional analyses will explore comparison between cohorts of documented clinical outcomes and complications since the most recent CIED procedure through the current change-out/revision procedure.

The first patient was enrolled by Dr. Ziad Issa, MD, MMM (Prairie Heart Institute of Illinois), an experienced clinical investigator who has participated in numerous studies spanning 15 years. Dr. Issa is also the lead author/editor of the 1st -- 3rd editions of the textbook "Clinical Arrhythmology and Electrophysiology: A Companion to Braunwald's Heart Disease."

"Excessive scar tissue formation around the CIED generator and leads pose significant challenges to operators during device and lead revision procedures as well as increase the risk of injury to leads, bleeding, and infection," said Dr. Issa. "We are very excited to be part of this important study that can potentially provide evidence-based solutions to mitigate these risks and improve outcomes."

"We are pleased to see the commencement of this important study, as we believe it has the potential to validate the significant contribution that a biological envelope can provide to patients receiving a CIED," said Ron Lloyd, President and CEO of Aziyo. "In addition, we believe this study has the potential to provide further insight into the ability of our CanGaroo Envelope to create a healthy, vascularized pocket to reduce complications that can arise with an implantable CIED, such as fibrotic capsule formation, device migration or erosion. We look forward to the participation of leading medical centers across the United States and the findings of this study following the anticipated completion of enrollment."