Aziyo Biologics Presents Clinical Data On CanGaroo Biologic Envelope In Patients Receiving Cardiac Implantable Electronic Devices
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Biotechnology: Electromedical & Electrotherapeutic Apparatus
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- Aziyo Biologics Inc (NASDAQ:AZYO) announced that data from the HEAL Study will be presented at the Heart Rhythm Society this Sunday.
- 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 Plc's (NYSE:MDT) 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 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.
- Key findings from the interim analysis include:
- Physicians scored CanGaroo reoperations as having 46% easier generator mobilization, 41% easier lead mobilization, and 43% less procedural difficulty than no envelope.
- Lead adhesion classification was scored as significantly less severe in the CanGaroo group compared to no envelope.
- 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).
- Price Action: AZYO shares are up 4.72% at $2.22 on the last check Friday.