Clear Health Pass Holdings, on behalf of the Tribal Biotechnology & Health Consortium, today announced the appointment of David Burke, MD, MA as Principal Investigator for the post-market clinical validation of Rampart™ DL Matrix (Q4347).

Dr. Burke is Department Chairman Emeritus of the Emory University School of Medicine and the Founding Director of the World Health Organization Collaborating Centre, USA-478. He is also the Founding Director of Education in the Department of Physical Medicine and Rehabilitation at Emory and has spent his career at the intersection of clinical medicine, rehabilitation science, and global health policy. His credentials in chronic wound care, clinical study design, and post-market evidence development are among the most respected in American academic medicine.

Dr. Burke’s mandate as Principal Investigator is to lead the post-market clinical validation work required under CMS Local Coverage Determination L35041 — the federal coverage framework for skin substitute grafts and cellular tissue products in the treatment of diabetic foot ulcers and venous leg ulcers. The validation work will generate the real-world evidence package the Consortium will deliver to CMS and the Medicare Administrative Contractors as a formal sovereign submission later in the year.

“Dr. Burke didn’t need to take on a new project at this stage of his career. He took this one because he understood what was at stake — the first tribally owned advanced wound care matrix entering the federal evidence record at the same scientific rigor as any product from any source in this market. We’re honored he’s leading this work, and we’re committed to a clinical program worthy of his standard.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

There is no tribal exception to clinical rigor, and the Consortium isn’t looking for one. A patient enrolled in the post-market study of Rampart™ DL Matrix is being treated through one of the most carefully designed clinical programs in this product category. The evidence Dr. Burke’s team produces will be held to the same standard as any submission from any source in the federal record — because the patients who benefit deserve nothing less.

About Clear Health Pass™  

Clear Health Pass™ is a bioinformatics, bio-surveillance. Clear Health Pass™ is a minority/veteran-operated organization in partnership as tribal is a portfolio partner of The Native American Venture Fund (NAVF). Clear Health Pass Holdings, LLC, DBA Clear Health Pass™ is an appointed “Tribal Agent” for The Tribal Consortium, a federal, Section 17 Tribal Corporation, whose tribal sovereignty’s authority is derived from The Indian Reorganization Act Of 1934 (IRA), 25 U.S.C. § 477. If you would like to know more information and investment opportunities with Clear Health Pass™ you can request information via this link

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