Clear Health Pass Holdings, LLC today completed its acquisition of exclusive worldwide commercial rights, administrative authority, and HCPCS Q-code holder responsibilities for Rampart™ DL Matrix (Q4347), the FDA-cleared advanced wound care matrix used by physicians across the United States to treat diabetic foot ulcers, venous leg ulcers, and surgical wounds.

The acquisition positions Clear Health Pass as the Authorized Tribal Agent and Exclusive Worldwide Licensee on behalf of the Tribal Biotechnology & Health Consortium. Rampart™ DL Matrix is now the only FDA-cleared, tribally owned skin substitute with an assigned Medicare Q-code in the United States — a first in American healthcare.

The underlying intellectual property is held in sovereign trust by the tribal economic development corporations of the Consortium, organized under Sections 16 and 17 of the Indian Reorganization Act, 25 U.S.C. §§ 5123–5124. Clear Health Pass operates the federal engagement, regulatory submissions, and worldwide commercialization functions in its capacity as Authorized Tribal Agent.

“There has never been a product like this in the Medicare system. A tribally owned, federally coded, FDA-cleared advanced wound care matrix — built by tribal nations, owned by tribal nations, brought to market through tribal sovereign authority. We’re not the first tribal enterprise. We’re the first tribal enterprise to do this, at this level, in this market. We feel the weight of that every day.”

— John Michael Cataldi, CEO, Clear Health Pass Holdings

What this means for tribal health and tribal nations

Economic sovereignty means something different when it’s written into a Medicare billing code. Owning a federally coded advanced wound care matrix means tribal revenue, tribal reinvestment in tribal health infrastructure, tribal workforce development, and tribal voice in federal coverage policy — all flowing from a product that serves Native and non-Native Medicare beneficiaries alike. The ownership is operational, not symbolic.

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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