The Tissue Reference Group at the FDA, Recognizes BioLab Sciences Membrane Wrap – Hydro™ as an HCT/P

The unique amniotic membrane allograft aids in the covering and protection of wounds

BioLab Sciences Membrane Wrap™ is a unique DUAL- LAYERED dehydrated human amnion membrane (dHAM) allograft composed primarily of a connective tissue matrix. It is minimally manipulated, preserving the properties that it exhibits in its natural state¹,². The presence of the connective tissue matrix aids in supporting and protecting the wound. ​ [1] Curr Eye Res. 2000 Mar;20(3):173-7 [2] Placenta 103 (2021) 104–119

PHOENIX–(BUSINESS WIRE)–Membrane Wrap – Hydro™, a hydrated human amnion membrane allograft by BioLab Sciences, has just been recognized by the Food and Drug Administration’s (FDA) Tissue Reference Group (TRG) as a human cell, tissue, or cellular or tissue-based product (HCT/P). This recognition may bring Membrane Wrap – Hydro™ one step closer to streamlining the reimbursement process for providers.

Membrane Wrap – Hydro™ is a novel BioLab Sciences product that contains a connective tissue matrix to aid in the covering and protection of wounds. It was developed by BioLab Sciences to protect burns, surgical wounds, diabetic and venous ulcers, and other chronic or difficult-to-heal wounds. This amniotic membrane, with its fibrous scaffold and inherent tensile strength can be affixed over the wound and provide protection over external factors and contaminants.

“Being recognized by the FDA as an HCT/P may support providers’ claims when applying for reimbursement of Membrane Wrap – Hydro™ in the near future,” said Jaime Leija, Chief Commercialization Officer at BioLab Sciences. “This represents a significant step forward in our strategy to advance wound care, improve the quality of life for patients and make our products more accessible.”

This product is extremely versatile in its applications, supporting protection for a variety of wounds, especially those that are difficult-to-heal. Application of Membrane Wrap – Hydro™, can serve as a protective barrier to all types of wounds, providing protective coverage from the surrounding environment.

About BioLab Sciences

BioLab Sciences is a regenerative medicine company focused on creating new ways to allow the body to heal itself. The biotechnology company, which was founded in 2018, is uncovering better ways to address various medical issues. Learn more at www.biolabsciences.net/.

Contacts

Beth Cochran, Wired PR
beth@wiredprgroup.com
(602) 758-0750

Posted in AZBio News.