FDA's Tissue Reference Group Recognizes Five New BioLab Holdings Amniotic Membrane Allografts as HCT/Ps

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

PHOENIX, Aug. 28, 2025 /PRNewswire/ -- BioLab Holdings, Inc. announced today that five of its amniotic membrane allograft products have received recognition from the Food and Drug Administration's (FDA) Tissue Reference Group (TRG) as human cell, tissue, or cellular or tissue-based products (HCT/Ps). This designation will help streamline the reimbursement process for providers and further validate the clinical utility of these advanced wound care solutions.

"This recognition by the FDA's TRG is a significant milestone for BioLab Holdings," said BioLab CEO Jaime Leija. "It reinforces our commitment to our continuum of care and supports our mission to improve patient outcomes through advanced wound care technologies."

The newly recognized products include:

• Tri-Membrane Wrap Flow^™ – Fenestrated triple-layer amnion-chorion-amnion allograft membrane
  
  
• Membrane Wrap- Lite Flow^™ – Fenestrated single-layer amnion allograft membrane
  
  
• Membrane Wrap Flow^™ – Fenestrated dual-layer amnion-amnion allograft membrane
  
  
• Membrane Wrap- Solo^™ – Single-layer amnion allograft membrane
  
  
• A/C-Wrap^™ – Dual-layer amnion-chorion allograft membrane

These products are designed to aid in the covering and protection of a wide range of wounds, including surgical wounds, burns, diabetic foot ulcers, venous leg ulcers and other chronic or difficult-to-heal wounds. Each membrane offers unique properties tailored to meet specific clinical needs, some with fenestration enhancing fluid exchange.

The TRG designation will support providers' claims when applying for reimbursement, making these products more accessible to patients who need them most. BioLab continues to lead the way in developing versatile, active solutions that serve as protective barriers and coverings in complex wound environments.

For more information about BioLab Holdings and its full portfolio of amniotic membrane allografts, visit biolabholdings.net. 

About BioLab Holdings, Inc.
BioLab Holdings, Inc. is a Phoenix-based medical manufacturer specializing in wound healing. Its products—including Membrane Wrap Lite^™, Tri-Membrane Wrap^™, Membrane Wrap^™, and Membrane Wrap - Hydro^™—use human tissue allograft derived from amniotic membrane to provide structural tissue for wound protection. BioLab's mission is to manufacture reliable and safe products with the highest quality to help optimize body performance through continuous innovation, education, superior customer service, and teamwork.

Contact: Kwyn Lowe
Phone: 406.314.5120
Email: [email protected] 

SOURCE BioLab Holdings, Inc.