FDA Approves Five Innovative Amniotic Membrane Allografts by BioLab Holdings for Advanced Wound Care
FDA Approves Five Innovative Amniotic Membrane Allografts by BioLab Holdings for Advanced Wound Care
In a significant advancement for wound care, BioLab Holdings, Inc. has announced the FDA's recognition of five of its cutting-edge amniotic membrane allograft products as human cell, tissue, or cellular or tissue-based products (HCT/Ps). This designation by the FDA's Tissue Reference Group (TRG) signifies the regulatory approval of these products, facilitating a more streamlined reimbursement process for healthcare providers and reinforcing the clinical efficacy of these advanced solutions.
Key Details of the Recognition
The newly recognized products include:
- - Tri-Membrane Wrap Flow™: This fenestrated triple-layer amnion-chorion-amnion allograft membrane serves as a versatile wound covering solution.
- - Membrane Wrap- Lite Flow™: A fenestrated single-layer amnion allograft membrane tailored to offer effective protection for various wounds.
- - Membrane Wrap Flow™: Featuring a dual-layer amnion-amnion design, this product enhances coverage for healing complex wounds.
- - Membrane Wrap- Solo™: This product is a single-layer amnion allograft membrane, specifically designed for enhanced performance.
- - A/C-Wrap™: A dual-layer amnion-chorion allograft membrane that provides vital structural support for wound management.
These allografts are engineered to address a diverse range of wounds—from surgical incisions to chronic conditions such as diabetic foot ulcers and venous leg ulcers. Their unique properties, particularly the fenestration in some products, significantly improve fluid exchange, optimizing conditions for healing.
The Impact of the FDA Recognition
According to BioLab's CEO, Jaime Leija, “This recognition by the FDA’s TRG is a substantial milestone for BioLab Holdings. It reinforces our commitment to propagate our continuum of care and enhances our mission to better patient outcomes with advanced technologies in wound care.”
The TRG designation is expected to simplify providers' efforts in filing reimbursement claims for these products, ensuring richer accessibility for patients in critical need of effective wound healing solutions. BioLab's continuous innovation in clinical technology enables them to remain leaders in providing versatile, protective solutions for challenging wound environments.
Advancing Healthcare Solutions
BioLab Holdings is dedicated to improving the quality of life for patients facing complicated wound healing challenges. Their array of products, including Membrane Wrap Lite™, Tri-Membrane Wrap™, Membrane Wrap™, and Membrane Wrap - Hydro™, all utilize human tissue allografts derived from amniotic membranes to ensure they maintain the highest standards of care.
To explore more about BioLab Holdings and its full product offering, please visit biolabholdings.net.
About BioLab Holdings, Inc.
Based in Phoenix, BioLab Holdings, Inc. specializes in manufacturing innovative products aimed at optimizing wound healing through advanced medical solutions. The firm is dedicated to continuous education and excellent customer service, ensuring their offerings align with the evolving needs of healthcare professionals and patients alike.
For inquiries, reach out to Kwyn Lowe via phone at 406.314.5120 or email at [email protected].
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.