BioLab Holdings Inc. Announces Multiple Clinical Trials to Advance Chronic Wound Care
The unique amniotic membrane allografts aid in the covering and protection of wounds
PHOENIX, Oct. 29, 2025 /PRNewswire/ -- BioLab Holdings, Inc. a Phoenix-based medical manufacturer specializing in wound care solutions, announced the ongoing development of several clinical trials designed to demonstrate the efficacy and safety of its Cellular, Acellular, and Matrix-like Products (CAMPs) in covering and protecting, non-healing wounds, including diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).
These trials are being conducted in response to urgent mandates from the MAC region for robust data to support product efficacy for inclusion in the upcoming Local Coverage Determination (LCD), effective January 1, 2026, for DFUs and VLUs.
BIOCAMP Trial
The BIOCAMP trial is a multicenter, prospective, randomized controlled study assessing the efficacy of human placental membrane products combined with standard of care (SOC) versus SOC alone in the management of nonhealing DFUs and VLUs. This novel platform-style trial simultaneously evaluates multiple products and wound types against an SOC arm. Preliminary data will be presented at the TRES conference on October 30.
"This study represents a major milestone in our commitment to advancing wound care through rigorous clinical research," said Dr. Marshall Medley, chief medical officer at BioLab. "By evaluating our full suite of amnion-based products in clinical settings, we aim to provide clinicians with robust data to guide treatment decisions for patients with chronic wounds."
CAMP RWE Trial
The CAMP RWE trial is a multicenter hybrid platform study comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single-layer amnion graft to a matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs. This hybrid protocol, which includes both retrospective SOC and prospective RWE treatment arms, will be submitted for publication with the help of Dr. Windy Cole.
Retrospective Study
BioLab is also conducting a real-world data collection trial evaluating human amniotic membrane(s) on diabetic foot ulcers, venous leg ulcers, pressure ulcers, and post-operative wounds. This study is designed to assess the efficacy of BioLab's products in previously treated patients and will be corroborated by randomized controlled trials on the same products and wound types.
"These studies are essential for meeting the MAC region's mandate for data and for establishing the efficacy of our products in chronic wound care," said BioLab Chief Science Officer Dr. Carlos Encinas. "Our goal is to ensure that providers and patients have access to safe, effective solutions for wounds that have not responded to conventional therapies."
Meta Analyses & Mega Meta Analysis by Serena Group
In addition to clinical trials, BioLab Holdings is supporting meta-analyses by Serena Group, including a mega-meta-analysis, to demonstrate that membrane products present similar healing rates regardless of brand, reassuring providers of the safety and efficacy of amniotic products.
The effective date for the proposed LCD is planned for January 1, 2026, for DFU and VLU wounds only. Other wound types will require meeting care standards prior to use, as usual, for chronic, non-healing wounds.
For more information about BioLab Holdings Inc. and its portfolio of advanced wound care solutions, visit biolabholdings.com
About BioLab Holdings Inc.
BioLab Holdings Inc. is a Phoenix-based medical manufacturer focused on wound healing and regenerative medicine. Its product portfolio includes Membrane Wrap Lite™, Tri-Membrane Wrap™, Membrane Wrap™, and Membrane Wrap-Hydro™, all derived from human amniotic membrane. BioLab is committed to delivering safe, high-quality products through innovation, education, and exceptional customer service.
Contact: Kwyn Lowe
Phone: 406.314.5120
Email: kwyn@evolveprandmarketing.com
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SOURCE BioLab Holdings, Inc.