BioLab Holdings Inc. Announces Multiple Clinical Trials to Advance Chronic Wound Care
Full Press Release:
Phoenix, AZ, October 22, 2025 – BioLab Holdings, Inc., a Phoenix-based medical manufacturer specializing in wound care solutions, announced the ongoing development of several clinical trials 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). The trials are in response to 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.
The trials include:
1. BIOCAMP Trial: A multicenter, prospective, randomized controlled study assessing human placental membrane products combined with standard of care (SOC) versus SOC alone for non-healing DFUs and VLUs. Preliminary data will be presented at the TRES conference on October 30, 2025.
2. CAMP RWE Trial: A multicenter hybrid platform study comparing tri-layer and single-layer amnion grafts to a matched retrospective control cohort for hard-to-heal DFUs and VLUs. The study will be submitted for publication with Dr. Windy Cole’s assistance.
3. Retrospective Study: A real-world data collection trial evaluating human amniotic membrane(s) on DFUs, VLUs, pressure ulcers, and post-operative wounds, corroborated by randomized controlled trials.
4. Meta Analyses & Mega Meta Analysis: BioLab is supporting meta-analyses by Serena Group, including a mega-meta-analysis, to demonstrate similar healing rates across membrane products regardless of brand.
5. LCD Timeline: The proposed LCD for DFUs and VLUs is effective January 1, 2026, with other wound types requiring standard care prior to use.
“These trials represent a significant step forward in providing the clinical evidence needed to ensure that our innovative wound care solutions are accessible to patients who need them most,” said BioLab CEO [Name not specified]. “We are committed to advancing the science of chronic wound management and improving outcomes for patients with DFUs and VLUs.”
About BioLab Holdings, Inc.
BioLab Holdings, Inc. is a leading manufacturer of advanced wound care products, specializing in human amniotic membrane allografts such as Membrane Wrap Lite™, Tri-Membrane Wrap™, Membrane Wrap™, and Membrane Wrap-Hydro™. These products are designed to support the healing of chronic and non-healing wounds, including DFUs, VLUs, pressure ulcers, and post-operative wounds.
For more information, visit www.biolabholdings.com.
Contact: [Contact info not specified]
Key Highlights:
- BIOCAMP Trial: Prospective RCT for placental membranes in DFUs/VLUs; preliminary data at TRES October 30, 2025.
- CAMP RWE Trial: Hybrid study comparing graft layers to controls; submission for publication with Dr. Windy Cole.
- Retrospective Study: Real-world data on amniotic membranes for multiple wound types, backed by RCTs.
- Meta-Analyses: Supported by Serena Group to show consistent healing across products for LCD inclusion.
- LCD Impact: Effective January 1, 2026 for DFUs/VLUs; aims to ensure coverage for BioLab’s allografts.
Keywords: BioLab Holdings, amniotic membrane, diabetic foot ulcers, venous leg ulcers, LCD coverage