BioLab Holdings, a Mesa-based medical manufacturer specializing in wound care products, has announced the initiation of clinical trials for its amniotic membrane tissue, a significant step forward in the treatment of venous leg ulcers that are often difficult to heal. The trials follow FDA approval of the product developed by its BioLab Sciences division.
The study is designed to evaluate the effectiveness of the amniotic membrane in managing venous leg ulcers of partial or full thickness. These chronic wounds, defined as skin defects that do not heal within 30 days, affect approximately 2.5% of the U.S. population and 10.5 million Medicare beneficiaries, according to BioLab Holdings. The company aims to address the complications and healthcare costs associated with these wounds, which are expected to remain a major healthcare challenge due to the aging population, increased obesity and diabetes rates, and infection risks.
Trial Design and Objectives
The clinical trial will take place at up to 25 sites across the United States, enrolling participants aged 50 to 85 who could benefit from the treatment. Participants will be randomly assigned to one of five groups, with four groups receiving different BioLab Sciences products and one group receiving the standard of care for venous leg ulcers. The study is expected to last several years.
"It is our mission to manufacture reliable and safe products with the highest quality to help optimize body performance," said Dr. Marshall Medley, chief medical officer for BioLab Holdings Inc. "Through these randomized clinical trials, we hope to bring our wound-healing products to more patients and ultimately provide better treatment options for chronic wounds."
Company Goals and Future Plans
BioLabs President and cofounder Jaime Leija emphasized the company's commitment to reducing unnecessary healthcare costs. "Biolab is committed to helping patients heal effectively and completely from chronic non-healing wounds," he stated. "Our clinical trials will provide our stakeholders – patients, providers, and payers – the data they deserve."
Chief Science Officer Carlos Encinas added that Bio Labs is continuously working on innovative products to aid wound patients. "This clinical trial will help establish the efficacy of our current products and bring them to more patients," he said. "With our new pipeline we will be conducting animal and clinical trials to better understand the mechanism of actions of these products and evaluate their efficacy, providing providers and patients with more options to help wounds heal."
