Trial will Evaluate Effectiveness of Human Amniotic Membrane(s) On Ulcers in Elderly Population
PHOENIX, Aug. 22, 2024 /PRNewswire/ — BioLab Holdings, Inc, a Phoenix-based medical manufacturer specializing in wound healing and wound care products, has submitted its BioLab Sciences-branded amniotic membrane tissue for clinical trials as a U.S. FDA-approved product. The study is designed to assess the clinical effectiveness of human amniotic membrane(s) for the management of difficult-to-heal partial- or full-thickness venous leg ulcers (VLU).
“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.”
BioLab Holdings, Inc. has submitted its amniotic membrane tissue for clinical trials as a U.S. FDA-approved product.
The trial will specifically evaluate four BioLab Sciences branded products – the Membrane Wrap Lite™, Tri-Membrane Wrap™, Membrane Wrap™, and Membrane Wrap – Hydro™ – versus the standard of care in subjects with eligible venous leg ulcers. All four products use human tissue allograft derived from amniotic membrane that provides structural tissue for covering and protection of the wound. The tissues are minimally manipulated, preserving the properties that the tissue exhibits in its natural state. Membrane Wrap – Hydro™ has the added benefit of being hydrated tissue, while Tri-Membrane Wrap™ is a triple-layer amnion-chorion-amnion product that provides stronger tensile strength to better support soft tissue repair.
The study will take place at up to 25 sites in the United States and will enroll eligible subjects ages 50-85 who could benefit from the products. Participants will be randomly assigned to five groups – one for each of the four products with standard of care, or solely receiving standard of care. It will take place over the course of a couple of years and will compare the additional beneficial effects of the four products after the standard of care has been provided against the standard of care alone. Participants’ health will be monitored closely throughout the study and will be assessed by time to wound closure, frequency of wound closure, rate of VLU improvement, and incidents of recurrence.
BioLab Holdings, Inc. aims to improve the care process for chronic wounds, defined as any skin defect, full or partial thickness, which doesn’t heal within 30 days. Chronic wounds affect 2.5% of the total U.S. population and 10.5 million Medicare beneficiaries. These wound types can lead to a range of complications and health care costs. Because of concerns surrounding the aging population, the threat of increased obesity and diabetes, and problems of infection, it is expected that chronic wounds will continue to be a major challenge within healthcare. BioLab Holdings Inc. strives to improve treatment options for these issues and limit the potential complications.
For more information on BioLab Holdings, Inc. and its products, visit biolabholdings.net.
About BioLab Holdings, Inc.BioLab Holdings, Inc. is a Phoenix-based medical manufacturer specializing in wound healing. Its products, Membrane Wrap Lite™, Tri-Membrane Wrap™, Membrane Wrap™, and Membrane Wrap – Hydro™, use human tissue allograft derived from amniotic membrane that provides structural tissue for use as a wound protectant covering. The products are minimally manipulated, preserving the properties that the tissue exhibits in its natural state. The company’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. For more information, visit biolabholdings.net.
Contact: Kwyn Lowe, [email protected]
SOURCE BioLab Sciences
