BioStem Technologies ((BSEM)) announced an update on their ongoing clinical study.
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BioStem Technologies is conducting a prospective, multicenter, randomized, controlled trial titled ‘A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM.’ The study aims to evaluate the safety and efficacy of the BioREtain® Amniotic Membrane (BR-AM) in conjunction with standard care, compared to standard care alone, for treating diabetic foot ulcers. This research is significant as it seeks to improve healing rates for a condition that often requires advanced therapy beyond standard care.
The intervention being tested is the BR-AM, a single-layer amniotic membrane allograft processed by BioStem Technologies. It is intended to enhance the healing of non-healing diabetic foot ulcers when used alongside standard care practices such as debridement and wound cleansing.
The study features a randomized, parallel assignment model with single masking to reduce bias. Its primary purpose is treatment-focused, aiming to determine the effectiveness of BR-AM in promoting wound closure.
The study commenced on October 28, 2024, with the primary completion date yet to be determined. The latest update was submitted on July 21, 2025. These dates are crucial for tracking the study’s progress and anticipating results that could influence market dynamics.
This clinical update could potentially impact BioStem Technologies’ stock performance positively, as successful outcomes may enhance investor confidence and market position. The study’s findings could also affect the competitive landscape, particularly if BR-AM proves more effective than existing treatments.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.