BioStem Technologies Highlights Success in Clinical Study for DFUs
Promising Clinical Results from BioStem Technologies
BioStem Technologies, Inc. (OTC: BSEM) has recently announced the results of its clinical trial focusing on diabetic foot ulcers (DFUs) using its innovative BioRetain® - Processed Amnion Chorion (BR-AC). The outcomes indicate remarkable effectiveness when compared with standard care, as reported in a prominent medical journal.
Significant Findings in the BR-AC Clinical Trial
Top-line results indicate that patients receiving the BR-AC treatment experienced superior clinical outcomes. Specifically, the probability of healing for those in the BR-AC group was reported at 53%, as opposed to only 31% in the standard care group. These findings underline the potential of this new treatment approach, highlighting its efficacy in a population struggling with non-healing diabetic foot ulcers.
Clinical Trial Design and Execution
The multicenter, randomized, controlled trial, known as the BR-AC-DFU-101 study, involved at least 71 patients at various sites across the U.S. The primary goal was to evaluate if combining BR-AC with standard care would lead to a higher likelihood of achieving complete wound closure within a 12-week timeframe compared to standard care alone. A rigorous patient selection process ensured only those with the most challenging wounds participated, emphasizing the study's credibility.
Expert Insights and Next Steps
Dr. Bert Slade, Chairman of the Medical Advisory Board, emphasized that the trial's design adhered to the highest industry standards, setting a new benchmark for clinical research in this particular field. Patients that showed improvement beyond a certain threshold with standard care alone were excluded, ensuring the focus remained on the most difficult cases. The upcoming publications will explore various secondary outcome measures, including time-to-closure and overall wound area reduction.
Understanding Diabetic Foot Ulcers
Diabetic foot ulcers are a challenging and widespread condition that significantly impacts patient health. Current statistics estimate that around 15% of individuals with diabetes will develop such ulcers, with 6% requiring hospitalization due to complications. This is alarming, as DFUs are responsible for many lower extremity amputations, further highlighting the need for effective treatment options.
Widening Impact and Market Need
The latest data suggests that millions have received treatment for DFUs, with these numbers expected to grow, especially in aging populations. This demographic trend intensifies the urgency for widespread access to effective therapies to mitigate the economic burden posed by these conditions on healthcare systems.
About BioRetain Technology
The BioRetain process, employed by BioStem, is noteworthy for its ability to preserve the natural integrity of amniotic tissue, thereby maximizing its healing potential. This patented method ensures that essential growth factors and structural components remain intact, providing a significant advantage over competitive products.
Supportive Infrastructure at BioStem
BioStem Technologies adheres to strict quality management practices, which are accredited by the American Association of Tissue Banks. This commitment to excellence is reflected in the rigorous production protocols followed at their FDA-registered facilities in Florida, where they manufacture a portfolio of advanced wound care solutions.
Frequently Asked Questions
What is the BioRetain® technology?
BioRetain® technology involves a six-step proprietary process that preserves the native components of amniotic tissue, enhancing its therapeutic properties for wound care.
What were the trial's main findings?
The clinical trial indicated that the BR-AC treatment had a significantly higher probability of achieving complete wound closure compared to standard care alone.
Why are diabetic foot ulcers significant?
Diabetic foot ulcers can lead to severe complications and are a leading cause of lower limb amputations in patients with diabetes, making effective treatments essential.
How does BioStem ensure product quality?
BioStem operates under strict quality management systems that comply with accreditation standards, ensuring their products meet high safety and efficacy levels.
What does the future hold for BioStem Technologies?
BioStem plans to further investigate its products through ongoing studies, including those targeting other challenging wound types, thus expanding its influence in advanced wound care.
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