BioStem Technologies Launches Pivotal Clinical Trial for Wound Healing
BioStem Technologies Launches Groundbreaking Clinical Trial
BioStem Technologies, Inc., a prominent MedTech company, has officially initiated the BR-AC-DFU-101 clinical trial to assess the efficacy of its innovative BioREtain® technology in treating diabetic foot ulcers (DFUs). This strategic study aims to compare the performance of their proprietary BR-AC (BioREtain - Amnion Chorion) with traditional treatment methods.
Understanding the Clinical Trial's Design
The BR-AC-DFU-101 clinical trial is designed to study a specific patient demographic suffering from non-healing diabetic foot ulcers. Enrolling 60 patients across 10 sites in the United States, this trial represents a significant step in addressing the needs of those with this chronic condition. The patients selected for this trial are those who display adequate perfusion but do not have any clinical signs of infection.
Participants will receive weekly assessments to monitor their wound healing progress, compliance with care recommendations, and evaluate the time taken for wound closure. Historical data indicate that only about 30% of patients achieve wound healing through standard treatments within a 12-week timeframe, highlighting a critical need for advanced therapeutic options.
Innovation in Wound Care: BioREtain® Technology
At the core of this clinical trial is BioStem’s proprietary BioREtain® process, recognized for its capability to retain the biological properties of perinatal tissue while preserving its structural integrity. This process aims to enhance the healing capacity of non-healing ulcers by applying this human placental allograft in weekly intervals.
Jason Matuszewski, the CEO of BioStem Technologies, expressed optimism about the trial. He remarked, “This study not only represents our commitment to advancing medical technology but also hopes to demonstrate the significant clinical benefits our products can offer to patients.” With a growing focus on expanding insurance reimbursement for innovative wound care solutions, BioStem looks to improve patient outcomes and enhance their quality of life through seamless wound healing.
Key Outcomes of the Clinical Study
The primary objective of the BR-AC-DFU-101 study is to establish whether combinations of BR-AC and standard care lead to a higher probability of complete wound closure within 12 weeks compared to standard treatment only. Secondary outcomes include a detailed analysis of wound area changes and the overall effectiveness of BR-AC applications necessary to achieve closure.
Market Impact of Diabetic Foot Ulcers
Diabetic foot ulcers stand as a pressing health challenge. Recent statistics suggest that up to 15% of diabetic individuals will develop foot ulcers, with 6% experiencing serious complications that require hospitalization. DFUs are linked to increased risk of amputations; studies reveal that a significant percentage of these patients may ultimately require such drastic interventions.
In terms of healthcare economics, the treatment of diabetic foot ulcers imposes a substantial financial burden, reportedly costing between $9 billion and $13 billion annually in the United States. As the numbers of DFU patients continue to rise, the importance of advanced treatments like BR-AC becomes increasingly evident, setting the stage for growth within the healthcare sector.
About BioStem Technologies, Inc. (OTC: BSEM)
BioStem Technologies is dedicated to harnessing perinatal tissue for regenerative medical solutions. Their innovative BioREtain® processing method is aimed at retaining critical growth factors while maintaining the tissue’s natural structure. As an industry leader focused on quality and efficacy in wound care, BioStem’s commitment to improving patient outcomes stands at the forefront of their mission.
Frequently Asked Questions
What is the goal of the BR-AC-DFU-101 clinical trial?
The goal is to evaluate the effectiveness of BioREtain® in achieving faster wound closure compared to standard care for diabetic foot ulcers.
How many patients will be involved in the study?
The trial will enroll 60 patients across 10 sites within the United States.
What is BioREtain® technology?
BioREtain® is a proprietary process developed by BioStem that preserves the biological properties and structure of allografts for use in regenerative therapy.
Why are diabetic foot ulcers significant?
They are a common complication among diabetics, often leading to severe health issues, including amputations and extensive healthcare costs.
Where can I find more information about the clinical trial?
More details can be found on Clinical Trials.gov under the BR-AC-DFU-101 study listing.
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