BioStem Technologies Takes a Major Step Forward in Wound Care
BioStem Technologies, Inc. (OTC: BSEM), a renowned name in the MedTech sector, is excited to announce that it has received Institutional Review Board (IRB) approval for a significant clinical study. This study focuses on the evaluation of the company’s innovative BioREtain technology specifically designed for treating venous leg ulcers (VLU), a condition that affects countless individuals across the country.
The motivation behind this clinical trial is to assess the effectiveness of BioStem's proprietary BioREtain Amnion Chorion (BR-AC) in comparison to standard treatment methods. By targeting patients suffering from non-healing VLUs, the study aims to uncover critical data that could bolster the adoption of BioStem’s unique technology in the marketplace.
The Vision of BioStem Technologies
CEO Jason Matuszewski emphasizes the importance of this clinical trial as part of the broader strategy to showcase the efficacy of their allograft products. In a recent statement, he shared, "This is our third prospective trial concerning various wound healing challenges. We are steadfast in our commitment to proving clinical superiority to benefit both healthcare providers and insurance payers. The earlier peer-reviewed study on diabetic foot ulcers yielded groundbreaking results, and we are optimistic about similar outcomes with VLUs."
Understanding BioREtain Technology
At the heart of BioStem's offerings is the BioREtain technology, which incorporates a proprietary six-step process aimed at preserving the essential properties of amniotic tissue. This meticulous technique is gentle and minimally invasive, ensuring the retention of the natural integrity of the tissue, which is crucial for effective wound treatment. BioStem’s allografts are not just innovative; they promise a better healing experience for patients due to their robust biological properties.
The Components of BR-AC
BR-AC consists of both amnion and chorion membranes, which together include an intermediate layer rich in collagen and an expansive mix of proteins, growth factors, cytokines, and chemokines. This combination results in a minimally manipulated dehydrated tissue allograft effective as a protective covering for soft tissue wounds.
Insight into the BR-AC-VLU Clinical Trial
Clinical Trial Overview
The clinical trial entitled "Non-healing Venous Leg Ulcers Treated with Standard Care, With or Without BR-AC" will recruit at least 60 participants across about 15 sites nationwide. This randomized, controlled study's primary objective is to ascertain whether the addition of BR-AC significantly improves the rate of complete wound closure, defined as 100% re-epithelialization, over a duration of 12 weeks.
Key Characteristics of the Clinical Trial
The trial will include a two-week run-in period where subjects will receive standard wound care only. Candidates who do not exhibit over 30% healing and remain eligible after the initial period will be randomly assigned to receive either standard care or standard care combined with BR-AC. Regular monitoring will be instituted to ensure adherence and to track healing progression.
Addressing the Challenge of Venous Leg Ulcers
Venous leg ulcers are persistent wounds that arise from insufficient blood circulation in the veins. Annual figures indicate that these ulcers affect roughly two million people in the United States alone. The wound care market dedicated to VLUs is projected to grow at a rate exceeding 4%, due to an increasing awareness of treatment options and advancements in technologies addressing wound management.
This growth can largely be attributed to the rising elderly population and increased incidences of chronic health conditions, propelling the market size to potentially reach several billion dollars in the upcoming years. Thus, the clinical efforts of BioStem Technologies are not just pioneering but timely as well.
Stay Connected with BioStem Technologies
To keep up with latest developments regarding BioStem Technologies and its innovative solutions in the realm of wound care, interested individuals can subscribe to the company’s communication channels, including email updates and social media platforms like Twitter and LinkedIn. Engaging with BioStem allows stakeholders to stay informed as clinical efforts progress and new findings emerge.
Frequently Asked Questions
What is the purpose of the clinical trial announced by BioStem?
The clinical trial aims to assess the effectiveness of BioStem's BioREtain technology in treating venous leg ulcers compared to standard care.
How does the BioREtain technology work?
BioREtain technology preserves the natural properties of amniotic tissue through a gentle, proprietary six-step process, ensuring effective wound healing.
What is BR-AC made of?
BR-AC consists of unseparated amnion and chorion membranes that provide a rich source of collagen and vital proteins for wound care.
What are venous leg ulcers, and who do they affect?
Venous leg ulcers are chronic wounds due to poor blood circulation, affecting up to two million people in the U.S. each year, especially the elderly and those with chronic conditions.
How can I stay updated on BioStem's developments?
You can join BioStem's email distribution list and follow their social media channels for the latest news and updates.
