BioStem Technologies’ Proprietary Amnion Chorion Product Receives IRB Approval for Venous Leg Ulcer Treatment Study
BioStem Technologies, Inc., a pioneering MedTech company based in Poomano Beach, Florida, has recently announced that it has secured Institutional Review Board (IRB) approval for a clinical study to assess the efficacy of its innovative BioREtain ® Amnion Chorion (BR-AC) product in the treatment of venous leg ulcers (VLU).
About BioStem Technologies and Its Proprietary BR-AC
BioStem Technologies is dedicated to the development, manufacturing, and commercialization of placental-derived products for advanced wound care. The company’s proprietary BR-AC is a human amnion and chorion membrane allograft that provides a rich source of extracellular matrix proteins and growth factors. These components are essential for the natural healing process and have shown promise in accelerating the healing of various types of wounds.
The Clinical Study
The clinical study, which is slated to begin soon, will be a randomized, controlled trial involving 100 patients with VLUs. The participants will be divided into two groups: one receiving standard of care treatment, and the other receiving BR-AC treatment. The primary endpoint of the study is the percentage of wound closure at 12 weeks. Secondary endpoints include the time to complete wound closure, wound size reduction, and patient-reported pain and quality of life.
Implications for Patients
For patients suffering from VLUs, this clinical study represents a potential game-changer in the treatment of these chronic wounds. Venous leg ulcers affect millions of people worldwide, and current treatments, such as compression therapy and topical agents, can be time-consuming, painful, and ineffective for some individuals. The use of BR-AC as a treatment option may lead to faster healing times, reduced pain, and improved quality of life for those affected.
- Faster healing times: The presence of growth factors and extracellular matrix proteins in BR-AC may accelerate the healing process.
- Reduced pain: The application of BR-AC could help alleviate pain associated with VLUs.
- Improved quality of life: Faster healing and reduced pain could lead to improved overall quality of life for patients.
Implications for the World
The successful outcomes of this clinical study could have far-reaching implications for the global healthcare industry. With an aging population and an increasing prevalence of chronic wounds, there is a growing need for effective and efficient wound care solutions. The use of BR-AC as a treatment for VLUs could lead to:
- Reduced healthcare costs: Faster healing times and improved patient outcomes could lead to cost savings for healthcare systems.
- Improved patient care: Effective treatments for VLUs can significantly improve the quality of life for patients and reduce their suffering.
- Global impact: The application of this technology in developing countries could help address the high burden of chronic wounds in these regions.
Conclusion
BioStem Technologies’ IRB-approved clinical study on the use of its proprietary BR-AC product for the treatment of venous leg ulcers represents a significant step forward in advanced wound care. The potential benefits for patients, such as faster healing times, reduced pain, and improved quality of life, are substantial. Furthermore, the global implications of successful study outcomes include reduced healthcare costs, improved patient care, and a potential impact on developing countries.
As we await the results of this groundbreaking study, it is an exciting time for the wound care industry and those suffering from venous leg ulcers. The potential for a more effective and efficient treatment option is a beacon of hope for many, and we look forward to the future developments in this field.
BioStem Technologies’ dedication to innovation and its commitment to improving the lives of patients through its placental-derived products is truly inspiring. The company’s continued research and development efforts are a testament to its mission to make a difference in the lives of those in need.
