Core Insights - BioStem Technologies, Inc. emphasizes the importance of the FDA's recent openness to Bayesian statistical methodologies in clinical trial design, which could enhance the efficiency and effectiveness of clinical studies in wound care [1][2][6] Group 1: FDA's Evolving Stance - FDA Commissioner Dr. Martin Makary described the agency's evolving stance on Bayesian approaches as a "leap forward" for clinical science, highlighting their potential to improve trial design and data integration [2] - The FDA's shift aligns with emerging regulatory guidance on Bayesian methods, indicating a more flexible approach to clinical trial methodologies [2] Group 2: BioStem's Clinical Research - BioStem's recent peer-reviewed randomized controlled trial demonstrated that BioRetain-processed allografts achieved superior outcomes in treating diabetic foot ulcers (DFUs), with the BR-AC arm being almost twice as likely to achieve lasting wound closure compared to standard care [3][4] - The trial utilized advanced statistical methods, including Bayesian regression, to quantify treatment effects and improve understanding of wound healing across diverse patient populations [3][4] Group 3: Benefits of Bayesian Methodologies - Bayesian methodologies are particularly beneficial in regenerative medicine and wound care, where datasets are often smaller and variability is high, allowing for more informed clinical decision-making [5] - The incorporation of prior knowledge with new data through Bayesian frameworks supports probabilistic interpretation, enhancing the relevance of clinical insights for healthcare stakeholders [5] Group 4: Commitment to Innovation - BioStem is dedicated to advancing evidence-based innovation in wound care through rigorous clinical research and real-world data analysis, supported by proprietary technologies like BioRetain and CryoTek [7] - The company aims to optimize the preservation of the natural structural and biological integrity of amniotic tissue, which is crucial for effective regenerative therapies [7][9]

Core Points - BioStem Technologies Inc. will release its second quarter 2025 financial results on August 14, 2025, and will host a conference call and webcast at 4:30 PM ET [3][4] - The conference call will include a review of the financial results and updates on the Company's Form 10 filing and Nasdaq uplisting, led by CEO Jason Matuszewski and CFO Michael Fortunato [4] - BioStem Technologies focuses on the development, manufacture, and commercialization of placental-derived products for advanced wound care, utilizing its proprietary BioREtain® processing method [6][7] Company Overview - BioStem Technologies is recognized as a leading innovator in the MedTech sector, specializing in allografts for advanced wound care [6] - The Company’s quality management systems are accredited by the American Association of Tissue Banks (AATB) and comply with Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [7] - BioStem's product portfolio includes brands such as AmnioWrap2™, VENDAJE®, and American Amnion™, all processed at its FDA registered and AATB accredited facility in Pompano Beach, Florida [7]

Core Viewpoint - BioStem Technologies, Inc. is showcasing its innovative placental-derived products for chronic wound care at the Symposium for Advanced Wound Care (SAWC) Spring meeting, emphasizing collaboration with Venture Medical, LLC to enhance patient management and treatment outcomes [1][2][3]. Company Overview - BioStem Technologies focuses on the development, manufacturing, and commercialization of placental-derived products aimed at advanced wound care [1][13]. - The company utilizes its proprietary BioREtain processing method to preserve the natural properties of perinatal tissue, ensuring the efficacy of its allografts [11][13]. Partnership Highlights - The collaboration with Venture Medical, LLC aims to streamline the logistics of managing patients requiring skin substitutes for chronic wound treatment [2][3]. - BioStem's leading products, AmnioWrap2 and Vendaje AC, are exclusively available through Venture Medical, which has effectively penetrated the physician office and mobile segments [3]. Event Participation - BioStem will co-exhibit with Venture Medical at the SAWC Spring meeting in Dallas, TX, from April 30 to May 4, 2025, featuring three accepted scientific posters on its advanced allograft portfolio [1][6]. - The booth schedule includes discussions on reimbursement landscapes, mobile wound care practices, and the benefits of BioStem's BioREtain technology [3][8]. Scientific Contributions - Three clinical and scientific posters accepted for presentation will demonstrate favorable outcomes with BioREtain technology and comparisons with competitive products [10]. - Ongoing randomized clinical trials are evaluating the treatment of diabetic foot ulcers and venous leg ulcers, with results expected later this year [10]. Educational Initiatives - A sponsored breakfast symposium titled "Healing Under Pressure: Advancements in Skin Substitutes for Pressure Ulcer Treatment" will address the importance of comprehensive care for patients with chronic wounds [5].