BioStem Technologies Highlights Alignment with FDA’s Openness to Bayesian Statistical Approaches in Clinical Research
POMPANO BEACH, Fla., Feb. 03, 2026 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of perinatal tissue derived products for advanced wound care, today underscored the significance of recent remarks from U.S. Food and Drug Administration (FDA) leadership signaling openness to expanded use of Bayesian statistical methodologies in clinical trial design and analysis.
FDA Commissioner, Dr. Martin Makary recently described the agency’s evolving stance on Bayesian approaches as a “leap forward” for clinical science, noting their potential to improve trial design, dose optimization, pediatric extrapolation, and integration of early-phase data into later-stage studies — a shift aligned with emerging regulatory guidance on Bayesian methods from the agency.
“This is an important and very positive signal from FDA leadership validating the advanced statistical analysis model used in our recently published peer reviewed randomized controlled trial that demonstrates superior outcomes with BioRetain® - processed allografts in diabetic foot ulcers,” said Jason Matuszewski, CEO and Chairman of BioStem Technologies. “We believe incorporating these metrics into clinical studies enables more efficient discovery; and in terms of our study, helps clinicians better understand the real-world complex wound healing performance of our products.”
In BioStem’s published DFU analysis, Bayesian regression and hurdle modeling were used to move beyond traditional binary endpoints, enabling the company to quantify probability of wound closure, magnitude of response, and treatment effect across heterogeneous patient populations. Similar statistics are expected to be included in the analysis of the Company’s ongoing VLU and DFU studies to enhance the understanding of the clinical benefits of the BioRetain technology.
That recently published study demonstrated that BioRetain-processed allografts achieved superior clinical outcomes in the treatment of patients with DFUs. Importantly, utilizing complete closure instead of initial incidence of closure, the BR-AC arm was almost twice as likely to achieve lasting wound closure than patients treated with standard of care alone. This trial was conducted with a degree of rigor not typically seen in the published literature. The patient selection criteria ensured that only those patients with the hardest-to-heal wounds were enrolled, and the definition of closure followed the 2006 FDA guidance for cutaneous ulcers, the most rigorous standards established.
“These approaches allow us to generate the kind of clinically meaningful insights that physicians, health systems, and policymakers actually need,” Matuszewski added. “Bayesian methodologies are particularly powerful in regenerative medicine and wound care, where datasets are often smaller, variability is high, and real-world evidence matters.”
Echoing this sentiment, Zwelithini Tunyiswa, CEO of Open Wound Research, noted, “FDA Commissioner Makary’s endorsement of Bayesian methods is a welcome recognition of the value these approaches bring to data analysis, synthesis, and planning. Bayesian methods allow for innovative designs, and more efficient use of time and resources through the principled incorporation of prior information and sequential learning. Moreover, their reporting of posterior probabilities oftentimes aligns better with wound-care stakeholders where decision-making under uncertainty is key.”
Bayesian statistical frameworks enable the responsible incorporation of prior knowledge alongside new data, supporting probabilistic interpretation and more informed clinical decision-making without compromising scientific rigor. BioStem believes these methods are well suited to biologic technologies and complex wound environments, where patient response can vary widely.
“Seeing the FDA openly embrace these tools is a strong step toward modernizing how evidence is evaluated and how innovation can move efficiently and safely to patients,” Matuszewski said.
BioStem remains committed to advancing evidence-based innovation in wound care through rigorous clinical research and real-world data analysis, supported by its proprietary BioRetain® process and CryoTek® cryopreservation technology, both designed to optimize preservation of the natural structural and biological integrity of amniotic tissue.
About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioRetain®processing method. BioRetain®has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established in compliance with current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes VENDAJE®, VENDAJE AC®, American Amnion™, American Amnion AC™, and Neox® and Clarix® product lines. For more information visit biostemtechnologies.com and follow us on X and LinkedIn.
Join BioStem’s Distribution List & Social Media:
To follow the latest developments at BioStem, sign up for the Company’s email distribution list HERE, and follow us on X and LinkedIn.
Contact BioStem:
Website: www.biostemtechnologies.com
E-Mail: info@biostemtech.com
X: @BSEM_Tech
Facebook: BioStemTechnologies
Phone: 954-380-8342
Investor Relations:
Philip Trip Taylor, Gilmartin
Group E-Mail: ir@biostemtech.com
© 2026 GlobeNewswire, Inc. All Rights Reserved.
