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BioStem Technologies Highlights Alignment with FDA’s Openness to Bayesian Statistical Approaches in Clinical Research
Globenewswire· 2026-02-03 21:05
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 recentl ...
BioStem Technologies Comments on Withdrawal of CMS CY 2026 Final Medicare Reimbursement Rule for Skin Substitutes
Globenewswire· 2026-01-07 21:05
Decision ensures continued patient access to VENDAJE® and VENDAJE AC® POMPANO BEACH, Fla., Jan. 07, 2026 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today commented on the withdrawal of all seven of the Centers for Medicare & Medicaid Services’ (“CMS”) Local Coverage Determinations (“LCD”) for skin substitute grafts/cellular and tissue-based produc ...
BioStem Technologies Products Placed on “12-Month Status Quo Period” List in Update to CMS CY 2026 Final Medicare Reimbursement Rule for Skin Substitutes
Globenewswire· 2025-12-18 12:00
Status Quo designation preserves DFU/VLU reimbursement eligibility for 2026, ensuring continued patient access to BioStem technology Coverage for the majority of BioStem’s non-acute revenue, treatment for pressure ulcers, also remains unaffected by CMS LCD updates POMPANO BEACH, Fla., Dec. 18, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today ...
BioStem Technologies to Host Second Quarter 2025 Financial Results Conference Call on August 14, 2025
Prism Media Wire· 2025-07-30 11:00
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]