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BioStem Technologies reports developments tied to its regenerative medicine business, which develops, manufactures and commercializes perinatal tissue allograft products used by clinicians across wound care and other specialties. Company updates commonly cover financial results, conference calls, clinical research presentations, and product portfolio activity involving brands such as Neox, Clarix, VENDAJE and American Amnion.
BioStem news also includes governance and compliance appointments, board changes, audited financial statement publication, and integration of completed asset acquisitions that expand its surgical and wound-care product offerings. Its disclosures describe proprietary BioRetain, CryoTek and SteriTek processing technologies, AATB-accredited quality systems, and operations aligned with current Good Tissue Practices and current Good Manufacturing Processes.
BioStem Technologies (OTC: BSEM) commented on CMS's withdrawal of all seven proposed Local Coverage Determinations for skin substitutes used to treat diabetic foot ulcers and venous leg ulcers, which would have taken effect on January 1, 2026. The company said the withdrawal ensures continued patient access to VENDAJE and VENDAJE AC and is not expected to impact its ability to serve patients and clinicians. BioStem emphasized its commitment to an evidence-based strategy and to investing in expanded clinical data to demonstrate differentiated performance versus alternatives.
BioStem Technologies (OTC: BSEM) announced that VENDAJE and VENDAJE AC were placed on a 12-month Status Quo list under CMS’s final LCDs for skin substitutes, effective Jan 1, 2026. This designation preserves Medicare reimbursement eligibility for DFU and VLU through 2026, with payment reviewed on a claim-by-claim basis by MACs.
CMS limits the final LCDs to DFU and VLU only, leaving payment and billing for other wound types—including pressure ulcers, which represent 41% of the chronic wound market and the company’s largest segment—unaffected. MACs will accept additional evidence through Dec 31, 2026, with reconsideration and updated determinations expected in early 2027.
BioStem Technologies (OTC: BSEM) launched a new placental-derived wound care line, American Amnion, at the Desert Foot conference (Dec 10-13, 2025) with Hands-On Workshops on Dec 11.
Products include American Amnion AC (full thickness DHACM with intermediate layer) and American Amnion (DHAM with intermediate layer), both preserved with BioRetain technology.
Clinical highlights cited: a randomized trial showing 53% wound closure vs 31% for standard care, a retrospective study reporting 14% faster time to closure and 27% fewer applications, and a noted 50% rise in placental product use in the VA over five years.
BioStem Technologies (OTC: BSEM) announced that VENDAJE and VENDAJE AC were added to Florida Medicaid’s covered skin substitutes list on Nov 25, 2025.
This inclusion expands BioStem’s Medicaid coverage to 13 state programs (including California, Texas, and Michigan), and the company says the move increases its addressable patient base in one of the largest Medicaid markets. The release cites more than 70 million Americans enrolled in Medicaid and an advanced wound care market estimated at $11 billion+ annually in the U.S.
BioStem is also soliciting regional distribution partners for the VENDAJE portfolio in Florida and other covered states.
BioStem Technologies (OTC: BSEM) reported third quarter 2025 results on November 13, 2025, including net revenue of $10.5 million and GAAP net income of $0.8 million (earnings per share $0.05). The company reported adjusted EBITDA of $2.7 million and cash and cash equivalents of $27.2 million as of September 30, 2025.
Operational highlights included a 40% quarter-over-quarter product volume increase, positive randomized controlled trial results for BioREtain submitted to CMS, remediation of prior FDA inspection issues with a clean 361 inspection, appointment of KPMG, a land purchase for a new headquarters site, and a VA partnership to launch American Amnion in Q4.
BioStem Technologies (OTC: BSEM) announced it filed restated interim financial statements for Q1 2024–Q2 2025 and restated annual statements for 2023 and 2024.
The restatement reclassifies bona fide services fees under the distribution agreement with Venture Medical from Sales and Marketing expense to contra revenue, reducing reported gross revenue and Sales and Marketing expense by the same amount while leaving EBITDA, net income, and cash flow unchanged. Balance-sheet presentation now nets amounts payable to Venture against Accounts Receivable from Venture. The company said the restatement follows US GAAP review with external advisors and is intended to enable an independent audit by KPMG and a planned uplist; audits are expected complete by end of Q1 2026. The company noted that percentage metrics (gross margin, EBITDA margin) will appear slightly different under net revenue presentation.
BioStem (OTC: BSEM) commented on CMS’s CY 2026 Physician Fee Schedule final rule reforming Medicare reimbursement for skin substitutes announced Nov 5, 2025.
BioStem said the rule creates a more transparent, predictable reimbursement framework, though the reimbursement level is lower than the company advocated. The company highlighted a Level 1 randomized controlled trial showing superior patient outcomes for its BioREtain placental allografts and said that study was submitted to CMS. BioStem also said its proprietary, vertically integrated BioREtain manufacturing delivers materially lower COGS and scalable production, and expects margins to remain robust under the new model.
BioStem Technologies (OTC: BSEM) announced it purchased a four-acre parcel at the Research Park at Florida Atlantic University in Boca Raton to serve as its future headquarters for administrative offices, manufacturing, and distribution.
The City approved up to $300,000 in economic incentives tied to the creation of up to 100 jobs over five years. The company has not set a timetable for relocation. BioStem highlights its FDA-registered, AATB-accredited manufacturing site in Pompano Beach and its placental-derived wound-care product portfolio, including AmnioWrap 2 and VENDAJE brands.
BioStem Technologies (OTC: BSEM) reported top-line randomized controlled trial results published in the International Journal of Tissue Repair showing BioRetain (BR-AC) produced higher lasting wound-closure rates than standard of care in hard-to-heal diabetic foot ulcers (DFUs).
Key metrics: probability of lasting closure 53% for BR-AC vs 31% for standard of care over a 12-week period; study enrolled 71 patients across 11 U.S. sites, initiated Q4 2024, with lasting closure defined as remaining closed for 4 weeks. Future publications will report secondary endpoints including time to closure, wound area/volume change, and number of BR-AC applications.
BioStem Technologies (OTC: BSEM) will release its third quarter 2025 financial results on Thursday, November 13, 2025, and will host a conference call and webcast at 4:30 PM ET.
The webcast will feature an overview of the quarter from Jason Matuszewski, CEO, and Brandon Poe, CFO. Conference ID and dial-in numbers are provided for North America and international participants, and a live webcast link is available for online attendees.