Welcome to our dedicated page for Biostem Tech news (Ticker: BSEM), a resource for investors and traders seeking the latest updates and insights on Biostem Tech stock.
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) announced management will present at the 46th Annual TD Cowen Healthcare Conference on Monday, March 2, 2026 at 3:50 pm ET in Boston, MA.
Interested parties can access live and archived webcasts via the company's investors website at ir.biostemtechnologies.com.
BioStem Technologies (OTC: BSEM) highlighted recent U.S. FDA leadership remarks endorsing expanded use of Bayesian statistical methods in clinical trials and tied that openness to its published randomized controlled trial using Bayesian regression and hurdle modeling.
The company said its DFU study showed superior clinical outcomes for BioRetain® processed allografts, with the BR-AC arm almost twice as likely to achieve lasting wound closure versus standard of care. BioStem plans to apply similar Bayesian analyses to ongoing VLU and DFU studies and cited its BioRetain and CryoTek technologies in preserving tissue integrity.
BioTissue (NASDAQ: BESM) completed the sale of its non-ocular Surgical and Wound Care business to BioStem (OTC: BSEM) on Jan 21, 2026. BioStem acquired exclusive rights to the Neox and Clarix product lines, and BioTissue's Surgical sales team and key support staff will join BioStem's commercial organization. BioTissue will continue manufacturing those products for BioStem while refocusing its commercial strategy on ocular therapies, including Prokera, CAM360 AmnioGraft, AmnioGraft, and AmnioGuard. Management frames the divestiture as a move to concentrate resources on eye care innovation and professional education.
BioStem Technologies (OTC: BSEM) closed an asset purchase of BioTissue Holdings' surgical and wound care business, acquiring the Neox and Clarix product lines plus a nationwide sales force and assigned GPO contracts to expand hospital inpatient and outpatient reach.
Deal consideration is an upfront cash payment of approximately $15 million, plus up to $10 million in regulatory milestone payments for 510(k) clearance and up to $15 million in commercial royalty milestones. The acquired assets generated ~$29 million in sales in 2025 and are expected to contribute positive EBITDA to BioStem in 2026. Post-closing cash and restricted cash is approximately $16 million. Barry Hassett was promoted to Chief Commercial Officer. A conference call is scheduled for Jan 22, 2026 at 8:00am ET.
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.