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BIOSTEM TECHNOLOGIES INC.
US SYMBOL: BSEM
Website | Latest News
BioStem Technologies (OTC: BSEM) just announced that its flagship products — VENDAJE® and VENDAJE AC® — have been granted a 12-month "Status Quo" period under the Centers for Medicare & Medicaid Services' (CMS) updated Local Coverage Determinations for skin substitutes, effective January 1, 2026.
What does this mean?
These products will CONTINUE TO BE ELIGIBLE FOR MEDICARE REIMBURSEMENT THROUGHOUT 2026 for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU). No disruption. No gap in coverage.
Even BIGGER news?
CMS clarified that the new rules ONLY apply to DFU and VLU indications — they do NOT impact reimbursement for pressure ulcers, which represent 41% of the Chronic Wound Market - AND - The MAJORITY of BioStem's Sales Volume & Medicare Revenue
"We appreciate the thoughtful and evidence-driven approach reflected in CMS's final LCD framework. We expect the Status Quo designation to provide uninterrupted payment for VENDAJE and VENDAJE AC in DFU and VLU applications throughout 2026, while coverage for the majority of BioStem's non-acute revenue — treatment for pressure ulcers — also remains unaffected by CMS LCD updates."
— Jason Matuszewski, CEO and Chairman of BioStem Technologies
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BioStem Technologies Products Placed on “12-Month Status Quo Period” List in Update to CMS CY 2026 Final Medicare Reimbursement Rule for Skin Substitutes
December 18, 2025 07:00 ET | Source: BioStem Technologies, Inc.
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 announced that its products, VENDAJE® and VENDAJE AC®, have been granted a 12-month status quo period in an update to Centers for Medicare & Medicaid Services’ (“CMS”) Local Coverage Determinations (“LCD”) for skin substitute grafts/cellular and tissue-based products for the treatment of diabetic foot ulcers (“DFU”) and venous leg ulcers (“VLU”) that will be effective on January 1, 2026.
Under the final policy, CMS and the Medicare Administrative Contractors (MACs) categorized products into three groups: Covered, Non-Covered, and 12-Month Status Quo. Products in the Status Quo category continue to be eligible for reimbursement in 2026 as long as their use meets the “reasonable and necessary” standard under section 1862(a)(1)(A) of the Social Security Act and other applicable requirements, and payment will be determined on a claim-by-claim basis at the MACs’ discretion. At the end of the 12-month period, the MACs will initiate a reconsideration of the LCD, reviewing additional evidence submitted by December 31, 2026, with updated determinations expected in early 2027.
Importantly, CMS clarified that the Final LCDs apply to DFU and VLU indications only. They do not impact payment for other wound types, enabling clinicians to maintain consistent care for their non-DFU/VLU patient populations. This includes pressure ulcers, which comprise the largest individual segment of the chronic wound market at 41%, as well as the majority of BioStem’s sales volume and Medicare-related revenue. As a result, the Company’s largest reimbursement segment remains unchanged, existing billing processes for pressure ulcers remain intact, and providers may continue using BioStem products across all indications without coverage interruption.
“We appreciate the thoughtful and evidence-driven approach reflected in CMS’s final LCD framework,” said Jason Matuszewski, Chief Executive Officer and Chairman of BioStem Technologies. “We expect the Status Quo designation to provide uninterrupted payment for VENDAJE and VENDAJE AC in DFU and VLU applications throughout 2026, while coverage for our core pressure ulcer business remains unaffected by these LCD changes. This preserves patient access, provider choice, customer continuity, and revenue stability for BioStem.”
Matuszewski continued, “Prior to the November evidence submission deadline, we provided CMS and the MACs with new clinical and scientific data, including results from our latest DFU study demonstrating statistically significant superiority over the standard of care. In addition, once the LCDs are finalized, we plan to continue dialog with CMS and the MACs to discuss our DFU trial findings in detail and to review progress on our ongoing VLU clinical trial. These discussions reflect our continued commitment to transparency, evidence generation, and proactive engagement as we work toward reclassification of VENDAJE and VENDAJE AC from Status Quo to Covered status during the 2027 reconsideration cycle. BioStem remains focused on generating rigorous clinical evidence and ensuring appropriate access to our BioRetain®-processed placental allografts.”
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BSEM POISED FOR A BOUNCE?
Even though BSEM's 2nd Quarter Earnings were phenomenal, the market reacted poorly to some insight from the company about increased competition.
What we are looking at here, appears to scream "BOUNCE".
If you read our previous alert on BSEM, we called out a "Falling Wedge Pattern" which consolidated at exactly $4.00, the same price BSEM closed today. Since that previous alert in October, we have seen the stock not just stabilize, but consolidate at this price.
WHAT IS A BOTTOM BOUNCE STOCK?
A temporary or full recovery/reversal from a prolonged decline or bear market. A bounce could be a small, short-lived recovery in the price of a declining security or signal a full reversal of the price. Frequently, downtrends are interrupted by brief periods of recovery - or small rallies - where prices temporarily rise. This can be a result of traders or investors closing out short positions or buying on the assumption that the security has reached a bottom. |
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BSEM also sits just under both the 50 (red line) and 20 Day (blue line) Moving Averages resistance which means a breach through BOTH could confirm a Bullish Sequence!
Not to mention, our MACD Indicator may CONFIRM A MOMENTUM SHIFT and still continues to trend up even while BSEM has traded sideways, indicating growing buying pressure.
When charts tighten like this, they often resolve with sharp moves.
Keep in mind, a return to its 52-week high of 19.28 would generate 382% GAINS!
THE BOTTOM LINE
We don't see setups like this every day. A MedTech company with Record-Breaking Revenue Growth to the tune of $301 MILLION yet still trades on the OTC?
With KPMG, one of the "BIG FOUR" accounting giants helping push toward a NASDAQ uplisting... it may not be long before this $4 play goes mainstream!
Now with Today's News, we can remove the uncertainty of medicare coverage, this is a HUGE deal for a medtech firm.
Keep in mind, BSEM's CEO is also BUYING more shares of BSEM at these low prices!!
Needless to say, Bottom-Bounce situations, with potential NASDAQ uplists don't come around often. You're going to want to have BSEM on your radar BEFORE it goes mainstream!
Make sure you put it on your screen RIGHT NOW and
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