- 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, FL, December 18, 2025 – PRISM MediaWire (Press Release Service – Press Release Distribution) – 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. 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.”
Jason Matuszewski, Chief Executive Officer and Chairman of BioStem Technologies
“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.”
Jason Matuszewski, Chief Executive Officer and Chairman of BioStem Technologies
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 AmnioWrap2™, VENDAJE®, VENDAJE AC®, VENDAJE OPTIC®, American Amnion™, and American Amnion AC™. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and LinkedIn.
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BioStem’s VENDAJE® and VENDAJE AC® have been granted a 12-month Status Quo period under CMS’s CY 2026 Final Medicare Reimbursement Rule for skin substitutes. Click here to read the full release: https://t.co/WQIRe52bLv#CMS #VENDAJE #VENDAJEAC #BioRetain #woundcare $BSEM pic.twitter.com/4OUwswmwUW
— BioStem Technologies (OTCQB: BSEM) (@BSEM_Tech) December 18, 2025
Forward Looking Statements:
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, certain statements, estimates and projections provided by BioStem Technologies, Inc. (the “Company”, “us” or “we”) with respect to anticipated future performance and generally relate to expectations or forecasts of future events. Words such as “expects,” anticipates,” “intends,” “plans,” “likely,” “will,” “believes,” “seeks,” “estimates,” “targets,” “believes,” “projects,” and variations of such words and similar expressions are intended to identify such forward looking statements. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the results of operations or plans expressed or implied by such forward-looking statements. Although we believe that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore such statements included in this press release may not prove to be accurate. Forward-looking statements in this press release relate to the our: ongoing commitment to deliver advance wound care solutions to improve the quality of life for patients; expectations regarding growth and the related driving factors; expectations regarding ongoing and future clinical trial results, including the anticipated timing of current and planned clinical trials; the commercial benefits from such clinical trials; the expectation that such trials will demonstrate the clinical superiority of the Company’s products, as well as our ability to demonstrate BioRetain’s competitive advantages; ability to capitalize and report clinically significant data over our competitors; and expectations regarding future operations, financial positions, estimated revenue, forecasts, prospects and plans.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions. The Company’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. The following is a list of risks, among others, that could cause actual results to differ materially from those contemplated by the forward-looking statements: the risk that the Company may not be able to achieve or maintain profitability in the future; the risk that the Company has derived the majority of our revenue from a distribution agreement; the risk that a material amount of revenues and accounts receivable are concentrated in one or more customers, and that if the Company loses or experiences a significant reduction in sales, the Company’s revenues may decrease substantially and materially affect the Company’s results of operations and financial condition; significant and continuing competition, which could adversely affect the Company’s business, results or operations and financial condition; the Company has incurred significant losses since inception and may incur losses in the future; and the impact of any changes to the reimbursement levels for the Company’s products. In addition, the Company’s performance remains dependent on the Company’s ability to convince physicians that the products are safe and effective alternatives to existing treatments and that the Company’s products should be used in their procedures given the regulatory, reimbursement and coverage environment; the risk that the Company may be unable to successfully market is products to the end users of such products; the risk that the Company will be unable to maintain adequate levels of reimbursement from public and private insurers and health systems which may result in changes to the ways in which the Company’s products are reimbursed in various sites of service and, as a result may adversely impact the Company’s financial results; the risk that the Company will be unable to produce sufficient data to support coverage of our products under the finalized LCDs or otherwise satisfy any regulatory requirements needed to ensure our products are eligible for Medicare reimbursement; the risk that end users do not use the Company’s products due to the uncertainty of reimbursement or coverage related to products in the “12-Month Status Quo Period,” the risk that the Company’s products may not meet the “reasonable and necessary” standard in Section 1862(a)(1)(A) of the Social Security Act and any other applicable requirements in order to be paid; the risk that MACs may make negative claim determinations; the risk that the FDA may in the future determine that certain products that are, or are derived from, human cells or tissues, do not qualify for regulation solely under Section 361 of the Public Health Service Act, and may require that the Company revise its labeling and marketing claims for these products or require the Company to suspend sales of such products until FDA pre-market clearance or approval is obtained, either of which could adversely affect the Company’s business, results of operations, and financial condition; the risk that the rate of reimbursement and coverage for the purchase of the Company’s products by government and private insurance may change; and the impact of any changes in applicable laws or regulations.
You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. There may be additional risks about which the Company is presently unaware of or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Contact BioStem Technologies, Inc.:
Website: www.biostemtechnologies.com
E-Mail: info@biostemtech.com
X: @BSEM_Tech
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Investor Relations:
Philip Trip Taylor, Gilmartin Group
E-Mail: ir@biostemtech.com
Source: BioStem Technologies, Inc.
