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 products for the treatment of diabetic foot ulcers ("DFU") and venous leg ulcers ("VLU") that would have been effective on January 1, 2026.
"We appreciate the thoughtful collaboration during this period between clinical partners, policymakers, and advocacy organizations as they continue to shape an evolving reimbursement environment that optimizes patient care while supporting innovation and fiscal responsibility," said Jason Matuszewski, CEO and Chairman of the Board of BioStem. "Importantly, the recent withdrawal of the LCDs is not expected to impact patient access to BioStem's technology or our ability to serve patients and clinicians. Even with broader coverage criteria, we continue to believe that long-term adoption and value creation will be driven by high-quality clinical evidence and remain firmly committed to an evidence-based strategy. BioStem will continue to invest in expanding its foundation of clinical data to demonstrate the differentiated performance of our proprietary technology relative to alternative options."
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.
Join BioStem's Distribution List & Social Media:
To follow the latest developments at BioStem, sign up for the Company's email distribution list HERE, and follow us on X and LinkedIn.
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 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
Facebook: BioStemTechnologies
Investor Relations:
Philip Trip Taylor, Gilmartin
Group E-Mail: ir@biostemtech.com
