BioStem Technologies Provides Comments on CMS CY 2026 Proposed Medicare Reimbursement Rule Changes for Skin Substitutes

Rhea-AI Summary

BioStem Technologies (OTC: BSEM), a MedTech company specializing in placental-derived wound care products, has responded to CMS's proposed changes for skin substitute reimbursement in CY 2026. The company supports the reform efforts aimed at addressing Medicare spending in this category.

CEO Jason Matuszewski emphasized their commitment to working with stakeholders during the 60-day comment period to optimize reimbursement methodology. The company is conducting randomized controlled trials (RCTs) for their BioREtain® technology across multiple indications, with initial results expected later this year.

Additionally, BioStem is progressing with its Form 10 filing and plans to provide updates on its Nasdaq uplisting during Q2 2025 earnings call.

Positive

• Company actively conducting randomized controlled trials (RCTs) across multiple indications
• Progress towards Nasdaq uplisting with ongoing Form 10 filing process
• Proactive engagement with CMS on reimbursement policy changes

Negative

• Potential impact of CMS reimbursement changes on skin substitute pricing
• Results from RCTs still pending and uncertain

The Company welcomes CMS’ efforts to reform skin substitute payment policy and will continue to engage with CMS and other stakeholders to optimize the proposed changes

POMPANO BEACH, Fla., July 17, 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, comments on the Centers for Medicare and Medicaid Services (“CMS”) release of the Calendar Year (“CY”) 2026 Physician Fee Schedule (“PFS”) proposal and the CY 2026 Outpatient Prospective Payment System (“OPPS”) proposal regarding reimbursement of skin substitutes.

“We continue to support reforming the reimbursement framework for skin substitutes, as addressing the rising Medicare spend in this category has long been a priority for CMS. We look forward to working closely with CMS, providers and industry stakeholders during the 60-day comment period to optimize the methodology for skin substitute reimbursement, with a goal of achieving a solution that appropriately recognizes value across the healthcare system,” said Jason Matuszewski, CEO and Chairman of the Board of BioStem. “We believe these reforms should ultimately benefit chronic wound care by promoting investment in innovation and improving outcomes for patients who depend on our treatments.”

Mr. Matuszewski added: “We continue to invest in randomized controlled trials (“RCTs”) across multiple indications, and we believe BioStem will be better positioned to drive continued market adoption with reported data for our BioREtain^® technology. These trials are intended to demonstrate the clinical superiority of BioREtain^®, which is the cornerstone of our commercial products, and we look forward to announcing initial results later this year.”

Separately, BioStem remains actively engaged in its Form 10 filing process and will provide additional updates on its planned Nasdaq uplisting during its second quarter 2025 earnings call.

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 per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE^®, VENDAJE AC^®, and VENDAJE OPTIC^®. 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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Contact BioStem Technologies, Inc.:
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStemTechnologies

Investor Relations:
Adam Holdsworth
BioStem Director of Investor Relations
E-Mail: adam@holdsworthco.com
Phone: 917-497-9287

Or

Gilmartin Group
Philip Trip Taylor, Principal
E-Mail: philip@gilmartinir.com
Phone: 415-937-5406

Note Regarding Forward-Looking Statements:
Except for statements of historical fact, this press release also contains forward-looking statements. These forward-looking statements relate to expectations or forecasts of future events, including with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate”, “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements in this press release include, among other things, statements regarding the Company’s: ability to clear all current SEC comments; expectations regarding filing an amended Form 10, including the timeframe therefor and the content therein; and expectations regarding the Company’s plan and ability to satisfy Nasdaq listing requirements. Forward-looking statements are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from the expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: the risk that the Company may be unable to list its stock on Nasdaq or maintain compliance with Nasdaq’s continued listing standards; the impact of any changes to the accounting treatment of the Company’s revenue and expenses; the risk of receiving additional comments from the SEC; the competition that the Company faces, which could adversely affect its business, results of operations and financial condition; the risk of rapid technological change, which could cause the Company’s products to become obsolete or cause the Company to become unable to effectively compete; the risk that the Company is unable to successfully market its products to the end users of such products; the risk that the Company may be unable to raise funds to expand its business; changes in applicable laws or regulations; and the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

FAQ

What changes did CMS propose for skin substitute reimbursement affecting BSEM in 2026?

CMS proposed changes to the Physician Fee Schedule (PFS) and Outpatient Prospective Payment System (OPPS) for skin substitute reimbursement. BioStem is actively engaging in the 60-day comment period to optimize the methodology.

When will BioStem Technologies (BSEM) release results from their BioREtain clinical trials?

BioStem expects to announce the initial results from their BioREtain® technology clinical trials later in 2025.

What is BioStem's (BSEM) progress towards Nasdaq uplisting?

BioStem is actively engaged in the Form 10 filing process and will provide updates on its planned Nasdaq uplisting during its second quarter 2025 earnings call.

How is BioStem Technologies responding to the CMS reimbursement changes?

BioStem is actively working with CMS, providers, and industry stakeholders during the 60-day comment period to optimize the methodology for skin substitute reimbursement, aiming for a solution that recognizes value across the healthcare system.