MTF Biologics’ AmnioBand® Membrane and AlloPatch® Pliable Confirmed as Covered Under Updated CMS Local Coverage Determinations

EDISON, N.J.--(BUSINESS WIRE)--MTF Biologics, a global nonprofit organization that saves and heals lives by honoring donated gifts and advancing the science of tissue transplantation, today announced that two of its aseptically processed allografts without terminal irradiation, AmnioBand^® Membrane, an allograft placental matrix, and AlloPatch^® Pliable an allograft dermal matrix, will remain among the 18 tissues covered under the newly updated Medicare Local Coverage Determinations (LCDs) for skin substitute grafts/cellular and tissue-based products for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). Coverage is effective January 1, 2026.

“This Medicare coverage decision affirms what clinicians and patients have experienced for years—that high-quality, evidence-based tissue therapies play a critical role in healing complex wounds,” said Joe Yaccarino, President and Chief Executive Officer of MTF Biologics. “As a nonprofit organization, we remain committed to advancing rigorous clinical evidence, ensuring patient safety and supporting providers with solutions that deliver meaningful outcomes and value.”

The update to the future effective LCDs was announced by the Centers for Medicare and Medicaid Services (CMS) on December 15, 2025. Coverage is based on published clinical evidence and implementation of the LCDs will help drive scientific advances in wound care treatment. Skin substitutes will be designated into one of three coverage categories: covered, non-covered and 12-month status quo period. The 18 products classified as “covered” were found to “meet the evidence threshold outlined in the LCDs that will be covered by Medicare.”

Backed by robust peer-reviewed published randomized controlled trials, AmnioBand^® Membrane and AlloPatch^® Pliable both remain covered for the treatment of DFUs, offering providers confidence and flexibility to choose between a clinically proven placental membrane and a dermal allograft solution. AmnioBand Membrane stands apart as one of only five tissues covered for both DFUs and VLUs, reinforcing its differentiated clinical evidence and broad applicability across chronic wound types.

The updated LCDs align with the medical coverage policies of most commercial health plans, ensuring broad market applicability of AmnioBand^® Membrane and AlloPatch^® Pliable for both new and existing distribution partners. As a result, healthcare providers and Medicare beneficiaries suffering from chronic, non-healing wounds can continue to access high-quality, safe, effective and economically advantageous tissue-forms.

MTF Biologics’ AmnioBand^® Membrane and AlloPatch^® Pliable key differentiators include:

• Aseptic Processing: Advanced chemical processing effectively manages bioburden variability in incoming tissue, upholding the highest standards of safety and quality, without terminal irradiation. Ensures all tissues undergo rigorous USP <71> sterility testing for safety.
• Dual-Tissue Offering: The only organization on the Medicare list offering both an allograft dermal matrix (AlloPatch^® Pliable) and an allograft placental matrix (AmnioBand^® Membrane).
• Proven Clinical Results: Peer-reviewed Level 1 clinical evidence demonstrating these tissues nearly double wound closure rates compared to standard of care, achieving closure with an average of four applications.
• Health Economic Evidence: Published studies demonstrating high-quality, aseptically processed tissues offer some of the lowest cost-to-closure rates and superior outcomes​.

Additional information and inquiries about MTF Biologics tissues covered by the updated CMS guidelines can be found at www.mtfbiologics.org/new-medicare-guidelines.

About MTF Biologics

MTF Biologics is a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients and advancing science. In partnership with organ and tissue recovery organizations, MTF Biologics provides exceptional services, resources, and expertise to donors and their families; tissue and organ transplant patients; and clinicians and scientists who advance patient care.

The International Institute for the Advancement of Medicine (IIAM), a Division of MTF Biologics, honors donors of non-transplantable organs by providing their gifts to the medical research community to combat and cure diseases. Statline, also a Division of MTF Biologics, provides specialized communications and technology expertise to organ, tissue, and eye procurement organizations, as well as the hospitals they serve. Its sister organization, Deutsches Institute for Zell-und Gewebeersatz – DIZG (The German Institute for Cell and Tissue Transplantation) expands its reach to patients across the globe.

For more information about our wound care portfolio, visit www.mtfbiologics.org.