Effective January 2026, CMS implemented flat-rate payment reform for skin substitute products at $127.14/cm². Dermalynx is structured for the post-reform reimbursement environment — contact us to discuss product selection in context of the new payment framework.
Used in wound coverage, ocular surface reconstruction, and as biological barriers in surgical applications.
Regulated under FDA 21 CFR Part 1271 as HCT/Ps. Section 361 products when minimally manipulated for homologous use.
Fresh, dehydrated, and cryopreserved configurations. Multiple size specifications available.
Cold chain maintained from manufacturer through delivery. Shelf life varies by preservation method — contact for current specifications.
Applied in joint, tendon, and soft tissue procedures. Used as a supplemental biological matrix in orthopedic and wound care settings.
FDA-regulated HCT/Ps under 21 CFR Part 1271. Regulatory classification depends on processing method and intended use.
Injectable preparations in multiple volume configurations.
Temperature-controlled storage required. Lot-level traceability maintained.
Used in complex wound reconstruction, hernia repair, breast reconstruction, and soft tissue reinforcement.
Classification varies — some ADMs are regulated as 361 HCT/Ps, others as Class II medical devices or 351 biologics depending on processing.
Sheet form in multiple thicknesses and dimensions. Meshed and non-meshed configurations.
Ambient or refrigerated storage depending on product. Full chain-of-custody documentation.
Indicated for chronic and acute wound management including diabetic foot ulcers, venous leg ulcers, and surgical wounds.
Subject to the January 2026 CMS flat-rate payment reform ($127.14/cm²). FDA classification varies by product — 361 HCT/P or PMA/510(k) pathway.
Various sizes and configurations. Product-specific application protocols.
Storage and handling per manufacturer specifications. Complete traceability documentation provided.
Applied in wound care, orthopedic, and surgical applications as biological scaffolds and barrier membranes.
Regulated as HCT/Ps under 21 CFR Part 1271 when meeting Section 361 criteria.
Membrane, particulate, and flowable preparations.
Temperature-controlled. Lot tracking from donor through recipient.
Used in wound coverage and as a biological matrix in surgical and wound care applications.
FDA-regulated under 21 CFR Part 1271. Section 361 HCT/P classification for minimally manipulated, homologous use products.
Dehydrated and cryopreserved preparations.
Cold chain or ambient depending on preservation. Full traceability maintained.