New procedural codes establish standardized pathway for clinical use of autologous heterogeneous skin construct across care settings
SALT LAKE CITY, Jan. 05, 2026 (GLOBE NEWSWIRE) -- PolarityBio©, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous multicellular skin therapy, today announced that the American Medical Association (AMA) has published new Category III CPT® codes (1044T, 1045T, 1046T, 1047T, 1048T, and 1049T) for its flagship autologous heterogeneous skin construct (AHSC) product, SkinTE®. The finalized codes, which become effective in July 2026, provide standardized procedural definitions for both full-thickness skin harvest and SkinTE graft application.
The establishment of these codes marks a pivotal milestone in PolarityBio's commercial readiness. By providing a clear framework for reporting and data capture, these Category III codes reduce administrative ambiguity for providers and support the development of internal utilization protocols. The full list of codes and their long descriptors can be accessed via the AMA CPT Category III directory.
Under the newly published guidelines, full-thickness skin harvest and application of the autologous heterogeneous skin construct are defined as separately reportable procedures and may be performed in physician offices, hospital outpatient departments, and inpatient settings. This flexibility enables health systems and clinical partners to integrate SkinTE into existing wound care workflows without requiring a single site-of-care model.
“The publication of these Category III CPT codes provides clarity and consistency for health systems and clinical partners evaluating the integration of SkinTE into their wound care programs,” said Ned Swanson, President and Chief Medical Officer of PolarityBio. “By establishing standardized procedural definitions, we are helping partners more easily assess implementation, utilization, and scalability as they consider broader adoption of autologous regenerative therapies.”
The reporting structure also reflects the specific clinical effort involved in the therapy. Codes 1044T-1046T pertain to the full-thickness skin harvest (reported in 5 sq cm increments), while codes 1047T-1049T cover the graft application (reported in 50 sq cm increments, or 0.5% of body surface area for pediatric patients). This granularity ensures that documentation accurately aligns with the anatomical location and the complexity of the treatment provided.
SkinTE is currently available for investigational use only. Submission of a biologics license application (BLA) to the U.S. Food and Drug Administration is expected in 2026, after which additional coding pathways, including HCPCS Level II coding, will be pursued in accordance with regulatory approval and CMS timelines.
About PolarityBio©
PolarityBio, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative biologics. PolarityBio’s first regenerative biologic is SkinTE®, an autologous multicellular skin therapy. PolarityBio has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and has completed the final pivotal study on SkinTE® needed to support a biologics license application (BLA) for a Wagner 1 diabetic foot ulcer indication. SkinTE® is available for investigational use only. Learn more at www.polaritybio.com.
Company Contact
connect@polaritybio.com
Investor Relations Contact
Parker Scott
IR@polaritybio.com
801-455-1440
Media Contact
Jessica Starman, MBA
media@elev8newmedia.com
