PolarityBio Secures Key Codes for SkinTE, Paving Path to Market

SALT LAKE CITY, UT – January 05, 2026 – In a strategic move that signals growing momentum toward commercialization, PolarityBio has announced that its flagship regenerative therapy, SkinTE®, has been assigned a new set of procedural codes by the American Medical Association (AMA). The publication of these Category III Current Procedural Terminology (CPT®) codes, set to become effective in July 2026, provides a standardized framework for physicians and hospitals to report the use of the novel skin regeneration treatment, a critical step in bridging the gap between clinical investigation and widespread market access.

The new codes (1044T-1049T) define the procedures for harvesting a patient's own skin and applying the resulting SkinTE® graft. While the therapy remains investigational pending a planned 2026 Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA), establishing this coding infrastructure early is a calculated maneuver aimed at smoothing the path for future clinical adoption.

A Strategic Step Toward Commercialization

For emerging biotechnologies, the journey to market is fraught with regulatory and administrative hurdles that extend far beyond FDA approval. PolarityBio's proactive pursuit of CPT codes demonstrates a sophisticated understanding of this landscape. Category III codes are specifically designed for new and emerging technologies, allowing for data collection on utilization and outcomes before a therapy is considered a standard of care.

These temporary codes do not guarantee reimbursement from payers like Medicare or private insurers. Instead, their primary function is to eliminate ambiguity in medical billing and record-keeping. By creating a uniform language for reporting SkinTE® procedures, the codes enable healthcare systems to track usage, monitor patient outcomes, and develop internal protocols. This data becomes invaluable, not only for internal assessments but also for building the body of evidence needed to eventually secure favorable reimbursement decisions.

“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, in a company statement. “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 code structure itself reflects the clinical workflow. Codes 1044T-1046T cover the full-thickness skin harvest, reported in increments of 5 square centimeters, while codes 1047T-1049T pertain to the application of the autologous graft, reported in 50 square centimeter increments. This granularity allows for precise documentation that aligns with the complexity and scale of the treatment, a feature that will be crucial for future health economic analyses.

Unlocking a New Frontier in Wound Care

The administrative milestone comes as PolarityBio nears a major clinical one. The company recently completed its pivotal Phase III clinical trial, COVER DFUS II, evaluating SkinTE® in the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs). These chronic wounds represent a massive and persistent unmet medical need. DFUs are notoriously difficult to heal, frequently leading to severe infections, hospitalization, and lower-limb amputations, with no new biologics having received BLA approval for a chronic wound indication since 1997.

SkinTE® aims to break this therapeutic stagnation. The technology uses a small sample of a patient's own full-thickness skin to create an autologous, heterogeneous skin construct. When applied to a wound, it is designed to regenerate all layers of the skin, including glands and hair follicles, creating functional tissue rather than just scar tissue.

The potential of this approach was recognized by the FDA in February 2025, when it granted SkinTE® a Breakthrough Therapy Designation. This status is reserved for treatments that may demonstrate substantial improvement over available therapies for serious conditions and is intended to expedite their development and review. Data from PolarityBio's Phase II study was promising, showing that 70% of patients treated with SkinTE® achieved wound closure at 12 weeks, compared to just 34% in the standard-of-care control group. With the final data from the larger Phase III trial expected in the first quarter of 2026, the company is positioning itself for a BLA submission later this year.

Navigating the Complex Reimbursement Landscape

While the new CPT codes and promising clinical data are significant tailwinds, the ultimate success of SkinTE® will hinge on navigating the notoriously complex U.S. reimbursement system. FDA approval confirms a product is safe and effective, but it does not compel payers to cover it. Securing reimbursement requires a separate, and often more arduous, process of demonstrating clinical utility and cost-effectiveness.

This is where the Category III codes become a foundational part of PolarityBio's long-term strategy. The data collected using these codes will be essential for discussions with the Centers for Medicare & Medicaid Services (CMS) and private insurers. They will help build the real-world evidence base needed to argue for conversion to permanent Category I CPT codes, which have assigned reimbursement values.

Furthermore, the therapy's Breakthrough Therapy Designation may open expedited reimbursement pathways. CMS programs like the New Technology Add-on Payment (NTAP) for inpatient settings and the recently finalized Transitional Coverage for Emerging Technologies (TCET) are designed to provide provisional coverage for innovative devices and biologics while more robust evidence is gathered. PolarityBio’s early coding work and regulatory designations position it well to leverage these programs, potentially accelerating patient access post-approval. Following regulatory approval, the company also plans to pursue HCPCS Level II codes, which are used to bill for products, supplies, and drugs, and would be necessary for reimbursement of the SkinTE® product itself.

Broader Implications for Regenerative Medicine

PolarityBio's methodical approach reflects the maturation of the regenerative medicine industry. As therapies become more complex, moving beyond simple molecules to living cellular constructs, the infrastructure of healthcare—coding, billing, and administration—must evolve alongside the science. The establishment of specific codes for an autologous skin construct is a sign that the healthcare system is beginning to create pathways for these advanced biologics.

In the highly competitive advanced wound care market, dominated by giants like 3M and Smith & Nephew offering dressings and devices, SkinTE®'s regenerative, autologous approach is a key differentiator. However, innovation alone does not guarantee adoption. By tackling the administrative and reimbursement challenges head-on, even before its product is on the market, PolarityBio is creating a template for other biotech firms.

As the Salt Lake City-based company prepares for its BLA submission, the healthcare industry will be watching closely. The journey of SkinTE®—from clinical trials and regulatory filings to coding and reimbursement strategy—will serve as a crucial case study on how to successfully translate groundbreaking regenerative science into a viable, accessible therapy for patients in desperate need of better solutions.