PolarityBio Announces Acceptance of Category III CPT® Code Application for Autologous Heterogeneous Skin Construct Graft by AMA CPT® Editorial Panel

Secured Category III CPT Codes Pave the Way for Broader Access to Regenerative Skin Construct

SALT LAKE CITY, Oct. 29, 2025 (GLOBE NEWSWIRE) — PolarityBio, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous regenerative skin multicellular therapy, today announced that the American Medical Association (AMA) CPT® Editorial Panel has accepted the company’s Category III CPT® Code Application for its Autologous Heterogeneous Skin Construct graft.

The acceptance establishes Category III CPT® codes X505T–X510T, creating a dedicated mechanism for providers to report autologous heterogeneous skin construct graft procedures in the clinical use of PolarityBio’s autologous skin multicellular therapy.

“The AMA’s acceptance of these Category III CPT® codes marks a consequential milestone in establishing the necessary infrastructure for broader clinical adoption of autologous heterogeneous skin construct grafts,” said John Stetson, Chief Executive Officer of PolarityBio. “This decision helps establish the infrastructure needed for data collection and reporting that will support future reimbursement pathways and expanded patient access to this innovative regenerative therapy.”

The new codes are scheduled to be released on January 1, 2026, and will become effective for clinical use in July 2026. Category III CPT® codes are temporary designations used for emerging technologies, services, and procedures. Acceptance by the AMA CPT® Editorial Panel enables critical data tracking to document clinical utility and value, key steps in the process of achieving broader reimbursement and adoption.

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 skin multicellular therapy. PolarityBio has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and is now pursuing 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

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Parker Scott
IR@polaritybio.com
801-455-1440

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Jessica Starman, MBA
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