PolarityBio

What PolarityBio does

PolarityBio (legal entity PolarityBIO Inc., formerly PolarityTE) is a privately held, clinical-stage biotechnology company founded in 2016 and headquartered in Salt Lake City, Utah. Its sole clinical asset is SkinTE, an investigational autologous heterogeneous skin construct (AHSC) — a multicellular therapy that harvests a full-thickness skin sample from the patient, processes it into organoid-like multicellular units containing living cells and matrix, and applies those units to the wound bed to initiate tissue repair. The lead indication is Wagner Grade 1 diabetic foot ulcers (DFUs) that have failed standard of care.

The company completed its pivotal Phase III COVER DFUS II trial (120 patients enrolled across U.S. clinical sites in 14 months, LPLV November 12, 2025) and submitted a Biologics License Application to the FDA in July 2026; SkinTE holds both FDA Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy (RMAT) designation. The American Medical Association has published dedicated Category III CPT codes (1044T–1049T) covering full-thickness skin harvest and graft application, effective July 2026. The product is currently distributed only through clinical trials and an FDA-cleared Expanded Access Program.

PolarityBio has no product revenue today. Its go-to-market is sales-led enterprise: pre-approval engagement with wound care specialists, podiatrists, vascular/plastic surgeons and advanced practice providers through clinical trials and EAP; post-approval, the company plans to commercialize SkinTE as a BLA-approved biologic reimbursed under CMS payment methodologies (typically ASP + 6%) via physician offices, hospital outpatient departments, and inpatient settings. Capital raised to date is approximately $22.5 million (May 2024), split between $12.5M equity and a senior secured credit facility of up to $10M from Avenue Venture Opportunities Fund.

Name

PolarityBio

Legal name

PolarityBIO Inc.

Website

https://polaritybio.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

PolarityBio is a clinical-stage biotechnology company developing SkinTE, an investigational autologous multicellular skin construct for Wagner Grade 1 diabetic foot ulcers. The company has completed Phase III trials, submitted a BLA to the FDA in July 2026, and holds FDA Breakthrough Therapy and RMAT designations.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Biologics - Wound Care

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts) (HLAHALAE)

akta.pro secondary industries

Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG), Wound Care & Diabetic Foot Infection (HLAKAGAK), Dermatology Specialty Pharmaceuticals (HLAIACAL)

Keywords

• Regenerative medicine biologics
• Autologous skin constructs
• Diabetic foot ulcer therapy
• Wound care biologics
• Cell-based tissue engineering

Headquarters

HQ city

Salt Lake City

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Others

Revenue model

1. Biologics Product Revenue (Post-Approval): Once approved, SkinTE will be commercialized as a BLA-approved biologic with reimbursement under existing CMS payment methodologies for biologics (typically ASP + 6%). The company notes that current CMS policy is set to reimburse BLA-approved biologics under existing payment methodologies following the January 2026 payment restructuring.
2. Investigational Product Access: Pre-approval revenue model not yet established. Product available only through clinical trials or FDA-cleared Expanded Access Program for investigational use.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

PolarityBio develops SkinTE, an investigational autologous cutaneous multicellular therapy (heterogeneous skin construct) designed to treat chronic wounds, with a current focus on Wagner Grade 1 diabetic foot ulcers. The product is manufactured from a patient's own full-thickness skin into organoid-like multicellular structures that are applied to the wound bed to initiate tissue repair. As of 2026, SkinTE is investigational and distributed only through clinical trials and an FDA-cleared Expanded Access Program, with a BLA submitted to the FDA following completion of the Phase III COVER DFUS II pivotal trial.

Product overview

PolarityBio is a clinical-stage biotechnology company developing regenerative tissue products. The company's primary product is SkinTE®, an autologous heterogeneous skin construct (AHSC) - an investigational regenerative multicellular biologic therapy. SkinTE is designed to initiate the wound healing process by providing healthy cells and chemokines in the wound bed for diabetic foot ulcer treatment. The company has completed Phase III pivotal trials (COVER DFUS II) and submitted a Biologics License Application to the FDA. SkinTE is currently available for investigational use only and is not yet FDA approved.

Differentiator

Problem solved

Functional benefit

Products and services

• SkinTE SkinTE is an investigational autologous cutaneous multicellular therapy (autologous heterogeneous skin construct) designed to initiate wound healing by providing healthy cells and chemokines in the wound bed. It is being developed for treatment of Wagner Grade 1 diabetic foot ulcers in adult patients who have not responded to standard of care after 4 weeks. Following application, multicellular units may engraft and serve as a cellular source within the wound bed, initiating cellular activity associated with tissue repair.

Quantifiable outcome

• 70% (35/50) wound closure at 12 weeks with SkinTE + SOC vs 34% (17/50) with SOC alone (p=0.00032) - Phase II trial
• +3 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Convatec: Convatec is a global medical products company with a significant advanced wound care business serving DFU and chronic wound patients. Comparable as a broad incumbent competitor with overlapping wound care product portfolio and physician relationships.
• Coloplast: Coloplast operates a sizable wound and skin care business alongside its core ostomy and continence franchises. Comparable as a broad wound care incumbent with overlapping DFU and chronic wound customer base.
• Integra LifeSciences: Integra LifeSciences offers a portfolio of regenerative wound care technologies including dermal regeneration templates (Integra Dermal Regeneration Template) used in complex wounds. Comparable as a broader wound care incumbent with overlapping regenerative tissue technology.
• Smith+Nephew: Smith+Nephew is a major medical device incumbent with a sizable advanced wound management portfolio serving DFU and chronic wound markets. Comparable as a broad wound care incumbent whose offerings overlap with PolarityBio's commercial channel.
• 3M Health Care (Solventum): Solventum (spun from 3M's Health Care business) includes a large advanced wound care portfolio including negative pressure wound therapy and skin substitute products. Comparable as a broad incumbent with overlapping DFU treatment offerings and established reimbursement infrastructure.

Direct peers

• Organogenesis Holdings: Organogenesis is a leading regenerative medicine company marketing Apligraf and other skin substitute biologics for chronic wounds including diabetic foot ulcers and venous leg ulcers. Directly comparable as a wound care biologic commercial-stage company in the same DFU and chronic wound category.
• MiMedx Group: MiMedx markets EpiFix and AmnioFix amniotic membrane-based skin substitute products for DFU, venous leg ulcers, and other chronic wounds. Directly competes with PolarityBio in the DFU skin substitute market with similar physician call points and reimbursement dynamics.

Emerging players

• Vericel Corporation: Vericel markets autologous cellular therapies including MACI for cartilage repair, providing a useful comparable for autologous cell-based biologic commercialization, manufacturing complexity, and reimbursement dynamics.
• Aroa Biosurgery: Aroa Biosurgery develops soft tissue regeneration products derived from ovine forestomach matrix for wound healing and soft tissue reconstruction. Comparable as an emerging regenerative medicine company with biologic matrix technology addressing chronic wound markets.
• Tela Bio: Tela Bio develops regenerative tissue matrices including products for soft tissue reconstruction. Comparable as a smaller emerging regenerative medicine company using biologic matrices, sharing similar regulatory and commercialization challenges in the wound care space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/PolarityBio_
• Facebookfacebook.com/PolarityBio

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PolarityBio