Advancing regenerative multicellular biologics for chronic wounds
PolarityBio is a late-stage biotechnology company addressing unmet needs in diabetic foot ulcers and other chronic wounds. Our lead investigational product, SkinTE®, is under FDA priority review.
SkinTE® is an investigational product and has not been approved by the FDA. Its safety and effectiveness have not been established.
Explore Our Science and Clinical Development
-
The Science of SkinTE®
The scientific basis for SkinTE®, an investigational autologous cutaneous multicellular therapy being studied in diabetic foot ulcers.
-
Publications & Research
Peer-reviewed publications related to SkinTE® and chronic wounds, including current investigational development and legacy scientific context.
-
Development Pipeline
SkinTE® is under FDA review for Wagner Grade 1 diabetic foot ulcers. See our pipeline of future regenerative multicellular biologic programs.
-
Expanded Access
An FDA-cleared program that provides eligible patients with investigational access to SkinTE® with approval.
Latest News
SkinTE is an investigational product and has not been approved or cleared by the U.S. Food and Drug Administration. Availability is limited to participation in clinical studies or under an Expanded Access Program.
All medical products carry potential risks. Safety data for SkinTE are being collected in ongoing clinical studies.
The information provided on this website is intended for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Statements on this site regarding investigational products are based on clinical research and have not been evaluated or approved by the U.S. Food and Drug Administration. Individual outcomes may vary.
This website may contain forward-looking statements regarding PolarityBio’s research programs, product candidates, and clinical development plans. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. PolarityBio undertakes no obligation to update such statements.
The information on this website is intended for residents of the United States and may not apply to other countries.