PolarityTE is a clinical-stage biotechnology company headquartered in Salt Lake City, Utah, developing regenerative tissue products. Its lead product, SkinTE, is a regenerative tissue product with an open IND and is available for investigational use only. The company is pursuing the first of two pivotal studies needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication. COVER DFUS II is a Phase III pivotal study evaluating SkinTE in Wagner 1 diabetic foot ulcers, planned to enroll up to 120 subjects across as many as 20 U.S. clinical sites, with a primary endpoint of DFUs closed at 12 weeks. The trial has enrolled approximately 20% of its target population and the company expects an interim readout in Q1 2025. Recent financing (equity plus a senior secured credit facility) strengthens the balance sheet and provides capital to advance the Phase III program and reach key data readouts.

Total raised

$23M

Funding rounds

2

Latest round

Equity

Latest activity

May 2024