PolarityTE Gets FDA Nod To Commence Phase 3 Study Of SkinTE In Chronic Cutaneous Ulcer Indication

PolarityTE Inc. (PTE), a company focused on regenerative tissue products and biomaterials, said on Tuesday that it has received FDA clearance to commence the first of two planned phase III trials of SkinTE to treat chronic cutaneous ulcers.

SkinTE is a human cellular and tissue-based product derived from a patient's own skin.

The first planned phase III trial, dubbed COVER DFUs, is designed to enroll up to 100 patients at up to 20 sites in the U.S. which will compare treatment with SkinTE plus the standard-of-care to the standard-of-care alone. Enrollment in this trial is expected to begin later this quarter or in early second quarter.

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