PolarityTE Seeks Authorization To Commence SkinTE Trial On Chronic Cutaneous Ulcers

(RTTNews) - PolarityTE Inc. (PTE) said that it has submitted an investigational new drug application or IND to the United States Food and Drug Administration, seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers.

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

PolarityTE expects to receive feedback related to this IND submission from the FDA within approximately 30 days. This could result in an accepted IND or, if FDA raises questions regarding certain aspects of the Company's IND, correspondence from FDA after which PolarityTE would work with FDA in an effort to resolve any outstanding issues.