Benzinga | Oct 7, 2021 08:12AM EDT

PolarityTE Says 'has developed a strong a plan to address the issues FDA identified' Related To Clinical Hold For Its SkinTE New Drug Application

PolarityTE, Inc. (NASDAQ:PTE) a biotechnology company developing regenerative tissue products and biomaterials, today provided an update regarding its Investigational New Drug Application (IND) for SkinTE(r) with a proposed indication for chronic cutaneous ulcers submitted to the Food and Drug Administration (FDA) in July 2021.



The Company received the clinical hold letter from FDA by the previously announced date of September 21, 2021. The hold issues are certain Chemistry, Manufacturing, and Control (CMC) items, which the Company will have to resolve prior to proceeding with a pivotal study. After a deep review of the letter, the Company believes that it has developed a strong a plan to address the issues FDA identified and is currently working diligently to prepare a complete response.

Additionally, PolarityTE has informally engaged with the FDA on certain points raised by the Agency regarding the proposed potency assays that the Company plans to implement. PolarityTE believes the opportunity to receive additional guidance from FDA prior to submitting a complete response could help the Company comprehensively address the hold issues identified by FDA to ultimately support an IND acceptance.

Richard Hague, Chief Executive Officer and President, commented, "We are thankful for the feedback from the FDA and we remain fully committed to having the clinical hold resolved so that we can commence our first pivotal study as quickly as possible." Richard continued, "We strongly believe in the potential for SkinTE in chronic cutaneous ulcers and look forward to continued engagement with the Agency as we work to advance SkinTE through the regulatory process."