PolarityTE: Falls on plans to stop commercial sales of skin treatment

RegenETP,

14/05/2021 13:53

** Tissue-based treatment developer's shares  PTE.O  fall
12.9% to $1.08 premarket
    ** Company said on Thursday it plans to wind down commercial
sales of its tissue-based product SkinTE by end of May in
compliance with end of U.S. FDA's enforcement discretion period
 urn:newsml:reuters.com:*:nBw4fvZ44a
    ** FDA recently said the grace period given to developers of
certain human cell, tissue based products (HCT/Ps) to assess
whether they needed to file an investigational new drug
application or marketing application with FDA, will conclude on
May 31, 2021
    ** SkinTE is currently marketed as a 361 HCT/P product,
which doed not require any pre-market review and approval
    ** Company expects substantial spending cuts, which will
mitigate effect on cash flow resulting from loss of SkinTE
revenue
    ** SkinTE is a product derived from a patient's own skin
intended for the repair, reconstruction, replacement or
supplementation of skin tissue
    ** PTE expects to file application with FDA seeking approval
for clinical studies of SkinTE in second half of 2021

 (Reporting by Mrinalika Roy in Bengaluru)
 ((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325))