SALT LAKE CITY, Oct. 7, 2021 /PRNewswire/ -- 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® 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."
About PolarityTE®
PolarityTE is focused on
transforming the lives of patients by discovering, designing, and
developing a range of regenerative tissue products and biomaterials
for the fields of medicine, biomedical engineering and material
sciences. Rather than manufacturing with synthetic and foreign
materials within artificially engineered environments, PolarityTE
manufactures products from the patient's own tissue and uses the
patient's own body to support the regenerative process. From a
small piece of healthy autologous tissue, the company creates an
easily deployable, dynamic, and self-propagating product designed
to regenerate the target tissues. PolarityTE's innovative methods
are intended to promote and accelerate growth of the patient's
tissues to undergo a form of effective regenerative healing.
PolarityTE's products, including SkinTE, are in the development
stage, and are not approved or available for clinical use. Learn
more at www.PolarityTE.com – Welcome to the Shift®.
Forward Looking Statements
Certain statements
contained in this release are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. They are generally identified by words such as "believes,"
"may," "expects," "anticipates," "intend," "plan," "will," "would,"
"should" and similar expressions. Readers should not place undue
reliance on such forward-looking statements, which are based upon
the Company's beliefs and assumptions as of the date of this
release. The Company's actual results could differ materially due
to the impact of the COVID-19 pandemic, future clinical studies,
and FDA regulatory matters, which cannot be predicted, and the risk
factors and other items described in more detail in the "Risk
Factors" section of the Company's Annual Reports and other filings
with the SEC (copies of which may be obtained at www.sec.gov).
Subsequent events and developments may cause these forward-looking
statements to change. The Company specifically disclaims any
obligation or intention to update or revise these forward-looking
statements as a result of changed events or circumstances that
occur after the date of this release, except as required by
applicable law.
POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES
SELF and WELCOME TO THE SHIFT are registered trademarks of
PolarityTE, Inc.
CONTACTS
Investors:
Rich
Haerle
VP, Investor Relations
PolarityTE, Inc.
ir@PolarityTE.com
(385) 315-0697
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SOURCE PolarityTE, Inc.