SALT
LAKE CITY, May 13, 2022 /PRNewswire/ --
PolarityTE, Inc. (Nasdaq: PTE) today announced that the U.S.
Food and Drug Administration (FDA) granted a Regenerative Medicine
Advanced Therapy (RMAT) designation to SkinTE under the Company's
open IND.
Established under the 21st Century Cures Act, RMAT designation
is a dedicated program designed to expedite the drug development
and review processes for promising regenerative medicine products,
including human cellular and tissue-based therapies. A regenerative
medicine therapy is eligible for RMAT designation if it is intended
to treat, modify, reverse, or cure a serious or life-threatening
disease or condition, and preliminary clinical evidence indicates
that the drug or therapy has the potential to address unmet medical
needs for such disease or condition. Similar to Breakthrough
Therapy designation, RMAT designation provides the benefits of
intensive FDA guidance on efficient drug development, including the
ability for early interactions with the FDA to discuss potential
ways to support accelerated approval and satisfy post-approval
requirements, potential priority review of the biologics license
application (BLA), and other opportunities to expedite development
and review.
Richard Hague, Chief Executive
Officer, commented "FDA granting our request for an RMAT
designation for SkinTE validates not only the strength of the
preliminary clinical evidence we have developed to date but also
demonstrates the seriousness of the conditions that we seek to
treat and the substantial nature of the unmet needs among the
patient populations that we aim to serve. We were pleased to
receive this news from the FDA nearly two weeks in advance of the
60-day time period that the Agency has to make such decisions.
The Agency has offered—and we look forward to capitalizing
upon—a multidisciplinary, comprehensive discussion between
PolarityTE and the FDA regarding the SkinTE development program,
including planned clinical trials and plans for expediting the
manufacturing development strategy. We are eager to work
closely with the Agency to identify potential means to accelerate
our development program and help bring a much-needed potential new
treatment to patients suffering from substantial unmet medical
needs."
About PolarityTE®
PolarityTE, Inc., headquartered in
Salt Lake City, Utah, is a
biotechnology company developing regenerative tissue
products. PolarityTE's first regenerative tissue product is
SkinTE®. PolarityTE has an open investigational new drug
application (IND) for SkinTE® with the U.S. Food and Drug
Administration (FDA) and is now pursuing the first of two pivotal
studies on SkinTE® needed to support a biologics license
application (BLA) for a chronic cutaneous ulcer indication.
SkinTE® is available for investigational use only. Learn more at
www.PolarityTE.com.
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:
PolarityTE Investor Relations
ir@PolarityTE.com
(385) 831-5284
Media:
David Schull or
Ignacio Guerrero-Ros
David.schull@russopartnersllc.com
Ignacio.guerrero-ros@russopartnersllc.com
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SOURCE PolarityTE, Inc.