PolarityTE Announces Completion of Target Enrollment in Diabetic Foot Ulcer Trial
January 21 2021 - 8:00AM
Business Wire
Company Expects to Release Topline Data at the Symposium on
Advanced Wound Care—Spring 2021
PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company
developing regenerative tissue products and biomaterials, announced
today it has completed target enrollment of 100 subjects in a
randomized controlled trial (RCT) evaluating SkinTE® plus standard
of care (SOC) versus SOC alone for the treatment of diabetic foot
ulcers (DFUs). PolarityTE plans to report topline data via press
release and presentation at the Symposium on Advanced Wound Care
(SAWC) Spring 2021 to be held May 12-16, 2021, barring any
unforeseen scheduling or other disruptions due to COVID-19. Details
for the SAWC 2021 Virtual Conference can be found at
https://www.sawcspring.com/.
The primary endpoint of this Diabetic Foot Ulcer Trial
(NCT03881254) is a comparison of the percent of index ulcers closed
at 12 weeks, and additional details regarding the trial can be
found at https://clinicaltrials.gov/ct2/show/study/NCT03881254.
David Seaburg, Chief Executive Officer, commented, “The
completion of target enrollment for this DFU RCT is an important
milestone for PTE and a step toward building what we believe will
be additional scientific evidence to support the potential benefits
SkinTE may offer patients suffering from debilitating diabetic foot
ulcers.”
Nik Sopko, MD, PhD, Chief Scientific Officer, commented,
“Enrollment completion of this trial in the midst of a global
pandemic highlights the tremendous efforts by trial investigators
and a dedicated PolarityTE team. We are incredibly grateful to all
of the patients who participated in this study and look forward to
presenting the results.”
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.
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 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. Our actual results could
differ materially due to 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).
POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES
SELF and WELCOME TO THE SHIFT are trademarks or registered
trademarks of PolarityTE, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210121005140/en/
Investors: Rich Haerle VP, Investor Relations PolarityTE,
Inc. ir@PolarityTE.com (385) 315-0697
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