PolarityTE Receives Allowance for Additional U.S. Patent
February 03 2021 - 4:15PM
Business Wire
PolarityTE’s U.S. Patent Portfolio is Growing
with Allowance of U.S. Patent Application No. 16/165,169
PolarityTE, Inc. (Nasdaq: PTE) is pleased to report the
U.S. Patent and Trademark Office (USPTO) has issued a Notice of
Allowance for U.S. Application No. 16/165,169 filed on October 19,
2018. This is the Company’s second patent allowance in the United
States. The newly allowed claims provide additional protection for
methods of making skin-regenerative compositions with the Company’s
minimally polarized functional unit (MPFU) technology as well as
methods of treatment utilizing the compositions.
Additionally, a decision to grant Patent Application No. PI
2017701990 was recently issued in Malaysia. The allowed claims in
Malaysia cover the same minimally polarized functional unit
compositions as those patented in the United Kingdom.
This news brings the Company’s total number of allowed patent
applications and granted patents worldwide to nine. The Company
continues to pursue additional patent applications in the United
States and abroad related to its regenerative technologies,
including SkinTE®.
David Seaburg, Chief Executive Officer, commented, “The
allowance of PolarityTE’s second U.S. patent is yet another step in
protecting our valuable regenerative medicine assets, most notably
SkinTE.” Mr. Seaburg continued, “This achievement further bolsters
our patent portfolio and speaks to the steadfast efforts of the
entire organization, including our intellectual property team.”
Jennifer Burdman, Chief Intellectual Property Officer,
commented, “As we’ve always said, the process of patent prosecution
takes time and we are committed to the investment of our time and
resources to protect PolarityTE’s patentable innovations through
this process. We are now seeing our efforts pay off and are pleased
that the USPTO has now twice recognized the patentability of our
MPFU-related innovations.”
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. Learn more at
www.PolarityTE.com – Welcome to the Shift®.
About SkinTE®
SkinTE is a human cellular and tissue-based product derived from
a patient’s own skin (autologous) intended for the repair,
reconstruction, replacement, or supplementation of skin tissue.
Aseptic surgical procedures and handling during skin harvest, wound
preparation, and SkinTE deployment are mandatory.
SkinTE is currently marketed as a human cell, tissue, and
cellular and tissue-based product regulated solely under Section
361 of the Public Health Service Act (PHS Act) and 21 CFR Part 1271
(i.e., as a 361 HCT/P). PolarityTE plans to file an investigational
new drug application (IND) with FDA followed by a biologics license
application (BLA) to have SkinTE regulated as a biologic under the
federal Food Drug & Cosmetic Act and Section 351 of the PHS Act
(i.e., as a 351 HCT/P), and will propose to FDA a plan for
transitioning SkinTE from a 361 HCT/P to a 351 HCT/P.
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
Report on Form 10-K 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 trademarks or registered
trademarks of PolarityTE, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210203005922/en/
Investors: Rich Haerle VP, Investor Relations PolarityTE,
Inc. ir@PolarityTE.com (385) 315-0697
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