PolarityTE™, Inc. (NASDAQ:COOL) today announced that the Company’s
lead product, SkinTE™, has been registered with the U.S. Food and
Drug Administration (FDA) pursuant to applicable regulations
governing human cells, tissues, and cellular and tissue-based
products (HCT/Ps). SkinTE™ is an autologous, minimally manipulated
construct intended for homologous uses of skin tissues. As an
FDA-registered HCT/P, SkinTE™ may now be made available for
appropriate human use in the United States. PolarityTE™ has
initiated a controlled, limited-market release of the product to
select medical institutions, and expects to accelerate
commercialization in 2018 as the company scales up manufacturing
efforts.
“The FDA registration of SkinTE™ is an important
regulatory step that sets the stage for commercialization and a
staged market entry of this revolutionary technology into clinical
application,” said Denver M. Lough, M.D., Ph.D., Chief Executive
Officer of PolarityTE™. “This achievement enables us to deliver an
entirely new and pragmatic solution for skin regeneration as well
as the ability to change the face and practice of regenerative
medicine toward patient-tailored tissue constructs.”
In pre-clinical studies, SkinTE™ demonstrated
full-thickness regenerative healing, nascent hair follicle
formation, cutaneous appendage development, immediate and complete
wound coverage, and the progressive regeneration of all skin layers
including epidermis, dermis and hypodermal layers.
(www.PolarityTE.com/products/SkinTE).
“This progressively-staged market release of
SkinTE™ to select institutions will give the Polarity team time to
scale manufacturing processes and facilities to meet future demands
of SkinTE™ as well as other tissue substrate technologies we have
in our translational development pipeline,” said Edward W. Swanson,
M.D., Chief Operating Officer of PolarityTE™.
About SkinTE™ and FDA Tissue
Establishment RegistrationSkinTE™ is regulated by the FDA
as an HCT/P solely under Section 361 of the Public Health Service
Act and 21 CFR 1271. The FDA has specific regulations governing
HCT/Ps. HCT/Ps that meet the criteria for regulation solely under
Section 361 of the Public Health Service Act and 21 CFR 1271 (361
HCT/Ps) are not subject to pre-market clearance or approval
requirements, but are subject to post-market regulatory
requirements.
SkinTE™ is processed and marketed in accordance
with the FDA’s requirements for human tissue and current good
tissue practices (21 CFR 1271) and is manufactured by American
Association of Tissue Banks (AATB)- and Foundation for the
Accreditation of Cellular Therapy (FACT)-accredited facilities.
Important Safety
InformationPoor general medical condition or any pathology
that would limit the blood supply and compromise healing, as well
as nonvascular surgical sites, should be considered when selecting
patients for SkinTE™, as such conditions may compromise successful
outcomes or lead to sub-optimal results.
Whenever clinical circumstances require
implantation in a site that is contaminated or infected,
appropriate local and/or systemic anti-infective measures must be
taken. Unused or expired tissue product should be discarded
according to local, state, federal and institutional requirements.
Utilization of the SkinTE™ construct, process and/or technology is
limited to healthcare professionals and facilities that are capable
of handling such tissue products.
Proper aseptic procedural and/or surgical
handling is mandatory when using SkinTE™. Failure to ensure proper
aseptic technique may result in contamination of the tissue product
and wound bed. Contamination of the tissue product and/or wound bed
due to failure to ensure aseptic technique could result in local,
regional, or systemic infection, partial or complete failure of
graft take, healing, and/or regeneration, serious injury, and/or
death. Failure to follow instructions may lead to sub-optimal
outcomes and/or product failure.
Potential adverse effects may include but are
not limited to the following: local tissue, wound bed, regional
tissue, or systemic infection, hypersensitive, allergic, or
other immune response to the product or trace amounts of
antibiotic retained from primary harvest, deleterious effects on
potential surrounding or adjacent autologous, allogeneic, or
xenogenic grafts, skin substitutes, or other reconstructions
including infection and/or failure of adjacent grafted material to
take and heal, requirement for further surgical operation(s) and/or
debridement, or death.
About PolarityTE™ PolarityTE™,
Inc. is a regenerative medicine company, and the first to
successfully regenerate full-thickness tissue. The Company's novel
regenerative medicine platform and proprietary technology employs a
patient's own cells for the healing of full-thickness,
functionally-polarized tissues. If clinically successful, the
PolarityTE™ platform will provide medical professionals with a
truly new paradigm in wound healing and reconstructive surgery by
utilizing a patient's own tissue substrates for the regeneration of
skin, bone, muscle, cartilage, fat, blood vessels and nerves. The
PolarityTE™ platform leverages natural and biologically-sound
principles which are readily adaptable to a wide spectrum of organ
and tissue systems. This revolutionary technology, paired with the
Company's world-renowned clinical advisory board, position
PolarityTE™ to drastically change the field and future of
translational regenerative medicine. More information can be found
online at www.PolarityTE.com.
Forward Looking
StatementsCertain statements contained in this release are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward looking
statements contained in this release relate to, among other things,
the Company's ongoing compliance with the requirements of The
NASDAQ Stock Market and the Company's ability to maintain the
closing bid price requirements of The NASDAQ Stock Market on a post
reverse split basis. They are generally identified by words such as
"believes," "may," "expects," "anticipates," "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 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.
Contacts:
Scott SantiamoRusso Partners
LLCScott.Santiamo@RussoPartnersLLC.com (718) 344-5843
David SchullRusso Partners
LLCDavid.Schull@RussoPartnersLLC.com (858) 717-2310
Corner Growth Acquisition (NASDAQ:COOL)
Historical Stock Chart
From Aug 2024 to Sep 2024
Corner Growth Acquisition (NASDAQ:COOL)
Historical Stock Chart
From Sep 2023 to Sep 2024