PolarityTE™ Lead Product, SkinTE™, is Approved for Use by Multiple Medical Institutions
October 19 2017 - 8:00AM
PolarityTE, Inc. (NASDAQ:COOL) today announced that multiple value
analysis committees have approved SkinTE™ for use at their
respective medical institutions as the Company continues its
commercialization efforts and manufacturing scale-up.
Clinical application is expected in the fourth quarter of 2017, and
data is planned to be released through multiple channels in the
first half of 2018.
“The approval of SkinTE™ by multiple medical
institutions’ value analysis committees validates our belief that
the medical community is eager to employ our technology and the
SkinTE™ product,” said Denver M. Lough, M.D., Ph.D., Chief
Executive Officer of PolarityTE™.
Dr. Lough continued, “we have received
tremendous interest from surgeons and other medical providers, and
we are committed to executing on our manufacturing and
commercialization strategy leading into 2018 to meet the
significant demand we are seeing and anticipating, and to address
the unmet needs of patients suffering from burns, wounds, and other
defects of skin tissues.”
About SkinTE™ and FDA Tissue
Establishment RegistrationSkinTE™ is marketed and
regulated by the U.S. Food and Drug Administration (FDA) as a human
cell, tissue, and cellular and tissue-based product (HCT/P) solely
under Section 361 of the Public Health Service Act and 21 CFR 1271.
HCT/Ps that meet the criteria for regulation solely under these
legal authorities are not subject to pre-market clearance or
approval requirements, but are subject to post-market regulatory
requirements.
SkinTE™ is processed and will be marketed in
accordance with the FDA’s requirements for human tissue and current
good tissue practices (21 CFR 1271) and is manufactured for
PolarityTE 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 use 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 potential 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:
John
StetsonInvestorRelations@PolarityTE.com(385) 237-2365
Scott SantiamoRusso Partners
LLCScott.Santiamo@RussoPartnersLLC.com(718) 344-5843
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