PolarityTE™ Announces Application of SkinTE™ on First Patients
December 15 2017 - 8:00AM
PolarityTE, Inc. (NASDAQ:COOL) announced that human use of SkinTE™
is underway, and the product is now on patients, at multiple
centers, within a variety of wound types and indications including
acute and chronic wounds, burn wounds, surgical reconstructions and
scar revisions. In addition, several patients with healed skin
grafts, the gold standard treatment, have undergone removal of
those grafts and replacement with SkinTE. Multiple medical centers
have scheduled additional procedures through the end of 2017, and
the Company expects an increasing number of applications during the
first half of 2018 to meet market demand for the product. As
clinical application grows, results and outcomes from the first
group of treated patients are expected to be published throughout
the first half 2018, addressing the many different patient
populations treated.
“Application of SkinTE across this wide spectrum of cutaneous
defects demonstrates the broad utility of this novel product beyond
burn care, and we look forward to the results for all of the
amazing patients being treated with SkinTE,” said Dr. Denver Lough,
Chief Executive Officer of PolarityTE. “We are confident and
believe that SkinTE will replicate its preclinical success and help
patients regenerate their own full-thickness, hair-bearing skin. We
did not set out to bring another iteration to the field of
regenerative medicine—we set out to change it entirely. Welcome to
the Shift™.”
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.
Investor ContactJohn Stetson
InvestorRelations@PolarityTE.com (385) 237-2365
Media ContactsScott Santiamo Russo Partners LLC
Scott.Santiamo@RussoPartnersLLC.com (718) 344-5843David
Schull Russo Partners LLC David.Schull@RussoPartnersLLC.com
(858) 717-2310
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