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TOPIC: PolarityTE, Inc. Not Waiting For FDA Approval With Autologous Wound Therapy

PolarityTE, Inc. Not Waiting For FDA Approval With Autologous Wound Therapy 15 Dec 2017 14:21 #10793

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www.polarityte.com/products/skinte

Interesting how this company is already commercializing under HCP/T regulations NOW while Cytori through its BARDA contract is still years away.

SALT LAKE CITY, Dec. 15, 2017 (GLOBE NEWSWIRE) -- 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 Registration
SkinTE™ 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 Information
Poor 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 .
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PolarityTE, Inc. Not Waiting For FDA Approval With Autologous Wound Therapy 15 Dec 2017 15:13 #10796

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PolarityTE - new company with not much of a proven track record - up .19 on the news?? - I do not think their skin application appears to even be in the same league as BARDA - JMHO.

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PolarityTE, Inc. Not Waiting For FDA Approval With Autologous Wound Therapy 15 Dec 2017 15:36 #10797

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Interesting WST
So they have been patient cloning skin for decades now. Send off a square inch and a few weeks later get 100 square inches back.
Without trying to over simplify, this appears to be a different twist on that.
Certainly something more familiar for surgeons in this approach.

RS
Thank goodness for PolarityTE it isn't in the same league as BARDA !!!

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PolarityTE, Inc. Not Waiting For FDA Approval With Autologous Wound Therapy 15 Dec 2017 15:40 #10798

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LOL, No proven track record??? I guess Cytori's track record makes you feel much more comfortable? At first I had my doubts about this company but the management team is very impressive. Their product appears to work to produce all layers of a full thickness burn including hair follicles and sweat blands and they are already treating patients. No mini lipo required. They have a big headstart here and no baggage.

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PolarityTE, Inc. Not Waiting For FDA Approval With Autologous Wound Therapy 15 Dec 2017 15:45 #10800

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Oh...just to clarify my above post when speaking of cloning for decades...when I said "they" I didn't mean PolarityTE

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PolarityTE, Inc. Not Waiting For FDA Approval With Autologous Wound Therapy 15 Dec 2017 16:08 #10801

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Wall Street Titan wrote: LOL, No proven track record??? I guess Cytori's track record makes you feel much more comfortable? At first I had my doubts about this company but the management team is very impressive. Their product appears to work to produce all layers of a full thickness burn including hair follicles and sweat blands and they are already treating patients. No mini lipo required. They have a big headstart here and no baggage.


Read the CEO's quote again and look a little deeper into the past! It's not quite BARDA. How much of the 1.5 million in sales is the fabricated skin?

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