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Press Release

PolarityTE™ Accelerates Sales Team for Targeted Regional Release of SkinTE™


Posted on: 09 May 18

SALT LAKE CITY, May 09, 2018 (GLOBE NEWSWIRE) -- PolarityTE, Inc. (Nasdaq:COOL) announced today that it is growing its commercial presence by hiring dedicated sales representatives on the East Coast to accelerate the regional market release of SkinTE™. SkinTE is a human cellular and tissue-based product derived from a patient’s own skin, and is intended for the repair, reconstruction, and replacement of skin tissue. SkinTE results have shown the regeneration of full-thickness (epidermis, dermis and hypodermis), functionally-polarized skin with all the appendages including hair and glands.

These dedicated sales representatives have extensive prior experience with major wound care companies and products, including product launches, and they will build on efforts to reach leaders in the field of plastic and reconstructive surgery as early adopters of SkinTE. Their regions span the Mid-Atlantic and the tri-state area of New York, New Jersey, and Pennsylvania.

“We look forward to continued growth in the adoption of SkinTE with our targeted sales strategy. Our market access and physician-lead clinical operations teams will continue to be integral to our deployment approach and will work in concurrence with the new team members to ensure providers have the necessary information and support during their initial uses of SkinTE,” commented Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE. He continued, “SkinTE was designed to be simple for providers to use and we believe it is a clear improved alternative to the current available therapies for skin defects. Our early clinical outcomes from the use of SkinTE continue to ignite provider-driven demand for a product poised to change the paradigm of regenerative medicine.”

About PolarityTE™
PolarityTE is a commercial-stage biotechnology and regenerative biomaterials company 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. The PolarityTE platform technology begins with a small piece of the patient’s own, or autologous, healthy tissue, rather than artificially manipulated individual cells. From this small piece of healthy autologous tissue, the company creates an easily deployable, dynamic and self-propagating product designed to enhance and stimulate the patient’s own cells to regenerate the target tissues. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures with the patient’s own tissue and uses the patient’s own body to support the regenerative process to create the same tissue from which it was derived. PolarityTE’s innovative method is intended to promote and accelerate growth of the patient’s tissues to undergo a form of effective regenerative healing.

About SkinTE™
SkinTE is intended to be used by physicians or other appropriate healthcare providers for homologous uses of skin tissues/integument. Patients who have suffered from an event, disease, process or acquired deficit that results in the functional loss or void of skin/integument systems can receive SkinTE as an adjunct and/or in place of split-thickness skin grafting, full-thickness grafting, temporizing skin coverage and/or skin substitute products.

SkinTE is for autologous use only. Aseptic technique during harvest and deployment of SkinTE is mandatory. SkinTE use is contraindicated in patients who have suffered autoimmune responses to the auto-transplantation of their own tissues.

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.

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. 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,” “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 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. Our 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).

CONTACT

Investors:
John Stetson
InvestorRelations@PolarityTE.com
(385) 237-2365

Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com 
(617) 535-7743

Media:
David Schull
Russo Partners LLC
David.Schull@RussoPartnersLLC.com  
(858) 717-2310

Jenna Mathis
jennamathis@polarityte.com 
(610) 751-3985

Sales:
Sales@PolarityTE.com 

GlobeNewswire
globenewswire.com

Last updated on: 09/05/2018

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