SALT LAKE CITY, Sept. 26, 2018 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE) today announced the successful recruitment of sales directors in key major metropolitan markets who will facilitate the second phase of the regional market rollout of SkinTE. SkinTE is a human cellular and tissue-based product derived from a patient's own skin 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. Recently, the advanced SkinTE technology and clinical results earned accolades including Best Presentation at the American Professional Wound Care Association's 17th Annual Clinical Conference. Additional clinical outcomes data and material on the technology will be presented at multiple upcoming medical conferences.
Ten individuals with more than 160 combined years of experience in medical sales for advanced wound care products, biologics, durable medical equipment, and therapeutics have joined PolarityTE under the leadership of Alain Adam, Vice President of Sales. As previously announced, Mr. Adam has nearly two decades of life-sciences sales leadership experience including national accounts, market development, and commercial enablement.
These new regional sales directors each bring significant relationships within their respective regions, having previously represented companies such as Acclarent (now subsidiary of Johnson & Johnson), BSN medical, GlaxoSmithKline, LifeCell, Medtronic, MiMedx, Misonix, Novadaq (acquired by Stryker), Smith & Nephew, and TEI BioSciences (acquired by Integra). It is anticipated that the sales force will be in the field and operational by January 1, 2019, covering the nation's major metropolitan regions.
"This strategically chosen team of pioneers is excited to introduce PolarityTE's ground-breaking SkinTE product to providers and hospital systems around the country. SkinTE offers a unique clinical outcome – full-thickness skin – which until now has only been an option to patients and providers through complicated and invasive surgical procedures," Mr. Adam commented. "SkinTE was designed to provide an advanced autologous skin regenerative technology that is permanent, and which can be used by all types of clinical providers, from mid-levels to surgeons, across the spectrum of wound care in all types of settings, from trauma centers to outpatient clinics."
SkinTE regional sales directors will first focus efforts on the major metropolitan areas in the following regions: Northeast, Mid-Atlantic, Southeast, Midwest, Texas, and California.
"It is humbling to see such incredible talent joining the PolarityTE team as we continue to advance the commercialization of SkinTE, building on successful early clinical outcomes from our limited market release in a variety of patients, cutaneous defects, and settings of care. This skilled and targeted team of regional sales directors will help bring SkinTE to more patients and providers who need innovative products that deliver what they truly need – the patient's own skin," said Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of 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.
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 is marketed as an HCT/P regulated by the FDA 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. 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).
POLARITYTE, the POLARITYTE logo, and SKINTE are trademarks or registered trademarks of PolarityTE, Inc.