SALT LAKE CITY, UT -- (Marketwired) -- 04/20/17 -- PolarityTE™, Inc. ("Polarity") (NASDAQ: COOL) announces the signing of a manufacturing agreement with Cell Therapy and Regenerative Medicine ("CTRM") at the University of Utah School of Medicine. CTRM is the established manufacturer of hematopoietic stem cell transplants for renowned institutions of the Salt Lake region such as the Huntsman Cancer Institute and Primary Children's Hospital. In addition, CTRM manufactures a variety of regenerative medicine products, is FACT accredited, and has technical expertise in current Good Tissue Practice (cGTP) and current Good Manufacturing Practice (cGMP).
Denver Lough, MD, PhD, Chairman and CEO, stated, "This agreement with CTRM should provide PolarityTE™ with rapid clinical translation of the promising products we are developing, and takes us one step closer to achieving our goal of clinical application of our launch product, SkinTE™. As we prepare for market entry in 2018, our established relationship with CTRM creates a springboard for the anticipated scale-up to address the large burn and chronic wound markets, with the pursuit of our own independent manufacturing facility. Plans are solidifying for a unique solution to both commercial and emergent relief manufacturing of SkinTE™ and future Polarity products. Our goal is not only to meet demand, but also to be able to deliver promptly around the globe when urgent response is needed."
About Cell Therapy and Regenerative Medicine (CTRM)
CTRM at the University of Utah is engaged in delivering some of the world's most advanced cellular therapies to patients. CTRM provides unique resources and expertise that few organizations can internally create to achieve large scale manufacturing of cell- and tissue-based products for clinical trials. Highly experienced CTRM staff support the Blood and Marrow Transplant (BMT) Programs at Huntsman Cancer Institute and Primary Children's Hospital to deliver high quality stem cell products for the treatment of adult and pediatric patients diagnosed with leukemia, lymphoma, aplastic anemia and other types of blood diseases and disorders. CTRM is also developing and providing novel clinical grade cellular and tissue engineered products via comprehensive "bench" to "bedside" services that coordinate efforts of clinicians, entrepreneurs, researchers and bioengineers. CTRM with its industry partners is translating some of the newest cellular and tissue based discoveries into clinical applications to extend and improve the quality of life for individuals suffering from debilitating diseases and injuries. For more information go to www.medicine.utah.edu/cell.
About PolarityTE™, Inc.
PolarityTE™, Inc. is the owner of a novel regenerative medicine and tissue engineering platform developed and patented by Denver Lough, MD, PhD. This radical 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 be able to 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. It is because PolarityTE™ uses a natural and biologically sound platform technology, which is readily adaptable to a wide spectrum of organ and tissue systems, that the company and its world-renowned clinical advisory board, are poised to drastically change the field and future of translational regenerative medicine. More information can be found online at www.polarityte.com.
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," "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.
Source: PolarityTE, Inc.
Released April 20, 2017