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Morning Huge Bio Deal " BMY " buying " CELG " could be the start of 2019 The Year of the BIOTECHs. GLTA
Going to repeat an old Cliché Setting up for the " Mother of All Short Squeeze "
Another nice press release:
PolarityTE and University Hospitals Cleveland Medical Center Announce System-Wide Approval of SkinTE(TM)Font size: A | A | A
8:00 AM ET 12/19/18 | PR Newswire
RELATED QUOTES
10:42 AM ET 12/19/18
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PTE
15.25 13.38%
Real time quote.
SALT LAKE CITY and CLEVELAND, Dec. 19, 2018 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE), a commercial-stage biotechnology company focused on transforming the lives of patients by discovering, designing and developing a range of regenerative tissue products using a patient's own tissue, and the University Hospitals Cleveland Medical Center jointly announced today that SkinTE(TM) is now available for use throughout the UH network of healthcare facilities. SkinTE is the first commercially-available autologous, homologous product that regenerates full-thickness skin that is fully-functional, and is an alternative to skin grafts and skin substitutes. UH is the first healthcare provider in the state of Ohio to offer SkinTE to its patients.
Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE said, "Our goal is to bring to market innovative, regenerative therapies that provide significant benefits to both patients and providers, and set new standards of care in wound and burn treatment. The agreement with University Hospitals is another example of our continued success in building strong relationships with national healthcare providers. We are thrilled to partner with UH in delivering a solution that is both clinically-beneficial and cost-effective and one that can improve the lives of their patients."
"SkinTE has made an immense impact on our pediatric patients at UH by minimizing donor skin site pain, discomfort and unsightly scarring. Patients and their parents have noticed that the regenerated skin is soft, pliable and non-adherent to the underlying wound. SkinTE is a complete paradigm shift from adherent split graft treatment of the last century," said Anand Kumar, MD, FACS, FAAP, Division Chief of Pediatric Plastic Surgery, Rainbow Babies Children's Hospital of Case Western Reserve University.
SkinTE is intended for the repair, reconstruction and replacement of lost or damaged skin due to burns, wounds, injuries, surgical reconstruction, scars and failed skin grafts. The UH network joins the growing list of healthcare facilities where SkinTE is approved for commercial use.
About University Hospitals / Cleveland, Ohio
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 40 outpatient health centers and 200 physician offices in 15 counties throughout northern Ohio. The system's flagship academic medical center, University Hospitals Cleveland Medical Center, located on a 35-acre campus in Cleveland's University Circle, is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; University Hospitals MacDonald Women's Hospital, Ohio's only hospital for women; and University Hospitals Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including "America's Best Hospitals" from U.S. News & World Report. UH is also home to Harrington Discovery Institute at University Hospitals -- part of The Harrington Project for Discovery & Development. UH is one of the largest employers in Northeast Ohio with 27,000 employees. For more information, go to www.UUhospitals.org. Follow UH on Facebook @UniversityHospitals and Twitter @UHhospitals.
About PolarityTE(R)
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. Learn more at www.PolarityTE.com -- Welcome to the Shift(R).
About SkinTE(TM)
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.
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.
Press Release: PolarityTE Announces Former FDA Official and Johnson & Johnson Executive Minnie Baylor-Henry Joins Board of Directors
PolarityTE Announces Former FDA Official and Johnson & Johnson Executive Minnie Baylor-Henry Joins Board of Directors
PR Newswire
SALT LAKE CITY, Dec. 11, 2018
SALT LAKE CITY, Dec. 11, 2018 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE), a commercial stage biotechnology 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, today announced the addition of Minnie Baylor-Henry to the Company's Board of Directors. Ms. Baylor-Henry is a regulatory affairs leader who served for nearly a decade at the U.S. Food and Drug Administration (FDA) before spending most of her career at Johnson & Johnson where she served in multiple roles, most recently as Worldwide Vice President of Regulatory Affairs. With this addition, the PolarityTE Board of Directors now includes nine individuals of varied backgrounds, seven of whom are independent.
While at the FDA, Ms. Baylor-Henry served as Regulatory Review Officer, Director/Branch Chief-Division of Drug Marketing, Advertising and Communications and National Health Fraud Coordinator at the FDA Office of Regulatory Affairs. Ms. Baylor-Henry's career at Johnson & Johnson included senior roles as the Vice President of U.S. Regulatory Affairs and Medical Affairs for Specialty Pharmaceuticals, Vice President of U.S. Regulatory Affairs and Medical Affairs for OTC products and Worldwide Vice President of Regulatory Affairs for Medical Devices. Additionally, Ms. Baylor-Henry was the National Director for Regulatory, Risk and Compliance for the life science division at Deloitte. She currently operates her own consulting firm, providing strategic regulatory affairs advice to pharmaceutical, biopharmaceutical and medical device companies.
As a leader in the life sciences regulatory field, Ms. Baylor-Henry served as the Chair of the Board of Directors for the Food and Drug Law Institute and the Drug Information Association, two of the most well-known and highly regarded associations for professionals in the food and drug space. Ms. Baylor-Henry received her pharmacy degree from Howard University's College of Pharmacy and a law degree from Catholic University's Columbus School of Law.
Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE commented, "We are thrilled that Ms. Baylor-Henry has joined our Board, and we look forward to capitalizing on her experience and wisdom as we continue to grow our product portfolio. Minnie's depth and breadth of knowledge across a variety of products, regulatory pathways and markets will be invaluable as we continue to develop and market products based on our platform technology."
Ms. Baylor-Henry commented, "After learning about PolarityTE and its potential to change the practice of medicine with its innovative technology and products, I was enthusiastic to join the Board and to be able to contribute to the company's success. I look forward to supporting PolarityTE's mission to bring medical technology to patients and providers that is truly different and life-changing."
About PolarityTE(R)
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. Learn more at www.PolarityTE.com -- Welcome to the Shift(R).
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, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are trademarks or registered trademarks of PolarityTE, Inc.
CONTACTS
Investors:
Rich Haerle
VP, Investor Relations
PolarityTE, Inc.
ir@PolarityTE.com
(385) 831-5284
Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 535-7743
Media:
Jenna Mathis
PolarityTE, Inc.
JennaMathis@polarityTE.com
(610) 751-3985
View original content to download multimedia:http://www.prnewswire.com/news-releases/polarityte-announces-former-fda-official-and-johnson--johnson-executive-minnie-baylor-henry-joins-board-of-directors-300763130.html
SOURCE PolarityTE, Inc.
/Web site: http://www.polarityte.com
> Dow Jones Newswires
Yep, looking good!
Looks like PTE brought in an industry veteran to put to rest any future regulatory concerns. PTE continues to move foward
Looks like people liked what they saw at that presentation yesterday, going by today's price action.
Me too. I'm long in PTE. It may take months or a year, but it's going to jump once those regional sales force operations they are putting together start doing their thing. And conference presentations like the one that takes place this Sunday should also help spread the word to the broader medical community.
Excited to see clinical results from PTE at conference on Sunday
Excited to see clinical results from PTE at conference on Sunday
Excited to see clinical results from PTE at conference on Sunday
Good news out today. SkinTE received a unique Q-code which allows for simplified reimbursement.
Citron's report is a bunch of steamy BS, more lies, misinformation, misdirection and grandiose accusations without facts. Citron has always made a killing on this template of an article since it is so difficult to sue them for it under US laws. They know they can get away with it, so continue to do so. They were sued and lost overseas.
Citron Report on PTE released today
https://citronresearch.com/polartityte-this-game-is-over-price-target-2/
Stock sounds basically worthless
Time to buy.
PolarityTE now has a stock symbol of $PTE. They were formerly known at $COOL.
PolarityTE is a regenerative skin and bone company. They take a small donor sample of skin or bone and use it to regenerate and grow a sort of paste which is applied to the open wound (burn victim skin replacement, for example) almost like spreading cake icing, where it grows as full thickness skin, complete with hair follicles, pigmentation, nerves, and sweat glands. It is a huge improvement from the current swiss cheesed sliced up skin graft methods. Some of their scientists are people who left prestigious jobs, such as the head of the burn center at Johns Hopkins, because they saw how promising this new method of skin replacement is compared to the old skin graft method of doing things. They completed animal testing, and human testing of the SkinTE, and are now expanding their operation and selling to hospitals and clinics in several locations, with plans to spread nationwide. Their bone division is still in the testing stages, but also looks very promising, able to grow back normal looking bone on damaged animal bones. And they are doing research to expand into other things such as cartilage and organs. And they also use their labs to do contract research for other companies as another way of making income. They have over 100 employees now. They are expanding rapidly. Many of the employees are big shareholders, yet there seems to be very little inside selling. An insider just yesterday bought a lot of additional shares. I've been following this company for over a year. I think they're just getting started. I have been accumulating slowly on the dips.
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