montanus
6 years ago
Barry Honig involved in Xechem scam
Barry Honig, Michael Brauser, Konrad Ackermann, David Blech, Margy Chassman manipulated, pumped and dumped Xechem Pharmaceutical, shut it down and steal the assets, sold Patents and drugs like Nicosan, now Xickle, and drug candidates worth millions to their new private firm Invenux for $45k with Dr. Swift as marionette. Xickle, scd101 in Phase 1 trial, most promissing drug for Sickle Cell, 4 billion market. Shareholders were screwed!!!
https://www.sec.gov/news/press-release/2018-182
Steponit
6 years ago
Addition to board of directors:
PolarityTE Names Ramses (Rainer) Erdtmann and David Seaburg to Bd of Directors >COOL
Aug 09, 2018 08:30:00 (ET)
PolarityTE, Inc. Announces the Addition of Ramses Erdtmann, Managing Partner at Point Sur Investors and Former Executive at Pharmacyclics, and David Seaburg, Managing Director at Cowen and CNBC Contributor, to the Board of Directors
SALT LAKE CITY, Aug. 09, 2018 (GLOBE NEWSWIRE) -- PolarityTE, Inc. (Nasdaq: COOL), 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 for the fields of medicine, biomedical engineering and material sciences, today announced the addition of Ramses (Rainer) Erdtmann and David Seaburg to the Board of Directors. Mr. Erdtmann is a Managing Partner at Point Sur Investors, a biotech investment fund focused on innovative therapies. Mr. Erdtmann previously worked at Pharmacyclics from 2008 through 2015 and remained with AbbVie as a consultant until 2016 post the acquisition of Pharmacyclics by AbbVie. Mr. Seaburg is a Managing Director at Cowen, Inc. and a CNBC contributor, regularly commenting on the financial prospects of companies and interacting with management teams and institutional investors.
Mr. Erdtmann is replacing Ned Swanson, MD, Chief Operating Officer, as a member of the Board of Directors. With the addition of Mr. Erdtmann and Mr. Seaburg to the Board of Directors, PolarityTE increases the number of Directors from seven to eight, with six of the Board's Directors being independent. Dr. Swanson remains the Chief Operating Officer and PolarityTE thanks him for his contributions to the Board since the formation of the Company.
During his time at Pharmacyclics, Mr. Erdtmann witnessed and helped grow Pharmacyclics from 47 employees and a market cap of $20 Million, to 634 employees and a market cap of $21 Billion. Mr. Erdtmann oversaw several departments and helped Pharmacyclics evolve into a fully integrated biotech company. He held a number of roles and, at various times, also had responsibility for Accounting, SEC Reporting, Audits, Corporate Communications and Investor Relations. He worked closely with the CEO and the Audit and Compensation Committee. Mr. Erdtmann actively participated in the final execution of key corporate milestones for Pharmacyclics, including the Collaboration Agreement with Johnson & Johnson in 2011 and the Merger Agreement with AbbVie in 2015.
Mr. Seaburg is a Managing Director and Head of Sales Trading at Cowen, a leading healthcare franchise in equities research, sales and trading and investment banking. Over the course of his more than 20 year career at Cowen in both Equity Sales Trading and Trading, Mr. Seaburg has advanced to increasingly senior roles at the firm. In 2006, Mr. Seaburg was named Head of Sales Trading and appointed to the firm's Equity Operating Committee. In his role at Cowen, Mr. Seaburg has interacted with thousands of healthcare investors and company management teams. Mr. Seaburg is a CNBC Fast Money Contributor and provides regular on-air market commentary for the network.
Denver Lough, CEO of PolarityTE said, "We are very pleased to have Mr. Erdtmann and Mr. Seaburg join the Board of Directors at this important stage in our development. Ramses' operational experience at Pharmacyclics during its transition into a multi-billion dollar commercial biotech company and David's investment expertise, long tenure at Cowen, and experience with healthcare management teams will be tremendously valuable as PolarityTE continues to execute on the business."
Ramses Erdtmann commented, "PolarityTE's products are truly transformational and life changing to many patients. I believe the company's mission and purpose are very important to the field of regenerative medicine. The team has made incredible advances to date and it is my honor join the board of directors, leverage my experience and support PolarityTE in achieving its long-term goals and potentials."
Mr. Seaburg commented, "I'm honored to join PolarityTE's Board and am convinced the proprietary technology being developed has real potential to change the paradigm of tissue regeneration, from skin wound care to various other tissues and organs. There are not many opportunities to be part of a company with a platform technology that has the potential to revolutionize medicine, and I'm eager to play an active role in this important process for PolarityTE."
About PolarityTE(TM)
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(TM)
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 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. 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.
CONTACTS:
Investors:
Rich Haerle
PolarityTE, Inc.
ir@PolarityTE.com
(385) 831-5284
Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 535-7743
Media:
David Schull
Russo Partners LLC
David.Schull@RussoPartnersLLC.com
(858) 717-2310
(END) Dow Jones Newswires
August 09, 2018 08:30 ET (12:30 GMT)
(MORE TO FOLLOW) Dow Jones Newswires (212-416-2800)
August 09, 2018 08:34 ET (12:34 GMT)
Steponit
6 years ago
Nice recent PR:
PolarityTE, Inc. Provides Commercial Update
Jul 25, 2018 09:00:00 (ET)
PolarityTE, Inc. Provides Commercial Update
SALT LAKE CITY, July 25, 2018 (GLOBE NEWSWIRE) -- PolarityTE, Inc. (Nasdaq:COOL), a commercial-stage biotechnology and regenerative biomaterials company, today announced an update on the Company's commercial progress. The Company's first product, SkinTE, has transitioned into Stage 2 of commercialization and has continued to be successful in regenerating autologous full-thickness skin in the treatment of complex wounds including acute and chronic wounds, traumatic and surgical defects, burn wound reconstruction and skin graft replacement. With continued growing physician, facility, and VAC committee purchase agreement approvals, the Company has begun generating revenues while improving the lives of patients.
A Recent Patient Story
This past weekend, a young patient treated with SkinTE and his family appeared in the press stating that "SkinTE gave [the patient] hope where there was absolutely none left waiting for him," that they were out of all other treatment options, and that they "have watched it save [his] life."
1 Month into Formal Stage-2 of SkinTE Commercialization
While the Company's Commercial Target Regional Market release has just begun in major metropolitan regions, SkinTE continues to gain approvals by Value Analysis Committees (VAC) in many hospitals, medical centers, and physician offices nationwide. To date, all hospitals, clinics, and practices that have completed their evaluations of the product have initiated purchase agreements with the Company. As a result, the Company continues to grow revenues and now expects to exceed both internal and Bloomberg consensus 3Q revenue estimates.
PolarityTE Quarterly Conference Calls
The Company will announce its third quarter results and provide a corporate update in the first half of September, and will host a formal conference call with key executive management.
Upcoming Clinical Outcomes Presentations at National Research Conferences
Clinical outcomes of SkinTE will be presented as part of the Scientific Program at the Annual Meeting of the American Society of Plastic Surgeons in Chicago (September 28-October 1, 2018). The Company also plans to host an investor webcast for this event, with details to follow.
PolarityTE Technologies and Intellectual Property
The Company continues to actively file patent and trademark applications to protect its intellectual property and grow its IP portfolio as it relates to core cell-tissue biotechnologies and advanced related technology derivates (RTDs). The Company remains engaged in normal patent prosecution with all three of its U.S. non-provisional patent applications: U.S. Application No. 14/954,335 published as US 2016/0151540; U.S. Application No. 15/650,656 published as US 2018/0154043; and U.S. Application No. 15/650,659 published as US 2018/0154044.
False Claims by Short Sellers, Competitors, and Malicious Agents
Despite the success observed with the initial roll out of SkinTE, there have been unsubstantiated rumors regarding the company and its lead product, SkinTE, by short sellers and competitors. While the company does not ordinarily comment on rumors and speculation, when these rumors start to affect SkinTE patients, their families, and their caregivers, we feel obligated to correct such misinformation. Individuals and/or groups on certain social media websites have recently engaged in deplorable attacks directed towards SkinTE patients and caregivers, and the Company condemns such disgusting and unacceptable bullying.
The Company is not a "fraud," as known short sellers have claimed recently, and will not let these misrepresentations affect patients whose lives are at risk. There are many examples of patients whose lives have been positively affected by SkinTE, several of which were presented during the June 25, 2018 KOL summit in New York City.
PolarityTE's First Priority Remains on Patients
The Company continues to develop disruptive and daring technologies that may upend the paradigm of existing treatments, and which challenge conventional thinking. PolarityTE remains squarely focused on and committed to delivering tangible benefits to patients with significant unmet needs.
About PolarityTE(TM)
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 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. 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.
CONTACTS:
Investors:
Rich Haerle
PolarityTE, Inc.
ir@PolarityTE.com
(385) 831-5284
Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 535-7743
Media:
David Schull
Russo Partners LLC
David.Schull@RussoPartnersLLC.com
(858) 717-2310
(END) Dow Jones Newswires
July 25, 2018 09:00 ET (13:00 GMT)
Steponit
6 years ago
I like this PR from last week. It tells me they are moving beyond the human testing stage into selling, (which will be followed by revenues).
"PolarityTE(TM) Accelerates Sales Team for Targeted Regional Release of SkinTE(TM)
May 09, 2018 08:30:00 (ET)
PolarityTE(TM) Accelerates Sales Team for Targeted Regional Release of SkinTE(TM)
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(TM). 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(TM)
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(TM)
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)."