PolarityTE Issues Statement On Misleading Internet Post
Oct 18, 2018 18:47:48 GMT
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Post by Deleted on Oct 18, 2018 18:47:48 GMT
SALT LAKE CITY, Oct. 18, 2018 /PRNewswire/ -- PolarityTE, Inc. (PTE), 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 issued the following statement in response to Citron Research:
The false and misleading assertions made by Citron, a publication well-known to be used as tool by notorious short sellers, are designed to negatively impact PolarityTE's share price for the benefit of short sellers and other colluding agents, and are contrary not only to PolarityTE's view, but also to that of our physician partners, KOLs, and SkinTE patients. As PolarityTE noted in a press release issued on October 9, 2018, unusual and suspected illegal trading activity in the Company's securities has been observed and has been reported to appropriate regulatory authorities. This conduct from Citron—whose founder has been barred from trading on certain exchanges in the past due to manipulative activity—is consistent with a pattern and practice of deliberate distortion to negatively impact PolarityTE. Those engaging in illegal manipulative trading activity such as "short and distort" schemes, "naked short" selling, and pre-arranged trading are accountable under federal laws enforced by the regulators. The Company will not be distracted from its patient-focused mission. Here are the facts:
Technology
PolarityTE remains focused on transforming the lives of patients with regenerative and functional tissue-based solutions, fulfilling a significant unmet need. SkinTE recently transitioned into Stage 2 of commercialization, and the Company's Commercial Target Regional Market release began in July 2018 in major metropolitan regions. SkinTE continues to gain approvals by Value Analysis Committees (VAC) in many hospitals, medical centers, and physician offices nationwide. In fact, our track record here is 100% -- 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 our third quarter 2018 financial results exceeded both internal and consensus estimates.
FDA
SkinTE™ is registered with the FDA as is required of human cells, tissues, and cellular and tissue-based products ("HCT/P") and regulated solely under Section 361 of the Public Health Service Act (i.e., as a "361 HCT/P"). PolarityTE is subject to routine post-market regulation, including facility inspections, by the FDA. PolarityTE does not comment on non-final observations related to interactions with the FDA that are part of the routine regulatory process. The Company has responded to the non-final observations and will continue to follow any guidance provided by the FDA.
Patent Application
Citron's statements about PolarityTE's patent applications (on which its first report was predicated) demonstrate at best clear lack of understanding about the patent application process, or a deliberate attempt to mislead investors and the public. Citron continues to portray the "final rejection" of one patent as a material event. In fact, what is called a "final rejection" (which patent experts consider misleading terminology) is a normal part of the patent application and approval process. According to a leading patent attorney and commentator on patent law, "Only those who are completely unfamiliar with patent practice and procedure could possibly make such an erroneous claim."1 Contrary to what Citron misleadingly suggests, the Company has responded to the USPTO and its patent prosecution continues on the referenced application as well as multiple additional applications.
Governance
Citron has also continued to focus on a number of individuals who are no longer affiliated with PolarityTE's Board of Directors or management. PolarityTE has an independent Board, composed of eight highly-qualified directors, all of whom were appointed in the past two years and six of whom are independent, who together bring a wide variety of biotechnology, regenerative medicine, healthcare delivery, operations, governance and finance expertise that is critical to PolarityTE's business. Since July 2018, the Company has appointed three new members to its Board, including Peter Cohen, former Board Member of the New York Stock Exchange (NYSE) and Chairman and CEO of Cowen Inc.; Ramses (Rainer) Erdtmann, Managing Partner at Point Sur Investors and formerly an executive at Pharmacyclics; and David Seaburg, Managing Director at Cowen.
PolarityTE is a company founded by healthcare providers and remains focused on its mission to create innovative and life-changing products to improve humanity.
The false and misleading assertions made by Citron, a publication well-known to be used as tool by notorious short sellers, are designed to negatively impact PolarityTE's share price for the benefit of short sellers and other colluding agents, and are contrary not only to PolarityTE's view, but also to that of our physician partners, KOLs, and SkinTE patients. As PolarityTE noted in a press release issued on October 9, 2018, unusual and suspected illegal trading activity in the Company's securities has been observed and has been reported to appropriate regulatory authorities. This conduct from Citron—whose founder has been barred from trading on certain exchanges in the past due to manipulative activity—is consistent with a pattern and practice of deliberate distortion to negatively impact PolarityTE. Those engaging in illegal manipulative trading activity such as "short and distort" schemes, "naked short" selling, and pre-arranged trading are accountable under federal laws enforced by the regulators. The Company will not be distracted from its patient-focused mission. Here are the facts:
Technology
PolarityTE remains focused on transforming the lives of patients with regenerative and functional tissue-based solutions, fulfilling a significant unmet need. SkinTE recently transitioned into Stage 2 of commercialization, and the Company's Commercial Target Regional Market release began in July 2018 in major metropolitan regions. SkinTE continues to gain approvals by Value Analysis Committees (VAC) in many hospitals, medical centers, and physician offices nationwide. In fact, our track record here is 100% -- 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 our third quarter 2018 financial results exceeded both internal and consensus estimates.
FDA
SkinTE™ is registered with the FDA as is required of human cells, tissues, and cellular and tissue-based products ("HCT/P") and regulated solely under Section 361 of the Public Health Service Act (i.e., as a "361 HCT/P"). PolarityTE is subject to routine post-market regulation, including facility inspections, by the FDA. PolarityTE does not comment on non-final observations related to interactions with the FDA that are part of the routine regulatory process. The Company has responded to the non-final observations and will continue to follow any guidance provided by the FDA.
Patent Application
Citron's statements about PolarityTE's patent applications (on which its first report was predicated) demonstrate at best clear lack of understanding about the patent application process, or a deliberate attempt to mislead investors and the public. Citron continues to portray the "final rejection" of one patent as a material event. In fact, what is called a "final rejection" (which patent experts consider misleading terminology) is a normal part of the patent application and approval process. According to a leading patent attorney and commentator on patent law, "Only those who are completely unfamiliar with patent practice and procedure could possibly make such an erroneous claim."1 Contrary to what Citron misleadingly suggests, the Company has responded to the USPTO and its patent prosecution continues on the referenced application as well as multiple additional applications.
Governance
Citron has also continued to focus on a number of individuals who are no longer affiliated with PolarityTE's Board of Directors or management. PolarityTE has an independent Board, composed of eight highly-qualified directors, all of whom were appointed in the past two years and six of whom are independent, who together bring a wide variety of biotechnology, regenerative medicine, healthcare delivery, operations, governance and finance expertise that is critical to PolarityTE's business. Since July 2018, the Company has appointed three new members to its Board, including Peter Cohen, former Board Member of the New York Stock Exchange (NYSE) and Chairman and CEO of Cowen Inc.; Ramses (Rainer) Erdtmann, Managing Partner at Point Sur Investors and formerly an executive at Pharmacyclics; and David Seaburg, Managing Director at Cowen.
PolarityTE is a company founded by healthcare providers and remains focused on its mission to create innovative and life-changing products to improve humanity.
