6-27-2018 - PolarityTE Provides Update on Key Opinion Leader Event and Addresses Misleading Report
SALT LAKE CITY, June 27, 2018 (GLOBE NEWSWIRE) -- PolarityTE, Inc. (Nasdaq:COOL) today announced that the Company hosted a successful meeting of key opinion leaders in New York City on June 25, 2018, addressing the use of SkinTE™ in complex wounds requiring cutaneous reconstruction. The three medical providers who presented at the event discussed the standard of care, limitations in the field, and their use of SkinTE, including patient outcomes and ongoing cases. The presentations emphasized the challenging nature of many of the complex wounds treated, and the encouraging and positive healing observed to date.
The Company’s primary focus is on transforming the lives of patients by discovering, designing and developing a range of regenerative cell and tissue-derived products that have the potential to significantly impact patient quality of life.
The Company also wishes to address certain statements made in an opinion piece published by a short seller to coincide with the KOL summit.
Intellectual Property
Regarding online statements about a “non-final rejection” and a “final rejection” notice from the USPTO, the Company notes that such statements refer to the receipt of office actions from the USPTO. Office actions are part of the normal patent prosecution process and are received on the “notification date” identified on each office action. The Company is actively pursuing a variety of claims within multiple published non-provisional patent applications in the U.S. The prosecution dialogue between an applicant and the USPTO commonly includes a series of office actions as well as the applicant’s responses to such office actions. It is common for a first office action to be referred to as a “non-final rejection,” and for a second office action to be referred to as a “final rejection.” Importantly, however, in each such instance the applicant has the opportunity to respond to the USPTO, as well as to continue prosecution thereafter. The Company recently received a second office action on one published patent application and is moving forward with a timely response. The process of patent prosecution before the USPTO can be lengthy. However, the Company does not feel that lack of issued patents should deprive patients of the very real potential benefits they can receive from our products in the interim.
Material Information about the Company’s intellectual property and risks related to obtaining patent protection are disclosed in our SEC filings and reports. The Company has highlighted repeatedly throughout our SEC filings and reports that we have applied for patent protection, that we do not own any issued patents on our technology, and that we rely on protecting our processes and technologies by seeking patent protection as well as by maintaining certain aspects as trade secrets. Our objective is to build a portfolio of patents, in conjunction with the continued protection of our trade secrets and know-how, in order to further protect our regenerative medicine platform and derivative technologies, as well as the manufacturing and deployment processes of those technologies.
S-8 Registration Statement
The Company strongly disputes any claim that any current directors or officers have sold shares of the Company’s stock in the last 12 months. These contentions are a mischaracterization of basic SEC registration practice. Registration of the securities issuable under an incentive stock plan is a routine event and does not equate to a sale of shares. The Company filed a registration statement on Form S-8 with the SEC on May 29, 2018, which covers shares and options granted to its current and former employees and directors under the Company’s incentive stock plan. The filing of a Form S-8 is a customary practice for publicly-held companies. None of the current officers and directors of the Company have sold shares. As is well known, directors, officers, and certain other insiders or affiliates are generally required to publicly report such sales within two days of sale. In addition, as the Company previously reported, its officers and directors continue to be subject to lock-up agreements that prohibit them from selling any shares until September 2018.
Shareholders and Other Companies
With respect to any statements regarding matters involving any of the Company’s shareholders, the Company relies upon the accuracy of SEC filings made by its shareholders. The Company does not comment on matters involving other companies.
The Company believes that there is strong momentum in the business and looks forward to sharing additional information about expected positive outcomes with SkinTE, and the ongoing development of the Company’s pipeline.
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