Calgary, Alberta, January 13, 2021 – FluroTech Ltd. (TSXV: TEST) (OTCQB: FLURF) (“FluroTech” or the “Company”), is pleased to announce it has retained PandiaDx LLC (“PandiaDx”) for regulatory guidance and services in preparation of its regulatory submissions to the U.S. Food and Drug Administration.
Melina Cimler, Ph.D. is the CEO and Founder of PandiaDx. She is a senior quality, regulatory, and in vitro diagnostic device expert with more than 30 years of experience in the life science and FDA-regulated diagnostic industry, leading regulatory, quality systems, clinical affairs, research, and product development organizations, with a focus on precision medicine.
She currently serves on the Board of Directors of Nanostics, Inc., and is a Scientific Board member of Athira Pharma, Inc., as well as an Expert Consultant of NDA Partners LLC.
Dr. Cimler previously served as Senior Vice President of Regulatory & Quality at Adaptive Biotechnologies until April 2018. She was formerly Head of Global Quality and Vice President of Quality, Regulatory, Clinical, and Government Affairs at Illumina, Inc., where she defined and executed regulatory strategy, resulting in the first next generation sequencing platform to receive FDA marketing authorization. Dr. Cimler has held executive leadership positions in quality, regulatory, clinical, and government affairs at Beckman Coulter, Inc., Abbott Molecular, Gen-Probe, Inc. (now Hologic), and C.R. Bard, and was head of Product Development at Epitope, Inc. (now OraSure Technologies). Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.
“We are honored to be working with Dr. Cimler as we prepare for the FDA submission process,” said Bill Phelan, CEO of FluroTest Systems Ltd. “Dr Cimler has a long history of success and is actively involved in providing guidance to a number of firms currently making FDA submissions. We will surely benefit from her guidance.”
FluroTech’s proprietary spectroscopy-based technology allows for the testing and identification of organic and inorganic compounds contained within biological samples for specific applications. Using technology that was first developed at the University of Calgary, FluroTech has created a two-part solution comprised of its CompleTest™ platform technology and consumable testing kits. Its accuracy has been independently validated. FluroTech continues to develop additional applications for the CompleTestTM platform technology. To learn more, visit FluroTech.com
About FluroTest Systems Ltd.
Unlike firms developing individual tests for the detection of SARS-CoV2, FluroTest is developing a complete system for surge-scale testing of viruses and other pathogens to be deployed in environments where significant numbers of people need to be tested rapidly and frequently. By combining and leveraging the disciplines of robotics automation, biochemistry (antibody labeling and binding), fluorescence detection and cloud computing, FluroTest believes it is creating the first pandemic defense platform of its kind.
FluroTest is seeking additional capital in the near-term and will also be exploring strategic partnerships with manufacturing and distribution companies to advance the deployment of the patent pending platform it is developing. To learn more, visit FluroTest.com
This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities. The securities described herein have not been and will not be registered under the United States Securities Act of 1933, as amended, or the securities laws of any state and may not be offered or sold within the United States or to or for the benefit or account of U.S. persons, absent such registration or an applicable exemption from such registration requirements.
Cautionary Statement Regarding Forward-Looking Information
This news release contains “forward-looking information” within the meaning of Canadian securities legislation. Forward-looking information generally refers to information about an issuer’s business, capital, technology or operations that is prospective in nature, and includes future-oriented financial information about the issuer’s prospective financial performance or financial position. The forward-looking information in this news release includes disclosure about the Company’s perusal of strategic alternatives for its Cannabis and Hemp sector focused business, its focus on pandemic testing devices, its proposed transaction to acquire up to 95% of FluroTest (“FluroTest Acquisition”), its efforts to obtain approval of the FDA and Health Canada, and the need for financing of FluroTest in the near term and the formation of strategic partnerships for the deployment and distribution of the technology. The Company made certain material assumptions, including but not limited to prevailing market conditions and general business, economic, competitive, political and social uncertainties, the ability to obtain FDA and Heath Canada approvals, as well as the ability to complete the FluroTest Acquisition on the terms set forth herein in a timely manner and to obtain the regulatory approvals required in connection with the same, to develop the forward-looking information in this news release. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements.
Actual results may vary from the forward-looking information in this news release due to certain material risk factors described in the Corporation’s Annual Information Form under the heading “Risk Factors”, the failure to complete the FluroTest Acquisition on the terms set forth herein in a timely manner or at all, the failure to obtain FDA or Health Canada approval for its products, the risk that regulatory approvals will not be received and the risk that changing circumstances will result in the decrease in demand for FluroTest’s products. The Company cautions that the foregoing list of material risk factors and assumptions is not exhaustive.
The Company assumes no obligation to update or revise the forward-looking information in this news release, unless it is required to do so under Canadian securities legislation.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy of this release.