Calgary, Alberta, February 16, 2021 – FluroTech Ltd. (TSXV: TEST) (OTCQB: FLURF) (“FluroTech” or the “Company”), a leading developer of spectroscopy-based technology, together with FluroTest, LLC (“FluroTest”), a first-mover in surge-scale rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, today announced that accomplished scientist and diagnostic test commercialization expert Dr. Timothy Holzer has joined FluroTech’s advisory board. Dr. Holzer is helping to design, manage and oversee the Company efforts as it embarks on its large-scale clinical trial with a major U.S.-based healthcare system partner to validate the performance of the FluroTest Pandemic Defense System.
The data collected from this study will be used to support FluroTest’s submission for Emergency Use Authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) and Health Canada for an Interim Order Authorization. Future submissions to additional regulatory bodies around the globe are also being considered. The Company will provide additional updates to the market as appropriate.
Dr. Holzer, who has dual American and Canadian citizenship, brings over 35 years of experience in clinical trials design and management, ISO 13485 and FDA QSR requirements, preparing regulatory submissions, and achieving successful delivery of commercial clinical diagnostic products and platform technologies to market. Earning his Ph.D. in Microbiology and Immunology, Dr. Holzer possesses a broad knowledge and experience base in oncology, molecular biology, genomics, microbiology, virology, immunology, biosensors, nanotechnology, and process development for automation integration.
“The opportunity to help design and deliver an accurate, high-throughput, low-cost testing system is precisely what’s needed to help reopen society,” said Dr. Holzer. “I’ve made a successful career out of assisting smaller companies with big ideas to obtain required clinical validation, and the FluroTest team is taking the necessary measures to move fast, maintain scientific integrity, and achieve its end goal of returning us all to normal lives.”
Throughout his career, Dr. Holzer has managed cross functional teams integrating scientific discovery, clinical and validation studies, engineering, sales and marketing, financing, and business development. He spent close to a decade at Abbott Laboratories Diagnostics Division, and has held senior management positions with companies throughout North America including DiagnoCure Inc, CompuCyte Corporation, IatroQuest Corporation, Cancer Genetics, and the Whitehead Institute Center for Genome Research.
“Tim is a fantastic addition to the team, supporting our efforts like a 21st-century’s Swiss army knife scientist,” said FluroTest CEO Bill Phelan. “He’s a skilled researcher with a successful history of managing scientific and product development programs as well as an executive management professional experienced at preparing and presenting technical and business reviews to regulatory agencies, customers, business partners, and investors. As we work through clinical trials and move forward with applications and approval processes, I know FluroTest will benefit from Tim’s deep experience.”
“Just this past weekend, Public Safety Minister Bill Blair said that the federal government is looking into implementing a system of regular COVID-19 testing for essential workers and truck drivers crossing the land border,” added Danny Dalla-Longa, CEO of FluroTech. “We don’t believe a patchwork quilt of PCR tests will be able to effectively handle the high volume of traffic in this environment. Mutations in the coronavirus variants are further elevating concerns, and public health experts are now talking about how best we can control the virus — not be controlled by it. With this, I expect Tim’s talents for helping companies take breakthrough concepts through to commercialization to prove extremely valuable.”
Readers are cautioned that, although FluroTest has achieved proof of concept prototype, the testing method and device is still in the early stages of development and accordingly FluroTest is not currently making any express or implied claims that the technology can, or will be able to, accurately detect the SARS-CoV-2 virus. The Platform is in the process of applying for EUA approval and considering other future submissions.
The goal of FluroTech’s research and technology is to develop cost effective detection methods which are sensitive, specific, and easy-to-use. By combining FluroTech’s proprietary spectroscopy-based technology with laboratory robotics automation and cloud computing, FluroTech, through the application of its technology and investment in FluroTest, has created a unique solution addressing the testing needs of the current and future pandemics. Using technology that was first developed at the University of Calgary, the FluroTest SARS-CoV-2 test is designed to identify patients with active virus infections; this is not necessarily the case for most of the currently approved PCR tests that are meant to identify patients with SARS-CoV-2 nucleic acid. FluroTech’s laboratory is led by Dr. Elmar Prenner, the original developer of the technology. Dr. Prenner serves as senior science advisor to FluroTech and brings over 28 years of expertise in fluorescence spectroscopy. To learn more, visit FluroTech.com
About FluroTest LLC
FluroTest, a first-mover in surge-scale rapid antigen testing for the detection of SARS-Co-V2 and other pathogens, is developing a pandemic defense and economic recovery system purpose-built for businesses and special-needs populations requiring cost effective, fast, and highly accurate testing for significant numbers of people. Unlike individual or low-throughput tests, FluroTest’s system is designed to be well-suited for high-traffic, high-risk pandemic environments including schools and colleges, hospitals and large healthcare facilities, athletic stadiums and performance venues, airline and cruise ship terminals, corporate campuses, shopping centers, manufacturing facilities, transportation and distribution hubs, and other large business and retail locations. Created to support executive business continuity efforts, the system combines and leverages the disciplines of robotics automation, biochemistry, fluorescence detection and cloud computing — processing thousands of tests per hour while delivering accurate, digitally verifiable results to a test taker’s mobile device within 5 minutes. To learn more, visit FluroTest.com
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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 ability of the Company’s testing devices to accurately and quickly detect COVID-19 and to process large numbers of samples in short time frames, the benefits of and demand for the Company’s testing devices, its efforts to obtain approval of the FDA and Health Canada, its potential partnership with a major U.S. based healthcare system and finalizing plans to conduct clinical trials and its intent to amalgamate with FluroTest Systems Ltd which owns a 95% interest in FluroTest LLC. 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 Health Canada approvals, the demand for its COVID-19 testing devices and their ability to perform as expected, its potential partnership with a major U.S. based healthcare system and finalizing plans to conduct clinical trials and its intent to amalgamate with FluroTest Systems Ltd which owns a 95% interest in FluroTest LLC 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 develop and commercialize its testing devices in a timely manner or at all, the failure to recognize the anticipated benefits from the devices, 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.
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