T2 Biosystems (NASDAQ:TTOO)
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6 Months : From Aug 2019 to Feb 2020
T2 Biosystems, Inc. (NASDAQ:TTOO) an emerging leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, announced today that it has been awarded a milestone-based contract of initial value of $6 million with a potential value of up to $69 million, if all contract options are exercised, from the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services’ (HHS).
The contract will enable a significant expansion of the Company’s current portfolio of diagnostics for sepsis-causing pathogens and antibiotic-resistance genes, which are designed to improve patient outcomes and reduce the growing threat of antimicrobial resistance. This contract will fund development through U.S. Food & Drug Administration (FDA) submission of new direct-from-blood diagnostic panels that will be run on the T2Dx Instrument and the development of a next generation T2Dx Instrument:
- The first panel developed will be a direct-from-blood panel for detection of biothreat pathogens, including threats such as B. anthracis, F. tularensis, Burkholderia spp., Y. pestis, R. prowazekii, and toxin genes.
- The second panel is expected to cover 99% of all bloodborne bacterial infections by means of ≥36 reported results, which include pan-Gram positive and pan-Gram negative results (detecting >250 species), in addition to the bloodborne antibiotic resistant threats identified by the Centers for Disease Control and Prevention (CDC).
- Along with the new panels, the BARDA award supports the development of a next-generation high-throughput instrument.
“By providing same-day results, T2 Biosystems’ existing technology has made a significant impact on therapy decisions, and this next generation of innovations has the potential to expand on this progress,” said Dr. Minh-Hong Nguyen, Professor of Medicine and Clinical & Translational Science Institute, University of Pittsburgh, and Director, Transplant Infectious Diseases and Antimicrobial Management Program of the University of Pittsburgh Medical Center. “With much more comprehensive coverage of the causative pathogens of bloodstream infections, this technology has the potential to rapidly and accurately diagnose and identify common bacterial causes of BSIs, and allow physicians to get patients started on appropriate therapy much sooner. It is a potential game changer for the way we practice medicine.”
“We are incredibly grateful to BARDA for this contract, which will allow us to continue to innovate, advance our product pipeline, and look forward to our public-private partnership with BARDA,” said John McDonough, chairman and chief executive officer of T2 Biosystems. “More importantly, we are looking forward to the opportunity to develop more technology that will truly transform the way bloodstream infections are diagnosed and managed and to continue to provide new advanced tools for improved antibiotic stewardship so that we can help save more lives and provide clinicians with the information they need to help prevent sepsis.”
About T2 BiosystemsT2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, and T2Bacteria® Panel, which was recently announced as the first and only in-vitro diagnostic test to receive approval for a New Technology Add-on Payment (NTAP) by CMS, are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00053.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding additional patients, timing of testing patients, anticipated product benefits, strategic priorities, product expansion or opportunities, growth expectations or targets, timing of FDA filings or clearances and anticipated operating expenses, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. "Risk Factors" in the company's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission, or SEC, on March 14, 2019, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.
Media Contact:Gina Kent, Vault Communicationsgkent@vaultcommunications.com 610-455-2763
Investor Contact:Zack Kubow, W2O Groupzkubow@w2ogroup.com415-658-6436