TTOO T2 Biosystems Inc

T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development of innovative diagnostic products for critical unmet needs in healthcare, ranked #22 among the top 50 fastest growing public companies in Massachusetts by the Boston Business Journal.

This recognition comes on the heels of several recent updates announced by the Company regarding expanding capabilities of its portfolio of groundbreaking rapid diagnostics and technology. This includes presentations at the Biodefense World Summit 2019 and the ASM Microbe 2019 earlier this month (video of presentations available here and here, respectively). One of the key products that was highlighted, the T2Bacteria® Panel, is the first and only FDA-cleared test to identify sepsis-causing bacterial pathogens directly from whole blood in 3 to 5 hours without the need to wait for blood culture, allowing patients to be placed on targeted antibiotic therapy faster. The T2Bacteria Panel is one of several panels that are approved or in development that are run on the Company’s T2Dx® Instrument, which is powered by miniaturized magnetic resonance (T2MR®) technology.

“It’s not only an honor for the growth of our company to be recognized by the Boston Business Journal editorial team, but it is also a reflection of the increasing importance being placed on  seeking solutions to improve the management of bloodstream infections and sepsis, which is one of the most common, costly and deadly illnesses,” said John McDonough, president and chief executive officer of T2 Biosystems. “Our technology serves as that very solution due to its ability to more rapidly identify sepsis-causing pathogens compared to blood culture-based technologies. We are excited to be acknowledged as a leader in the space and look forward to continuing to drive innovation that enables improvements in patient outcomes.”

For patients in septic shock, rapid targeted treatment is critical because it is estimated that each hour of delayed treatment increases mortality risk nearly 8%, and as many as 80% of sepsis deaths could be prevented with rapid diagnosis and treatment. 1 Additionally, earlier targeted therapy can help offset the costs associated with sepsis, such as length of stay and readmission rates. Clinical data being generated by independent clinical users demonstrates the T2Bacteria Panel’s ability to benefit tested patients in the emergency department by providing information that leads to more rapid time to delivery of effective therapy, de-escalation of unnecessary therapy, and helping avoid premature discharge and readmission to the emergency department.

1 Kumar, A., et al, (2006). Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Critical care medicine, 34(6), 1589-1596.

The T2Bacteria Panel, which received U.S. Food and Drug Administration (FDA) clearance in May 2018, is complemented by the T2Candida® Panel, which is the first and only FDA-cleared direct from whole blood diagnostic for detection of fungal pathogens that are associated with sepsis.

The Company is also developing the T2Resistance™ Panel, which was recently granted Breakthrough Device designation by the FDA and is designed to detect 13 resistance genes from both gram-positive and gram-negative pathogens directly from whole blood. Initial data demonstrates that the T2Resistance Panel identifies these resistance genes with an average time of 5.3 hours compared to an average of 30 hours (and up to 95 hours) using conventional methods. The T2Resistance Panel is expected to be available for research use only (RUO) in the United States and receive CE-Mark for commercial availability in Europe by the end of 2019.

The annual list from Boston Business Journal is based on information obtained from Bloomberg Business News, Yahoo! Finance and SEC filings, and ranks companies by revenue growth from 2016 to 2018.

About T2 Biosystems T2 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 and 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. 

Forward-Looking Statements This 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 (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 Communications gkent@vaultcommunications.com   610-455-2763

Investor Contact: Zack Kubow, W2O Group zkubow@w2ogroup.com 415-658-6436