T2 Biosystems Enters into Distribution Agreement to Expand its Innovative Rapid Diagnostic Technologies to Puerto Rico and th...
September 25 2019 - 7:30AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development
of innovative diagnostic products for critical unmet needs in
healthcare, announced today that it entered into an exclusive
distribution agreement that allows the Company to introduce its
rapid diagnostic technologies, including the T2Bacteria® and
T2Candida® Panels, in Puerto Rico and the U.S. Virgin Islands,
which have approximately 64 hospitals that could benefit from T2’s
products.
“We are proud to announce this distribution agreement with
Bionuclear Puerto Rico, which will give us an opportunity to make a
positive impact on clinicians and patients in 64 hospitals in the
region,” said John McDonough, chairman and chief executive officer
at T2 Biosystems. “This expansion will enable us to take yet
another step forward in our fight against sepsis and the negative
consequences associated with it, including high mortality rates,
rising hospital expenses, and growing antimicrobial
resistance.”
T2 Biosystems is the company behind the T2Bacteria Panel, which
was the first in-vitro diagnostic test to receive approval for a
New Technology Add-on Payment (NTAP) by the United States Centers
for Medicare & Medicaid Services (CMS). The panel is the only
FDA-cleared test to identify sepsis-causing bacterial pathogens
directly from whole blood without the need to wait for blood
culture, and its counterpart for fungal bloodstream infections is
the T2Candida Panel, the first and only FDA-cleared
direct-from-whole blood diagnostic for detection of fungal
pathogens that are associated with sepsis. Both panels provide
results in three to five hours instead of days. The products are
two 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.
The distribution agreement follows the recent announcement that
T2 Biosystems 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 US Department of Health and Human Services (HHS).
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, 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.
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, 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
Communications gkent@vaultcommunications.com
610-455-2763
Investor Contact: Zack Kubow, W2O Group
zkubow@w2ogroup.com 415-658-6436
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