T2 BIOSYSTEMS RECEIVES CE MARK FOR T2BACTERIA™ PANEL ENABLING COMMERCIALIZATION IN EUROPE
July 18 2017 - 8:00AM
T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the
development of innovative diagnostic products to improve patient
health, announced today that it has received a CE Mark for its
T2Bacteria Panel, allowing for the sale and distribution of the
product within the European Union and those countries accepting the
CE Mark. The T2Bacteria Panel runs on the Company’s proprietary
T2Dx® Instrument and provides highly accurate species-specific test
results of targeted bacterial infections direct from whole blood in
as fast as about 3.5 hours, and without the need for a
time-consuming blood culture. The T2Bacteria Panel is currently
available in the United States for Research Use Only (RUO) and the
Company is in the final stages of completing the FDA pivotal trial,
after which a 510(k) application will be submitted to the FDA.
Patient enrollment in the trial is currently 92% complete and the
company is very pleased with the product performance demonstrated
to date, which for the prospective arm of the study is showing an
average sensitivity of 96% and average specificity of 98%.
The T2Candida® Panel and the T2Dx Instrument were both CE-marked
and FDA-cleared in 2014 and now, combined with the new T2Bacteria
Panel, provide a comprehensive sepsis solution for hospitals in
Europe. Consistent with previous guidance, the company believes it
is on track to potentially receive FDA clearance of the T2Bacteria
Panel by the end of 2017 enabling a US commercial launch in early
2018. Once the clinical trial is complete, the company will provide
a full update on the product performance metrics submitted to the
FDA.
“The CE Mark of our T2Bacteria Panel is a significant milestone
in our mission to save lives and improve healthcare by empowering
clinicians to more effectively treat patients with sepsis faster
than ever before,” said John McDonough, president and chief
executive officer. “Our T2Sepsis Solution now includes T2Candida
and T2Bacteria, creating a significant opportunity to expand our
target hospitals and positioning T2 Biosystems for accelerated
commercial growth.”
CE Mark confirms that the product meets the Essential
Requirements of the European Directive on In Vitro Diagnostic
Medical Devices. The T2Bacteria Panel will be commercially
available as part of the T2Sepsis Solution in Europe in the third
quarter 2017.
The T2Bacteria Panel identifies six of the most deadly and
prevalent bacteria species that are often not covered by empiric
therapy. The prevalence of bacterial infections is high in
hospitals across the world and the T2Bacteria Panel identifies
approximately 90% of all gram-negative infections coming in through
the emergency department and approximately 70% of
community-acquired infections in the emergency department. Current
broad spectrum antimicrobial therapy regimens only cover 60% of all
bloodstream infections. Test results generated from the T2Candida
Panel and T2Bacteria Panel, when coupled with current empiric
therapy practices, may empower healthcare teams to effectively
treat up to 95% of all bloodstream infections presenting in
hospitals within the first 4 hours.
Additionally, the company is seeing significant interest from
new and existing customers in working with the T2Bacteria RUO Panel
under a Research Use Only program where customers can begin early
validation testing to accelerate adoption post FDA clearance.
“We are pleased to be close to finalizing the submission of our
T2Bacteria Panel to the FDA,” said Tom Lowery, chief scientific
officer. “Even more encouraging are the early responses we have
been receiving from hospitals taking advantage of the T2Bacteria
Panel under the RUO program. We believe the RUO program will
provide independent data for hospitals to present at conferences
and for publications later this year and into 2018.”
T2 Biosystems will provide an additional, more comprehensive
update on its upcoming second quarter 2017 financial update call
and at this time is reiterating its prior financial guidance.
About T2 Biosystems T2 Biosystems is
dedicated to developing innovative diagnostic products to improve
patient health. With the FDA-cleared T2Dx Instrument and
T2Candida Panel targeting sepsis and a range of additional
products in development, T2 Biosystems is an emerging
leader in the field of in vitro diagnostics. The Company is
utilizing its proprietary T2 Magnetic Resonance technology, or
T2MR®, to develop a broad set of applications aimed at lowering
mortality rates, improving patient outcomes and reducing the cost
of healthcare by helping medical professionals make targeted
treatment decisions earlier. T2MR enables the fast and sensitive
detection of pathogens, biomarkers and other abnormalities in a
variety of patient sample types, including whole blood. For more
information, please visit www.t2biosystems.com.
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. 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, the performance of the Company's diagnostic products
and the ability to bring such products to market. 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. For more information on risk factors for T2
Biosystems, Inc.’s business, please refer to the Company’s Annual
Report on Form 10-K, filed with the Securities and Exchange
Commission on March 15, 2017, under the heading “Risk
Factors,” and other filings the Company makes with
the Securities and Exchange Commission from time to time.
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, it disclaims any obligation to do so, even if
subsequent events cause its views to change. 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.
Company Contact:
Darlene Deptula-Hicks, T2 Biosystems
SVP & Chief Financial Officer
ddeptula@t2biosystems.com
603-553-5803
Media Contact:
Matthew McKillip, T2 Biosystems
mmckillip@t2biosystems.com
518-577-3466
Investor Contact:
Chris Brinzey, Westwicke Partners
chris.brinzey@westwicke.com
339-970-2843
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