Company provides update of events and outlook for near term opportunity
VANCOUVER, BC--(Marketwired - Mar 1, 2017) - Breathtec
BioMedical, Inc. (CSE: BTH.CN) (CNSX: BTH) (CSE: BTH) (FRANKFURT: BTI) (OTCQB: BTHCF) (the "Company" or
"Breathtec"), a medical diagnostics company focused on developing, in-licensing and commercializing proprietary,
innovative and best-in-class breath analysis devices for the early detection of infectious and life threatening diseases wishes
to address recent corporate events and to provide an update regarding its immediate outlook and future plans.
Breathtec's technology portfolio continues to move ahead with a number of ongoing activities and recent achievements as
summarized below.
FAIMS Technology:
Breathtec continues to progress its flagship FAIMS technology with the recent completion of developmental testing
of a V2 prototype design. The new design addressed a number of issues that have held back other companies in pursuit of a highly
sensitive and truly portable hand held FAIMS device. Key features include the use of a novel and highly efficient non-radioactive
ionization source as well as a new square wave generation system. Both components significantly improve the analytical
performance over the V1 prototype, while simultaneously considerably reducing the size of the device. These new design features
as well as refinements in the design of the miniaturized FAIMS cells and the miniaturization of all high voltage and low voltage
electronic components has resulted in a truly unique device that will be the subject of new Intellectual Property for the
Company.
The Company will now begin the performance testing phase of the new V2 prototype in order to continue to characterize the
analytical performance of the system in preparation for a pilot clinical study scheduled for the fall of 2017. These studies pave
the way for a pivotal full clinical study of a selected disease state which we currently project will commence in early 2018. We
have completed regulatory evaluations to determine the clinical and regulatory path to market for the FAIMS technology, and have
established a clear path to market that is reasonable in both time and cost. A pre-submission meeting with the FDA will be
scheduled in the upcoming months to verify our understanding of the regulatory and clinical testing requirements for
commercialization of the technology.
In related news, the Company announced today that it has entered into an extension of its 2016 research agreement through 2017
with the Yost Research Group at the University of Florida Chemistry Department. The agreement provides continuity to the ongoing
research central to Breathtec's FAIMS R&D program. The Company is very pleased to continue working closely with Dr. Yost and
his team drawing from their deep knowledge and expertise in the field of FAIMS.
NaNose Technology:
The Company further reports on the continuing evaluation of the NaNose technology in a Company-sponsored clinical
study which began early this year in the City of Surrey's Health &Technology District. The team reports progress of the
study is slower than expected due to several technical challenges which have provided a significant new understanding of the
technology, and are being addressed through the application of dedicated scientific and engineering efforts. We have also
completed regulatory evaluations to determine the clinical and regulatory path to market for the NaNose technology, and have
established a clear path to market.
Alongside this activity, Breathtec has also been expanding its team by engaging experienced consultants and are working hard
at establishing Quality System and Design Control processes which will allow the Company to complete its tech platform
development phase in preparation for regulatory submission and approvals for both the US and Canadian markets as well as Ex-US
marketplaces.
Company CEO, Guy LaTorre comments, "We have the right technology and the right team to get to market and will be working
diligently to accomplish this in an efficient and time sensitive manner. Our goals are ambitious and challenging but we feel
confident that, with the ongoing support of our stakeholders, partners and shareholders alike, we will continue to make
significant contributions to the field of breath analysis which will deliver value for patients, the medical community, and our
investors."
ON BEHALF OF THE BOARD
"Guy LaTorre"
CEO & Director
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accuracy of the content of this news release. This news release contains forward-looking statements relating to product
development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts.
Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar
expressions. All statements other than statements of historical fact, included in this release are forward-looking statements
that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results
and future events could differ materially from those anticipated in such statements. Important factors that could cause actual
results to differ materially from the Company's expectations include the failure to satisfy the conditions of the relevant
securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations.
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect.
Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and
unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not
to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the
time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking
statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements
contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of
the included forward-looking statements as expressly required by applicable law.