Breathtec BioMedical, Inc. (BTH.CN) (
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.”
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