Echo's non-invasive CGM system to be designated as Class 2 medical device in China

Aug 12 2015

Echo Therapeutics, Inc. (NASDAQ: ECTE), a medical device company focused on non-invasive continuous glucose monitoring (CGM) and associated technologies, today announced that, after numerous consultations with the Chinese government, its strategic partner, Medical Technologies Innovation Asia (MTIA), Ltd., believes that Echo's locally produced needle-free CGM products will be designated as a Class 2 medical device. Class 2 medical devices have a review period of 90 working days after filing submission with the Medical Device Evaluation Center of the China Food and Drug Administration (CFDA). A formal and final designation from the CFDA is determined only at the time of submission.

As previously announced, Echo and MTIA are in the process of finalizing manufacturing assets in China and completing internal testing in support of the CFDA clinical trial and commercialization. Clinical sites for the approximately 120-patient trial have been identified and secured. Following CFDA approval, MTIA and Echo will share net sales of Echo's CGM in the licensed territory.

"China represents the first key market for Echo and we are focused on supporting MTIA's efforts to bring the technology to the 100 million diabetics in China. Additionally, we will build on this momentum as we move toward making our products accessible globally," said Scott W. Hollander, Echo's President and CEO. "In early June, I personally visited each of the manufacturing facilities in China and feel confident that MTIA has the assets in place to support their commercial efforts in the future.

"While the formal and final designation is never made until submission, my team and I continue to build a strong relationship with the CFDA while we work diligently to bring this important product to the market," said Bai Ge, Managing Director of MTIA.