ISELIN, N.J., Aug. 12, 2015, NASDAQ, ECTE, /PRNewswire/ — 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.
About Medical Technologies Innovation Asia
Medical Technologies Innovation Asia (MTIA) is a fully integrated medical device company focused on accelerating and delivering game-changing technologies that improve existing standards of care to meet unmet significant clinical needs and challenges, especially in oncology, diabetic, cardiovascular and other aging-related disease. Headquartered in Hong Kong, the company has manufacturing and sales facilities throughout mainland China. MTIA has established sales channels in more than 1,000 hospitals across China’s provinces, including national, top-tier regional and military institutions. MTIA is also the leading investor to pilot a number of State-Owned Enterprise giants of China in the healthcare area plus one of the potentially biggest market capitalization pharmaceutical companies who also has dramatic marketing and sales presence in the diabetic and cardiovascular disease treatment field.
About Echo Therapeutics
Echo Therapeutics is developing its non-invasive, wireless, continuous glucose monitoring (CGM) system. A significant opportunity exists for the Company’s CGM to be used in the outpatient diabetes market and in the fitness, weight loss and personal lifestyle wearable-health space. A longer-term opportunity also exists in the hospital settings. Echo developed its needle-free skin preparation device as a platform technology that allows for enhanced skin permeation enabling extraction of analytes, such as glucose, and enhanced delivery of topical pharmaceuticals.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo’s clinical studies, the safety and efficacy of Echo’s CGM System, the failure of future development and preliminary marketing efforts related to Echo’s CGM System, Echo’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo’s and its partners’ ability to develop, market and sell Echo’s CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its CGM System. These and other risks and uncertainties are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2014, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.