Echo Therapeutics, Inc. Announces Successful CFDA Meeting
ISELIN, N.J., April 28, 2015 /PRNewswire/ -- Echo Therapeutics, Inc. (NASDAQ: ECTE), a medical device company focused on non-invasive continuous glucose monitoring and associated technologies, today announced that its strategic partner, Medical Technologies Innovation Asia (MTIA), Ltd., held a meeting with the Medical Device Evaluation Center of the China Food and Drug Administration (CFDA), Beijing Branch, on April 23, 2015 to define its strategy and clinical pathway for CFDA regulatory approval. Under the terms of Echo's collaboration agreement with MTIA, MTIA is responsible for obtaining regulatory approval for the product in the licensed territories, including the Peoples' Republic of China, Hong Kong, Macau and Taiwan.
Positive feedback from the meeting is assisting MTIA in executing its strategy to initiate and complete the clinical development for Echo's continuous glucose monitoring system in China. MTIA expects to commence the CFDA clinical trial and safety testing in the second half of 2015 following completion of product manufacturing and internal testing. Clinical sites for the approximately 120-patient trial have been identified and secured. Echo and MTIA are in the process of finalizing manufacturing assets in China in support of the clinical trial and commercialization.
The CFDA is the main administrative authority in charge of regulation and control of medical devices for China. With CFDA approval, MTIA will be able to manufacture, market and distribute Echo's CGM in China and the other licensed territories. Echo and MTIA will share net sales of the product generated in the licensed territory.
"We found the meeting to be positive, productive and informative, and we look forward to partnering with the CFDA as our program progresses. The clinical guidance provided by the CFDA has encouraged us to proceed with our plans to initiate the trial of Echo's continuous glucose monitor this year," said Bai Ge, Managing Director of MTIA. "We continue to believe that Echo's technology holds tremendous promise to benefit the control of diabetes and to capitalize on the significant Chinese market."
"We are very pleased with the outcome of the meeting with the CFDA as a great deal of effort and planning have gone into preparations for the clinical development program," said Scott W. Hollander, Echo's President and CEO. "This meeting represents Echo's strong commitment to MTIA, and to advancing our product closer to commercialization in China and those diabetes patients in need of improved glucose control. In May, I plan to meet with MTIA management in China and will provide more details with regard to the expected timeline of the trial and the CFDA regulatory pathway as they unfold."
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 fitness, weight loss and personal lifestyle wearable-health space. A longer-term opportunity also exists in the outpatient diabetes and 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.
For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
SOURCE Echo Therapeutics, Inc.