Jun 13, 2016
ISELIN, N.J., June 13, 2016/PRNewswire/ - Echo Therapeutics, Inc. (NASDAQ: ECTE), a medical device company focused on non-invasive continuous glucose monitoring (CGM) and associated technologies, today announced that it has received Institutional Review Board (IRB) approval for a new clinical protocol. The new protocol will allow expanded testing of the Company's CGM system and now permits Echo to recruit both pediatric and adult subjects for its internal and external studies.
An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines. The primary goal of an IRB is to safeguard the rights, safety and welfare of participants in research studies.
'We are very excited about the approval of our new clinical protocol. This important achievement enables the company to dramatically expand the clinical testing of our CGM system on a diverse population, including adolescents and children. Initial studies, testing components of our NextGen system, are expected to begin in the coming weeks,' said Scott W. Hollander, Echo's President and CEO.
Approximately 208,000 Americans under age 20 are estimated to have diagnosed diabetes. Research now shows that prolonged hyperglycemia - high blood glucose levels - can lead to the early development of serious complications in children, such as cardiovascular disease and kidney disease. The National Institute for Health and Care Excellence (NICE) advises children and young people with type 1 diabetes and their family members to routinely perform at least 5 glucose tests per day. Continuous glucose monitoring (CGM) has the potential to transform care for children with type 1 diabetes.
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, 2015, 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
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SOURCE Echo Therapeutics, Inc.