Company Selects Clinical Research Organization for Clinical and Regulatory Pathway
Jun 29, 2016
ISELIN, N.J., June 29, 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 began stand-alone and integrated testing of its NextGen continuous glucose monitoring system (CGM) prototype components and formally selected a Clinical Research Organization (CRO) for its regulatory and clinical strategy. Rigorous testing of each component independently and as an integrated system will continue as the Company optimizes its system in preparation for future clinical and regulatory trials. Echo began hardware and software testing of the NextGen Exfoliator and the Bluetooth transmitter. As previously announced, the Company continues to test the NextGen sensor element and hydrogel. Verification testing of the new Application Programming Interface (API) and software application (App) is complete.
Echo’s NextGen CGM system is more consumer-friendly and substantially less expensive than the prior version. The new streamlined design includes a self-use exfoliator, a new exfoliator tip, a more sensitive sensor element with increased consistency, and a reusable transmitter and battery. Transmitted glucose information is displayed on a new CGM App using Echo’s API technology.
“I am excited about the progress our Development Team has made in the development and testing of the NextGen components and on integrating them into a system. We received very positive feedback from our demonstration of the NextGen self-exfoliator and App at the 2016 American Diabetes Association Scientific Sessions in New Orleans this month.” said Scott W. Hollander, Echo’s President and CEO. “We look forward to collaborating with our experienced CRO on the clinical development and regulatory pathway of our technology.”
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
SOURCE Echo Therapeutics, Inc.