ISELIN, N.J., May 3, 2016 /PRNewswire/ — Echo Therapeutics, Inc. (Nasdaq: ECTE), a medical device company focused on non-invasive continuous glucose monitoring (CGM) and associated technologies, today announced important advances in its next generation continuous glucose monitoring (CGM) system and its progress toward commercialization in China.
Echo has made significant progress in the development and initial internal clinical testing of key components of its next generation (NextGen) system. Important advancements were made in the NextGen sensor element, hydrogel and other key components of the Company’s highly disruptive technology to the episodic, needle-based glucose monitoring business. Improvements include a higher sensitivity to glucose with increased consistency, a shorter warm-up time, and resistance to acetaminophen interference. Additionally, the new streamlined design, that includes a flexible target base and transmitter housing, is more consumer-friendly and substantially less expensive than the prior version. A working prototype of the next generation CGM system is scheduled for June 2016.
In parallel to the progress made on the next generation system, Echo’s strategic partner Medical Technologies Innovation Asia (MTIA) is finalizing plans for the commencement of the upcoming China Food and Drug Administration (CFDA) clinical trial and the eventual regulatory approval and commercialization of Echo’s CGM in China. As previously announced, MTIA believes that Echo’s locally produced needle-free CGM will be designated as a Class 2 medical device with a review period of 90 working days after filing submission. A formal and final designation from the CFDA is determined only at the time of submission. Approval of Echo’s CGM in China will signify the first non-invasive CGM to address the world’s largest diabetes population. In March, Echo’s team visited China where testing of the Company’s CGM showed linearity between locally manufactured sensors and U.S. produced sensors, marking the successful technology transfer. Echo’s final obligation related to the CFDA clinical trial is the software transfer, scheduled for mid-May, of the application program interface (API) and software application (App). The API allows for the development of third party applications while increasing the security of Echo’s intellectual property.
“Echo has entered a new phase as we have developed and initiated testing of our NextGen system and approach the commencement of the CFDA regulatory trial. We have made tremendous strides toward our goal of delivering life-changing tools to people worldwide with diabetes,” said Scott W. Hollander, Echo’s President and CEO. “We remain on track to deliver our remaining milestones as scheduled and I look forward to providing a more detailed update in our conference call tomorrow.”
As previously announced, Echo will hold a conference call tomorrow, May 4, 2016, at 4:30 p.m. ET to provide an update on the Company’s progress and milestones. Participants can call (855) 327-6837 and reference Echo Therapeutics or pre-register for the call at http://bit.ly/1Wsz21D. The archived audiocast will be available for thirty (30) days following the call by visiting the Events section of Echo’s website at www.echotx.com.
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.