PHILADELPHIA, July 3, 2013 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its non-invasive Symphony® CGM System as a needle-free, wireless continuous glucose monitoring system, today issued a mid-year update to its shareholders outlining the progress it has made this year, its upcoming key strategic priorities and milestones, and its efforts to conserve cash.
Highlights for First Half of 2013
- Echo submitted a pre-submission package to the U.S. Food and Drug Administration (FDA) for its Symphony CGM System for use in the hospital critical care environment.
- Echo received agreement from its Notified Body in Europe on its clinical trial plan supporting CE Marking of its Symphony CGM System. Additionally, the Company received Institutional Review Board (IRB) approval of its clinical trial from each of its study sites that enabled the commencement of a clinical evaluation of Symphony that will support the Company's CE Mark Technical File.
- Echo achieved International Standards Organization (IS0) 13485 certification. ISO 13485 is the internationally recognized standard that prescribes consistent processes for the development, design and manufacturing of medical devices, and is considered an important step towards securing product commercialization approval by European and other international regulatory agencies.
- Echo held discussions with multiple potential business partners for the further development and distribution of Symphony as part of its strategy going forward. Echo is exploring a variety of partnership opportunities that exist in both the critical care and outpatient settings, and across numerous geographical areas.
- Echo presented an expanded analysis of data collected from the clinical study of its Symphony CGM System in critically ill patients at Tufts Medical Center in Boston, MA. The data were presented during Display and Professor Walk Rounds at the Society of Critical Care Medicine's Annual Meeting in January.
- Echo has scheduled a meeting with the Food & Drug Administration (FDA) this summer during which it hopes to obtain FDA's guidance regarding the U.S. regulatory pathway for Symphony, the proper approach to refining the pivotal trial protocol and endpoints, and preparing the pre-marketing application.
- Echo expects to complete its multi-center European regulatory trial of the Symphony CGM System in critically ill patients.
- Echo plans to submit the Conformite Europeenne (CE) Technical File. CE Marking is critical to enabling the commercial sale of Symphony in the EU and other countries that recognize the CE Mark.
- Echo plans to commence its multi-center pivotal FDA clinical trial subsequent to IRB approval. The safety and efficacy data obtained from the pivotal trial are expected to support a Premarket Approval application.
In an effort to achieve its critical EU regulatory milestones, Echo adopted initiatives intended to eliminate and/or defer certain expenditures in order to control costs and extend its cash runway. During the past twelve months, the Company has incurred significant costs associated with the development of Symphony in anticipation of commercialization. Echo believes these past expenditures contribute to a strong foundation for the Company and strengthen its position with potential corporate partners.
As part of its current strategy, the Company is actively pursuing a corporate partnership for Symphony's commercialization in the hospital critical care market. Echo believes that obtaining such a partner would allow it to leverage the commercial infrastructure of its partner, significantly reducing the need for the Company to establish its own sales, marketing and distribution infrastructure.
"Our team believes in Echo's ability to be an innovator in the CGM hospital market, resulting in better patient outcomes, reduced nursing burden, and potential cost-savings for hospitals. Our management team is dedicated to realizing the potential of our technology for the benefit of our shareholders, clinical practitioners and patients," stated Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "We intend to leverage our existing capital to secure a corporate partnership as Symphony moves toward commercial approval. Our management team is focused on meeting this goal following EU approval and initiation of our FDA pivotal trial."
About Echo Therapeutics
Echo Therapeutics is developing the Symphony CGM System as a non-invasive, wireless continuous glucose monitoring system. Our target is patients who could benefit from glucose monitoring in the hospital setting, including critical care. Significant opportunity also exists for patients with diabetes to use Symphony in the outpatient setting. Echo is also developing its needle-free skin preparation component of Symphony, the Prelude® SkinPrep System, as a platform technology to enhance drug 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 ongoing studies, including the safety and efficacy of Echo's Symphony CGM System, the failure of future development and preliminary marketing efforts related to Echo's Symphony 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 the Symphony 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 Symphony 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, 2012, 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 (215) 717-4104 firstname.lastname@example.org
SOURCE Echo Therapeutics, Inc.