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.
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