Building on the strong foundation with which we finished 2012, Echo is focused on completing several key milestones during 2013 that will enable us to begin generating revenue.
- Echo expects to achieve International Standards Organization (IS0) 13485 certification in the first quarter of 2013. ISO 13485 is the globally recognized Quality System standard that prescribes consistent processes for the development, design and manufacturing of medical devices, and is considered a step towards securing product commercialization approval by European and other international regulatory agencies.
- Echo is preparing for a multi-center European regulatory trial of the Symphony tCGM System in critically ill patients and a subsequent Conformite Europeenne (CE) Technical File submission in the first half of 2013. CE Marking would enable the commercial sale of Symphony in the EU and other countries that recognize the CE Mark.
- In anticipation of a review of and determination regarding its CE Mark application in the second half of 2013, Echo has begun significant commercial planning activities. Echo is preparing for European launch in target markets by the end of the year.
- Echo is intensifying partnership discussions as Symphony nears commercialization. The company is exploring a variety of partnership opportunities that exist in both the critical care and outpatient settings, and across numerous geographical areas.
- Echo expects to meet with the Food & Drug Administration (FDA) in early 2013 to discuss the proposed pivotal clinical study during a Pre-PMA Submission meeting. We plan to commence the pivotal clinical trial in the second half of 2013. The safety and efficacy data obtained from the pivotal trial are expected to support a Premarket Approval application.
- Echo plans to increase its scientific communication via oral presentations, poster sessions, and exhibitions at major medical meetings in Europe and the U.S., to strengthen awareness in the key opinion leader community.
- Echo will provide continued communication with the investment community through upcoming investor conferences and regular updates on the company's progress.
Thank you for your investment in the continued success of our company. We look forward to keeping you informed of our progress throughout the year.