Oct. 3, 2013
/PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a medical device company developing its Symphony
CGM System as a non-invasive, wireless, continuous glucose monitoring system, today announced a corporate update covering Company activities, expected near-term achievements and comments on recent events.
The Company's corporate objectives for the remainder of 2013 are as follows:1. Complete the EU Regulatory Clinical Trial 2. File for CE Marking3. Attain Food & Drug Administration (FDA) Guidance for U.S. Regulatory Pathway4. Implement Significant Cost Reduction Initiatives
EU Regulatory Clinical Trial
Echo continues to enroll subjects in its multi-center European regulatory trial of the Symphony CGM System in surgical patients in hospital critical care units. Slower than expected initial enrollment in the trial and other issues inherent in clinical studies conducted in hospital critical care units caused delays in the anticipated completion of the trial in the 3
quarter of 2013. Echo now expects to announce the top-line clinical results during the 4
quarter of 2013.
Submit for CE Marking
Following successful completion of the EU clinical trial and preparation of the Conformite Europeenne (CE) Technical File, the Company plans to submit the file for European approval late in the 4
quarter of 2013. Subsequent to the completion of the EU approval process, a decision will be made on when to initiate a limited launch of the Symphony CGM System. The decision will be based on a number of factors including the timing and implementation of product enhancements that have been identified in the ongoing clinical trial.
U.S. Food & Drug Administration Guidance
Echo has received comments from the FDA Center for Devices and Radiological Health on the pre-submission package that was filed in
. The FDA has notified the Company that the meeting scheduled for the 4
quarter of 2013 may be postponed due to a lapse in appropriations resulting from the recent U.S. Federal Government shutdown. The outcome of the meeting will assist Echo in identifying and defining its strategy to complete the product and clinical development pathway for U.S. regulatory submission of the Symphony CGM System for use in the hospital critical care environment. Echo plans to commence its multi-center, pivotal FDA clinical trial in the second half of 2014, following completion of certain system enhancements and receipt of Institutional Review Board (IRB) approvals.
Cost Reduction Initiatives
The Company has implemented a number of substantial cost reduction measures in ways that will not diminish Echo's ability to execute on its short-term objectives as part of a restructuring plan recommended by
Robert F. Doman
, Echo's Executive Chairman and Interim CEO, and approved by Echo's Independent Board of Directors on
September 30, 2013
. This will be achieved through cost-cutting initiatives aimed at reducing operating costs, particularly marketing and manufacturing expenditures and corporate general and administrative costs. While improving operating efficiency and containing costs are on-going priorities, Echo has targeted cost reductions across all aspects of its operations in both external spend and head count. On
September 30, 2013
, Echo implemented a staff reduction of approximately 33% of the Company's workforce. As a result of these initiatives, the 4
quarter burn rate is expected to decrease by approximately 35-40% from the quarterly burn rate experienced during the first three quarters of 2013.
"It's important to recognize this shift as part of a continuing effort to focus our efforts and resources on our short-term corporate objectives in order to drive future shareholder value. I strongly believe in our management team's ability to execute on our plan to better position the Company to realize its long-term potential," said Mr. Doman. "We highly value all of our employees and deeply regret having to make these workforce reductions. However, these reductions were essential to better align ongoing expenses with our short-term objectives and position Echo for future growth."