Echo Therapeutics Submits Pre-Submission Package to FDA for Symphony® CGM System

  Echo Therapeutics Submits Pre-Submission Package to FDA for Symphony® CGM

PR Newswire

PHILADELPHIA, June 10, 2013

PHILADELPHIA, June 10, 2013 /PRNewswire/ --Echo Therapeutics, Inc. (Nasdaq:
ECTE), a company developing its needle-free Symphony^® CGM System as a
non-invasive, wireless continuous glucose monitoring system, today announced
that it has submitted a pre-submission package to the U.S. Food and Drug
Administration (FDA) for the Symphony CGM System for use in the hospital
critical care environment. In conjunction with the pre-submission package,
the Company has requested a meeting with the FDA to work cooperatively on the
clinical and regulatory plan to support FDA approval of the System.

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"As the Company now begins to sharpen its focus on gaining FDA approval, we
are committed to obtaining as much FDA input and agreement as possible
regarding the design of the pivotal trial. The pre-submission with the FDA is
a significant milestone on our path to advance Symphony towards U.S.
commercialization. Following the feedback we expect to receive from our
meeting with the FDA, we plan to initiate the pivotal U.S. clinical trial for
Symphony," stated Patrick T. Mooney, M.D., Chairman and CEO of Echo
Therapeutics. "Hospital-based continuous glucose monitoring remains a
significant unmet need and, to our knowledge, no CGM has yet been cleared or
approved by the FDA specifically for use in critical care units. We will
continue to work diligently to complete the clinical and regulatory
requirements to pursue this unmet medical need and to make Symphony available
to clinicians as quickly as possible. "

The pre-submission documentation has been submitted to the FDA in order to
obtain the Agency'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.

The FDA's Pre-Submission Program is intended to allow applicants the
opportunity to obtain targeted FDA feedback in response to specific questions
related to product development, including planned non-clinical evaluations,
proposed clinical study protocols, or data requirements, prior to making a
submission to the Agency. For more information on the Pre-Submission Program,
visit the FDA website at

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

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may
constitute forward-looking statements including, without limitation, the
statement regarding our plan to initiate the pivotal U.S. clinical trial for
Symphony, 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

For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications

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SOURCE Echo Therapeutics, Inc.

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