This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Echo Therapeutics Provides Mid-Year Update To Shareholders

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. 

(Logo: http://photos.prnewswire.com/prnh/20120801/NE50071LOGO )

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.

Upcoming Catalysts

  • 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.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,080.14 +21.45 0.12%
S&P 500 2,117.69 +4.76 0.23%
NASDAQ 5,092.0850 +36.0220 0.71%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs