Echo Therapeutics, Inc. 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
o 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.
o 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.
o 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.
o 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.
o 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
o 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.
o Echo expects to complete its multi-center European regulatory trial of the
Symphony CGM System in critically ill patients.
o 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.
o 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.
As part of its current strategy, the Company is actively pursuing a corporate
partnership for Symphony's commercialization in the hospital critical care
market. Echo believes that obtaining such a partner would allow it to
leverage the commercial infrastructure of its partner, significantly reducing
the need for the Company to establish its own sales, marketing and
distribution infrastructure.
"Our team believes in Echo's ability to be an innovator in the CGM hospital
market, resulting in better patient outcomes, reduced nursing burden, and
potential cost-savings for hospitals. Our management team is dedicated to
realizing the potential of our technology for the benefit of our shareholders,
clinical practitioners and patients," stated Patrick T. Mooney, M.D., Chairman
and CEO of Echo Therapeutics. "We intend to leverage our existing capital to
secure a corporate partnership as Symphony moves toward commercial approval.
Our management team is focused on meeting this goal following EU approval and
initiation of our FDA pivotal trial."
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