Regulatory Path Forward Following FDA Meeting
St. Paul, minn,
March 15, 2010
EnteroMedics Inc. (NASDAQ: ETRM), the developer
of medical devices using neuroblocking technology to treat
obesity and other gastrointestinal disorders, announced today
that it has submitted an Investigational Device Exemption (IDE)
application with the US Food and Drug Administration (FDA)
for the Company's next-generation Maestro(R) RC System in the
treatment of morbid obesity using VBLOC(R) vagal blocking therapy.
The submission is the first step in the iterative IDE review
process in support of a possible Premarket Approval (PMA) application.
"This IDE submission marks an important next step in advancing
our Maestro RC System toward a pivotal study in obesity," said
President and CEO Mark B. Knudson, Ph.D. "We look forward
to working through the IDE review process with the FDA. We
expect to be in a position to provide an update on our strategy
after this process has reached a conclusion."
About EnteroMedics Inc.
EnteroMedics is a development stage medical device company focused on the design
and development of devices that use neuroblocking technology to treat obesity
and other gastrointestinal disorders. EnteroMedics' proprietary neuroblocking
technology, VBLOC(R) vagal blocking therapy, is designed to intermittently
block the vagus nerves using high-frequency, low- energy, electrical impulses.
These electrical impulses are delivered by a neuroregulator which is powered
either by an external controller (Maestro RF System) or an integrated rechargable
battery (EnteroMedics' next-generation Maestro RC System). EnteroMedics is
currently conducting a feasibility study examining VBLOC Therapy's effects
on blood glucose levels in diabetic patients outside of the United States.
For more information, visit www.enteromedics.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements about EnteroMedics
Inc. Our actual results could differ materially from those discussed due to
known and unknown risks, uncertainties and other factors including our limited
history of operations; our losses since inception and for the foreseeable future;
our lack of regulatory approval for our Maestro(R) System for the treatment
of obesity; our preliminary findings from our EMPOWER(TM) pivotal trial; our
ability to comply with the Nasdaq continued listing requirements; our ability
to commercialize our Maestro System; our dependence on third parties to initiate
and perform our clinical trials; the need to obtain regulatory approval for
any modifications to our Maestro System; physician adoption of our Maestro
System and VBLOC(R) vagal blocking therapy; our ability to obtain third party
coding, coverage or payment levels; ongoing regulatory compliance; our dependence
on third party manufacturers and suppliers; the successful development of our
sales and marketing capabilities; our ability to raise additional capital when
needed; our ability to attract and retain management and other personnel and
to manage our growth effectively; potential product liability claims; potential
healthcare fraud and abuse claims; potential healthcare legislative reform
and our ability to obtain and maintain intellectual property protection for
our technology and products. These and additional risks and uncertainties are
described more fully in the Company's filings with the Securities and Exchange
Commission, particularly those factors identified as "risk factors" in
the Company's Form 10-K dated March 12, 2009. We are providing this information
as of the date of this press release and do not undertake any obligation to
update any forward-looking statements contained in this document as a result
of new information, future events or otherwise.
Caution-Investigational device. Limited by U.S. Federal law to investigational
The implantation procedure and usage of the Maestro(R) System carry some risks,
such as the risk generally associated with laparoscopic procedures and those
related to treatment as described in the EMPOWER clinical trial informed consent.
SOURCE: EnteroMedics Inc.
About Charter Life Sciences
Charter Life Sciences (“CLS”) is a life sciences venture capital
firm with offices in Palo Alto, California and Cincinnati, Ohio. CLS focuses
on providing the initial venture capital to companies that are developing innovative
products for significant unmet medical needs. The CLS team draws on its extensive
medical, operational and start-up company experience to work collaboratively
with its portfolio companies to develop their clinical, operational and financing
strategies. For additional information on CLS, please visit www.clsvc.com.
Ted Rossman/Lisa Kelaita
New Venture Communications