EnteroMedics Announces
Regulatory Path Forward Following FDA Meeting
St. Paul, minn,
januray 28, 2010
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical
devices using neuroblocking technology to treat obesity and other gastrointestinal
disorders, announced today that, following a recent meeting with the U.S. Food
and Drug Administration (FDA) to discuss the Company's EMPOWER(TM) study results
and the regulatory process, the Company intends to submit an Investigational
Device Exemption (IDE) application for a clinical trial to support a possible
Premarket Approval (PMA) application for the next-generation Maestro(R) RC
System in the treatment of morbid obesity.
"We had a constructive dialogue with the FDA about the regulatory steps
necessary to move beyond the EMPOWER trial," stated Mark B. Knudson, Ph.D.,
President and Chief Executive Officer of EnteroMedics. "The Agency and
the Company discussed regulatory direction for the Maestro System and the product
approval process in support of our efforts to bring VBLOC therapy to market.
As an outcome of this meeting, we will begin the next step in that regulatory
process by preparing an IDE application for submission in the first quarter
of 2010." Dr. Knudson added: "The Company remains fully committed
to supporting the patients from the EMPOWER trial of the Maestro RF System."
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
use.
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.
CONTACT:
Ted Rossman/Lisa Kelaita
New Venture Communications
(650) 343-2735
trossman@newventurecom.com
lkelaita@newventurecom.com
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