EnteroMedics Announces
Weight Loss, Hypertension and Diabetes Data from EMPOWER and
ENABLE Studies
St. Paul, minn,
januray 14, 2010
ST. PAUL, Minn., Jan 14, 2010 (BUSINESS WIRE) -- EnteroMedics
Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology
to treat obesity and other gastrointestinal disorders, today announced clinical
results from two studies of VBLOC(R) vagal blocking therapy, including additional
data from its EMPOWER(TM) study in obesity and interim clinical results from
its ongoing VBLOC-DM2 ENABLE (DM2) study in diabetes using the next-generation
rechargeable (RC) device. For all studies, the Maestro(R) System continues
to meet its safety goals, with no therapy-related serious adverse events reported
across the various study populations.
"Results from multiple studies of the Maestro System, which include over
400 implanted subjects, remain encouraging, with signs of clinically meaningful
weight loss and control of obesity related co-morbidities as well as a safety
profile unmatched among bariatric surgical procedures," said President
and CEO Mark B. Knudson, Ph.D. "Patients in the DM2 study, who use the
RC Maestro System for approximately 14 hours a day, experience both meaningful
weight loss and significant reductions in their HbA1c levels. Further, because
the DM2 study uses the next-generation RC device, it shows promise in resolving
patient compliance for those patients that did not use the device for the prescribed
amount of time in the EMPOWER trial and earlier studies."
Dr. Knudson added: "We look forward to meeting with the FDA during the
current quarter to determine the appropriate regulatory path forward for the
Maestro System as a treatment for morbid obesity and its related co-morbidities,
diabetes and hypertension."
Additional EMPOWER Study Results
The Company today announced additional data from a detailed review of its EMPOWER
study, which included the following:
--Weight loss corresponded directly to
hours of use for patients in the treatment arm. At 12 months, results were
as follows:
| Daily use |
<6 hrs |
greater-than or equal to 6 <9 hrs |
greater-than or equal to 9 <10 hrs |
greater-than or equal to 12 hrs |
| Percent EWL (BMI Method) |
4.7 |
12.9 |
21.5 |
29.5 |
| |
|
|
|
|
--Weight loss corresponded directly to hours of use when
both the treatment and control arms are combined:
| 12 Months from Implant (BMIMethod) <6 hrs |
greater-thanorequalto9hours/day<9hours/day
p-value |
| Subjects achieving greater-than or equal to 25%
EWL |
|
N=128 |
N=125 |
|
| Average daily use in subjects |
|
39.1% |
12.0% |
p<0.0001 |
| |
|
11.2 hrs |
7.7 hrs |
p<0.0001 |
The EMPOWER study is a randomized, double-blind, controlled pivotal study designed
to evaluate the safety and efficacy of the Maestro System in the treatment
of obesity. EnteroMedics previously announced preliminary findings from a detailed
review of the study which suggest that vagal blocking therapy may promote safe
and effective weight loss as an adjunct to behavioral support, diet and exercise
in morbidly obese patients. The review further suggested that weight loss effects
were evident in both the treatment and control arms because the control arm
of the trial, which was intended to be inactive, apparently provided a low-intensity
blocking signal that introduced VBLOC Therapy in human subjects.
VBLOC-DM2 ENABLE study
The DM2 study is an ongoing feasibility study of the Maestro System in obese
patients with Type-2 diabetes mellitus. The study includes subjects implanted
with the RC device and was designed to evaluate the system's safety and efficacy.
Study data include:
--HbA1c change (baseline 7.7%):
Percent Visit (post-device activation) Hba1c change HbA1c n p
| Week 1 |
-0.3 |
7.4 |
19 0.0206 |
| Week 4 |
-0.7 |
7.0 |
19 0.0002 |
| Week 12 |
-0.9 |
6.8 |
18 0.0019 |
| 6 Months |
-0.8 |
6.9 |
19 0.0062 |
| |
|
|
|
--Percent excess weight loss (BMI Method from Implant):
| Visit (post-device activation) |
EWL |
n |
p |
Week 12 |
-23.6 |
18 |
<.0001 |
6 Months |
-26.4 |
19 |
<.0001 |
--Change in mean arterial pressure in Hypertensive Subjects (baseline 99.5
mmHg, average) in mmHg:
| Visit (post-device activation) |
MAP change |
n |
p |
| Week 1 |
-7.8 |
10 |
0.0102 |
| Week 4 |
-12.3 |
10 |
0.0046 |
| Week 12 |
-9.9 |
9 |
0.0007 |
| 6 Months |
-12.9 |
10 |
0.0018 |
About VBLOC Therapy
EnteroMedics developed VBLOC(R) vagal blocking therapy to offer bariatric
surgeons and their patients a less invasive alternative to existing surgical
weight loss procedures that may present significant risks and alter digestive
system anatomy, lifestyle and food choices. VBLOC Therapy is delivered via
the Maestro(R) System through laparoscopically implanted leads to intermittently
block the vagus nerves using high-frequency, low-energy electrical impulses.
VBLOC Therapy is designed to target the multiple digestive functions under
control of the vagus nerves and to affect the perception of hunger and fullness.
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.
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 presentation 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 pivotal trial; our ability
to complete our other clinical trials, or significant delays in the completion
of our clinical trials; our ability to timely 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;
our ability to obtain and maintain intellectual property protection for our
technology and products; and risks related the offering and ownership of our
common stock. These and additional risks and uncertainties are described more
fully in our Form 10-K filed with the SEC on March 12, 2009. We are providing
this information as of the date of this presentation including our best estimates
on obesity and bariatric surgery market calculations 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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