EnteroMedics Announces EMPOWER Trial Hypertension Data

EnteroMedics Announces EMPOWER Trial Hypertension Data Presented at
the American Heart Association's 2012 Scientific Sessions 
ST. PAUL, MN -- (Marketwire) -- 11/07/12 --  EnteroMedics Inc.
(NASDAQ: ETRM), the developer of medical devices using neuroblocking
technology to treat obesity, metabolic diseases and other
gastrointestinal disorders, today announced that hypertension data
from a subgroup analysis of the EMPOWER trial were presented today at
the American Heart Association's 2012 Scientific Sessions, held on
November 3-7, 2012 in Los Angeles, CA.  
The EMPOWER trial is a randomized, double-blind, controlled pivotal
study designed to evaluate the safety and efficacy of the Maestro(R)
System using VBLOC(R) vagal blocking therapy in 294 obese subjects. A
subgroup analysis was conducted to determine if VBLOC Therapy would
improve blood pressure prior to significant weight loss in obese
subjects with hypertension, as defined by elevated blood pressure at
baseline by JNC-7 guidelines (n=37, Group A) or history of
hypertension (n=58, Group B) at baseline. The analysis was performed
in a subset of subjects who had ≥ 9 hours therapy delivered per
day to 12 months. 
Subject Demographics  


 
-----------------------------------------------------------------
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                   Group A                    Group B                       
                   (Elevated Blood Pressure)  (History of Hypertension)     
----------------------------------------------------------------------------
# of Subjects      37                         58                            
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BMI (kg/m2)        41+/-1                     41+/-1                        
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Age (Years)        50+/-1                     51+/-1                        
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Female/Male        31/6                       47/11                         
----------------------------------------------------------------------------

 
Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure
(DBP) from Baseline 


 
  -------------------------------------------------
----------------------
  Group A (Subjects with Elevated Blood Pressure) (P < .001)             
  -----------------------------------------------------------------------
                         Baseline    Week 2      Week 4      12 Months   
  -----------------------------------------------------------------------
  SBP (mmHg)             145+/-2     -17+/-3     -17+/-3     -18+/-3     
  -----------------------------------------------------------------------
  DBP (mmHg)             89+/-2      -9+/-2      -8+/-2      -10+/-2     
  -----------------------------------------------------------------------
  % Excess Weight Loss   N/A         9+/-2       12+/-1      21+/-4      
  -----------------------------------------------------------------------
  Group B (Subjects with History of Hypertension) (P < .001)             
  -----------------------------------------------------------------------
                         Baseline    Week 2      Week 4      12 Months   
  -----------------------------------------------------------------------
  SBP (mmHg)             134+/-2     -10+/-2     -9+/-2      -13+/-2     
  -----------------------------------------------------------------------
  DBP (mmHg)             84+/-1      -6+/-1      -6+/-1      -7+/-1      
  -----------------------------------------------------------------------
  % Excess Weight Loss   N/A         9+/-1       13+/-2      23+/-3      
  -----------------------------------------------------------------------

 
"The results of this substudy analysis are remarkable, in that VBLOC
Therapy has demonstrated a clinically meaningful, non-pharmacologic,
immediate and sustained reduction in blood pressure in obese subjects
with hypertension," said Robert M. Carey, M.D., Professor, Division
of Endocrinology and Metabolism, University of Virginia Health
System. "This effect suggests that VBLOC Therapy may offer the first,
non-pharmacologic intervention for hypertension in obese subjects, a
clinical outcome that, with available obesity surgical treatments,
has never before been achieved."  
Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive
Officer, added: "These data suggest that VBLOC Therapy may
significantly reduce blood pressure in obese subjects with
hypertension, an effect which appears to be independent of weight
loss and achieves a greater magnitude of reduction at higher baseline
blood pressure values. These data add to our extensive clinical
experience with VBLOC Therapy and the Maestro System in obesity and
its related co-morbidities of hypertension and diabetes. We have
begun the process of amending our CE Mark certification to include
these effects on hypertension and diabetes, adding to our obesity
certification."  
About Maestro(R) System 
The Maestro System delivers VBLOC(R) vagal blocking therapy via two
small electrodes that are laparoscopically implanted and placed in
contact with the trunks of the vagus nerve just above the junction
between the esophagus and the stomach. The Maestro RF System, used in
the EMPOWER trial reported here, is powered by an external battery,
contained in a mobile controller, via a transmit coil. The newer
Maestro RC System is powered by an internal, rechargeable battery.
The battery is recharged as needed via an external mobile charger and
transmit coil. 
About VBLOC(R) 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(R) 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(R)
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 medical device company focused on the development
and commercialization of its neuroscience based technology to treat
obesity and metabolic diseases. EnteroMedics' proprietary technology,
VBLOC(R) vagal blocking therapy, delivered by a pacemaker-like device
called the Maestro(R) Rechargeable System, is designed to
intermittently block the vagus nerves using high-frequency,
low-energy, electrical impulses. VBLOC allows people with obesity to
take a positive path towards weight loss, addressing the lifelong
challenge of obesity and its comorbidities without sacrificing
wellbeing or comfort. EnteroMedics' Maestro Rechargeable System has
received CE Mark and is listed on the Australian Register of
Therapeutic Goods.  
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
commercial regulatory approval for our Maestro(R) System for the
treatment of obesity in the United States or in any foreign market
other than Australia 
and the European Community; 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; international commercialization and
operation; 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;
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 annual
report on Form 10-K filed March 15, 2012. 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 Federal (United States)
law to investigational use.  
The implantation procedure and usage of the Maestro(R) System carry
some risks, such as the risks generally associated with laparoscopic
procedures and those related to treatment as described in the
ReCharge clinical trial informed consent.  
Contact:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
ir@enteromedics.com 
 
 
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