Satiety, Inc. announced today the presentation of data from the
first clinical trial evaluating its TOGa(TM) System for treatment of
obesity. The TOGa(TM) (for "transoral gastroplasty") Procedure is the
first designed to mimic established restrictive surgical procedures
for obesity, but to be performed completely transorally, without
incisions.
Data from the TOGa pilot trial was presented at two major medical
meetings in the U.S. and Europe this week. On Monday, Dr. Steven
Edmundowicz of Washington University, St. Louis, presented data from a
single center in the President's Plenary Session at the American
College of Gastroenterology Annual Scientific Meeting in Las Vegas,
Nevada. In the trial at Hospital Regional 1(degree) de Octubre ISSSTE
in Mexico City, 12 obese patients were treated starting in February
2006 by Dr. Gerardo de Jesus Ojeda and Dr. Fabian Luis Cuevas. All
patients were treated safely, without any serious adverse events, and
the procedure was well tolerated.
Dr. Edmundowicz commented, "The clinical benefit to obese patients
treated by currently available bariatric surgery is well established,
and the TOGa procedure is exciting because it uses the same mechanism,
restriction, but with a much less invasive approach. We are encouraged
by the early results of this safety and feasibility trial. If the TOGa
Procedure is shown to be safe and effective, it could significantly
increase the number of patients that are eligible for obesity
treatment because it is less invasive. This is a promising first
step."
In a separate presentation today at the 14th United European
Gastroenterology Week in Berlin, Germany, Professor Jacques Deviere,
MD, PhD of Erasme Hospital in Brussels, Belgium, presented
comprehensive safety, feasibility, and 3-month weight loss data for
all 21 patients treated in the pilot trial, including patients from
the Mexico site as well as nine patients he treated with his
multi-specialty bariatric team in Brussels. All patients were treated
safely and the procedure was well tolerated. Endoscopy and barium
studies showed well-healed, persistent restrictions in the majority of
patients. At three months, patients had lost an average of 24.7
pounds, and 20.5% of their excess body weight.
Professor Deviere, the principal investigator of the TOGa Pilot
Trial said, "This trial was an important step in establishing the
acute safety of the procedure, with minor adverse events being similar
to those seen during routine upper GI procedures. Tissue healing was
good, and we showed that it is possible to achieve a durable
restrictive pouch. The weight loss seen in this study is encouraging,
and we are optimistic that anatomic and weight loss results may
improve above what is seen here in future trials, which will
incorporate improvements in the device."
In the TOGa procedure, an endoscopic device is inserted through
the patient's mouth into their stomach to create a small stapled
restrictive pouch. A second device is passed to tighten the outflow
tract of the pouch to limit the amount of food a patient can eat in a
single meal. The safety of the procedure is currently being evaluated
in this pilot study. A second trial evaluating both the safety and
effectiveness of the procedure for U.S. FDA approval is expected to
begin in the first half of 2007.
Greg Patterson, President and CEO of Satiety, Inc. commented
"Satiety is pleased to have achieved this important clinical milestone
demonstrating safety and feasibility in humans. While the trial was
not designed to focus on weight loss, we are encouraged that the
patients lost a significant amount of weight in this first-in-man
trial. The TOGa Procedure promises to be a breakthrough technology as
it replicates current proven restrictive obesity surgeries, but does
so simply by stapling the stomach from the inside out, without the
need for incisions. We think this procedure could dramatically expand
the treatable patient population as well as enable new categories of
endoscopically trained physicians to treat bariatric patients, thus
improving accessibility to treatment for obesity and its
comorbidities. We look forward to the next step in the clinical trials
process and, ultimately, the commercialization of this technology to
benefit obese patients worldwide."
About Obesity, Current Treatment
Obesity is a global disease that affects more than 300 million
people, according to the World Health Organization. Obesity causes or
contributes to numerous serious medical conditions including type 2
diabetes, hypertension, cardiovascular disease, arthritis, sleep
apnea, and certain types of cancer. In the United States, it is
estimated that obesity is linked to approximately 300,000 deaths
annually and leads to approximately $100 billion in direct healthcare
expenditures. Approximately 22 million adults in the United States are
considered morbidly obese. This morbidly obese population underwent
approximately 170,000 bariatric surgical procedures in 2005, and this
procedure base is growing at approximately 18% per year. While the
number of surgeries is growing, it is estimated that only 1.2% of
eligible patients are treated each year.
The most common treatments for obesity - diet, exercise and
pharmacologic therapy - have poor long-term success rates. Obesity
surgery, which entails surgical restriction of the size of the stomach
with or without rerouting the intestine to cause malabsorption, has
been proven to be the only effective means of achieving sustainable
weight loss in patients. While the current surgical treatments for
obesity are effective, they are major surgical procedures involving
irreversible reconstruction of gastrointestinal anatomy or requiring
surgical implants. Many patients who could benefit from these
procedures forego surgery due to the significant complications and
long-term adverse event rates associated with these procedures.
About the TOGa(TM) Procedure and Satiety, Inc.
The TOGa Procedure is a completely transoral procedure designed to
achieve similar weight loss to restrictive surgeries. The procedure is
designed to be less invasive, require significantly less recovery time
and have dramatically reduced complications, compared to existing
surgical options. In the TOGa Procedure, the physician introduces a
stapling device transorally and creates a restrictive pouch at the
entry of the stomach. The effect is anatomically similar to other
restrictive procedures, which physically restrict the amount of food a
patient can eat. The procedure is non-surgical, endoscopic, and may be
performed by properly trained bariatric surgeons, general endoscopic
surgeons, and gastroenterologists. The TOGa System is an
investigational device, and is not approved by the FDA or European
regulatory agencies.
Satiety, Inc. is headquartered in Palo Alto, California, and is
focused on the development of a less invasive treatment for obesity.
The company was founded in 2001 through a collaboration of medical
device incubators Thomas Fogarty Engineering and The Foundry. The
Company is funded by leading venture capital investors including Three
Arch Partners, Morgenthaler Ventures, Venrock Associates and ABS
Ventures.
