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Satiety, Inc.'s New Transoral Procedure for Treating Obesity Shows Promising Results in First Clinical Trial



    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.