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

PALO ALTO, Calif.--(BUSINESS WIRE)--Oct. 25, 2006--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.


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