PALO ALTO, Calif.--(BUSINESS WIRE)-- Satiety, Inc. announced that its TOGA® System which enables an incision-free weight loss procedure was named one of the Top 10 Medical Innovations for 2011 by a group of 60 experts from the Cleveland Clinic. The TOGA System was the only therapeutic medical device named to the list among a field of innovative drugs, diagnostics, vaccines and monitoring equipment. One of the selection criteria was that “the innovation had to have significant clinical impact and offer significant patient benefit in comparison to current practices.” The TOGA System was noted as potentially making a weight loss procedure more accessible “for patients who want to lose weight and improve their health but without undergoing major surgery.” In the U.S., there are approximately 22 million surgical candidates by BMI, but only about 1% of these patients undergo surgery each year. According to Company market research, one of the primary reasons many of these patients do not choose surgery is because of their concerns about surgical complications. The TOGA Procedure may be an attractive option for some of these patients who are currently not opting for surgery.
“We were thrilled to be named as one of the upcoming top 10 medical innovations by this renowned group. We developed the TOGA System to be more acceptable to patients eligible for surgery, and it’s very exciting to know that the experts at the Cleveland Clinic see the TOGA Procedure as an important future choice in the care of these patients,” said Eric Reuter, President and Chief Executive Officer of Satiety, Inc. “We look forward to submitting our clinical trial data in the next few months for evaluation by the FDA.”
To read about the Top 10 Innovations for 2011 on the Cleveland Clinic website, visit http://www.clevelandclinic.org/INNOVATIONS/SUMMIT/topten11/index.html.
The TOGA System has recently been evaluated in a multi-center, randomized, sham-controlled study, the outcomes of which will be used to seek FDA approval to market the system in the U.S.
About Obesity, Current Treatment
Obesity is a global disease that affects more than 300 million people worldwide, according to the World Health Organization. Obesity causes or contributes to numerous serious health conditions including type 2 diabetes, hypertension, cardiovascular disease, arthritis, sleep apnea, and certain types of cancer. Approximately 22 million adults in the U.S. are eligible for weight loss surgery by U.S. NIH BMI criteria (BMI > 40 or >35 with an obesity-related health condition).
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 re-routing the intestine to cause malabsorption, has been proven to be the only effective means of achieving sustainable weight loss in obese patients. While the current surgical treatments for obesity are effective, they are major surgical procedures. Many patients who could benefit from these procedures forego surgery due to fear of complications and other reasons. ASMBS estimates that 220,000 patients underwent bariatric procedures in the U.S. in 2008, or approximately 1% of the eligible population.
About the TOGA® Procedure and Satiety, Inc.
The TOGA® Procedure is an incision-free restrictive procedure for obesity. The procedure is designed to be less invasive, require shorter recovery time, and have fewer complications compared to existing surgical options. In the TOGA Procedure, specialized flexible stapling instruments are passed through the patient’s mouth into the stomach, where they are used to create a narrow passageway for food (a “sleeve”). The sleeve slows the movement of food through the stomach, giving patients a feeling of fullness after a smaller meal. The procedure is performed without any surgical cutting, and no implant is left behind, only staples. Over 450 patients have been treated worldwide to date. The TOGA System has received the CE Mark, but has not been approved by the FDA for sale in the United States.
Satiety, Inc. was founded in 2000 through a collaboration of medical device incubators Thomas Fogarty Engineering and The Foundry, and is headquartered in Palo Alto, California. Visit Satiety at www.satietyinc.com.
Rachel Croft, 650-320-2127
Vice President of Marketing
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