In clinical studies, people using SmartByte lost 38% excess body weight in only 4 months.1
SmartByte has been studied in 5 clinical trials with over 300 people. Based on the safety and effectiveness results from 2 of these clinical trials, the FDA cleared SmartByte for sale in September 2016. Results from the 2 additional clinical trials have been published in distinguished medical journals.
In clinical studies, people using SmartByte as directed lost 38% excess body weight (4.4% total body weight, 8.8 lbs. for a 200 lb. person) in 4 months. People who did not use SmartByte as directed lost an average 14.6% excess body weight in 4 months.
In a published clinical trial, people ate 533 fewer calories per day by using SmartByte.2 It takes 3,500 calories to burn 1 pound of fat. It’s well known in medical literature that losing weight has a positive impact on improving health.3
The SmartByte Device is intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range 27-35 kg/m2 in conjunction with behavioral modification instruction. SmartByte is not for people with eating disorders or who are pregnant. Individual results may vary.
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PROPRIETARY MEDICAL TECHNOLOGY
The small, removable, custom-molded SmartByte Device is comfortably placed on the roof of your mouth, only when you eat.
It helps you to take smaller bites & eat more slowly which gives your body time to realize that you’re feeling full so you’ll be satisfied with less food and fewer calories.4
It’s important to use SmartByte regularly. People who used SmartByte during more meals lost more weight.
The SmartByte Device is the only FDA-cleared wearable to help you manage your weight.
Through our Personal Coaching Program, you will be assigned to a Care Team specially selected based on your profile, lifestyle and goals. Each Care Team includes a behavior change specialist and a certified professional such as a registered dietician.
Over the course of 52 weeks, you’ll work with your Care Team to maximize the benefits of your SmartByte System and adopt new healthy habits to help you achieve your weight & health goals.
SmartByte Personal Coaching is the only behavioral modification program that leverages a medical device, app & coaching to help improve both how you eat and what you eat.
The Self-Monitoring App connects to a sensor in your SmartByte Device and sends usage data to the SmartByte System. You will also receive a cellular-enabled scale that automatically captures your weight data for display within the App.
Gathering this data provides you and your coach with a comprehensive view of your results so you can track progress towards your goals in real-time – together.
The SmartByte Self-Monitoring App is the only digital platform that integrates eating behavior with weight loss results in real-time.
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2 Walden H., et al., A new dental approach to reducing food intake. Obesity Research 2004; 12: 1773-1780.
3 Moore, L., Weight loss in overweight adults and the long term risk of hypertension: The Framingham Study. Arch Intern Med. 2005; June 13; 165(11): 1298-303.
4 McGee, T. L., Grima, M. T., Hewson, I. D., Jones, K. M., Duke, E. B. and Dixon, J. B. (2012), First Australian Experiences With an Oral Volume Restriction Device to Change Eating Behaviors and Assist With Weight Loss. Obesity, 20: 126–133.