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CLINICALLY-PROVEN RESULTS

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.

COMPETITIVE VALUE

 
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PRESCRIBED BY DOCTORS

 
 

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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.


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BEHAVIORAL SCIENCE

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.


 
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Improve Both How You Eat & What You Eat

Our coaches leverage evidence-based techniques to help clients implement small modifications – “mini mods” – to their eating habits, diet and lifestyle that will help lead to lasting weight loss. The coaches also promote consistent and correct use of the SmartByte Device to help clients achieve the best results possible.

The program is highly adaptive to clients' individual needs and preferences with real-time adjustments to treatment plans based on detailed analysis of their lifestyle, habits and clinical results. Ongoing communication with their coaches includes phone calls, text messaging and email – all customized to their preferences.


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DIGITAL INTELLIGENCE

The Self-Monitoring App connects to a sensor in your SmartByte Device and sends usage data to the SmartByte Weight Management 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.

ONLY AVAILABLE FROM SELECT DOCTORS NEAR YOU

  • Boston, MA Area
    Lahey Hospital & Medical Center
    Atrius Health
    Lincoln Associates
    Skin & Laser Surgery Center New England
  • Atlanta, GA Area
    Resurgia Health Solutions
    Atlanta Diabetes Assocites
  • Indianapolis, IN Area
    Dr. Erin's Weight Loss
    Doctors Direct LLC
    Riverview Hospital Endocrinology
  • Greenville, SC Area
    Doctor for Life
  • Raleigh, NC Area
    North Hills Internal and Integrative Medicine
    Eastern Carolina Medical Center
  • Minneapolis, MN Area
    Minnesota Center for Obesity, Metabolism and Endocrinology
  • Buffalo, NY Area
    Inspired Health Group
  • Princeton, NJ Area
    Princeton Endocrinology & Weight Management Associates
  • Philadelphia, PA Area
    Abington Endocrinology & Weight Management Associates
    Collegeville Family Medicine
    Medical Weight Loss of Harrisburg
  • Pittsburgh, PA Area
    Cardinal Endocrinology
  • Greenwich, CT Area
    Greenwich Hospital
  • Las Vegas, NV Area
    Las Vegas Endocrinology

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1 FDA, Department of Health & Human Services, SmartByte Device, Regulation Number: 21 CFR§ 876.5981, 2016.
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.