The SmartByte WEight Management System

Clinically-Proven Safe & Effective • FDA-Cleared • Prescribed by Your Doctor

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A Clinically Proven Solution

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

SmartByte is for weight management in overweight/obese individuals with a body mass index (BMI) of 27-35 kg/m2 and with behavioral modification instruction. SmartByte is not for people with eating disorders or who are pregnant. Individual results may vary.


Physican Recommended

 

“In my practice, once a therapy has a solid research behind it, I find the next important thing is to have patient enthusiasm for the treatments I prescribe.  I can say unequivocally that I have rarely seen patients so excited about a new treatment as they are with SmartByte which I am confident bodes well for compliance and powerful results.”

- Dr. Bruce Bode, Atlanta Diabetes Associates


Weight Management becomes a lifelong goal for every patient who has overweight or obesity. At first, the goal is decreasing weight, but then it is keeping the lost weight off. The SmartByte System provides patients with a non-invasive way to feel fullness sooner. It works by decreasing the oral volume so it takes longer to eat a meal, giving the brain time to register the fullness.  At the end of the day, people using the SmartByte System do not eat as much. Since the SmartByte System really helps patients modify their behavior effectively, it should have a long-lasting effect for most of them.

- J. Michael Gonzalez-Campoy, MD, PhD, FACE
Minnesota Center for Obesity, Metabolism and Endocrinology, PA (MNCOME)


I prescribe the SmartByte System to give my patients a tool that helps them lose weight.  Most patients have struggled for years and are looking for something to help them overcome their barriers to losing weight. The SmartByte System is not medication and it is not surgery.  Many patients are nervous about considering medications because they are worried about the side effects.  Often, patients are also not interested in surgery because it is permanent and comes with a certain level of risk.  The SmartByte System offers patients a tool that fills the gap between simply dieting and more aggressive medical therapy.

- Amanda Powell, MD
Lahey Hospital and Medical Center


The SmartByte Weight Management System is Unique

EFFECTIVE

FDA-cleared on multiple trials
& prescribed by a doctor

EASY

Only use when while eating; add diet
& exercise to fit lifestyle

SAFE

Wearable device with no prescription
drugs or surgical procedures

SUPPORTIVE

Personal Coach to help achieve
& maintain your goals

 

SmartByte is for weight management in overweight/obese individuals with a body mass index (BMI) of 27-35 kg/m2 and 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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[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., et al., 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.