How Does SmartByte® Work?
SmartByte naturally activates the body’s appetite, hunger, and satiety hormones to help people feel full before overeating. While it achieves similar effects to synthetic pharmaceutical compounds, SmartByte leverages natural GLP-1 and other endogenous hormones, allowing them to work as intended without systemic drugs. This eliminates gastrointestinal discomfort, vomiting, diarrhea, nausea, and the risk of pancreatitis or thyroid cancer. SmartByte is the first and only bariatric medical device designated Non-Significant Risk by the FDA.
Is Scientific Intake Backed by Science?
It is well-documented that individuals who eat slowly tend to have lower body weight. More than fifty clinical, epidemiological and meta-analysis studies conducted over the past 30 years have established that eating slowly, increasing chewing, and savoring food enables the stomach to signal the brain that it is full before overeating occurs.
Are There Peer Reviewed, Published Scientific Studies on SmartByte?
Four published clinical trials on SmartByte have demonstrated consistent efficacy. The first study showed SmartByte users were satisfied on -23% less food compared to non-users – semaglutide trial subjects were satisfied on -24% less. A subsequent four-month study on SmartByte showed that median compliance of 8 uses per week over 16 weeks resulted in mean weight loss of -6.4%. For those that used the device 13 or more times during a week the mean weight loss was -9.4 %. For the same period semaglutide achieved -5.8% and tirzepatide -8.2%. Additionally, numerous clinical, epidemiological, and meta-analysis studies conducted over the past 50 years have established a clear link between rapid eating and overweight/obesity.
Has SmartByte Passed FDA Scrutiny?
Yes. Scientific Intake is FDA cleared (De Novo) with special controls assuring safety and efficacy. It is the first and only bariatric medical device designated non-significant risk by FDA. It is also approved in the EU, the United Kingdom, Brazil, Canada and Australia.
Does Scientific Intake Have Patent Protection for SmartByte?
Yes- the company has multiple, recent patents which, along with FDA special controls and trade secrets, preclude competition.
When is SmartByte Used?
The device is used only during meals and is stored in its case afterward. It is user-controlled, and research data indicate that increased usage across meals correlates with greater weight loss
Can I Still Taste Food When SmartByte is Used?
Yes, since taste is registered by the taste buds on the tongue, the device has no impact on one’s ability to taste. In fact, SmartByte users report that the taste and enjoyment of food are enhanced because they chew and savor their food more thoroughly.
How Does SmartByte Feel?
SmartByte is designed to fit each user’s oral anatomy precisely. It is easy to insert and remove, with many users comparing the experience to wearing contact lenses—they notice it on the first day or two, then quickly get used to it. New users often comment that they are making better food choices and enjoying the tastes and textures of food again.
Can People Talk With SmartByte in Place?
You can easily talk with SmartByte, though speech may sound different at first. Most people quickly adjust to speaking with it. Unlike pharmaceutical options, 100% compliance is not required. The user controls when to use the device, so skipping a meal is not a problem.
Can People See When I am Using SmartByte ?
No, it is designed to be discreet and cannot be seen by other people when in place.
How is SmartByte cleaned and stored?
It comes with an attractive, discreet carrying case to protect it when not in use. SmartByte is cleaned with a soft-bristled toothbrush and toothpaste, then rinsed with cold water.
How long does SmartByte last?
FDA required tests showed that it will last 1.5 years with 100% compliance.
What does the SmartByte® WeightSync digital patient management platform do?
The embedded sensor captures precise individual usage time and sends that data to a custom app. In addition to automatically recording compliance, the app can show progress to goal weight, send reminders, and provide details of your weight loss journey to a coach, medical professional or peer group. This real-time, individualized data adds a new support dimension to the weight management experience, one not found in pharmaceutical compounds used for weight loss.
Can anyone get SmartByte?
Currently, the device is approved for adults 18 and older in good oral health. Given the safety profile and widespread use of oral devices in children and teens, we believe that research on individuals under 18 would also verify its benefits.
Does insurance cover SmartByte?
Not at this time, but it can be paid for with an HSA funding plan. The cost of the device will be finalized by the acquiring company but is expected to be equivalent to the cost of two to three months of GLP-1 injections. We believe that insurers will find our lower-cost, FDA-cleared step therapy attractive compared to the lifelong expense of synthetic GLP-1 RA drugs.
Are consumer market research or SmartByte user experience comments available?
Yes, both are available and are very helpful in understanding how this alternative to synthetic GLP-1 drugs is embraced by consumers.
Can SmartByte be used instead of GLP-1 RA drugs? With GLP-1 RA Drugs? If GLP-1 RA drugs are discontinued, will SmartByte allow weight loss to continue to be maintained?
Yes to all of the above. Eating slowly increases the postprandial response of anorexigenic gut hormones GLP-1 and others causing loss of appetite. Because SmartByte does not introduce systemic drugs into the body there is no drug interaction. If a patient decides to discontinue the drugs due to cost, side effects or achieving their goal weight, Scientific Intake can use the body’s natural GLP-1 and other hormonal defenses against overeating to maintain the weight lost with the drugs.
Do you have other questions?
As SmartByte is a new, never before seen Medtech category with no predictive device, you may have more questions. Please do not hesitate to contact us at [email protected]. We are here to assist you with any further inquiries.