U.S. Residents

The Scientific Intake website is not intended for a U.S. audience. The website describes our product, Sensor Monitored Alimentary Restriction Therapy (SmartByte™). The product has not been cleared for marketing by the Food and Drug Administration and is not available for sale in the U.S.

SmartByte™ is limited by U.S. law to investigational use only. It has been designated Non Significant Risk by the FDA.

Outside the U.S., Scientific Intake's SmartByte™ is designated a Class I medical device and has been granted the CE Mark (Europe), and has been approved by Health Canada, Anvisa ( Brazil) and TGA (Australia).

I Understand

Maintaining a Healthy Weight

Maintaining a healthy body weight is important because being even moderately overweight can cause many other serious health problems. In nearly every developed country, over half of the adult population is overweight or obese. Co-morbidities such as heart disease, stroke, diabetes, respiratory problems, GERD, low self-esteem, sleep apnea, osteoarthritis and some cancers are directly related to obesity. Scientists who specialize in overweight and obesity agree that a loss of 3% – 4% of body weight can  improve co-morbidities.

Body Mass Index (BMI) is often used to assess body fat and screen for weight categories that can increase health risks. As defined by the World Health Organization (WHO) BMI of 25 is considered normal weight. BMI between 25 and 30 is classified as overweight, BMI 30 – 35 is Class I obesity, BMI 35 – 40 is Class II obesity and BMI greater than 40 is Class III obesity.

Current FDA approved options for weight loss are limited and side effects or complications are common:

  • Pharmacotherapy. Recently published studies confirm that pharmacological treatments for excess weight cause only modest weight loss over placebo with marginal long-term results. They work by affecting the brain, the heart or the digestive system. Side effects can include cardiovascular complications, lack of bowel control and unnerving psychological changes. Pharmaceutical therapy is generally not reimbursed by insurance resulting in out of pocket costs of $1,500 a year or more. Many physicians are hesitant to prescribe these drugs due the side effects profile and unknown effects of longer term use.
  • Surgery. At the other extreme, for individuals with BMI > 35, surgical procedures such as gastric bypass and adjustable gastric banding are available. Bariatric surgery has severe side effects such as GERD, inability to eat certain foods, dumping syndrome and vitamin deficiency.  Also, it can result in serious complications during and after the procedure, so it is generally not indicated for patients who are overweight or Class I obese. Another recently approved option is a pacemaker like device implanted in the body with electrical leads attached to the vagus nerve.
  • Endoscopic Placement. This involves placing a liquid filled balloon in the stomach using a tube inserted down the throat. Recipients often report nausea and discomfort during use which is limited to six months. The balloon is then retrieved with another endoscopic procedure. This temporary placement is also not covered by insurance and costs $6,000 to $8,000 for the six months it is in place.

SmartByte™ is a small, non-surgical, non-endoscopic device containing no pharmacological compounds. It is made made specifically for your mouth for maximum effectiveness.  It is used only while eating. It is controlled by the user and limits food intake at the mouth, not in the stomach or intestines.

© 2017 Scientific Intake Limited Co.