Several years ago, our founder and board chairman, Bill Longley, got a call from a friend and former senior official at the FDA. He was asked to come to Washington D.C. and meet the inventors of a new medical device with an innovative approach to weight management. Bill had recently sold the medical internet company he co-founded to WebMD and was intrigued. All he was told was that the device was disruptive, low risk and intuitive - there was nothing else like it.
A week later Bill met Lynn, an artist and Al, an international banker and learned that how we eat is as important as what we eat. Lynn had a condition that limited the capacity of her mouth. When eating, she took small bites and chewed her food thoroughly. She tasted and savored her food and explained that she could not “wolf down” a meal like most people. The result was her stomach signaled her brain that she was full before she overate. She was often the last to finish eating, but also the slimmest person at the table.
Lynn and Al knew being overweight had a major impact on health and self-confidence. They developed a custom fit, removable device that imitated Lynn’s oral condition. The small, user controlled insert was only placed in the roof of the mouth when eating and was not visible to others. Some friends tried it and confirmed that it was comfortable and it worked. They ate less to feel satisfied and their clothes felt looser after a week.
The concept was so innovative that a patent lawyer obtained broad patent protection. Other medical device companies were approaching excess weight using surgery to place restrictive devices in or around the stomach. No one was focused on the mouth, the gateway to the body. Lynn, an accomplished artist and Al, an international banker, decided that they wanted to license their patent to Bill.
An agreement was signed and the journey began. Bill’s first step was to get his own device. A lifelong rapid eater, he actually tasted his food for the first time in years. His weight went from 221 to 208 in just over two months and he never gained it back. Next, he showed the device to top medical, research and academic experts on weight management at Yale, Columbia, UC Davis, Penn, Harvard and LSU. Their positive reactions were unanimous and encouraging.
To see what happened in the real world Bill recruited 24 people in 3 cities to try it. After 32 days, their average weight change was minus 5.9 pounds. This was followed by a visit to the prestigious Pennington Biomedical Research Center at LSU where Bill met Dr. Donna Ryan and her team to commission a sophisticated clinical study. The device users ate 23% less food to feel satisfied than non-users. After peer review, the study was published in the journal Obesity becoming part of the body of science on weight management.
Scientific Intake was founded and staffed. The years that followed saw more successful published studies over longer periods validating the benefits of SmartByte. Each year saw new improvements to optimize results and ease of use. Bill learned that people don’t always keep accurate compliance records so he invented a small sensor to put in the device and software to automatically keep track of usage and progress to goal weight.
In the fall of 2016, after multiple clinical trials confirmed safety and efficacy to rigorous U.S standards, SmartByte received market clearance from the U.S. Food and Drug Administration. It is the only cleared weight management device designated non-significant risk by the FDA.
To support SmartByte users Scientific Intake added personalized coaching and a new smart phone app using each individual’s sensor data .
Now, after years of careful research and development, Scientific Intake’s SmartByte® is available to play an important role in addressing America’s expanding weight epidemic.