BOSTON - October 8, 2018: Scientific Intake, a company dedicated to developing innovative technology for weight management, announced today significant growth and support hires in the Southeast market.
Davina Frick was hired as the Regional Sales Director for the Southeast in July of 2018. Frick’s background includes sales, marketing, and practice development. Her previous experience ranges from small business ownership, management, hospital operating room representation, and consultative territory sales. Frick’s passions of helping her clients build meaningful business and helping their patients feel better were natural compliments to Scientific Intake’s mission. Frick leads our Southeast team of practice development managers in the charge to increase public awareness of SmartByte®. “Davina is a dedicated and determined addition to the team.” said Ron Self, CEO of Scientific Intake. “ We’re excited to have her and confident on her contributions to the our future”.
Patricia Saccardo joined Scientific Intake in October of 2018 as the North Carolina Practice Development Manager. Saccardo served our country as a Marine, and her background includes a wealth of sales experience, patient consultation, and internal practice development. She is passionate about helping fueling client success along with patient awareness and compliance of SmartByte. Davina Frick, RSM, says “Patricia is an outstanding addition to our team.” said Davina Frick RSM for Scientific Intake. “ Her energy, experience and passion to provide consultative service to our customers is a perfect combination”.
SmartByte by Scientific Intake is the first and only FDA-cleared medical device designed to ingrain mindful eating. It has been clinically proven in multiple published studies to significantly reduce caloric intake, allowing users to feel satisfied on less food. The custom fit device is placed in the roof of the mouth when eating, resulting in smaller bites, increased chewing and greater savoring of food. Slowing intake and encouraging mindful eating allows the body’s natural defense against overeating, the satiety response, time to work. SmartByte’s seamless integration of medical device, personal coaching and sensor monitoring can be used alone or combined with other therapies. To learn more please visit SmartByte.com. Privately held and headquartered in Boston, Scientific Intake’s mission is to help people reduce the burden of weight management and live healthier lives.
About Scientific Intake
Scientific Intake is a Medical Device and Digital Health company that is scientifically-reinventing weight management with our flagship product the SmartByte™ Weight Management System. SmartByte seamlessly integrates a medical device, personal coaching, and a self-monitoring app to help people manage their weight and live healthy lives. SmartByte is the first and only, FDA-cleared personal weight management system. Privately held and headquartered in Lawrence, Massachusetts, Scientific Intake’s mission is to help people reduce the burden of obesity-related chronic diseases through weight management
SmartByte 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.
BOSTON – Scientific Intake, a company dedicated to developing innovative technology for weight management, announced Patricia K. Scheller has been elected as the Chairwoman of the Board and Ronald T. Self as Interim Chief Executive Officer.
Scientific Intake, which sells the patented SmartByte®, the first FDA-cleared, non-invasive, removable weight management device, welcomed Mr. Self and Ms. Scheller to its board earlier this year.
Ms. Scheller stated, “The Board and I want to thank our predecessors that established the company, oversaw the clinical testing that established the ability of SmartByte to significantly reduce caloric intake and guided the company to its regulatory clearance by the FDA.”
Ms. Scheller, former CEO of Viveve, has a proven track record of identifying and establishing untapped new markets and business opportunities. She led the successful global launch of the first coronary stent to achieve $1B in annual sales; oversaw a novel women’s health product; and worked to expand Band-Aid® Brand wound care products into new home health care direct-to-consumer channel. She spent 15 years at Johnson & Johnson and brings operational experience as CEO in several start-up companies, including Viveve, which she took public and listed to Nasdaq.
Ms. Scheller holds a B.S.E. degree in Biomedical Engineering from Duke University and has completed executive education programs at Massachusetts Institute of Technology, Harvard University, Columbia University and Northwestern University.
Mr. Self, who currently consults with leading private equity firms, brings a wealth of sales, marketing and operating knowledge to the board. Over the past 15 years, he has partnered with middle-market private equity investors as CEO to lead their business technology services companies. He has driven the professional transformation and growth of numerous companies -- increasing profitability and successfully selling four. Previously, Mr. Self-began his career in various field sales, marketing and general management positions at Procter & Gamble, Pepsi-Cola and Coca-Cola USA.
Mr. Self holds a B.B.A. in Marketing from the University of Houston and completed graduate studies at Darden and Emory Universities. He has been recognized for his intuitive leadership by American Executive magazine.
Unlike weight management devices that must be surgically implanted, SmartByte is designated as a Non-Significant Risk product by the U.S. Food and Drug Administration. It combines a simple, user-controlled medical device to modify behavior, a proprietary sensor to keep track of progress towards goal weight and one-on-one, personal coaching to support users.
About SmartByte ®
SmartByte by Scientific Intake is the first and only FDA-cleared medical device designed to ingrain mindful eating. It has been clinically proven in multiple published studies to significantly reduce caloric intake, allowing users to feel satisfied on less food. The custom fit device is placed in the roof of the mouth when eating, resulting in smaller bites, increased chewing and greater savoring of food. Slowing intake and encouraging mindful eating allows the body’s natural defense against overeating, the satiety response, time to work. SmartByte’s seamless integration of medical device, personal coaching and sensor monitoring can be used alone or combined with other therapies. To learn more please visit smartbyte.com. Privately held and headquartered in Boston, Scientific Intake’s mission is to help people reduce the burden of weight management and live healthier lives.
FDA Clears First “Non-Significant Risk” Medical Device for Weight Management
Atlanta--Scientific Intake, a company dedicated to developing new products for overweight and obese consumers, announced today that the U.S. Food and Drug Administration (FDA) has cleared SmartByte® for use as an aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) of 27 to 35 in conjunction with behavioral modification instruction.
Scientific Intake’s patented SmartByte is the first non-significant risk medical device of its kind that FDA has cleared for weight management in the overweight and obese population.
SmartByte is designed to occupy space in the roof of the mouth. It is made for each individual based on his or her oral anatomy, and is inserted by the user during meals and snacks, or while drinking caloric drinks. It works by decreasing the capacity of the mouth. The device slows intake by limiting bite size and increasing oral processing allowing users to feel satisfied on less food.
Each SmartByte contains an embedded sensor that automatically records usage every five minutes for up to 14 months. Proprietary software calculates adherence and progress to weight goals with easy-to-understand graphic displays.
Every clinical trial conducted with SmartByte demonstrated that use of the product resulted in better weight management.
Scientific Intake CEO William Longley said: “SmartByte replaces willpower. While the product itself is intuitive and easy to use, we studied SmartByte carefully in several controlled clinical trials. The evidence is clear: it works. Being hungry all the time and not being able to eat the foods they like are often cited as reasons why people fail to achieve their goals. SmartByte is designed to help address those issues by changing how you eat, not what.”
Mr. Longley added: “We all know eating slowly is beneficial, and a large body of science confirms it, but it is hard for people to change behavior. Our device is designed to help ingrain the new behavior and our sensor accurately provides feedback on adherence and progress. With multiple published clinical studies and now FDA clearance, this product will soon be available for the intended patient population. SmartByte provides a weight management option for patients without requiring surgery or implanting devices.”
Scientific Intake’s Chief Medical Officer Donna Ryan MD FACP, past President of the Obesity Society and President of The World Obesity Federation, has been involved with Scientific Intake since her tenure at the Pennington Biomedical Research Center, where the first feasibility study on SmartByte™ determined that users reduced their food intake by 23% to feel satisfied, compared to a control group without the device.
Dr. Ryan said, “SmartByte is an important new tool in our toolbox that can be widely used with confidence. At last we have an FDA-cleared device that can help people manage their weight – and clinical testing has demonstrated a very strong and favorable safety profile. In addition, patients do not need to undergo surgery or multiple endoscopic procedures to use the device, unlike approved implanted weight loss devices. SmartByte can be used with any diet the patient chooses and in any situation.”