By simulating
Torus Palatinus, a condition found in nature and common
among thin people, the device displaces volume in the palatal
vault. This enhances savoring, precludes food gulping and slows
food intake, thereby allowing satiety signals to trigger on
smaller amounts of food. The intended result is that users feel
satisfied on less food.
Highlights of the study were as follows:
- 48.78% of the device group
lost 5% or more of their total body weight
- 4.48% of the control group
lost 5% or more of their body weight
- The difference in success
rates between device and control groups was
statistically significant with a P value of < .0001
The 174 patient, prospective,
randomized study, conducted at five clinical centers in the U.S.
over a four month period will be submitted to the Food and Drug
Administration (FDA) in May as part of an application
seeking 510(k) clearance for the Scientific Intake Device(TM).
The device has already been designated by FDA as non-significant
risk.
The IRB approved study was conducted in accordance with the
FDA's Investigational Device Exemption (IDE) regulations. The
custom made Scientific Intake Device(TM) will be made
individually for each patient from medical grade acrylic with
soft edges and nitonal-like clasps. The device is designed to
fit comfortably during eating and to be easily and quickly
inserted and removed.
Scientific Intake's proprietary "Compliance Microsensor"
embedded in each device plays a key role in remote monitoring
while providing user friendly medical informatics that both
patients and physicians can
interpret at a glance. Mitchell Roslin M.D., F.A.C.S., Chief of
Obesity Surgery at New York's Lenox Hill Hospital and Chief
Medical Officer at Scientific Intake comments:
"These results are superior
to weight loss achieved by pharmaceutical therapies with none
of the unpredictable, unpleasant side effects. These data add
to the growing body of science linking rate of food intake to
satiety signals and excess caloric consumption.
"Devices that force people to eat less have all focused on the
stomach. We now have data that shows limiting food intake at
the oral cavity, a far more accessible part of the human body,
can be used to treat patients ranging from overweight to
morbidly obese. This predicate device can serve as a template
for a variety of future oral interventions."
William Longley, CEO of
Scientific Intake, added "According to this study, we clearly
exceeded the endpoint of showing increased weight loss in
patients using the device as compared to the control group. We
are excited about our potential to make a real difference in the
obesity epidemic and are hopeful that our 510(k) submission will
be satisfactory to FDA so that Scientific Intake can begin
playing a major role in a healthier America. Our broad IP
portfolio and product pipeline covering all aspects of dietary
restriction at the point where food enters the body will be
investigated in future studies."
The study began February 9, 2006 and was run by Alquest, Inc., a
contract research organization based in Minneapolis, Minnesota.
The clinical trial results confirm previous studies with the
Scientific Intake Device(TM). In one study, conducted at The
Pennington Biomedical Research Center at Louisiana State
University and published in the peer reviewed journal Obesity
Research in November 2004, food intake of
thirty-two overweight participants was monitored for two days.
The food intake of the subjects using the Scientific Intake
Device(TM) was 23% less than participants not using the device.
Longer term case studies from research performed in Atlanta,
Knoxville, and Detroit showed similar results. Twenty-four
subjects were initially weighed and fitted for a device. After
30 days of using the device, the
average weight loss average for all subjects was 5.88 pounds.
Medical research has shown that satiety is gradually reached
long after most adults have finished eating. Once the satiety
signal has been received, the desire to consume additional food
is greatly diminished. The theory behind the Scientific Intake
Device(TM) is that if ingestion of food occurred more slowly,
the satiety signal would be initiated and received prior to the
consumption of unnecessary additional amounts of food. One way
to encourage slower eating is to reduce the size of bites of
food with the introduction of a device that decreases oral
capacity by displacing area in the palatal vault. This causes
slower intake and more thorough, longer chewing times.
The Scientific Intake Device(TM) is investigational and not
currently approved for sale in the U.S. |
