Now introducing The Pylo-Sphere; a revolutionary weight loss device that will change the way people who suffer from obesity can lose weight without requiring surgery. The Pylo-Sphere uses balloon technology to create fullness after eating small amounts causing you to stop eating . We have a world class team including a FDA regulatory agent, mechanical engineer and legal counsel. We have patents in China, Hong Kong and Canada . The USA and Europe are pending and expected to be issued this year.
The intent is to place the device in a short outpatient procedure. Once we obtain FDA approval we will do our first human trial. The device blocks the outlet of the stomach all the food has to move though a small channel in the device to be digested. This creates the fullness feeling. I observed this weight loss in people who have a similar obstruction do to ulcer disease in there stomach which is the inspiration for this device. These people lost weight however did not seem to get sick.
What We Need & What You Get
We need 2 million dollars to get this device through the preliminary FDA process known as a IDE ( investigational device exemption). This will get us through our first human trial and one step closer to everyday use in people who need it. This process is expensive and requires a lot of steps. We have finished animal trials with this device and believe it can be safely placed in people. However through a very careful expert team process we have to prove this to the FDA .
I have spent most of my career treating obesity and it’s complications. I have also treated many people with complications of gastric bypass and lap band. I am passionate to get this device on the market so people have a effective solution to lose weight without surgery .
With the IDE we can do a small human study and the value of the company would likely increase . This places us in the position of getting additional funding so we can get this device to the purple who need it. The market is very large and open for new technology .
The Impact
I believe the Pylo-Sphere is a game changer to help millions of people world wide lose weight without surgery safely and effectively . Once they lose the weight the device can be removed then replaced if needed. The device is designed to stay in the stomach 90 days. In the future we may be able to extend that time to 6 months. The device can be replaced if someone needs more time to lose weight.
Other Ways You Can Help
Make some noise tell you friends about the Pylo-Sphere! Help us get this device approved so we can change the world of obesity treatment. Thank you! www.indiegogo.com