Israel biomed company Tulip Medical has completed its first clinical trial with 16 patients, in which a 4% reduction in weight was observed in the patients. The company is developing a pill that expands in the stomach, inflates like a balloon, and creates a sense of satiety,
This trial was intended to first test the safety of the product, and it was therefore not administered in conjunction with a nutritional plan, and was not tested against a control group. Test results indicate that the product has no side effects. During the trial, the pill was consumed more than 600 times. The company is moving on to an advanced clinical trial, in which the product will be administered as part of an inclusive weight-loss program.
Tulip CEO Nir Betser said, “Our product is a pill that expands into a balloon in the stomach, and is later digested. It is made of materials that are familiar to the digestive tract, and it applies pressure to the stomach walls, which creates a sensation of satiety.”
The company, which was founded in 2005, and has 15 employees, was chosen in 2008 as one of “Globes” most promising start-ups. Tulip chairman Dr. Shimon Eckhouse, a group of Canadian investors, the Health 7 fund, and Agate Investment have invested in the company. According to IVC data, Tulip has raised $9 million to date.
Betser said: “A balloon that is permanently implanted in the stomach already exists. This product has not been approved for marketing in the US, and it has many limitations. It is implanted in a semi-surgical procedure, it sometimes causes nausea to the point that anti-nausea medication is needed, and it can pop, and reach the intestine in a manner that puts the patient at risk for intestinal blockage. Furthermore, the stomach gets used it its presence, which reduces the sense of satiety.”
The expanding pill, which is digested within a few hours, was created to solve the problems of the balloon product, without reducing its efficacy. Betser says that the company went through many processes before it succeeded in creating a balloon that is really digested within a few hours, that doesn’t leave harmful materials behind, and that does not have calories of its own.
Another company operating in Israel, GelSys is developing “pearls” that expand in the stomach and create a sense of satiety. “This is an interesting company. They are similar to us, but mostly different,” says Betser, “Their product is flushed from the stomach relatively quickly, and they therefore list also the matter of their impact on sugar absorption among their benefits, for the treatment of diabetes. Our product works directly on the mechanism of the stomach.”
Eckhouse said, “This company’s path was a bit long. We started with a particular solution, and after a while, we understood that the product needs to be a bit heavier and more substantial than we had thought, in order for it to have a real impact on the stomach. We needed to show significant results in the animal trials in order to be allowed to enter human trials. We demonstrated that the product does do what we said it does - expands, dissolves, and passes through - both in animals, and in humans, and that it has an impact on weight.”
Eckhouse says that the product may receive approval in the EU by the end of this year, but will not be commercially launched this year. The intention is to sell the product, with a prescription, to people with a body mass index (BMI) between 25 and 35 who are trying to lose weight.
Published by Globes [online], Israel business news - www.globes-online.com - on March 4, 2015
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