According to recent reports from the Taub Center, Israel is lagging way behind the rest of the world in regard to diabetes treatment, with 11% of the nation’s mortality rate attributed to the disease. In a comparison of 37 developed countries (including the US, land of the deep-fried Twinkie), Israel’s diabetes-related mortality rate puts it in 35th place for women, and 36th place for men.
The disease is one of the world’s top-10 killers. According to the International Diabetes Federation, 6.7 million deaths were caused by diabetes in 2021. The foundation also estimates that over 530 million adults (ages 20-79) are afflicted with the condition, and projects that number will grow by an additional 110 million by 2030.
What can be done?
Clearly, diabetes is a big problem that needs to be solved, both for the sake of Israel and the world – and the small but competent team at Allevetix is pretty sure they’ve got something that can help.
Allevetix is a med-tech start-up with humble beginnings. Starting as a project for the company Allmed Solutions, Allevetix quickly gained interest following its initial success, branching into a company of its own, headed by Ziv Kalfon. Though he left his position as CEO earlier this year, Kalfon is responsible for the creation of Allevetix’s core product, the NobiX, a medical device intended as an alternative for gastric bypass surgery.
I HOPE YOU’RE NOT SQUEAMISH
Gastric bypass is among the most common bariatric procedures for weight loss, typically for patients who suffer from severe obesity. Put simply, the procedure surgically adjusts the size of the stomach, decreasing its capacity for food and expediting digestion. This leads to significant weight loss in patients who have tried other options to no avail.
Many patients who have undergone the procedure, however, have noted a surprising side effect.
“One side effect that was unexpected was that, two or three days after the procedure, people noticed that they had a tremendous amount of improvement in controlling their diabetes,” said Prof. Oz Shapira, current CEO of both Allevetix and Allmed Solutions. “Their insulin requirements dropped, their sugar levels dropped – it was completely unanticipated.”
The reason for the sudden diabetes control is that the gastric bypass effectively skips over the first stretch of the small intestine, called the duodenum. That, in turn, triggers a complex hormonal response in the body that Shapira described to The Jerusalem Post as both “complex” and “beyond the scope of this meeting.”
“Bottom line,” he said, is that “this bypassing of the duodenum resulted in a dramatic improvement in diabetes control, independent of weight loss.”
“This bypassing of the duodenum resulted in a dramatic improvement in diabetes control, independent of weight loss.”Professor Oz Shapira, current CEO at Allevetix
WHILE GASTRIC bypass is reversible, it is still an invasive procedure, and carries a small offering of potential complications.
“It’s a big operation,” said Shapira. “It is done under general anesthesia.... It has significant complications, recurrence for a variety of reasons, and there’s an associated morbidity rate, albeit very small – less than 1%.”
RING AROUND THE ROSIE (OR PYLORUS, WHICHEVER)
Allevetix’s NobiX offers an alternative to gastric bypass surgery by placing a Teflon-coated sleeve in the duodenum via the mouth, throat and stomach, in a 30-40 minute procedure done under conscious sedation (meaning there’s no need for a hospital stay afterward). The sleeve is held in place by a collapsible steel ring that rests in the stomach, too big to fit through the passage to the intestine, called the pylorus.
The sleeve lines the duodenum, blocking the absorption of food matter for a brief stretch of intestine. In so doing, Shapira explained, the device “delays gastric emptying, which mimics the effect of [gastric bypass].”
As an analogy, imagine tying a windsock to a hula hoop with a short piece of string, then dropping it into a manhole. The sock enters the can, but the hoop keeps it from falling in as trash passes through and drops into the smelly caverns below.
Here's the solution:
This solution is an iteration on an abandoned technology from other inventors that used small metal barbs inserted into the pylorus as an anchor. It doesn’t take a medical degree to contemplate why that could be a bad idea.
“It’s not a good idea to use barbs to anchor things into a biological system. Lo and behold, you cause significant problems: most importantly, micro perforations of the inner lining of the bowel, resulting in the introduction of bacteria which lead to liver abscesses,” Shapira said. Put simply: “It was very poorly tolerated by the patients.”
NobiX’s innovative ring anchor is also collapsible, which means that once target weight loss has been achieved by a patient (typically within a year), the entire device can be removed the same way it was put in – with a quick oral-access procedure.
Asked whether or not the NobiX would have a lasting effect against diabetes following its removal, Allevetix said that “the diabetes that the product is dealing with is a result of unhealthy eating and habits. After taking out the NobiX, the disease is not supposed to return – as long as the patient maintains new healthy habits and lifestyle.”
MORE LIKE “BYE-ABETES”
So far, the device has performed well during clinical trials. The company hopes to enroll another 10-20 patients by the end of the year. Allevetix has plans to open sites in Hungary and Israel, and is currently in talks with Rambam Hospital in Haifa and Hadassah Medical Center in Jerusalem.
Shapira acknowledged NobiX’s enormous potential, noting that it could be a fundamental tool in the global struggle against diabetes and obesity.
“We believe it will be one of the cornerstones of the treatment of these two major epidemics.”