Senior Staff Writer

A handful of companies received a green light from the FDA last year to launch devices intended to treat metabolic disorders, including obesity and type 2 diabetes, and several other technologies are in various stages of development. One of the most interesting aspects of this competitive market is the wide array of approaches these companies are taking to treat this patient population. Some companies have designed balloon-based devices, some are making gastric sleeves, some are implanting devices that block signals between the brain and the stomach while others are exploring gastric artery embolization using injectable beads. Adding even more flavor to the pot is GI Windows Inc., an early-stage company that is taking a more magnetic approach to treating metabolic disorders.

GI Windows debuted its technology Saturday at Digestive Disease Week in San Diego. The West Bridgewater, Mass.-based company is developing a non-surgical system deployed through the working channel of an endoscope with the intention of creating a small bowel diversion similar to what is commonly performed in metabolic surgery. The magnetic devices are designed to self-assemble from a linear shape to an octagonal geometry. Two devices are deployed and join together through magnetic attraction to create a large-diameter, compression anastomosis. The anastomosis (a connection between two hollow or tubular structures or organs) forms in seven to 10 days and the magnets then pass through the GI tract and are eliminated, leaving no foreign body behind.

James Wright, president and CEO of GI Windows, told Medical Device Daily that what sets the technology apart from other devices that have been introduced to treat type 2 diabetes and/or obesity is that the magnets are not meant to stay in the body and only the tissue-based anastomosis is left behind.

"A lot of these things that have come along are always subject to an implant or 'how long does it last' because the GI tract is very good at getting rid of things," Wright said. "With a chronic disease like type 2 diabetes, you want an effect that's going to last. This effect stays there."

The genesis of the company

Co-founders Christopher Thompson and Marvin Ryou, interventional gastroenterologists at Brigham and Womens Hospital and researchers at Harvard Medical School, began pre-clinical investigations into non-surgical approaches to treating metabolic disorders back in 2008. Saturday the company presented six-month safety and efficacy results of the first clinical series evaluating the endoscopic creation of a dual-path enteral diversion using the technology.

Ryou told MDD that the magnets are delivered in two different places in the small intestine using two standard endoscopes. One magnet is deployed in the early part of the small bowel, while the other magnet is deployed in the ileum, which is toward the end of the small bowel. After they are deployed, the magnets find each other in the intestine, he said, and that is the end of the procedure. Ryou said the procedure is performed under general anesthesia and is envisioned to be an out-patient procedure.

It takes a couple of days for the magnets to burrow through and create the anastomosis, he said, but "from what we can tell so far it is extremely durable, probably permanent." Afterwards the patient is left with two pathways for digesting food. One pathway is what the doctor referred to as the native limb in which food will go down as intended to safeguard against malnutrition and then it will be diverted into the treatment limb, entering the ileum earlier than it would have before the procedure.

"That's essentially what causes the treatment effect, which has been outstanding," he said.

The Inspiration

The idea of creating a diversion with a compression anastomosis is not new, Ryou said. "We know from the medical literature and our own research that the anastomoses that are formed using compression are extremely robust and probably better than anything you can make compared to conventional sutures and staples, which is how they're made today," he said. "When you try to create something endoscopically with compression devices or magnets, historically we were restricted to small magnets and they would consequently form small anastomoses and you wouldn't get quite the same treatment effect. The durability of these anastomoses, while they were quite good, were also an issue."

That's where the idea of self-assembling magnets came from, he said. From a procedural standpoint, Ryou said he and Thompson were inspired by work that was done mostly in Brazil. Investigations there were actually cutting out a small segment of the ileum and splicing it in upstream in the early small intestine, Ryou said. "If you can imagine the gut being the alphabet from A to Z, they're basically cutting out the letter R and splicing it in between J and K. And those patients were getting incredible treatment effects from a diabetes standpoint."

The data

At DDW data was presented on 10 obese patients in Europe with a mean body mass index of 41. Four patients had type 2 diabetes and three more were considered to be in the pre-diabetic range. The company reported that the dual-path enteral diversion was safely created in all patients and the magnetic devices were expelled without incident. At six months, all patients experienced significant reductions in HbA1c and fasting blood glucose levels. For patients with pre-diabetes, HbA1c levels were reduced from a mean baseline of 6.1 percent to 5.25 percent at six months and fasting blood glucose levels dropped from 119 mg/dl to 105 mg/dl. Patients with type 2 diabetes showed a decrease of HbA1c from a mean baseline of 7.8 percent to 6.0 percent at six months, with a decrease in fasting blood glucose levels from 177 mg/dl to 111mg/dl. All patients had fasting blood glucose levels move from the diabetic or pre-diabetic range to the normal range at six months, the company said. The mean weight loss for all patients was about 28 pounds, representing a 10.6 percent decrease in total weight loss.

"The effects are seen quickly but then they're lasting through six months and we also will be presenting, in the future, on our 12 month data on these patients and I can tell you that the effect does seem to last through that 12 month period as well," Wright said.

He also noted that, compared to many other weight loss device studies, the post-procedure regimen for the patients in this study was easy and there were no strict dietary requirements. "These patients didn't need a lot of hand-holding, they didn't need a lot of counseling, they weren't on a prescribed diet," Wright said.

Because the study participants were not tightly regulated in terms of diet and lifestyle after the procedure, Ryou said the trial represents, in many ways, a real-world scenario. He told MDD he personally visited the study site and interviewed eight of the 10 patients regarding their quality of life after the procedure. "Many of them said they would do the procedure again if they had the choice and many wanted to know how they could get their family members involved to undergo the same procedure," he said.

Wright said the patients in this study group will be followed for three years. "We think the long-term effect is part of the value proposition here," he said.

The company's next steps include building more clinical data, which means larger studies with a control group and more specific criteria.

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