Fractyl gains traction with balloon ablation device for Type 2 diabetes

As scientists target gastrointestinal tract procedures as a way to treat Type 2 diabetes, Fractyl Labs is forging ahead with its balloon ablation device for the disease to cash in on the trend.

A growing body of evidence shows that certain types of weight loss surgery can help Type 2 diabetes better than diet and exercise alone, The Wall Street Journal reports, and companies like Fractyl are rolling out innovative technologies that provide alternatives to traditional treatment. Fractyl's water-filled balloon device, Revita DMR, burns the lining of the duodenum, a part of the small intestine that produces hormones that regulate food intake and blood sugar, to improve blood glucose levels in patients. The procedure, called duodenal mucosal resurfacing, could be used to treat individuals with diabetes who aren't a good fit for or who opt out of weight-loss surgery.

Waltham, MA-based Fractyl has already charted progress with its device, showing in a recent study of 39 patients that its technology helped reduce hemoglobin A1C levels (HbA1c) up to 6 months after the procedure. The ongoing trial will include 50 patients across 10 sites, and the company plans to kick off a double-blinded, sham-controlled second phase of the study with 240 patients during the second quarter next year in Europe and Brazil.

Investors seem sold on Revita's efficacy. Last September, Fractyl, a 2015 Fierce 15 company, reeled in $40 million in a Series C round on the heels of promising clinical trial results for the device. Type 2 diabetes cost the U.S. healthcare system $245 million in 2012, Fractyl pointed out at the time, and the company's Revita system can be performed endoscopically in a clinical setting without much pain or discomfort--a potential selling point for payers.

Fractyl CEO Dr. Harith Rajagopalan

"The patient would come into the endoscopy suite and would be placed under anesthesia such as propofol," Fractyl CEO Harith Rajagopalan told FierceMedicalDevices earlier this year. "Endoscope and catheters are inserted and the procedure of ablating would be performed. Then the patient wakes and goes into recovery. It takes about an hour--with iterative improvements to the device we think we can get to less than that."

Still, not everyone is as enthusiastic about the benefits of duodenal procedures. "I am absolutely not convinced this procedure is going to fly," Michel Gagner, a clinical professor of surgery at Florida International University, told the WSJ. Trials of duodenal mucosal procedures should show that endocrine cells that are dysfunctional with diabetes are present in the duodenum, and that the procedure actually decreases those cells, Gagner said. And burning the lining of the organ could produce scar tissue that will narrow the intestinal pathway, prompting nausea and other side effects, he added.

- read the WSJ story (sub. req.)

Special Report: FierceMedicalDevices' 2015 Fierce 15 - Fractyl Laboratories