Wings help this device take on type 2 diabetes in the duodenum

Procedures in the gut are showing promise for treating type 2 diabetes patients, but not without a fight from the duodenum.

That’s where Minneapolis-based Endogenex’s investigational ReCET (Re-Cellularization via Electroporation Therapy) system delivers nonthermal pulsed electric field (PEF) energy to mucosal and submucosal tissue to initiate cell regeneration.

Overcoming that obstinate organ was an early obstacle for the startup, Endogenex CEO Stacey Pugh said in a Medical Design & Outsourcing interview.

“One of the biggest challenges we saw in our feasibility trials was you don’t make the duodenum happy — it’s an organ that’s designed to kick you out — and you don’t make it happy when you’re delivering high-voltage electrical pulses over and over again through it,” she said.

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The minimally invasive catheter system has a metallic canister that deploys a flexible circuit against the duodenum’s thin wall, delivers nanosecond energy pulses (which Pugh notes is not ablative or denervative), and then returns into the canister.

“The goal is to create as much optimum wall opposition to that circuit and in adherence to that circuit while you’re delivering these nanosecond pulse,” Pugh said. “It takes us about a minute worth of total energy activation broken into two segments when we’re delivering these pulses, and we really want to hold that tight, consistent and still.”

But the circuit’s flexibility and a lack of clear visibility was causing a problem during the design stage, Pugh said. “When we would bring our circuit back in, we were constantly looking to make sure we weren’t catching tissue.”

Visibility was more of a challenge on distal end than the proximal end. The team’s solution was to add triangular polyurethane wings that roll out with the circuit and keep the duodenal tissue — the villus and modal structures — from getting caught in the process.

“Those wings, when they’re out, keep tissue away and it makes the act of opening and closing and moving so much more simple,” Pugh said.

“It’s been a pretty radical simplification from our last generation technology to this,” Pugh said. “Even though much of the energy signature’s the same, it was a big move forward in usability for the technology, something as simple as that.”

Endogenex recently released positive results of its technology from its REGENT-1 clinical studies in the U.S. and Australia. (REGENT is an abbreviation from the study’s name, “Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes.”)

“These results from the integrated REGENT-1 analysis provide the first peer-reviewed evidence demonstrating that non-thermal pulsed electric field-based duodenal therapy can produce clinically meaningful and durable improvements in glycemic control, body weight, and markers of insulin resistance through 48 weeks with a single endoscopic procedure,” said Dr. David O’Neal, the corresponding author of the results published in Diabetes, Obesity and Metabolism.

Read more from our interview with Pugh about the Endogenex ReCET system here and watch for more at Medical Design & Outsourcing soon, including her advice for device design and medtech careers. Sign up for our free MDO newsletter so you don’t miss it!