Boston-based Morphic Medical has secured EU CE mark approval for RESET, a novel duodenal-jejunal bypass liner designed to address obesity and type 2 diabetes through a minimally invasive approach that mimics the metabolic effects of gastric bypass surgery.
Device Mechanism and Clinical Application
RESET is implanted endoscopically into the upper region of the small intestine and remains in place for up to nine months. The device creates a physical barrier between intestinal wall receptors and food, enhancing natural gut hormones in a manner comparable to glucagon-like peptide-1 (GLP-1) agonists. This mechanism targets the underlying metabolic causes of obesity and type 2 diabetes.
The device is positioned as a less-invasive alternative for patients with type 2 diabetes and obesity who have not responded adequately to medications or require a therapeutic bridge before bariatric surgery.
Clinical Evidence and Outcomes
A UK study conducted at the Sandwell and West Birmingham National Health Service Trust provided compelling evidence for RESET's efficacy. The study demonstrated that patients with diabetes and obesity achieved an average weight reduction of 17.4kg at three-year follow-up after treatment. Additionally, participants experienced a 1.9% reduction in blood glucose levels, alongside improvements in blood pressure and cholesterol profiles.
"This critical regulatory milestone is an important step toward delivering on our promise and accomplishing our mission to alleviate the symptoms of obesity and metabolic disorders such as T2D for patients fighting these global epidemics," said Joseph Virgilio, Morphic Medical's president and CEO.
US Regulatory Pathway
While RESET has gained European approval, the device remains available only for investigational use in the United States. Morphic Medical is currently enrolling patients in the STEP-1 RESET pivotal trial (NCT04101669) to support a regulatory filing with the US Food and Drug Administration.
The STEP-1 trial is designed as a multi-center, randomized, sham-controlled study planning to enroll 264 patients to evaluate RESET's safety and effectiveness. The trial is scheduled for completion in 2026.
Virgilio emphasized the company's focus on serving patients who have exhausted conventional treatment options: "We're excited to help patients who have failed to achieve their goals through a programme of diet, exercise, and medical management, and are looking for an alternative therapy."
