Morphic Medical has obtained an EU CE mark for RESET, a device designed to target the underlying cause of obesity and type 2 diabetes (T2D).
The Boston-headquartered company鈥檚 RESET is a novel duodenal-jejunal bypass liner (DJBL) that mimics the effect of gastric bypass surgery and is positioned as a less-invasive option for people with T2D and obesity who have not responded well to medications or require a 鈥榖ridge鈥� ahead of bariatric surgery.
Implanted endoscopically into the upper region of the small intestine and left in place for up to nine months, RESET creates a physical barrier between receptors in the intestinal wall and food. The approach has been demonstrated to improve weight reduction and metabolic conditions by enhancing natural hormones in the gut in a manner comparable to glucagon-like peptide-1 (GLP-1) agonists.
A UK study conducted at the Sandwell and West Birmingham National Health Service (NHS) Trust demonstrated that RESET鈥檚 use in individuals with diabetes and obesity resulted in an average weight reduction of , and a 1.9% reduction in blood glucose levels alongside improvements in blood pressure and cholesterol.
Morphic Medical president and CEO, Joseph Virgilio commented: “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.
鈥淲e’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.鈥�
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By GlobalDataRESET is currently only available for investigational use in the US. To support a regulatory filing with the US Food and Drug Administration (FDA), Morphic is currently enrolling patients in the STEP-1 RESET pivotal trial (NCT04101669).
Planned for completion in 2026, STEP-1 is a multi-centre, randomised, sham-controlled trial that plans to enrol a total of 264 patients to evaluate the safety and effectiveness of RESET, as per the study鈥檚 listing on clincialtrials.gov.
