Morphic Medical obtains CE mark for obesity treatment
The Boston-headquartered company's 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 'bridge' 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's use in individuals with diabetes and obesity resulted in an average weight reduction of 17.4kg at the three-year follow up after receiving the treatment, 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.
'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.'
RESET 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's listing on clincialtrials.gov.
"Morphic Medical obtains CE mark for obesity treatment" was originally created and published by Medical Device Network, a GlobalData owned brand.
The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
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