US-based medical device company Morphic Medical has received CE mark approval for its RESET system, a medical device targeting obesity and type 2 diabetes.
The RESET system is an incision-free, endoscopic solution designed to aid individuals with obesity and metabolic disorders like type 2 diabetes.
It offers a non-surgical alternative to medications, insulin injections, and irreversible surgeries, for those with morbid obesity or obesity with concurrent cardiometabolic risk.
The RESET system functions as a duodenal-jejunal bypass liner (DJBL), which is implanted endoscopically into the upper small intestine.
It remains in place for up to nine months before being removed, and acts as a barrier between intestinal receptors and food.
The device promotes weight reduction and metabolic improvements by enhancing gut hormones, similar to GLP1 pharmacotherapy.
The EC approval confirms that the RESET system meets all European Commission (EC) safety, health, and environmental protection standards.
It paves the way for its commercial launch in the European Union (EU) and other regions that recognise CE marking.
Morphic Medical president and CEO Joseph Virgilio said: “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 program of diet, exercise, and medical management, and are looking for an alternative therapy.
“Regulatory approval under EU MDR allows us to immediately offer RESET to the millions of patients suffering from uncontrolled obesity and cardiometabolic disorders throughout Europe.”
The RESET system is intended to complement lifestyle changes and medications in managing morbid obesity or obesity with at least one cardiometabolic risk factor.
It aims to prevent nutrient contact with the mucosal lining of the duodenum and proximal jejunum, promoting weight loss, glycaemic control, and reducing obesity complications.
The device is approved for a maximum implant duration of nine months.
In a study conducted in the UK by Dr Bob Ryder of the Sandwell and West Birmingham NHS Trust, the RESET system showed significant results.
Participants experienced an average weight loss of 17.4kg and improved blood glucose levels, with HbA1c levels dropping from 9.1% to 7.2%.
In addition, the study noted improvements in blood pressure and cholesterol levels, reducing cardiovascular risk.
The amount of insulin required by patients decreased significantly, with 37% discontinuing insulin use altogether.
Three years after the treatment, 77% of patients experienced sustained improvements in weight and HbA1c levels, showcasing the procedure’s durability.
International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) President Ricardo Cohen said: “RESET is a non-surgical, endoscopic sleeve that lines the upper intestine to mimic some physiological effects of gastric bypass—boosting GLP-1, reducing insulin resistance, and improving blood sugar and weight control.
“It offers a less-invasive option for people with type 2 diabetes and obesity who haven’t responded well to medications or need a “bridge” before bariatric surgery.”
