Morphic Medical gains CE Mark for RESET endoscopic device

Morphic Medical has received CE (Conformité Européenne) Mark approval for the RESET System, which according to the company is designed to provide patients living with obesity and metabolic disorders such as T2DM with the first incision-free, endoscopic solution for immediate weight reduction and metabolic improvement.

RESET is a thin, flexible 60cm sleeve that is endoscopically implanted within the small intestine by a trained physician. The implant secures itself with an anchoring mechanism at the upper portion of the small intestine. Placement is performed as an outpatient procedure that does not require incisions.

This duodenal-jejunal bypass liner is left in place for up to nine months and then removed endoscopically. The RESET System is intended to be used as an adjunct therapy to lifestyle and/or medication(s) for the management of morbid obesity and/or obesity in the presence of at least one concurrent cardiometabolic risk factor, eg type 2 diabetes and/or dyslipidaemia.

It is also intended to prevent contact of ingested nutrients with the mucosal lining of the duodenum and proximal jejunum (via the RESET Liner) in patients in order to promote weight loss, weight-loss mediated glycaemic control and to minimise the likelihood of obesity-related complications such as cardiovascular disease and/or deterioration of underlying T2DM.

Ricardo Cohen

"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,” said Professor Ricardo Cohen, President of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). “It offers a less-invasive option for people with T2DM and obesity who haven't responded well to medications or need a "bridge" before bariatric surgery."

A UK study¹ by Dr Bob Ryder of the Sandwell and West Birmingham NHS Trust reported treatment with RESET in people living with diabetes and obesity that demonstrated an average 17.4 Kg reduction in weight and a considerable improvement in blood glucose levels (average HbA1c reduced from 9.1% to 7.2%) a 1.9% reduction, alongside improvements in blood pressure and cholesterol which reduces cardiovascular risk. The amount of insulin required by the patients also reduced considerably with 37% discontinuing insulin use altogether. The RESET procedure also demonstrated encouraging durability data three years after treatment with 77% of patients maintaining their improvements in both reduction of weight and HbA1c.

"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,” said Joseph Virgilio, President and CEO of Morphic Medical. "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 most commonly reported complications of RESET are gastrointestinal in nature. They include nausea, vomiting, and upper abdominal pain of mild to moderate severity and are mostly prevalent in the early days and weeks following placement. Uncommon risks include liver abscess, device-related bleeding, device migration, pancreatitis, or other infections, any of which may result in endoscopic or surgical removal of the device.

The CE Mark designation ensures RESET has met all European Commission safety, health and environmental protection requirements. The certification of RESET enables commercial launch in the European Union (EU) and other geographies that recognise CE marking. RESET is not approved for sale in the US and is limited by federal law to investigational use only.

Reference

1. Ryder et al. Duodenal-jejunal bypass liner for treatment of T2DM and obesity: 4-year outcomes in the first National Health Service (NHS) EndoBarrier service. British Journal of Diabetes 2022.