Morphic Medical Announces CE Mark for RESET® Endoscopic Device Therapy

RESET^® is a minimally invasive, endoscopic, outpatient procedure designed to reduce weight and improve cardiometabolic health conditions such as Type 2 Diabetes.

BOSTON, July 7, 2025 /PRNewswire/ -- Morphic Medical, creator of the world's first medical device designed to target the underlying cause of obesity and type 2 diabetes, today announced CE (Conformité Européenne) Mark approval for the RESET^® System designed to provide patients living with obesity and metabolic disorders such as Type 2 Diabetes (T2D) with the first incision-free, endoscopic solution for immediate weight reduction and metabolic improvement. 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 recognize CE marking.

Many patients with obesity and T2D have poor glycemic control despite diet, lifestyle management, and medications. Although Roux-en-Y gastric bypass can be highly effective, it is an invasive and irreversible surgical procedure. RESET is a novel duodenal-jejunal bypass liner (DJBL) which is implanted endoscopically into the upper part of the small intestine, left in place for up to 9 months, and then removed endoscopically. The liner provides a physical barrier between receptors in the intestinal wall and food which has shown weight reduction and improved metabolic conditions by enhancing the guts natural hormones similar to GLP1 pharmacotherapy.

A UK study 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.¹

Joseph Virgilio, President and CEO of Morphic Medical, stated, "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." He added that, "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."

Professor Ricardo Cohen, President of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) says, "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."

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, e.g., type 2 diabetes and/or dyslipidemia. 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 described above in order to promote weight loss, weight-loss mediated glycemic control and to minimize the likelihood of obesity-related complications such as cardiovascular disease and/or deterioration of underlying type 2 diabetes. RESET is indicated for a maximum implant duration of nine months.

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.

About Morphic
Morphic Medical is the developer of RESET, an endoscopically delivered therapy which offers a non-surgical, alternative treatment for morbid obesity and/or obesity in the presence of concurrent cardiometabolic risk factor, e.g., type 2 diabetes and/or dyslipidemia. RESET is not approved for sale in the United States and is limited by federal law to investigational use only. Founded in 2003, Morphic Medical is headquartered in Boston, Massachusetts. For more information, please visit morphicmedical.com or follow us on Twitter and LinkedIn.

Morphic Medical Media Contact:
Investor Relations
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