Morphic Medical Secures CE Mark for RESET® Therapy Device

Morphic Medical, a pioneer in medical technology, has announced the receipt of the CE Mark for its innovative RESET® endoscopic device, aimed at treating obesity and type 2 diabetes (T2D). This milestone, achieved on July 7, 2025, allows the company to market its device across the European Union and other regions acknowledging CE certification.

The RESET System represents a groundbreaking approach as the first incision-free, endoscopic solution that targets the underlying causes of obesity and metabolic disorders. According to Joseph Virgilio, President and CEO of Morphic Medical, "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."

The RESET device is designed as a duodenal-jejunal bypass liner (DJBL), which is implanted endoscopically into the upper small intestine. It functions for a maximum duration of nine months, providing a physical barrier that reduces food contact with intestinal receptors. This mechanism has shown significant effects in enhancing the body's natural hormone levels, similar to pharmacotherapies like GLP-1, which are widely used in managing diabetes.

A pivotal study conducted by Dr. Bob Ryder of the Sandwell and West Birmingham NHS Trust revealed promising results from the RESET treatment. Participants demonstrated an average weight loss of 17.4 kg, alongside a reduction in HbA1c levels from 9.1% to 7.2%. The research also highlighted improvements in blood pressure and cholesterol levels, indicating a reduced cardiovascular risk. Notably, 37% of participants were able to discontinue insulin use entirely.

Professor Ricardo Cohen, President of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), emphasized the significance of the RESET device, stating, "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."

The clinical implications of the RESET device extend beyond mere weight loss; it represents a potential paradigm shift in treating obesity and related metabolic disorders. By providing a less invasive alternative to traditional surgical options, such as Roux-en-Y gastric bypass, the RESET device could serve as a critical bridge for patients who have struggled to achieve desired outcomes through conventional methods.

Morphic Medical plans to leverage this CE Mark approval to reach millions of patients experiencing uncontrolled obesity and cardiometabolic disorders across Europe. However, the device is currently not approved for use in the United States and remains investigational.

This innovative technology underscores the urgent need for effective treatments in the face of rising obesity rates, which have become a global health crisis. According to the World Health Organization, obesity has nearly tripled worldwide since 1975, necessitating new therapeutic avenues to combat this epidemic.

As the RESET System prepares for launch in Europe, Morphic Medical's commitment to addressing the challenges posed by obesity and T2D positions it as a key player in the evolving landscape of medical devices aimed at improving metabolic health. The future of obesity treatment may indeed rest on innovations such as these that prioritize patient safety and efficacy without the invasiveness associated with traditional surgical interventions.