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Weight Loss Device Gains European Approval

A novel medical device offering a minimally invasive approach to weight loss and type 2 diabetes management has secured CE Mark approval, paving the way for its introduction in Europe. The RESET system offers hope for those struggling with obesity and related metabolic issues.

Incision-Free Solution

Morphic Medical’s RESET system, designed to combat the root causes of obesity and type 2 diabetes, has received CE Mark approval. This certification confirms that RESET meets the stringent safety, health, and environmental standards mandated by the European Commission. According to Joseph Virgilio, President and CEO of Morphic Medical, this “critical regulatory milestone is an important step toward delivering on our promise.”

How RESET Works

RESET utilizes a duodenal-jejunal bypass liner (DJBL) that is endoscopically implanted in the small intestine’s upper region. Remaining in place for nine months, the liner acts as a barrier between the intestinal wall receptors and food. This process leads to weight reduction and metabolic enhancements by stimulating the gut’s natural hormones, similar to GLP-1-based medications.

Promising Study Results

A study in the UK, led by **Dr. Bob Ryder** at the Sandwell and West Birmingham NHS Trust, highlighted the efficacy of RESET in individuals with diabetes and obesity. Participants experienced an average weight loss of 17.4 kg, alongside an average HbA1c reduction from 9.1% to 7.2%, a 1.9% reduction. Improvements in blood pressure and cholesterol levels, which can reduce cardiovascular risks, were also observed.

Notably, 37% of patients were able to discontinue insulin usage. Data collected three years post-treatment showed that 77% of patients sustained improvements in both weight and HbA1c levels. Roughly 37 million Americans, or 11.3% of the population, have diabetes (CDC 2024).

Expert Opinion

**Professor Ricardo Cohen**, President of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), describes RESET as “a non-surgical, endoscopic sleeve that lines the upper intestine to mimic some physiological effects of gastric bypass—boosting GLP-1reducing insulin resistance, and improving blood sugar and weight control.” He suggests that it provides a less invasive option for those who haven’t responded well to medication or require a bridge before bariatric surgery.

Intended Use

The RESET system is designed as an adjunct therapy alongside lifestyle changes and medication for managing morbid obesity and/or obesity with at least one cardiometabolic risk factor, such as type 2 diabetes or dyslipidemia. By preventing nutrient contact with the duodenum and proximal jejunum lining via the RESET Liner, it aims to promote weight loss, improve glycemic control, and minimize obesity-related complications like cardiovascular disease and type 2 diabetes deterioration.

Morphic Medical, the developer of RESET, is based in Boston, Massachusetts. The RESET system is currently limited to investigational use in the United States.