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Morphic Medical Secures CE Mark for RESET® Therapy

Morphic Medical has officially announced the approval of the CE Mark for its groundbreaking RESET® procedure, highlighting a significant development in obesity and type 2 diabetes treatment. This innovative endoscopic therapy is the first of its kind, specifically designed to tackle the root causes of these debilitating conditions.

What is RESET®?

The RESET® procedure is a minimally invasive, outpatient endoscopic approach that not only helps patients achieve weight loss but also improves vital metabolic health markers, including those associated with type 2 diabetes. It represents a revolutionary shift in how obesity and metabolic disorders are treated, moving away from more invasive surgical options like the Roux-en-Y gastric bypass, which is both irreversible and requires significant recovery time.

Unlike traditional surgical procedures, RESET® involves a duodenal-jejunal bypass liner (DJBL) that is inserted endoscopically into the upper part of the small intestine. This device remains in place for up to nine months, before being removed through a subsequent endoscopic procedure.

Clinical Success and Benefits

Clinical trials conducted in the UK have showcased remarkable outcomes for patients undergoing the RESET® procedure. Led by Dr. Bob Ryder from Sandwell and West Birmingham NHS Trust, the study reported an average weight reduction of 17.4 kg among participants, alongside significant improvements in blood glucose levels. The average HbA1c, a key indicator of diabetic control, decreased from 9.1% to 7.2%, marking a notable shift towards improved metabolic health. Patients also experienced enhancements in blood pressure and cholesterol levels, directly reducing their cardiovascular risk factors.

Moreover, insulin dependence saw a dramatic decrease, with 37% of participants discontinuing insulin altogether. Follow-up data indicated that three years post-treatment, 77% of individuals maintained their weight loss and improvements in HbA1c levels, underscoring the durability of the RESET® therapy's effects.

A Vision for Effective Treatment

Joseph Virgilio, CEO of Morphic Medical, expressed his enthusiasm over this regulatory milestone, emphasizing the profound impact that RESET® will have on those struggling with uncontrolled obesity and related metabolic conditions. "This CE Mark approval allows us to provide an effective option to millions who have not achieved desired outcomes through diet, lifestyle changes, or medical treatment," he noted.

In addition, Professor Ricardo Cohen, President of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), highlighted the advantages of RESET® as a non-surgical alternative that simulates the physiological effects of gastric bypass. This therapy can notably enhance GLP-1 secretion, reduce insulin resistance, and improve both glycemic control and weight loss, offering a less invasive pathway for individuals who have not responded positively to previous treatments.

Conclusion

The RESET® system is tailored for patients dealing with morbid obesity or those with at least one accompanying cardiometabolic risk factor, such as type 2 diabetes or dyslipidemia. It is designed to prevent nutrients from directly contacting the duodenum and proximal jejunum, facilitating weight loss and improving glycemic control while minimizing risks associated with obesity.

As Morphic Medical continues to lead the charge in innovative healthcare solutions, the approval of the RESET® device marks a pivotal moment in the fight against obesity and its associated health risks. As they prepare for commercial rollout within the European Union and regions recognizing the CE Mark certification, the potential for transforming lives remains promising as they strive to alleviate the burden of obesity and diabetes worldwide.