Morphic Medical's Groundbreaking RESET Device
Morphic Medical, a pioneer in medical technology, has recently secured the CE (Conformité Européenne) Mark for its revolutionary RESET® System. This system is designed to deliver a non-surgical solution for addressing obesity and Type 2 Diabetes (T2D), two of the most pressing health challenges of our time. The RESET procedure promises to change how these conditions are treated, giving patients an effective option that has been missing from the current landscape.
Understanding the RESET® System
The RESET device is a minimally invasive, outpatient endoscopic therapy that targets the root causes of obesity and T2D. Unlike traditional surgical methods, such as gastric bypass, which are invasive and irreversible, the RESET System implements a duodenal-jejunal bypass liner (DJBL) that is placed endoscopically in the small intestine. This device stays in the patient for up to nine months, after which it is removed. The liner creates a barrier that alters food flow and gastrointestinal hormone responses, essentially mimicking metabolic effects similar to those seen with pharmacological treatments such as GLP-1 medications.
Significant Health Benefits
Recent studies cited by Morphic Medical highlight the profound effectiveness of the RESET System. A notable UK study led by Dr. Bob Ryder from the Sandwell and West Birmingham NHS Trust reported an average weight reduction of 17.4 kg among patients with diabetes and obesity who underwent the RESET procedure. More importantly, participants showed improvements in their glycemic control, with average HbA1c levels dropping from 9.1% to 7.2%, alongside lower blood pressure and cholesterol levels, which are crucial indicators of cardiovascular health.
An astounding 37% of patients in the study were able to stop using insulin altogether, showcasing the potential for the RESET System to not only assist with weight management but also impact diabetes treatment positively. Furthermore, long-term data reveal that about 77% of patients maintained these health benefits three years after the treatment, indicating the durability of the RESET therapy.
A New Era in Metabolic Health
Joseph Virgilio, the President and CEO of Morphic Medical, expressed confidence in this innovative treatment's potential. He stated, “This critical regulatory milestone is an essential step toward fulfilling our mission to alleviate the symptoms of obesity and metabolic disorders such as T2D.” He emphasized that many patients who struggle to achieve their weight loss and glycemic control goals through diet, exercise, and medications are in urgent need of alternative solutions—solutions that RESET provides.
Professor Ricardo Cohen, President of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), explains that RESET offers a less invasive option for managing diabetes and obesity, targeting individuals who have not found success with traditional medications or are considering surgical weight-loss interventions.
Conclusion
With CE Mark approval, the RESET System stands poised for commercial launch throughout Europe and in regions that recognize CE certification. This advancement opens new doors for millions of patients battling obesity and related metabolic disorders. Morphic Medical's innovative approach signifies a real shift towards more effective, less invasive treatment options, thereby paving the way for a healthier future. As the reset on obesity management continues, stakeholders are encouraged to pay attention to how technologies like RESET will transform lives worldwide.
Morphic Medical continues to lead in this space, promising to bring significant changes to treatment methodologies for obesity and Type 2 Diabetes. For more information about their offerings or to stay updated on progress, visit
morphicmedical.com.