#USA #Boston, Massachusetts #Morphic Medical #RESET #Endoscopic Therapy

Morphic Medical Achieves CE Mark for RESET® Therapy

Morphic Medical, a pioneer in developing medical devices, has recently announced the approval of its innovative RESET® endoscopic device, marking a significant milestone in the fight against obesity and type 2 diabetes. This groundbreaking therapy has received the prestigious CE Mark, indicating compliance with European safety and health regulations, and is now poised for commercialization across the European Union and other regions that recognize the CE marking.

What is RESET®?

RESET® is a minimally invasive, outpatient procedure designed specifically to address obesity and enhance cardiometabolic conditions such as type 2 diabetes. Unlike traditional surgical options, which are often invasive and irreversible, RESET® offers a non-surgical alternative that can directly target the underlying issues of metabolic dysfunctions.

The device is essentially a duodenal-jejunal bypass liner that is implanted endoscopically in the upper intestine. This liner remains in place for up to nine months, creating a physical barrier between food and intestinal receptors to decrease food intake and enhance the body's natural secretion of hormones vital for metabolic regulation. The procedure aims to mimic the effects of pharmacological interventions like GLP-1 therapy by promoting weight loss and improving metabolic conditions.

Clinical Efficacy

In a notable study led by Dr. Bob Ryder from the Sandwell and West Birmingham NHS Trust, RESET® demonstrated promising results among participants suffering from obesity and type 2 diabetes. On average, patients achieved a weight reduction of 17.4 kg, and significant improvements were observed in glucose control, with HbA1c levels dropping from 9.1% to 7.2%. Additionally, the system yielded substantial benefits in lowering blood pressure and cholesterol levels, which contribute to reducing cardiovascular risks.

Interestingly, the therapy led to a considerable decrease in insulin requirements, with 37% of participants completely ceasing insulin use. Long-term follow-up data showcased remarkable sustainability; three years post-treatment, 77% of patients maintained their weight loss and improvements in HbA1c, indicating lasting benefits of the RESET® treatment.

Significant Regulatory Milestone on the Horizon

Joseph Virgilio, the CEO of Morphic Medical, emphasized the importance of this regulatory achievement, stating, “This crucial regulatory step is a significant leap toward fulfilling our mission to alleviate the burdens of obesity and metabolic disorders for those struggling to manage these overwhelming health challenges. We are excited to offer RESET® to patients who have not succeeded with traditional dietary and lifestyle interventions.” This statement underscores Morphic’s commitment to providing effective alternative therapies for patients facing the dual crises of obesity and metabolic diseases.

Professor Ricardo Cohen, president of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), also noted that RESET® mirrors some physiological benefits of gastric bypass surgery, like GLP-1 stimulation and enhanced insulin sensitivity, making this non-surgical option highly relevant for individuals who do not respond adequately to medications or are awaiting bariatric surgery.

Conclusion

Overall, the RESET® system represents a significant advancement in the therapeutic landscape for obesity and related metabolic disorders. By combining the benefits of surgical techniques with a less invasive approach, Morphic Medical is leading the charge toward innovative solutions that address the rising obesity epidemic and the global health challenges associated with type 2 diabetes. As they move forward with commercializations under the EU MDR, the hope is to reach millions of individuals grappling with uncontrolled obesity and cardiometabolic complications throughout Europe. The reset position is clear: a healthier future is within reach, thanks to innovative medical advancements like the RESET® therapy.