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Morphic Medical's Breakthrough: CE Mark for RESET®

Morphic Medical has recently achieved a significant milestone by obtaining the CE Mark for its innovative RESET® system, a state-of-the-art endoscopic device designed to address obesity and type 2 diabetes (T2D). This achievement opens the door for expanded access to a treatment that could potentially change the lives of many patients suffering from these conditions.

A Revolutionary Approach to Weight Loss and Metabolic Health

The RESET® device offers a minimally invasive, outpatient procedure that provides immediate weight reduction and improvements in cardiometabolic health. With its groundbreaking design, the RESET system acts as a duodenal-jejunostomy bypass liner (DJBL) which can be endoscopically implanted in the small intestine. After a maximum duration of nine months, it is removed through a similar endoscopic procedure.

The device operates by creating a physical barrier between food and the receptors in the gut wall. This modulation of natural hormones akin to GLP-1 pharmacotherapy results in weight loss and significant improvements in metabolic health. Morphic Medical aims to cater to patients who, despite adhering to dietary programs or medications, struggle with obesity and have poor blood sugar control.

Clinical Evidence Supporting RESET®

A study conducted by Dr. Bob Ryder at the Sandwell and West Birmingham NHS Trust revealed promising results for patients undergoing the RESET treatment. Participants experienced an average weight loss of 17.4 kg, alongside substantial improvements in their blood sugar metrics—HbA1c values decreased from 9.1% to 7.2%, a reduction of 1.9%. Additionally, improvements in blood pressure and cholesterol levels were noted, lowering the risk of cardiovascular complications. Remarkably, 37% of patients were able to completely discontinue their insulin use, showcasing the effectiveness of the RESET system.

In follow-up assessments, 77% of patients maintained their weight loss and HbA1c improvements even three years post-treatment, highlighting the longevity of benefits offered by this innovative device.

Regulatory Milestones and Future Prospects

Joseph Virgilio, the President and CEO of Morphic Medical, emphasized the significance of receiving the CE Mark, stating it represents a crucial regulatory milestone in their mission to alleviate the symptoms of obesity and metabolic disorders like T2D. The approval allows for the immediate introduction of RESET to millions of European patients grappling with uncontrolled obesity and related conditions.

The approval under the EU Medical Device Regulation (MDR) enables Morphic Medical to offer this vital treatment option to patients who have not achieved their health goals through lifestyle changes and medical interventions alone.

Expert Opinions on RESET®

Professor Ricardo Cohen, President of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), noted that the RESET system mimics some physiological effects of traditional gastric bypass surgeries without the invasiveness of surgical procedures. This makes it a viable option for individuals with T2D and obesity, especially those who do not respond well to conventional medications or need a temporary solution prior to potential bariatric surgery.

Conclusion

As populations globally continue to face challenges linked to obesity and metabolic disorders, Morphic Medical's RESET system offers a novel, non-invasive alternative designed for patients with pressing health needs. With a focus on comprehensive patient care, this innovative treatment aligns with evolving medical standards and the urgent demands posed by rising obesity rates. For more information about this pioneering technology and its implications for healthcare, visit Morphic Medical's website.