Morphic Medical Gains CE Mark for Innovative RESET Therapy

Morphic Medical Gains CE Mark for Innovative RESET Therapy

RESET is a minimally invasive, endoscopic, outpatient procedure designed to reduce weight and improve cardiometabolic health conditions such as Type 2 Diabetes.

Morphic Medical, a pioneering company focused on tackling obesity and metabolic disorders, has recently achieved CE Mark approval for its RESET System. This marks a significant milestone for patients struggling with obesity and conditions such as Type 2 Diabetes (T2D), providing a safe and effective incision-free option for weight reduction and metabolic health enhancement. With the CE Mark designation, Morphic Medical assures that RESET meets all necessary safety, health, and environmental standards set by the European Commission.

Patients dealing with obesity and Type 2 Diabetes often find it difficult to maintain glycemic control, despite lifestyle changes and medications. Traditional surgical options like Roux-en-Y gastric bypass, while effective, come with risks and are irreversible. The RESET System introduces an innovative solution by using a duodenal-jejunal bypass liner (DJBL) that can be implanted endoscopically into the upper small intestine for up to nine months, offering a novel way to manage weight and improve metabolic conditions.

Research conducted in the UK led by Dr. Bob Ryder, from the National Health Service, highlighted the effectiveness of RESET in individuals with obesity and diabetes. Patients in this study experienced an average weight loss of 17.4 kg and significant improvements in blood glucose levels, highlighted by a reduction in average HbA1c levels from 9.1% to 7.2%. This improvement in health was accompanied by reduced insulin needs, with 37% of participating patients completely discontinuing their insulin treatment. Moreover, the data showed promising long-term effectiveness, with 77% of patients maintaining their weight loss and improved HbA1c levels three years post-procedure.

Joseph Virgilio, President and CEO of Morphic Medical, emphasizes the importance of this regulatory milestone, stating that it enables the company to reach millions of patients across Europe who are struggling with uncontrolled obesity and metabolic disorders. He conveyed excitement about offering an alternative to those who have been unsuccessful in managing their conditions through traditional approaches involving diet, exercise, and medication.

Professor Ricardo Cohen, President of the International Federation for the Surgery of Obesity and Metabolic Disorders, praised the RESET System for its potential to provide a non-surgical option that mirrors some of the physiological benefits of gastric bypass surgery. The system not only aids in GLP-1 hormone production, which boosts metabolism but also helps in reducing insulin resistance.

The RESET System is designed as an adjunct therapy to lifestyle changes and existing medications for the management of morbid obesity and related metabolic risk factors like Type 2 Diabetes and dyslipidemia. It works by creating a physical barrier in the intestine that limits food contact with the mucosal lining, promoting weight loss and improving glycemic control. The system aims to minimize the risk of obesity-related complications, such as cardiovascular disease.

Significance of CE Mark Approval

The recent CE Mark approval opens up new avenues for patient treatment within the European Union and other regions that recognize CE certification, showcasing Morphic Medical's commitment to pioneering solutions in the field of obesity and metabolic disorders.

Understanding the RESET Procedure

RESET is a groundbreaking therapy that offers life-changing possibilities for patients suffering from obesity and Type 2 Diabetes. By addressing the core mechanisms that lead to these conditions without the need for invasive surgery, patients can explore new strategies for weight management. The procedure allows for significant health improvements, enabling individuals to reclaim their quality of life.

Future of Weight Management Solutions

The advancements seen with the RESET System signal a broader shift towards innovative, non-invasive weight management solutions. As more patients and healthcare providers recognize the value of such therapies, the future of obesity treatment looks promising. Morphic Medical is at the forefront of this change, dedicated to enhancing the lives of those affected by obesity and metabolic diseases.

Frequently Asked Questions

What is the RESET System?

The RESET System is a minimally invasive endoscopic therapy designed to treat obesity and improve conditions such as Type 2 Diabetes by implanting a duodenal-jejunal bypass liner.

How does RESET differ from traditional surgical options?

Unlike traditional surgical approaches like gastric bypass, RESET is non-invasive and can be reversed after nine months, offering a safer alternative for many patients.

What kind of results have patients experienced with RESET?

Patients have reported significant weight loss and improvements in blood sugar levels, with many even being able to reduce or eliminate their need for insulin.

Who is the target demographic for the RESET therapy?

RESET is intended for patients who are obese or have Type 2 Diabetes, particularly those who have not achieved desired results from diet and lifestyle changes.

Will RESET be available in other regions outside Europe?

Currently, RESET is approved for commercial use in the European Union, with further expansion depending on regulatory approvals in other regions.

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