Morphic Medical Secures CE Mark Approval for Innovative Device
Morphic Medical Receives CE Mark Approval for RESET Device
RESET is a minimally invasive, endoscopic, outpatient procedure designed to reduce weight and improve cardiometabolic health conditions such as Type 2 Diabetes.
Morphic Medical has made significant strides in the fight against obesity and its related health conditions. The company has announced the prestigious CE (Conformité Européenne) Mark approval for its innovative RESET System, which is aimed at providing a much-needed, incision-free solution for individuals battling obesity and metabolic disorders, particularly Type 2 Diabetes (T2D). This important designation ensures that RESET meets European standards for safety, health, and environmental protection, paving the way for its commercial launch across the European Union and beyond.
Many patients struggling with obesity and T2D often face challenges in managing their conditions, despite trying various lifestyle modifications and medications. Traditional surgical options, like Roux-en-Y gastric bypass, may provide effective results but can be invasive and irreversible. The RESET System offers a groundbreaking alternative as a duodenal-jejunal bypass liner (DJBL) that is implanted through an endoscopic procedure, where it remains for a maximum of nine months before being removed endoscopically. This liner serves as a barrier, influencing the interaction between nutrients and gut receptors, leading to significant weight reduction and improvements in metabolic health.
Recent findings from a UK study led by Dr. Bob Ryder at the Sandwell and West Birmingham NHS Trust showcased remarkable outcomes from the RESET procedure. Patients experienced an average weight loss of 17.4 kg and notable decreases in blood glucose levels, with average HbA1c reducing significantly from 9.1% to 7.2%. Additionally, many participants reported improved cardiovascular health, including lower blood pressure and cholesterol levels. Impressively, 37% of patients stopped using insulin altogether, demonstrating the RESET system's efficacy in managing T2D. What's more, a follow-up after three years indicated that 77% of patients maintained their weight loss and glycemic improvements.
Joseph Virgilio, the President and CEO of Morphic Medical, expressed enthusiasm about this regulatory achievement, stating, "This critical regulatory milestone is an important step toward delivering on our promise and accomplishing our mission to alleviate the symptoms of obesity and metabolic disorders such as T2D for patients fighting these global epidemics. We aim to assist those who have struggled to achieve their health goals through conventional means and are seeking a viable alternative therapy. Regulatory approval under EU MDR allows us to introduce RESET to millions of patients dealing with uncontrolled obesity and associated disorders throughout Europe."
Professor Ricardo Cohen, a notable voice in the field and President of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), emphasized the benefits of the RESET system, explaining, "RESET is a non-surgical, endoscopic sleeve that lines the upper intestine to mimic some physiological effects of gastric bypass—boosting GLP-1, reducing insulin resistance, and improving blood sugar and weight control. It offers a less-invasive option for people with type 2 diabetes and obesity who haven't responded well to medications or need a 'bridge' before bariatric surgery."
The RESET System is designed to act as an adjunct therapy alongside lifestyle changes or medications for the management of morbid obesity and its related cardiometabolic risks, such as type 2 diabetes. By preventing direct contact between consumed nutrients and the mucosal lining of the duodenum and proximal jejunum, the therapy not only promotes weight loss but also aims to facilitate improved glycemic control, minimizing the likelihood of complications associated with obesity.
About Morphic Medical
Morphic Medical specializes in developing innovative therapies, such as the RESET system, which presents a non-surgical alternative for treating morbid obesity and associated cardiometabolic risks, including type 2 diabetes. Founded in 2003 and based in Massachusetts, Morphic Medical is dedicated to transforming the way obesity and metabolic disorders are managed. It is important to note that RESET is currently not approved for sale in the United States and is limited to investigational use only.
Contact Information
For further inquiries, please reach out to Morphic Medical's Investor Relations team at +1 (781) 357-3296.
Frequently Asked Questions
What is the RESET system and how does it work?
The RESET system is an endoscopically delivered device designed to help patients with obesity and Type 2 Diabetes manage their condition by acting as a barrier to food in the upper intestine, promoting weight loss and improved metabolic health.
What are the benefits of receiving a CE Mark?
A CE Mark signifies that a product meets stringent health, safety, and environmental requirements set by the European Commission, enabling its commercial availability across the EU.
Can the RESET system be used by everyone with obesity?
The RESET system is intended for individuals with morbid obesity and at least one concurrent cardiometabolic risk factor, such as type 2 diabetes or dyslipidemia.
What is the duration of the RESET system's implant?
The RESET liner is designed to remain in place for a maximum duration of nine months, after which it is removed endoscopically.
How has the effectiveness of the RESET system been demonstrated?
Clinical studies have shown significant weight loss and improvements in blood glucose levels, alongside reductions in insulin use and other metabolic health markers in patients treated with the RESET system.
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