Celanese Series A: Morphic Medical's RESET® System Secures CE Mark for Obesity Treatment
- Morphic Medical's RESET® System receives CE Mark approval for its innovative obesity treatment without traditional surgical incisions.
- The device shows significant weight loss and metabolic health improvements in clinical studies, with 77% maintaining results after three years.
- CE certification enables Morphic Medical to launch the RESET System across the EU, transforming obesity management for many patients.
Morphic Medical's RESET® System Gains CE Mark Approval, Paving the Way for Innovative Obesity Treatment
Morphic Medical recently celebrates a significant regulatory victory with the CE Mark approval for its RESET® System, an innovative minimally invasive endoscopic procedure designed to combat obesity and improve cardiometabolic health, particularly for patients suffering from Type 2 Diabetes (T2D). This groundbreaking device stands out as the first to address the root causes of obesity and T2D without the need for traditional surgical incisions. By implanting a duodenal-jejunal bypass liner (DJBL) into the small intestine, the RESET System alters gut hormone responses, fostering substantial weight loss and metabolic improvements in patients.
Clinical studies underscore the efficacy of the RESET System, with one conducted by Dr. Bob Ryder in the UK revealing remarkable outcomes. Patients utilizing the device experience an average weight loss of 17.4 kg, coupled with a significant reduction in blood glucose levels, as evidenced by a decrease in HbA1c from 9.1% to 7.2%. Furthermore, 37% of participants successfully discontinue insulin use, alongside notable improvements in blood pressure and cholesterol levels, which collectively contribute to a decreased risk of cardiovascular complications. Long-term data shows that three years post-treatment, 77% of patients maintain their weight loss and improvements in metabolic health, indicating the RESET System's potential as a sustainable solution for obesity management.
Joseph Virgilio, President and CEO of Morphic Medical, emphasizes that the CE Mark approval is a crucial milestone in their mission to offer effective alternatives for individuals grappling with obesity and metabolic disorders. With this certification, Morphic Medical is poised to launch the RESET System across the European Union and other markets recognizing CE certification, potentially transforming the treatment landscape for millions affected by these widespread health issues. By providing a safe and incision-free solution, the RESET System addresses a critical gap in obesity management, particularly for patients who have found limited success through traditional dietary and medication approaches.
In additional industry news, Comar, a prominent healthcare packaging company based in Voorhees, NJ, has secured CE certification under the EU Medical Device Regulation. This achievement reflects Comar's commitment to regulatory excellence and patient safety, enhancing its Unique Device Identification (UDI) labeling capabilities. With stringent compliance measures in place, Comar positions itself as a trusted partner for clients navigating the complexities of the European market.
As Morphic Medical launches the RESET System, the broader medical device industry continues to evolve, with innovative solutions and regulatory advancements paving the way for improved patient outcomes in obesity and metabolic health management.
