Morphic Medical Receives NUB Status for RESET® Endoscopic Device Therapy in Germany

Morphic Medical has made headlines by securing the NUB (Neue Untersuchungs- und Behandlungsmethoden) status in Germany for its innovative RESET® Endoscopic Device Therapy. This milestone is significant as it allows German hospitals to apply for additional reimbursement for the use of the RESET® therapy, thereby boosting the prospects for broader adoption and quicker commercial deployment.

The RESET® system is groundbreaking, as it has been designed specifically to assist patients dealing with obesity and metabolic disorders, including Type 2 diabetes (T2D). This minimally invasive endoscopic procedure aims to not only facilitate immediate weight loss but also improve metabolic health in patients who struggle with these conditions.

The NUB 1 status is a crucial step towards reimbursement within the German healthcare system. It is granted after a thorough evaluation of new methods and technologies, confirming that the therapy is supported by substantial clinical evidence. This recognition means that hospitals can seek additional reimbursement while further pathways for extended reimbursement are still being assessed.

This decision rests on an extensive array of peer-reviewed publications, real-world registry data, and clinical experiences gathered by researchers, validating the safety and effectiveness of providing duodenojejunostomy ring therapies for patients battling obesity and Type 2 diabetes. Mike Gutteridge, CEO of Morphic Medical, emphasized the importance of this milestone: "Recognition by the NUB is a major advancement for Morphic Medical and for the patients and hospitals in need of evidence-based endoscopic metabolic therapies. This status does not reflect just a single study; it is the result of a credible body of evidence that has been built over years of clinical research and real-world usage. It aids in constructive reimbursement discussions with German health centers while reinforcing trust in RESET® as a clinically significant therapy.”

With the NUB status granted, Morphic Medical is poised to collaborate with leading hospitals in Germany to support individual NUB applications, enhancing clinical adoption. The company remains steadfast in its commitment to post-market clinical follow-up, actively participating in registries and generating evidence to support long-term reimbursement and inclusion in treatment guidelines.

About Morphic Medical

Founded in 2003 and headquartered in Boston, Massachusetts, Morphic Medical specializes in developing RESET, an endoscopic therapy that provides a non-invasive alternative for patients struggling with morbid obesity and/or obesity accompanied by cardiometabolic risk factors like Type 2 diabetes and dyslipidemia. Notably, RESET is not yet approved for sale in the United States, as its use is restricted for experimental purposes under federal law. For more detailed information, interested parties can visit morphicmedical.com or follow them on social media platforms like Twitter and LinkedIn.

For further inquiries, please reach out to Morphic Medical’s investor relations team.