First Patient Treated With Morphic Medical’s Intestinal Sleeve

Morphic Medical announced the first commercial patient treatment with RESET, the company’s therapy designed to target the underlying cause of obesity and type 2 diabetes.

The procedure was performed last month at King’s College Hospital NHS Foundation Trust in London by Professor Bu’Hussain Hayee, Ph.D., the Trust’s clinical director for liver, endoscopy, and gastroenterology. The procedure marks the first time RESET has been used outside of a clinical trial and provided as a standard treatment. The procedure, which takes under 30 minutes to perform, was completed successfully and without complication.

“Treating our first commercial patient with RESET is a defining moment for Morphic. It shows that what began as pioneering clinical research is now becoming a reality in everyday medical practice. RESET delivers substantial, durable improvements in both weight and blood sugar control, and does so through a safe, minimally invasive and fully reversible procedure that takes under 30 minutes to perform,” stated Morphic Medical President/CEO Mike Gutteridge. “With CE Mark approval, MHRA registration, and now the first U.K. patient treated, we are moving quickly to bring RESET to the people and health systems that need it most. Obesity and type 2 diabetes are among the greatest healthcare challenges of our time, costing billions each year and reducing quality of life for millions of people. RESET offers a proven alternative to lifelong medication or invasive surgery—one that can make a lasting difference to patients and relieve the pressure on overstretched healthcare budgets.”

Morphic is marketing its RESET treatment as a first-of-its-kind thin sleeve that lines the upper part of the intestine for up to nine months. The sleeve helps patients lose weight and improve blood sugar control by changing the way food is absorbed and the gut signals hunger to the body.

Unlike surgery, RESET is put in and taken out with a simple endoscopy procedure, and is fully reversible. More than one in five adult Europeans are living with obesity, and that figure is expected to rise to one in four in the United Kingdom. In addition, diabetes costs the NHS almost £14 billion annually.

Recently published data from the world’s largest registry of RESET patients—comprising real-world outcomes in 1,298 patients across 37 centers in 12 countries, including NHS hospitals in Birmingham, London, Southampton, Manchester and Glasgow—confirm that RESET delivers substantial and durable benefits:

• Patients lost an average of 18.9% of their total body weight
• Blood sugar levels—as measured by HbA1c, the standard test for long-term glucose control—fell by 1.3%, with the greatest improvements seen in patients starting at higher levels
• Benefits were durable, with 77% of patients maintaining improvement three years after RESET was removed
• The new research-driven, nine-month treatment approach delivers all the benefits of weight loss and blood sugar reduction, with fewer complications than the 12-month approach

RESET was recently commercially registered for sale by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), completing an important legal requirement for U.K. sales. The MHRA registration followed July’s CE (Conformité Européenne) Mark designation. Morphic Medical has begun offering RESET in Germany, with plans to expand across the European Union and other countries recognizing CE certification.

“RESET represents an important new option for people living with obesity and type 2 diabetes. It’s a minimally invasive procedure that can be done in 30 minutes, with patients going home the same day, and no alteration to anatomy,” Dr. Hayee said. “We also know the benefits last well beyond the removal of the device. King’s has a history of care for patients with diabetes and being able to perform the first commercial RESET procedure here in the U.K. is a proud milestone. I look forward to offering this therapy to more patients.”

Morphic Medical developed RESET, the first incision-free, endoscopically delivered therapy designed to treat obesity and related metabolic disorders such as type 2 diabetes. RESET is a duodenal-jejunal bypass liner (DJBL) that is implanted and removed endoscopically, remaining in place for up to nine months. By creating a temporary barrier in the upper intestine, it has been shown to support significant weight loss and improved blood sugar control by enhancing natural gut hormone responses, in a way similar to GLP-1 therapies.

RESET addresses a major global health need, with an estimated 93 million adults in Europe living with obesity and type 2 diabetes. It has been endorsed in the latest clinical guidelines for obesity treatment by both the European Society for Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE). Founded in 2003, Morphic Medical is headquartered in Boston.