Morphic Medical Inc obtains regulatory approval

The Board of Crystal Amber is pleased to announce that MMI, the medical device company in which it owns 98% of the issued share capital, has received CE Mark certification for its revolutionary RESET® therapy. This is the first endoscopic, non-surgical treatment for both obesity and Type 2 diabetes in Europe.

This CE designation, which ensures RESET® has met all European Commission safety, health and environmental protection requirements, will allow access to treatment for the estimated 93 million patients in Europe living with obesity and type 2 diabetes.

With CE Mark approval now in place, MMI will begin offering RESET® in Germany, with plans to expand across the European Union and other countries recognising CE certification. UK approval for RESET® is expected in the coming weeks.

Clinical studies have shown that RESET® significantly exceeds international safety and effectiveness standards for endoscopic weight-loss treatments. On average, patients lost 19% of their total body weight within a year - outperforming the threshold set by leading medical societies.

Importantly, both the European Society for Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE) have endorsed RESET® in their latest clinical guidelines for obesity treatments - a strong validation from the medical community.

The treatment is a simple, 20-minute outpatient procedure that delivers long-lasting benefits for both weight loss and blood sugar control, allowing patients to avoid alternatives such as more invasive gastric surgery or expensive GLP-1 drug therapies, which typically result in patients regaining weight once they discontinue the drug.

RESET® works by placing a temporary liner in the small intestine, helping patients improve their metabolism and control blood sugar levels without major surgery. The product essentially works to enhance the body's GLP-1 hormones which transmit a feeling of fullness to the brain. This helps reduce the risk of serious complications like heart disease and worsening diabetes.

With nearly 60% of adults in Europe living with overweight or obesity, and type 2 diabetes rates rising sharply, healthcare systems are under increasing financial pressure as Governments balance the cost of managing chronic diseases against other priorities like increasing defence spending.

RESET® offers a new, affordable, and highly effective option that could reduce the long-term burden on public health budgets, with diabetes costing the NHS almost £14bn alone in 2021/22 according to one 2024 study (York Health Economics Consortium).

Christopher Waldron, Chairman of Crystal Amber, commented:

"Since 2020, Crystal Amber has been the sole provider of development capital of more than £25 million to support MMI. Our continued activism, vision and commitment has yielded a 98 per cent shareholding in a business with the potential to help millions of people improve their health, while offering governments a cost-effective alternative to drug-based treatments. In a time when public spending is stretched thin, solutions like this could be even more valuable than ever. We are very excited by the scale of the opportunity."