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MMI's RESET achieves UK regulator registration

27 Aug 2025 07:00

RNS Number : 7655W
Crystal Amber Fund Limited
27 August 2025
 

27 August 2025

 

Crystal Amber Fund Limited

("Crystal Amber", the "Company" or the "Fund")

 

Morphic Medical's RESET obesity and diabetes treatment achieves commercial registration from UK regulator

 

The Board of Crystal Amber is pleased to announce that Morphic Medical Inc. ("MMI"), the medical device company in which the Fund owns 96.7% of the issued share capital, has achieved a significant UK milestone for its revolutionary RESET® therapy, the first endoscopic, non-surgical treatment for both obesity and type 2 diabetes in Europe.

RESET® has now been commercially registered for sale by the Medicines and Healthcare products Regulatory Agency (MHRA), completing an important legal requirement for sales of the product into the UK market.

The MHRA registration follows July's CE Mark designation, which ensures RESET® has met all European Commission safety, health and environmental protection requirements, allowing access to treatment for the estimated 93 million patients in Europe living with obesity and type 2 diabetes. MMI has begun offering RESET® in Germany, with plans to expand across the European Union and other countries recognising CE certification.

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.

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 obesity or being overweight, 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).

Mike Gutteridge, Chief Executive of MMI, commented:

"We're delighted to achieve MHRA registration, which marks an important step in the journey to commercialising the RESET therapy in the UK and help hundreds of thousands of people improve their health, while offering governments a cost-effective alternative to drug-based treatments. Coming so soon after our CE Mark certification, the momentum behind the business is building quickly and we remain hugely excited by the scale of the opportunity."

 

For further enquiries please contact:

 

Crystal Amber Fund Limited

Chris Waldron (Chairman)

Tel: 01481 742 742

www.crystalamber.com

 

Allenby Capital Limited - Nominated Adviser

Jeremy Porter/ Dan Dearden-Williams

Tel: 020 3328 5656

 

Winterflood Investment Trusts - Broker

Joe Winkley/Neil Langford

Tel: 020 3100 0160

 

Crystal Amber Advisers (UK) LLP - Investment Adviser

Richard Bernstein

Tel: 020 7478 9080

 

 

 

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