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RNS Number : 7765X Crystal Amber Fund Limited 20 February 2025
20 February 2025
Crystal Amber Fund Limited
("Crystal Amber Fund", the "Company" or the "Fund")
Update on Morphic Medical Inc.
Crystal Amber Fund is pleased to provide the following update regarding its
largest investment by value, Morphic Medical Inc. ("MMI"), in which the Fund
holds 97.6% of its issued share capital.
On January 31st, 2025, MMI completed another important regulatory milestone in
its EU filing, with the successful conclusion of the Medical Device Reporting
("MDR") audit of its appointed manufacturer Medical Murray. The final
Technical Review by the Notified Body is scheduled for March 2025 and MMI
remains confident in its path to CE certification.
MMI has now gathered a robust collection of new real-world data supporting the
sustained efficacy of RESET® for the treatment of Obesity and Diabetes from
the ABCD worldwide registry, the latest data will be shared at several key
conferences throughout 2025.
Pending the CE certification, the company is ready to enter key markets in
Europe, the UK and the Middle East and will roll out a comprehensive
commercial and clinician training program to customers and selective
distribution partners. Revenue projections are being bolstered by positive
customer feedback ahead of market re-entry. In Germany, over 100 hospitals
are planning to apply for NUB funding for RESET, the reimbursement procedure
for novel drugs and devices not yet included in the aG-DRG system. While in
the UK, three large NHS Trusts have initiated the economic business case for
RESET®.
MMI is currently in discussions with several strategic investors interested in
the endoscopic treatment of obesity and diabetes. According to the World
Obesity Federation ~ 2.2 billion people suffer from overweight and obesity,
yet only 6% are treated. Every year, nearly 5 million deaths are driven by
high BMI (≥ 25 kg/m2) and associated cardiometabolic disease. RESET® is
an investigational medical device for people living with uncontrolled type 2
diabetes and obesity that is sought to bridge the gap between partially
effective medications, insulin injections, and irreversible surgery.
Chris Waldron, Chairman of Crystal Amber commented:
"MMI has not only cleared another regulatory hurdle, but it also now has an
imminent date for final Technical Review and in the light of positive feedback
has reinforced our confidence in MMI's revenue projections."
About Morphic Medical Inc.
MORPHIC's product, RESET, is a thin, flexible implant that lines the proximal
small intestine and mimics gastric bypass bariatric surgery as food bypasses
the duodenum and the upper intestines. Unlike gastric bypass surgery, RESET is
reversible, minimally invasive, and temporary. It does not permanently alter
the patient's anatomy and uniquely targets the body's own blood glucose
control mechanisms. This is achieved through a 20-minute endoscopic procedure.
The patient will typically retain the device for nine months, after which the
device is removed
For further enquiries please contact:
Crystal Amber Fund Limited
Chris Waldron (Chairman)
Tel: 01481 742 742
www.crystalamber.com (http://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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