German regulator grants reimbursement status to Morphic Medical’s Reset obesity device
Morphic Medical’s Reset obesity treatment device received NUB status in Germany, allowing hospitals to seek supplementary reimbursement. The company said U.S. FDA study enrollment is continuing after protocol changes to accelerate recruitment.
Morphic Medical Inc. has received NUB status for its Reset® obesity treatment device in Germany, allowing hospitals to apply for supplementary reimbursement, according to a press release from Crystal Amber Fund Limited, which owns a majority stake in the company. The NUB designation, which enables pricing and reimbursement for innovative in-patient treatments, was awarded following evaluation of data from over 200 studies on safety, efficacy and durability of the Reset® system.
Morphic Medical describes Reset® as the “world’s first medical device focused on treating the root cause of obesity and type 2 diabetes.” The device has already received European CE mark and UK regulatory approval, with procedures performed in both the UK and India.
The company has established distribution agreements in Spain, Belgium, Netherlands, Czech Republic and the Middle East, while patient enrollment for its U.S. FDA study continues. The FDA recently approved changes to the study protocol that will accelerate patient recruitment, with seven procedures scheduled for February 2026.
To meet anticipated demand, Morphic Medical has arranged with contract manufacturers to begin large-scale production of the Reset® device.
Crystal Amber Fund, which holds approximately 97.8% of Morphic Medical’s aggregate preferred and common shares, has invested an additional $8 million in the company since July 2025 at $0.48 per share. The fund stated it plans to maintain its investment until FDA approval, which is expected in either 2028 or 2029.
According to the press release, Morphic Medical is in discussions with potential investors, including multinational medical device companies, regarding possible investment at what the company believes would be a premium to Crystal Amber’s current carrying value.