03 July 2026
03 July 2026
The study is set to include up to 40 patients with chronic limb-threatening ischaemia.
Thermo Fisher will provide integrated manufacturing, clinical research and commercial readiness services.
The approval is supported by data from the STEER, Phase IIIb STRENGTH and Phase I/II STRONG studies.
The introduction of Model 2 into Europe aims to support Hyperfine’s international commercial objectives.
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