Noctrix Health is a developer of a prescription-grade non-pharmaceutical therapeutic for the treatment of moderate-to-severe Restless Leg Syndrome (RLS) in patients who are resistant to pharmaceutical treatments. The therapeutic called the NTX100 Nidra Tonic Motor Activation (TOMAC) System consists of two bands that are worn on the patient's lower legs that function as neurostimulation devices. The device electrically activates peroneal nerves bilaterally to produce muscle activation compatible with sleep and suppressing symptoms of RLS. The company has carried out studies on the therapeutic to clinically validate its treatment capabilities.
In April 2023, Noctrix Health was granted its De Novo request from the FDA, allowing it to begin marketing its Nidra TOMAC system. Previously, in June 2020, Noctrix was granted FDA Breakthrough Device Designation.
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