On April 19, 2023, Noctrix Health announced it received FDA De Novo approval for its NTX100 Tonic Motor Activation (TOMAC) System, which is intended to treat symptoms of moderate to severe restless legs syndrome (RLS) and improve sleep quality in patients who are refractory to medications.

About the NTX100 TOMAC System

Noctrix Health’s prescription therapy features a pair of devices worn on the lower legs. According to the company’s press release, the devices electrically activate the peroneal nerves bilaterally to produce tonic, sustained muscle activation compatible with sleep, which, in turn, supresses symptoms of RLS.

Results of a multi-center, randomized, sham-controlled study of the device indicate it was well-tolerated by patients and did not result in any significant adverse effects.

The non-pharmacologic therapy represents an alternative for patients who do not respond to RLS medications, the company notes. Prior to the De Novo approval, the FDA had granted “breakthrough device designation” for the therapy in May 2020.

About restless legs syndrome

RLS, a neurological sleep disorder, causes uncomfortable sensations and an irresistible urge to move the legs, particularly in the evening and night. The condition, often described as a crawling or creeping sensation, can lead to difficulty falling asleep, reduced sleep duration, daytime sleepiness, irritability, concentration issues, and an increased risk of depression or anxiety, but it is usually manageable with medication and lifestyle adjustments.

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