Noctrix Health: NTX100 Tonic Motor Activation

The main articles are:

• Medical Wearable Electronics (Global Market)
• Neurostimulators

2023: FDA marketing authorization NTX100

Noctrix Health has received approval from the US health industry regulator (FDA) to sell a wearable device it has developed designed to treat restless leg syndrome. Authorization was issued immediately after the successful completion of a randomized placebo-controlled trial that tested the efficacy of Noctrix Health technology. Information about this appeared on April 19, 2023.^[1]

As noted, thanks to the FDA approval, the system proposed by Noctrix Health has become the first and so far the only (at the time of obtaining permission from the regulator) therapy available for patients with moderate to severe restless leg syndrome resistant to drugs.

Noctrix Health's Wearable Neurostimulator for Restless Legs Syndrome is approved for sale in the U.S.
Photo: noctrixhealth.com

According to the American Mayo Clinic, treatment for restless legs syndrome is usually divided into two main categories: prescription drugs, including opioids, muscle relaxants and drugs that increase dopamine levels, and external, topical procedures such as warm baths, leg massages, wraps and more.

Noctrix Health is committed to bridging this gap using a neurostimulation-based approach. The system proposed by the company consists of two belts put on each leg at night, and is designed to activate the muscles of the legs. The technology is called the Tonic Motor Activation NTX100, which emphasizes continuous, prolonged stimulation of nerves, and this distinguishes it from phase activation, in which shorter pulses of electricity are sent. When the belt is placed on the leg just below the knee and activated, it begins to send electrical impulses aimed at the fibula nerves, which are responsible for movement and sensation in the lower leg and foot. The procedure is designed to reduce symptoms and improve sleep quality, as restless legs syndrome often worsens in the evening and at night when people are sitting or lying down.

A randomized trial of Noctrix Health technology enrolled 133 people with moderate to severe restless leg syndrome, refractory to medical treatment. For the first four weeks, they used Noctrix wearables and a dummy version of the system, after which all participants used Noctrix technology for another four weeks.

According to the company, the study achieved all seven primary and secondary efficacy outcomes with statistical significance. The primary outcome was measured by how many participants noted "significant" or "very significant" improvement in symptoms of restless leg syndrome on the Clinical Global Impression - Improvement seven-point scale, and six secondary outcomes accounted for improvement on several other scales, including symptom severity on the physician's own data and data, sleep quality, and more.

In addition, according to Noctrix, none of the study participants experienced any significant adverse events after using the neuromodulation system.

"It is particularly impressive that the use of this therapy has led to persistent and clinically meaningful improvements in symptom severity and sleep quality in a population of patients suffering from severe restless leg syndrome despite the use of standard drugs. The safety profile of this device only adds to its value, "principal investigator Dr. Richard Bogan said in a statement[2]

As specified, Noctrix Health wearable devices are designed specifically for people whose restless legs syndrome does not respond to effective treatment with pharmaceuticals. With FDA approval, such individuals will soon be able to access Noctrix technology.

2020: FDA designation of breakthrough device

In 2020, the American industry regulator health care FDA Noctrix Health awarded the status of a breakthrough device, recognizing the potential of the technology in filling the area of ​ ​ unmet health care needs and opening a direct communication channel between the company and the FDA.

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