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Rapid relief for refractory RLS

A clinically proven breakthrough therapy for adults with Restless Leg Syndrome (RLS) who are refractory to medication.

Rapid Relief

>80% of patients reported symptom relief during or after a 30-minute treatment.1

Proven Safe

Zero serious device-related

adverse events reported
at 6+ months.2,3

High Adherence

91% of subjects in the extension
study continued to actively use
therapy after 6+ months.3

1. Noctrix Health. Data on File. CL-10 Report, Analysis of acute relief from NTX100 TOMAC. 2. Noctrix Health data on file.
Restful Trial (NCT04874155). 3. Noctrix Health data on file. Extension Trial (NCT05196828).

Clinically proven to provide sustained symptom relief​

The efficacy and safety of TOMAC therapy was evaluated in a multi-center, randomized, sham-controlled clinical trial and a subsequent 6-month extension study.1,2
50 %

of patients were
responders at 32-weeks.

Responders were rated to have “very much improved” or “much improved” symptoms by an investigator.

5

point reduction in
IRLS score at 32-weeks.

Sustained therapy use over 6+ months saw disease-modifying benefits in even severe, refractory RLS patients.

20 %

decrease in sleep disturbances (MOS-II score) at 32-weeks.

Sustained therapy use over 6+ months resulted in clinically significant reduction in sleep disturbances and significant reduction in sleep onset latency.

1. Noctrix Health data on file. Restful Trial (NCT04874155). 2. Noctrix Health data on file. Extension Trial (NCT05196828).

The science behind
TOMAC therapy

Nidra uses a novel technology called Tonic Motor Activation (TOMAC) to stimulate the nervous system and improve symptoms of RLS.1
  1. Non-invasive peroneal nerve stimulation activates afferent neural pathways.

  2. Neural response evokes tonic muscle activity in the lower leg.

  3. Sustained and sleep-compatible tonic muscle activation relieves RLS symptoms by mimicking neural signals from voluntary leg movements.

1. In adults with primary, moderate-severe RLS who are resistant to medications.

The Science behind TOMAC therapy

Nidra uses a novel technology called Tonic Motor Activation (TOMAC) to stimulate the nervous system and improve symptoms of RLS.1
Loop
  1. Non-invasive peroneal nerve stimulation activates afferent neural pathways.

  2. Neural response evokes tonic muscle activity in the lower leg.

  3. Sustained and sleep-compatible tonic muscle activation relieves RLS symptoms by mimicking neural signals from voluntary leg movements.

1. In adults with primary, moderate-severe RLS who are resistant to medications.

Personalized
Therapy Support

Every patient prescribed Nidra therapy receives a comprehensive coaching and titration session, during which Nidra therapy is customized to fit their needs. Regular follow-up is included to ensure proper usage and adherence.

Get started on the path to relief

Taking the first step is easier than you think.

Device Delivery

Your devices and all supplies are conveniently shipped directly to your home and a Therapy Support Specialist will be in touch to review your onboarding to Nidra therapy. *Make sure to fully charge your devices within 24 hours of your personalized device titration session.

Therapy
Personalization

Personalized device titration at your doctor’s office or a designated medical facility. Our team will reach out to schedule your device titration session to personalize your therapy at a designated medical facility.

Therapy Onboarding

Your Nidra representative will reach out to discuss your first week of therapy, answer any questions, and confirm you are starting to experience relief from your symptoms. 

You will receive a follow-up call to monitor your progress and ensure you are consistently experiencing relief with Nidra therapy.

Receive an additional call for ongoing support and to confirm that you are consistently experiencing impactful relief and sleep improvement.

Therapy
Personalization

Our team will be here for you at every stage of your journey toward achieving lasting relief from your RLS symptoms. 90% of people reported an improvement in their symptoms over 8 weeks.1,2

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Important Safety Information
and
Indications For Use

INDICATION
The NTX100 Tonic Motor Activation (TOMAC) System is intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome and to improve sleep quality in adults refractory to medications.*

Rx Only. Caution: Federal law restricts this device to sale by or on the order of a medical professional.
*FDA De Novo Number DEN220059

© 2023 Noctrix Health, Inc. All rights reserved.

MKT-8 Rev 2.0

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All information on this website is provided for informational purposes only and is not intended to be a substitute for any professional medical advice or any medical diagnosis or treatment. Nidra is intended for prescription use only and is only available for commercial sale in the United States by or on the order of a physician. Individual patient experience may vary.

Important Safety Information

IMPORTANT SAFETY INFORMATION
Contraindications
The Nidra TOMAC System is contraindicated for use in patients with the following:

  • Diagnosis of epilepsy or other seizure disorder
  • Active medical device implant anywhere in the body, including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators
  • Metal implant in the leg at the therapy site (not including knee replacements)
  • Known allergy to device materials (or severe previous reaction to medical adhesives or bandages)
  • Cellulitis, open sores, or injury at or near the location of therapy device application
  • The device cannot be used while driving, operating machinery, or during any activity in which electrical stimulation can put the patient at risk of injury

Potential Complications
There is a potential for the following side effects, which are typically mild to moderate and resolve over time:

  • Mild skin irritation from use of adhesives.
  • Temporary interference with sleep while wearing the device. For some people, the device may be uncomfortable. For others, the device may interfere with preferred sleep positions.
  • Proper use of the device as described in the Instructions for Use (IFU) can help reduce or prevent the following complications: Discomfort, paresthesia (tingling or prickling sensation), or otherwise irritating or uncomfortable sensations during treatment. This risk is reduced by adjusting the stimulation intensity.

This list is not all inclusive. Please refer to the Instructions for Use. for all of the important warnings and precautions before using or prescribing this product.