Noctrix Health Announces Favorable Inclusion of Nidra Tonic Motor Activation (TOMAC) Therapy in New American Academy of Sleep Medicine (AASM) Clinical Practice Guidelines for Restless Legs Syndrome (RLS)

PLEASANTON, CA / ACCESSWIRE / October 3, 2024 /Noctrix Health, a leader in innovative neuromodulation therapies, is pleased to announce that the American Academy of Sleep Medicine (AASM) has published new clinical practice guidelines for the treatment of Restless Legs Syndrome (RLS) and Periodic Limb Movement Disorder (PLMD). In these newly updated guidelines, the use of high-frequency bilateral peroneal nerve stimulation-such as the Nidra™ device by Noctrix Health-has been recognized with a favorable recommendation for its effectiveness in reducing symptom severity in patients with RLS. The consensus statement also quote that TOMAC therapy "represents an alternative approach to pharmacological agents and the potential adverse systemic effects that come with them. (AASM Guidelines 2024)."

The guidelines represent a significant shift in the treatment paradigm for RLS, moving away from long-standing pharmacological options like dopaminergic agonists. The AASM now suggests against the standard use of these medications, stating: "In adults with RLS, the AASM suggests against the standard use of levodopa, pramipexole, transdermal rotigotine, and ropinirole"(AASM Guidelines 2024). This change is largely driven by an overwhelming body of evidence linking these medications to augmentation-a worsening of symptoms with prolonged use.

In contrast, the AASM guidelines highlight the clinical benefits of high-frequency bilateral peroneal nerve stimulation, with clinically significant improvement in disease severity observed in patients who used the therapy, many of whom had previously struggled with refractory RLS symptoms. The guideline further concludes that adverse effects are "trivial", making it a well-tolerated option for long-term management of the condition.

"We are thrilled that the AASM has recognized the value of a non-pharmacologic intervention in its updated practice guidelines- a huge win for patients who express a strong preference for a wearable device therapy to treat this debilitating condition. This further strengthens our resolve to continue expanding access to this breakthrough therapy and allow more patients to benefit from the use of efficacious and lower-risk treatment options such as Nidra^TM," said Shri Raghunathan, CEO of Noctrix Health.

"The inclusion of high-frequency bilateral peroneal nerve stimulation in the latest AASM guidelines marks a significant advancement in the treatment of RLS," said Dr. Mark Buchfuhrer, a renowned national RLS expert and a sleep medicine physician at Stanford University. "As a non-pharmacological option, TOMAC therapy offers patients a much-needed alternative, especially for those who have experienced challenges with traditional therapies. Having seen the tangible benefits both as a principal investigator on clinical trials and in real-world usage settings in my practice, I am thrilled for more patients to be able to access therapies like Nidra^TM."

For full reference:
Winkelman et al. (2024). Treatment of Restless Legs Syndrome and Periodic Limb Movement Disorder: An American Academy of Sleep Medicine Clinical Practice Guideline. Journal of Clinical Sleep Medicine.

About Noctrix Health

Noctrix Health, Inc. is a medical device company dedicated to developing clinically validated breakthrough medical technologies that improve the quality of life for patients with chronic medical conditions. The Nidra^TM Tonic Motor Activation (TOMAC) Therapy is a first-in-class, non-pharmacologic therapy for reducing symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and improving sleep quality in adults who are refractory to medications.

For additional information including full prescribing information, safety, and contraindications, visit www.nidrarls.com.

Media contact: matt.ziglar@noctrixhealth.com

SOURCE:Noctrix Health, Inc.

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