Noctrix Health announces publication of landmark results from randomized clinical trial and long-term extension study of its revolutionary Tonic Motor Activation (TOMAC) therapy for Restless Legs Syndrome (RLS) in Sleep

• Dual feature in the prestigious, peer-reviewed journal, Sleep show that TOMAC therapy was safe and effective in adults with RLS refractory to medications, with all primary and secondary endpoints successfully met with no serious or severe device-related adverse events.
• Mean change in International RLS Rating Scale (IRLS) of -11.3 points and a mean responder rate (CGI-I) of 72.7% at week 24 for patients on TOMAC therapy.
• Long-term TOMAC treatment led to a substantial reduction in frequency of RLS symptoms from 5.9 nights to 3.2 days per week and a mean reduction of -17.2 points on the MOS-II sleep scale.

PLEASANTON, Calif., July 26, 2023 /PRNewswire/ -- Noctrix Health, Inc. announced a double feature in the renowned peer-reviewed journal, Sleep, showcasing the outcomes of two major clinical trials that assessed TOMAC therapy for the treatment of RLS. The two papers feature the results from the RESTFUL study (NCT04874155), a multi-center, randomized, sham-controlled clinical trial, and a subsequent 24-week extension study (NCT05196828). This major accomplishment comes after the FDA-granted the technology a "Breakthrough Device Designation" in May 2020 and subsequent market authorization in April 2023. The prescription therapy includes a pair of neuromodulation devices worn on the lower legs that electrically activate the peroneal nerves bilaterally to produce tonic, sustained muscle activation, and suppress symptoms of RLS. The mechanism of action behind this therapy was also published earlier this month in the Journal of Clinical Sleep Medicine, the official journal of the American Association of Sleep Medicine (AASM).

The RESTFUL study enrolled a total of 133 adult participants with medication-refractory, moderate-to-severe, primary RLS and reported statistical significance for all seven efficacy outcomes. The therapy was well-tolerated by patients and did not result in any significant adverse events. These data were taken into consideration by the US FDA to grant a De Novo authorization, making the NTX100 TOMAC System the first and only therapy of its kind for patients with moderate-severe, drug-refractory RLS.

The extension study reinforced and further improved on these results to demonstrate that long-term use of TOMAC therapy provides robust and durable benefits at very low risk to patients. Mean responder rates (CGI-I) and mean change in the International RLS Rating Scale (IRLS) improved from 63.6% and -7.4 points at 8 weeks (end of RESTFUL RCT) to 72.7% and -11.3 points at 24 weeks, respectively. Significant sleep quality improvements were also seen, as measured by a mean change of -17.2 points on the MOS-II sleep scale at 24 weeks from baseline.

Further to these compelling results, patients on long-term TOMAC treatment experienced a 3.5-fold increase in symptom-free days per week, with the average frequency of RLS symptoms reducing from 5.9 to 3.2 days per week over the duration of use.

In a statement from Noctrix Health, President and CEO Shri Raghunathan said, "The official publication of our clinical trial data in Sleep is an important milestone and an honor. We are grateful for the opportunity to highlight this work in a top-tier journal like Sleep to bring the impressive results of this research and the amazing work of our clinical investigators to the public. Our focus now is on executing our upcoming controlled release in the US and bringing the Nidra^™ NTX100 therapy to the deserving patients who so desperately need it."

"As someone who has been at the forefront of clinical management of RLS for many years, I'm truly excited for our patients and clinicians alike when there are new options being studied and advanced through the regulatory and commercial processes. Publication of these results is an important milestone to including TOMAC therapy as an option to add to our arsenal," said John Winkelman, MD, Ph.D., one of the authors of the published RESTFUL Study and the Chief of the Sleep Disorders Clinical Research Program at Massachusetts General Hospital

"We are excited to embark on our controlled release of the Nidra^™ NTX100 therapy in select states nationwide in the coming months. This well-planned deployment will enable us to effectively manage the introduction of this highly anticipated therapy. By adopting this approach, our primary goal is to acquire valuable insights, collect user feedback, and enhance our offerings, ensuring a seamless and optimal experience for both users and prescribers.", said Ross Sylvia, who recently joined the leadership team as the company's Senior Vice President, Sales & Marketing. Mr. Sylvia brings a rich experience of commercializing innovative devices in markets like spine and most recently, Diabetes management at Tandem Diabetes. The company also announced the addition of Justin Kelly, Senior Vice President, Patient Access to the commercial leadership team. Mr. Kelly joins Noctrix Health after leading the reimbursement and market access programs to support successful launches of revolutionary products like Optune (Novocure, Inc) and Omnipod (Insulet Corporation).

About Noctrix Health
Noctrix Health, Inc. is a medical device company committed to developing clinically validated breakthrough medical technologies that improve the quality of life for patients with chronic medical conditions. The NTX100 Tonic Motor Activation (TOMAC) Therapy is the first-in-class, non-pharmacologic therapy for reducing symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and improving sleep quality in adults refractory to medications.

For more information, visit www.nidrarls.com and www.noctrixhealth.com

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SOURCE Noctrix Health, Inc.