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FDA grants breakthrough designation to wearable device for Restless Legs Syndrome

Dr. Kamal Kant KohliWritten by Dr. Kamal Kant Kohli Published On 2020-06-05T11:43:54+05:30  |  Updated On 5 Jun 2020 6:13 AM GMT
FDA grants breakthrough designation to wearable device  for Restless Legs Syndrome

SAN FRANCISCO - Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its wearable NTX100 Neuromodulation therapy designed for the treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications. RLS is the second...

SAN FRANCISCO -  Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its wearable NTX100 Neuromodulation therapy designed for the treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications.

RLS is the second most common sleep disorder in the world and impacts over 10% of the adult population in the US, with an estimated 3 million cases each year and is mainly treated using dopaminergic drugs. Patients report painful sensations of tingling and an urge to move their feet which particularly worsens during evenings and nights. "Today, an estimated third of all RLS patients remain refractory or continue to have severe symptoms despite being on medications for years and that doesn't even include the millions that cannot tolerate medication side-effects and would like an alternative," said Allan May, member of Noctrix Health's board of directors. Drugs, particularly dopaminergic ones, pose a high risk of "augmentation" of the condition especially with higher doses that are often required to treat moderate-severe RLS symptoms. Noctrix Health aims to treat RLS symptoms with its wearable neuromodulation platform that targets specific peripheral nerve fibers in a manner that is comfortable to wear to sleep.

The FDA Breakthrough Devices Program is a two-phase process intended to help patients receive timely access to breakthrough technologies that provide a more effective treatment than current standard of care for a life-threatening, or irreversibly debilitating disease. The treatment needs to have shown promising early clinical evidence that demonstrate an improvement over standard of care in order to be eligible for this designation. Shri Raghunathan, President & CEO of Noctrix Health, said: "We are thrilled that the FDA recognizes the promising potential that the therapy provides to millions of patients and very much look forward to working together with the agency during Phase 2 of this process to make this therapy available to patients expeditiously."

About Noctrix Health, Inc.

Noctrix Health, Inc. is a pioneer in developing the next generation of wearable therapeutics that employ its neurostimulation platform to treat symptoms of chronic neurological conditions, with an initial focus on sleep disorders.

restless legs syndrome therapy food and drug administration usfda fda restless legs syndrome 
Dr. Kamal Kant Kohli
Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Before Joining Medical Dialogues, he has served at important positions in the medical industry in India including as the Hony. Secretary of the Delhi Medical Association as well as the chairman of Anti-Quackery Committee in Delhi and worked with other Medical Councils in India. Email: editorial@medicaldialogues.in. Contact no. 011-43720751

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