Medical device and MedTech insights, news, tips and more
Noctrix Health granted FDA Breakthrough Device Designation for wearable Restless Legs Syndrome Therapy
June 3, 2020
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.”
Written by: Noctrix Health, Inc.
Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.
We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.
Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.