MCRA LLC, a medical device-focused regulatory advisory firm and clinical research organization, assisted Noctrix Health in obtaining marketing authorization via a De Novo Request from the US Food and Drug Administration (FDA) for the NTX100 Tonic Motor Activation (NTX100 TOMAC) System for patients with restless legs syndrome.
The device is indicated to reduce symptoms of primary moderate-severe restless legs syndrome and improve sleep quality in adults refractory to medications. The NTX100 TOMAC System is an externally worn medical device that applies low-level electrical stimulation to peripheral nerve fibers in the leg.
MCRA’s team of neurology, digital health, and biocompatibility experts was retained by Noctrix Health to support strategy, development, and submission of the De Novo Request to the FDA and collaborated with Noctrix Health to resolve all FDA questions during the review of the De Novo.
John Doucet, MCRA’s vice president of regulatory affairs—neuromodulation and evolving therapies, says in a release, “We are proud to have collaborated with Noctrix Health to achieve this important milestone for the company. The timeline for development, submission, and review of the De Novo request was minimized by MCRA’s broad and deep regulatory expertise in neurology, digital health, cybersecurity, biocompatibility, and other areas. I want to specifically thank the FDA Office of Neurological and Physical Medicine Devices for the collaborative and interactive nature of their review. Their commitment to the spirit of the breakthrough device program played a significant role in expediting patient access to this important new treatment for patients diagnosed with restless legs syndrome.”
Shri Raghunathan, CEO at Noctrix Health, says in a release, “Working with MCRA’s team of experts has been a true pleasure. Our De Novo submission was supported by their wealth of expertise, allowing us to receive marketing authorization in a short period of time. We look forward to continuing to work with MCRA’s wide range of experts as we expand in the medical device industry.”
The De Novo Request was submitted in September 2022 and granted in April 2023. Noctrix Health previously was granted the breakthrough device designation in May 2020 for use of the NTX100 TOMAC to treat drug-refractory restless legs syndrome.