MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System

WASHINGTON, May 8, 2023 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in assisting Noctrix Health obtain marketing authorization via a De Novo Request from the U.S. Food and Drug Administration (FDA) for the NTX100 Tonic Motor Activation (NTX100 TOMAC) System. The device is indicated to reduce symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and to 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 to treat Restless Legs Syndrome (RLS). RLS is the second most common sleep disorder in the world, contributing to what the Centers for Disease Control and Prevention have labeled a public health epidemic. With more than 10% of the Western adult population affected, and 81% of those with clinical RLS approaching their doctor for relief, RLS places a heavy economic burden on the healthcare system. Noctrix Health was granted the breakthrough device designation in May 2020 for use of the NTX100 TOMAC to treat drug-refractory RLS.

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. The De Novo Request was submitted in September 2022 and granted in April 2023. This short review period highlights the intensive communication and collaboration between the Noctrix Health, FDA, and MCRA teams to expedite access to the NTX100 TOMAC System for the indicated patients and reduce the symptoms of RLS, improve their sleep quality, and improve their quality of life.

John Doucet, MCRA's Vice President of Regulatory Affairs – Neuromodulation and Evolving Therapies, said, "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 said, "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."

MCRA is pleased to continue supporting neurological innovation in the medical device industry by helping clients navigate global regulatory challenges.

About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client's industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. www.mcra.com

About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com

About Noctrix Health: Noctrix Health is a medical device company committed to developing high-quality, clinically validated breakthrough medical technologies that improve the quality of lives of 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.noctrixhealth.com.

For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: ahoward@mcra.com

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SOURCE MCRA, LLC