Noctrix Health, Inc.

Noctrix Health, Inc. is a medical device company specializing in clinically validated wearable therapeutics for chronic neurological disorders. The company's flagship product is Nidra, a prescription-grade wearable device employing Tonic Motor Activation (TOMAC) therapy for the management of Restless Legs Syndrome (RLS). Noctrix received FDA Breakthrough Device Designation in June 2020 and obtained De Novo clearance in April 2023. The RESTFUL pivotal trial, published in dual feature in SLEEP journal (July 2023), demonstrated clinical efficacy. The company achieved first commercial shipment in July 2023. CMS issued dedicated HCPCS codes and reimbursement payment for Nidra therapy and supplies in October 2024. The company's leadership comprises medical device experts, neuroscientists, and consumer electronics engineers. Noctrix is backed by leading venture and angel investors. The product is indicated for patients with RLS and is positioned as a prescription-grade therapeutic with consumer-grade user experience. The device addresses a significant unmet need in chronic neurological disease management, with established reimbursement pathways and clinical practice guideline inclusion from the American Academy of Sleep Medicine (AASM).