Nexalin Technology, Inc. announced continued advancement toward its planned pivotal clinical trial evaluating HALO™ Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin’s planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical research organization engaged to oversee trial execution, regulatory preparation, and patient recruitment.
The randomized, triple-blinded, sham-controlled study is designed to enroll a minimum of 150 participants across the United States. Structured as a fully decentralized trial, participants are expected to complete treatments and assessments remotely within Nexalin’s recently launched NeuroCare virtual clinic and its advanced Electronic Data Capture (EDC) system. The NeuroCare virtual clinic is designed to eliminate traditional site visit requirements, while expanding access to a broader patient population.
The pivotal study is designed to support the planned de novo insomnia submission to the U.S. Food and Drug Administration and represents a key milestone in the execution of Nexalin’s global strategy to expand its DIFS™ platform into high-prevalence neuropsychiatric indications.
The pivotal study to support Nexalin’s planned FDA submission builds on Nexalin’s previously reported and published clinical results in chronic insomnia, including a 120-participant randomized, double-blind, placebo-controlled, multicenter study published in the Journal of Psychiatric Research. In that study, Nexalin reported clinically meaningful and statistically significant improvements across key sleep parameters compared to placebo, with no significant adverse effects reported. Nexalin’s Gen-2 15 mA device has also received regulatory approvals internationally for insomnia and related indications.
Insomnia affects approximately 30 million adults in the United States, with many patients reporting dissatisfaction with existing treatment options due to concerns regarding dependency, tolerability, or long-term use. The global insomnia therapeutics market represents a multi-billion-dollar annual opportunity and continues to grow as awareness and diagnosis increase.
HALO™ Clarity leverages Nexalin’s proprietary 15 mA DIFS™ technology, which is engineered to target deeper brain structures associated with sleep regulation and other mental health conditions. Unlike conventional transcranial stimulation approaches primarily targeting cortical regions, DIFS™ is engineered to modulate deeper neural circuits implicated in sleep architecture, offering a potential non-pharmacological treatment alternative.
Under the collaboration, Lindus Health is expected to provide comprehensive clinical research services, including protocol finalization, regulatory preparation and submission support, patient recruitment strategy, study management, data oversight, biostatistics, and medical writing.
The planned study will include adults aged 22 to 65 with moderate to severe insomnia, who are expected to be randomized to receive either active HALO™ Clarity therapy or sham treatment for four weeks, followed by a four-week follow-up period to evaluate durability of response.
“This planned pivotal trial marks an important milestone for Nexalin,” said Mark White, Chief Executive Officer of Nexalin Technology. “Insomnia is a large and underserved market where millions of patients are seeking drug-free treatment options. Advancing HALO™ Clarity toward a fully powered pivotal study designed to support our planned FDA submission reflects the maturity of our DIFS™ platform and our commitment to expanding its clinical reach. We believe successful execution of this study and continued advancement along the FDA pathway will position Nexalin to pursue regulatory clearance in a high-demand market, further validate the broader potential of our technology, and support our ongoing efforts to expand regulatory pathways across additional indications.”
“We are pleased to collaborate with Nexalin in the advancement of this important study,” said Michael Young, Co-CEO of Lindus Health. “Our team looks forward to supporting the execution of a rigorous, patient-centric trial designed to evaluate this novel approach to insomnia treatment.”
Nexalin continues to focus on strengthening the clinical and regulatory foundation of its DIFS™ platform as it advances toward potential commercialization across multiple neuropsychiatric indications.
Source Globe Newswire
