Nexalin Technology, Inc. (NASDAQ: NXL) announced that it has entered into agreements to advance its planned pivotal clinical trial for the HALO™ Clarity non‑invasive neurostimulation headset, targeting moderate‑to‑severe insomnia. The 160‑participant, randomized, triple‑blinded, sham‑controlled study is designed to support a De Novo Classification Request to the U.S. Food and Drug Administration. Enrollment is slated to begin in the second quarter of 2026, marking a key milestone in the company’s regulatory strategy for the HALO platform.
The trial will be conducted in partnership with Lindus Health, an accountable research organization that will oversee protocol finalization, regulatory and ethics submissions, patient identification, data oversight, biostatistics and medical writing. The study will also employ a decentralized model through Nexalin’s NeuroCare virtual clinic, allowing patients to participate remotely and reducing site‑visit requirements.
"Advancing this pivotal clinical trial toward enrollment marks an important step in the continued execution of our FDA regulatory strategy," said CEO Mark White. "We believe the Nexalin HALO™ Clarity medical device represents a unique and advanced approach to non‑invasive drug‑free treatment for patients with moderate‑to‑severe insomnia. This study is designed to initiate our planned De Novo FDA submission strategy and, assuming it is successful, would further strengthen the clinical and regulatory case for mental health treatment in a large and underserved market.",
While the clinical milestone is significant, Nexalin’s financial position remains precarious. The company reported a net loss of approximately $8.22 million for the year ended December 31 2025, increasing its accumulated deficit to about $92.87 million. An auditor’s report raised substantial doubt about the company’s ability to continue as a going concern, and the company has not maintained the minimum bid price of $1.00 per share for 30 consecutive business days, violating Nasdaq Listing Rule 5550(a)(2). These factors underscore the need for additional funding to support the trial and future development.
The HALO™ Clarity device has already received regulatory approvals in several international markets, including China, Brazil, Oman, and Israel, and the company’s Gen‑2 15 milliamp neurostimulation device has been cleared in those jurisdictions. The upcoming U.S. trial will be a critical step toward establishing a new product category under the De Novo pathway, potentially opening a large and underserved market for non‑pharmacologic insomnia treatment.
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