May. 8 at 7:35 PM
$NXL
* Tangible and structured progress toward De Novo classification with the FDA (an important regulatory pathway for novel devices such as HALO Clarity).
* Execution of a formal agreement with Lindus Health (a professional CRO) to conduct a pivotal clinical trial for insomnia treatment — a major and concrete step.
* The study is well-designed: 160 participants, triple-blind, sham-controlled (gold standard).
* Expected start of patient recruitment in Q2 2026 (i.e., very soon).
* Ongoing progress with the FDA on the Gen-2 program for Alzheimer’s treatment (Q-Submission + meeting).
