Gen-3 HALO Clarity passed usability, feasibility, and electrical testing.

Summary: Nexalin Technology Inc has successfully tested its Gen-3 HALO Clarity neurostimulator, passing key safety and design verifications, and the company is now boosting production to 500 units in anticipation of US clinical trials aimed at validating the device’s efficacy for at-home insomnia treatment.

Key Takeaways:

  • Nexalin Technology completed the first full production test run of its Gen-3 HALO Clarity neurostimulator, meeting usability, design verification, and electrical safety standards.
  • Following successful testing, Nexalin is increasing production, expecting to manufacture about 500 units in Q3 2024 in preparation for upcoming clinical trials.
  • The HALO Clarity device allows for at-home treatment and remote physician monitoring, potentially lowering treatment costs and improving patient compliance pending FDA approval.

Nexalin Technology Inc announced it has completed the first full production test run and successfully performed usability, feasibility design verification, and electrical safety testing for its new Gen-3 HALO Clarity 15 milliamps neurostimulation device in the US. 

As a result, the company is now ramping up manufacturing in advance of its planned clinical trials and expects to produce approximately 500 units in the third quarter of 2024.

“I am thrilled to report that the HALO Clarity passed a series of rigorous tests, validating our manufacturing process and illustrating that our device meets the highest product standards. Given this success, we are now accelerating production of the HALOClarity device to support our upcoming clinical trials,” says Mark White, CEO of Nexalin Technology, in a release. “Not only does the HALOClarity device build on extensive clinical data demonstrating the potential therapeutic effect of our prior generation devices, but it adds a whole new level of functionality, enabling treatment from the comfort and convenience of one’s own home, as well as remote monitoring by a physician.”

Prepping for Clinical Trials

Nexalin plans to conduct clinical trials of the HALO Clarity in the US and is in the process of consulting with the US Food and Drug Administration (FDA) as part of its pre-submission meetings. 

The company expects that its upcoming clinical trials will be completed in an expedited timeframe and at a considerably lower expense since the HALO Clarity treatment can be administered at home, as opposed to a hospital or outpatient clinical setting, and the resulting data can be captured and patient response can be contemporaneously transmitted electronically. 

Contingent upon FDA approval, the home-use aspect of HALO Clarity is expected to reduce patient treatment costs, while increasing compliance with applicable standards.

The first generation of Nexalin Technology Inc’s neurostimulator cleared the US Food and Drug Administration (FDA) for the treatment of insomnia in 2003. Nexalin no longer manufactures that device. 

Photo caption: Gen-3 HALO Clarity

Photo credit: Nexalin Technologies