Nexalin’s neurostimulation device receives approval in Israel

HOUSTON - Nexalin Technology, Inc. (NASDAQ:NXL) announced Thursday that its Gen-2 Console (SYNC) neurostimulation device has received regulatory approval from the Israeli Ministry of Health. The news comes as the company’s stock has shown strong momentum, gaining 4.73% in the past week and trading at $1.55.

The 15 milliamp device, which uses Deep Intracranial Frequency Stimulation technology, adds Israel to the list of countries where Nexalin has secured regulatory clearance, following prior approvals in China, Brazil, and Oman.

"We are extremely proud to have received regulatory clearance in Israel, which is recognized worldwide for its rigorous and highly respected health regulatory standards," said Mark White, CEO of Nexalin Technology, in a press release statement. InvestingPro data shows the company holds more cash than debt on its balance sheet, with a current ratio of 10.44, providing financial flexibility as it pursues international expansion.

The company describes its technology as non-invasive and designed to help treat mental health disorders by penetrating structures in the mid-brain associated with these conditions.

According to the company, this approval supports its strategy to expand its presence across the region, with discussions already underway with potential distribution partners to launch commercial sales in Israel. Despite the expansion efforts, InvestingPro analysis indicates Nexalin is currently overvalued based on Fair Value metrics, with analysts not anticipating profitability this year.

Nexalin Technology develops neurostimulation products aimed at addressing mental health issues. The company states that its next-generation devices are designed to generate enhanced patient response without adverse side effects. With a market capitalization of $27 million and revenue of just $0.17 million in the last twelve months, the small-cap company is trading at a high revenue valuation multiple.

The announcement comes as the company continues to pursue additional international markets for its neurostimulation technology. Investors should note that Nexalin’s stock exhibits high price volatility, with a beta of 3.64, making it significantly more volatile than the broader market. Get access to 8 more exclusive InvestingPro Tips for NXL to make more informed investment decisions.

In other recent news, Nexalin Technology announced an amendment to its equity distribution agreement with Maxim Group LLC, increasing its at-the-market equity program from $3.1 million to $10 million. As of the announcement, approximately $4.27 million in shares remain available for sale under this expanded program. Nexalin’s proprietary technology has shown positive clinical results, specifically its 15 milliamp Gen-2 Nexalin Deep Intracranial Frequency Stimulation (DIFS) technology, which demonstrated significant cognitive improvements in patients with mild Alzheimer’s disease. These findings were published in Radiology, highlighting statistically significant improvements in Mini-Mental State Examination scores compared to a control group.

Additionally, Nexalin Technology’s warrants, issued during its initial public offering, expired and were delisted from the Nasdaq Stock Market. The warrants, exercisable for one share of common stock at an exercise price of $4.15, expired by their terms, and a Form 25 was filed with the Securities and Exchange Commission to indicate their delisting. These developments reflect Nexalin’s ongoing financial and clinical activities, providing investors with new insights into the company’s current status.

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