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Announces Regulatory Approval to Sell Nexalin's Gen-2, 15 mA Neurostimulation Device by the Brazilian Health Regulatory Agency

Key Takeaway: Nexalin Technology, Inc. has received regulatory approval from the Brazilian Health Regulatory Agency to sell its Gen-2, 15 mA neurostimulation device. This marks the company's second regulatory approval outside of China in 2024, emphasizing Brazil's importance as a market. With a population of over 215 million and more than 35 million suffering from mental health disorders, Nexalin aims to leverage this approval to expand further into South America. The company is currently in discussions with potential distributors to enhance market presence.

Market Sentiment Analysis

POSITIVE FACTORS

  • Regulatory approval from the Brazilian Health Regulatory Agency for Gen-2 device.
  • Expands Nexalin's market presence in Brazil, which has a significant population afflicted with mental health disorders.
  • CEO indicates strong market potential and ongoing discussions with key distributors in South America.

Full Press Release Details

Announces Regulatory Approval to Sell Nexalin's Gen-2, 15 mA Neurostimulation Device by the Brazilian Health Regulatory Agency
June 13, 2024 3:00 PM
Brazil represents the 9th largest economy in the world with more than 35 million afflicted by mental health disorders
HOUSTON, TX, June 13, 2024 (GLOBE NEWSWIRE) - Nexalin Technology, Inc. (the "Company" or "Nexalin") (Nasdaq: NXL; NXLIW) today announced that its second generation (Gen-2), 15 milliamp (mA) neurostimulation device has been granted regulatory approval by the Brazilian Health Regulatory Agency, a regulatory body of the Brazilian government responsible for approving new drugs and medical devices.
Mark White, CEO of Nexalin Technology, stated, "We are pleased to announce approval to sell our Gen-2 neurostimulation device in Brazil, which represents our second regulatory approval outside of China since the start of this year. Brazil is an important market as it represents the 9th largest economy in the world with a population in excess of 215 million. Among this population, more than 35 million are afflicted with mental health disorders. Moreover, this approval is an important springboard into other markets within South America. We are rapidly advancing discussions with a key distributor in this market and look forward to providing further updates."
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin's products are believed to be non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device was recently approved in Oman and China. Additional information about the Company is available at: https://nexalin.com/.
FORWARD-LOOKING STATEMENTS
This press release contains statements that constitute "forward-looking statements," These statements relate to future events or Nexalin's future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that Nexalin or its management "believes", "expects", "anticipates", "plans", "intends" and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or Nexalin's actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Report on Form 10-K for the year ended December 31, 2023 and other filings as filed with the Securities and Exchange Commission. Copies of such filings are available on the SEC's website, www.sec.gov. Such forward-looking statements are made as of the date hereof and may become outdated over time. Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Crescendo Communications, LLC
RedChip Companies Inc.

Frequently Asked Questions

What device received regulatory approval in Brazil?

Nexalin's Gen-2, 15 mA neurostimulation device received approval.

How many people in Brazil suffer from mental health disorders?

Over 35 million people in Brazil are afflicted with mental health disorders.

What technology does Nexalin use for its devices?

Nexalin uses bioelectronic medical technology for neurostimulation.

When was Nexalin's device approved in Brazil?

The device was approved by the Brazilian Health Regulatory Agency on June 13, 2024.

Where else has the Gen-2 device received approval?

The Gen-2 device has also been approved in Oman and China.

Last updated: Jun 18, 2024