Nexalin Technology Announces Regulatory Approval to Sell Nexalin’s Gen-2, 15 mA Neurostimulation Device by the Brazilian Health Regulatory Agency (Anvisa)
Nexalin Technology announced the regulatory approval of its Gen-2, 15 mA neurostimulation device by the Brazilian Health Regulatory Agency (Anvisa) on June 13, 2024. This marks Nexalin's second regulatory approval outside China this year. Brazil, the ninth largest economy globally with over 215 million people, includes more than 35 million individuals suffering from mental health disorders. CEO Mark White highlighted the strategic importance of this approval, positioning it as a gateway to broader South American markets. Nexalin is in advanced talks with a key distributor in Brazil, promising more updates soon.
- Regulatory approval by the Brazilian Health Regulatory Agency for Gen-2 device.
- Brazil is the ninth largest economy with over 215 million population.
- 35 million people in Brazil afflicted with mental health disorders.
- Second regulatory approval outside China this year.
- Potential gateway to other South American markets.
- Advanced discussions with a key distributor in Brazil.
- None.
Insights
The regulatory approval granted to Nexalin Technology for its Gen-2, 15 mA neurostimulation device opens up a significant opportunity in Brazil, a market with a considerable population suffering from mental health disorders. This device can potentially cater to more than 35 million individuals, increasing the company's market reach.
Brazil's economy, being the 9th largest globally, has a substantial healthcare expenditure, making it an attractive market for medical technologies. The approval demonstrates regulatory trust in Nexalin's product quality and compliance, which bodes well for future approvals in other South American countries. This step aligns with their geographical expansion strategy.
In the short term, investors should watch for partnership announcements with local distributors, as these will be critical for market penetration and revenue generation. If effectively executed, this could lead to an increase in revenue streams and potentially enhance shareholder value.
From a financial perspective, entering the Brazilian market could significantly boost Nexalin's revenue. Brazil's large population and the high prevalence of mental health disorders present a considerable market potential. If the company captures even a small percentage of this market, it could lead to meaningful revenue growth.
However, it's important to consider the execution risks associated with market entry strategies. Establishing distribution networks, regulatory compliance and local market competition are factors that could impact profitability. Investors should look for subsequent financial reports to gauge the sales traction of the Gen-2 device in Brazil.
In the long run, successful penetration into the Brazilian market can set a precedent for further expansions in other Latin American countries, potentially leading to a compounded growth effect on the company’s revenues and profitability.
The Gen-2 neurostimulation device by Nexalin represents a significant advancement in non-invasive treatments for mental health disorders. Such devices offer an alternative to traditional pharmacological therapies, which often come with side effects. The approval by Anvisa suggests that the device has met regulatory safety and efficacy standards, which is a positive endorsement of its therapeutic potential.
In a country with over 35 million individuals affected by mental health issues, the introduction of this device could improve treatment accessibility and outcomes. Furthermore, it supports the growing trend towards non-invasive and patient-friendly treatment options in mental health care. Monitoring patient adoption rates and clinical feedback from Brazil could provide valuable insights into the device’s effectiveness and market reception.
This development not only reinforces the scientific credibility of Nexalin's neurostimulation device but also positions the company well within the evolving landscape of mental health treatments.
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.
Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
Dave Gentry, CEO
RedChip Companies Inc.
407-491-4498
NXL@redchip.com
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