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New Study Shows Nexalin’s Deep Intracranial Frequency Stimulation (DIFS) Significantly Improves Memory and Cognitive Function in Alzheimer’s Patients

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Nexalin Technology (Nasdaq: NXL) has announced promising results from a clinical trial of its Deep Intracranial Frequency Stimulation (DIFS) technology for mild Alzheimer's disease. The study, published in Alzheimer's Research & Therapy, showed significant improvements in memory and cognitive function among patients treated with DIFS.

Key findings include:

  • Statistically significant improvement in memory (ADAS-Cog scores)
  • Significant increases in MMSE (p = 0.041) and MoCA (p = 0.025) scores
  • Enhanced neural activity and increased blood flow in the hippocampus
  • Well-tolerated treatment with minor side effects

The study involved 46 patients, with 23 in the DIFS group. Functional MRI scans revealed increased blood flow to hippocampal regions, important for memory function. Nexalin is planning further clinical trials to explore different waveform frequencies and enhance clinical response.

Positive
  • Significant improvement in memory function as measured by ADAS-Cog
  • Statistically significant increases in MMSE (p = 0.041) and MoCA (p = 0.025) scores
  • Enhanced neural activity and increased blood flow in the hippocampus observed through fMRI
  • Well-tolerated treatment with only minor side effects
  • Results published in a leading peer-reviewed journal, Alzheimer's Research & Therapy
Negative
  • None.

Insights

This study represents a significant breakthrough in Alzheimer's treatment research. The statistically significant improvements in cognitive function, particularly in memory, are remarkable given the challenging nature of Alzheimer's disease. The increase in MMSE scores (p = 0.041) and MoCA scores (p = 0.025) are particularly noteworthy, as these are widely recognized cognitive assessment tools.

The fMRI data showing increased neural activity and blood flow in the hippocampus is especially intriguing. This suggests that DIFS may be addressing the underlying neural decline associated with Alzheimer's, rather than just managing symptoms. This could potentially slow disease progression, which would be a game-changer in Alzheimer's treatment.

However, it's important to note that with only 46 patients enrolled, this is still a relatively small study. Larger, multi-center trials will be necessary to confirm these promising results and establish DIFS as a viable treatment option. The company's plans for further trials with different waveform frequencies could yield even more promising results.

From an investment perspective, this news is highly positive for Nexalin Technology (NXL). The Alzheimer's treatment market is vast and largely underserved, with current therapies offering efficacy. A non-invasive, drug-free treatment showing significant cognitive improvements could be extremely valuable.

The publication in a leading peer-reviewed journal adds credibility to the research and could attract attention from larger pharmaceutical companies. Potential partnerships, as mentioned by the CEO, could provide significant upside for NXL's valuation.

However, investors should be cautious. With a market cap of just $10.9 million, NXL is a micro-cap stock, which inherently carries high risk. The path from promising clinical results to FDA approval and commercialization is long and expensive. The company will likely need additional funding to conduct larger trials, which could lead to dilution for current shareholders.

Overall, while the news is very promising, investors should carefully consider the high-risk, high-reward nature of this investment opportunity.

Groundbreaking Trial Reveals DIFS Increases Neural Activity and Blood Flow in the Hippocampus, Offering Hope for Alzheimer’s Treatment

HOUSTON, TX, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today announced results from a clinical trial demonstrating improvements in memory and cognitive function for patients with mild Alzheimer’s disease using its proprietary Deep Intracranial Frequency Stimulation (DIFS) technology. The full results have been published in Alzheimer’s Research & Therapy, one of the leading peer-reviewed journals in the field, further underscoring the scientific rigor and clinical importance of this research. The study can be accessed here.

The study, which enrolled 46 patients, showed that those in the DIFS group (23 patients) saw notable improvements in key cognitive markers, including significant gains in Mini-Mental State Examination (MMSE) scores (p = 0.041) and Montreal Cognitive Assessment (MoCA) scores (p = 0.025). The intervention also led to increased local neural activity in the hippocampus, a crucial area of the brain for memory processing, as revealed by functional MRI (fMRI) scans. Notably, the fMRI results showed that Nexalin’s DIFS treatment increased blood flow to the hippocampal regions, areas critical to memory function, further emphasizing the potential of this non-invasive therapy in combating neural decline associated with Alzheimer’s disease.

Key Findings:

  • Significant Memory Function Improvement: The DIFS group exhibited a statistically significant improvement in memory, as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), compared to the sham group.
  • Cognitive Gains: Patients treated with DIFS saw meaningful progress in global cognitive function, with significant increases in Mini-Mental State Examination (MMSE) scores (p = 0.041) and Montreal Cognitive Assessment (MoCA) scores (p = 0.025).
  • Increased Hippocampal Activity and Blood Flow: Functional MRI (fMRI) revealed enhanced neural activity and increased blood flow in the hippocampus, a critical region for memory processing, suggesting that DIFS may positively influence brain function and slow the progression of Alzheimer’s disease.
  • Tolerability: The treatment was well-tolerated, with minor side effects such as mild tingling during stimulation sessions, all of which resolved quickly.

Dr. David Owens, Chief Medical Officer of Nexalin, commented, “We are thrilled with the results from the TRANSFORM-AD study, particularly the significant improvement in memory function. This study marks a major milestone for Nexalin’s Deep Intracranial Frequency Stimulation technology and validates our belief that non-invasive brain stimulation has the potential to transform the treatment landscape for Alzheimer’s disease. Improving cognitive outcomes, especially in memory, is crucial for enhancing the quality of life for patients and their families. The fMRI data showing increased blood flow to the hippocampal regions further emphasizes the potential of this therapy in addressing the underlying neural decline seen in Alzheimer’s patients. These findings are especially encouraging given the limited treatment options currently available for Alzheimer’s disease, which focus largely on managing symptoms rather than addressing the underlying neural decline.”

Mark White, CEO of Nexalin Technology, further noted, “Our DIFS technology shows great promise as a drug-free alternative or in combination with existing treatments by working directly on the brain's electrical activity to modulate cognition. The increase in both neural activity and blood flow in critical areas like the hippocampus indicates that this therapy could potentially slow disease progression. Looking ahead, we have already started planning a robust clinical trial utilizing different waveform frequencies to enhance the clinical response. We remain committed to advancing our patented technology and are actively exploring potential partnerships with the aim of offering a safe, effective, and non-invasive option for patients worldwide suffering from Alzheimer’s and other devastating mental health conditions.”

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 has been approved in China, Brazil, and Oman.  

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



FAQ

What is the effectiveness of Nexalin's DIFS technology for Alzheimer's patients?

Nexalin's DIFS technology showed significant improvements in memory and cognitive function for mild Alzheimer's patients, with notable gains in MMSE and MoCA scores, and increased neural activity and blood flow in the hippocampus.

How many patients were involved in Nexalin's (NXL) DIFS clinical trial?

The clinical trial involved a total of 46 patients, with 23 patients in the DIFS treatment group and 23 in the sham (control) group.

What were the key findings of Nexalin's (NXL) DIFS study for Alzheimer's treatment?

Key findings include significant improvement in memory function (ADAS-Cog scores), increases in MMSE and MoCA scores, enhanced neural activity and blood flow in the hippocampus, and good tolerability with minor side effects.

What are Nexalin's (NXL) future plans for DIFS technology in Alzheimer's treatment?

Nexalin is planning a robust clinical trial using different waveform frequencies to enhance clinical response and is exploring potential partnerships to offer DIFS as a treatment option for Alzheimer's patients worldwide.

Nexalin Technology, Inc.

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