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Nexalin Technology Announces Landmark Study on Alzheimer's Disease and Deep Intracranial Frequency Stimulation Published in Journal of Alzheimer's Disease

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Nexalin Technology (NXL) published a landmark study in the Journal of Alzheimer's Disease demonstrating the effectiveness of their Deep Intracranial Frequency Stimulation (DIFS) technology. The study, involving 46 patients over three weeks, showed significant improvements in brain function and cognitive performance in Alzheimer's patients. Key findings include increased neuronal activity, enhanced brain connectivity, improved blood flow, and sustained cognitive benefits over a three-month follow-up period. The treatment proved safe and well-tolerated, with no serious side effects reported. The study validates DIFS as a potential non-pharmacological treatment option for Alzheimer's disease, which affects over 50 million people globally.

Nexalin Technology (NXL) ha pubblicato uno studio rivoluzionario nel Journal of Alzheimer's Disease che dimostra l'efficacia della loro tecnologia di Stimolazione della Frequenza Intracranica Profonda (DIFS). Lo studio, che ha coinvolto 46 pazienti per un periodo di tre settimane, ha mostrato miglioramenti significativi nella funzione cerebrale e nelle performance cognitive dei pazienti affetti da Alzheimer. I principali risultati includono un aumento dell'attività neuronale, una connettività cerebrale migliorata, un flusso sanguigno ottimizzato e benefici cognitivi sostenuti nel periodo di follow-up di tre mesi. Il trattamento si è rivelato sicuro e ben tollerato, senza segnalazioni di effetti collaterali gravi. Lo studio convalida il DIFS come una potenziale opzione di trattamento non farmacologico per la malattia di Alzheimer, che colpisce oltre 50 milioni di persone a livello globale.

Nexalin Technology (NXL) publicó un estudio pionero en el Journal of Alzheimer's Disease que demuestra la efectividad de su tecnología de Estimulación de Frecuencia Intracraneal Profunda (DIFS). El estudio, que involucró a 46 pacientes durante tres semanas, mostró mejoras significativas en la función cerebral y el rendimiento cognitivo en pacientes con Alzheimer. Los principales hallazgos incluyen un aumento de la actividad neuronal, una conectividad cerebral mejorada, un flujo sanguíneo optimizado y beneficios cognitivos sostenidos durante un periodo de seguimiento de tres meses. El tratamiento demostró ser seguro y bien tolerado, sin efectos secundarios graves reportados. El estudio valida el DIFS como una posible opción de tratamiento no farmacológico para la enfermedad de Alzheimer, que afecta a más de 50 millones de personas en todo el mundo.

Nexalin Technology (NXL)Journal of Alzheimer's Disease에 그들의 심층 두개내 주파수 자극(DIFS) 기술의 효과를 입증하는 획기적인 연구를 발표했습니다. 이 연구는 46명의 환자를 대상으로 3주 동안 진행되었으며, 알츠하이머 환자들의 뇌 기능 및 인지 능력이 상당히 향상되었음을 보여주었습니다. 주요 발견으로는 신경 활동 증가, 개선된 뇌 연결성, 혈류 개선 및 3개월 추적 관찰 기간 동안 지속된 인지적 혜택이 포함됩니다. 이 치료법은 안전하고 잘 견딜 수 있으며, 심각한 부작용은 보고되지 않았습니다. 이 연구는 DIFS를 알츠하이머병의 잠재적인 비약물 치료 옵션으로 검증하며, 이 병은 전 세계적으로 5천만 명 이상에게 영향을 미치고 있습니다.

Nexalin Technology (NXL) a publié une étude révolutionnaire dans le Journal of Alzheimer's Disease démontrant l'efficacité de sa technologie de Stimulation de Fréquence Intracrânienne Profonde (DIFS). L'étude, impliquant 46 patients pendant trois semaines, a montré des améliorations significatives de la fonction cérébrale et des performances cognitives chez les patients atteints d'Alzheimer. Les principales conclusions incluent une activité neuronale accrue, une connectivité cérébrale renforcée, une amélioration du flux sanguin et des bénéfices cognitifs durables durant une période de suivi de trois mois. Le traitement s'est avéré sûr et bien toléré, sans effets secondaires graves rapportés. L'étude valide le DIFS comme une option de traitement non pharmacologique potentielle pour la maladie d'Alzheimer, qui touche plus de 50 millions de personnes dans le monde.

Nexalin Technology (NXL) veröffentlichte eine bahnbrechende Studie im Journal of Alzheimer's Disease, die die Wirksamkeit ihrer Technologie der Tiefen Intrakraniellen Frequenzstimulation (DIFS) demonstriert. Die Studie, die 46 Patienten über einen Zeitraum von drei Wochen umfasste, zeigte signifikante Verbesserungen der Gehirnfunktion und der kognitiven Leistung bei Alzheimer-Patienten. Zu den wichtigsten Ergebnissen gehören eine erhöhte neuronale Aktivität, verbesserte Gehirnvernetzung, optimierter Blutfluss und nachhaltige kognitive Vorteile während einer drei Monate dauernden Nachbeobachtungszeit. Die Behandlung erwies sich als sicher und gut verträglich, ohne berichtete schwerwiegende Nebenwirkungen. Die Studie validiert DIFS als potenzielle nicht-pharmazeutische Behandlungsoption für die Alzheimer-Erkrankung, die mehr als 50 Millionen Menschen weltweit betrifft.

Positive
  • Clinical study demonstrated significant improvements in cognitive function
  • Treatment effects sustained over three-month follow-up period
  • No serious side effects reported during the trial
  • Technology addresses large market with over 50 million Alzheimer's patients globally
Negative
  • None.

Insights

This landmark study on Nexalin's Deep Intracranial Frequency Stimulation (DIFS) technology represents a significant breakthrough in Alzheimer's treatment. The research demonstrates remarkable efficacy through:

  • Significant increases in neuronal activity and glucose metabolism in key brain regions
  • Sustained cognitive improvements over a 3-month period
  • Enhanced brain connectivity and blood flow
  • Strong safety profile with no serious side effects

The study's robust design with 46 patients and use of advanced imaging (rs-fMRI) provides compelling evidence for DIFS's potential. For a small-cap company ($26.7M), this peer-reviewed validation in the Journal of Alzheimer's Disease substantially increases credibility and commercial potential in the $37B global Alzheimer's treatment market.

This development positions Nexalin uniquely in the rapidly growing Alzheimer's treatment market. With 50 million+ global Alzheimer's patients and projections reaching 113 million by 2050, the commercial opportunity is substantial. The non-invasive nature and strong safety profile of DIFS provides a competitive advantage over traditional pharmacological approaches. For investors, key value drivers include:

  • Large addressable market with significant unmet needs
  • Validated technology through peer-reviewed research
  • Potential for rapid market adoption due to safety profile
  • Multiple revenue streams through treatment centers and technology licensing

New Data Confirms DIFS Improves Cognitive Function and Restores Brain Activity in Alzheimer's Patients


HOUSTON, TX, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today announced publication of a landmark study titled, “Altered Neuronal Activity Patterns of the Prefrontal Cortex in Alzheimer’s Disease After Transcranial Alternating Current Stimulation (tACS): A Resting-State Functional Magnetic Resonance Imaging Studyi” in the Journal of Alzheimer's Disease. This study builds on recent findings from Nexalin's Deep Intracranial Frequency Stimulation (DIFS) research and further highlights the effectiveness of non-invasive neurostimulation in enhancing brain function and improving cognitive performance in patients with mild Alzheimer’s disease (AD).

This new research involved 46 patients, randomly assigned to receive either real DIFS or sham treatment for 30 one-hour sessions over a period of three weeks. Resting-state functional magnetic resonance imaging (rs-fMRI) was used to track changes in brain activity, showing that Nexalin’s proprietary DIFS technology significantly alters neuronal activity in key regions of the brain, providing a non-pharmacological, safe treatment option for Alzheimer’s.

Key Findings of the Study Include:

  • Increased Neuronal Activity and Glucose Metabolism: Patients receiving real DIFS exhibited significant increases in fractional amplitude of low-frequency fluctuation (fALFF) in key brain areas like the prefrontal cortex. fALFF, which measures regional spontaneous neuronal activity, has been shown to correlate with glucose metabolism, a crucial process for cognitive function that is often impaired in Alzheimer’s patients. This suggests that DIFS may help restore metabolic functions within the brain, contributing to improved cognition.
  • Sustained Cognitive Benefits: After three weeks of treatment, patients showed improvements in cognitive function, which were sustained over a three-month follow-up.  Increased neuronal activity was observed in regions such as the superior parietal lobule and inferior temporal gyrus, both of which are critical for memory and cognitive processing. These results indicate that DIFS has long-lasting effects, potentially offering extended cognitive support for Alzheimer’s patients.
  • Enhanced Brain Connectivity: The study found improvements in regional homogeneity (ReHo) in the left middle frontal gyrus and right superior medial frontal gyrus, indicating better synchronization of neural activity between different brain regions. The modulation of brain networks by DIFS underscores its potential to improve cognitive function by enhancing brain communication pathways.
  • Correlations with Improved Blood Flow and Brain Function: Enhanced blood flow was observed in several critical regions, correlating with the increases in neuronal activity. This improvement in both glucose metabolism and blood flow suggests that DIFS can help restore disrupted metabolic processes in the brain, which are commonly affected in Alzheimer's patients. Increased blood flow, particularly in memory-related areas, aligns with previous findings on Nexalin’s DIFS technology, further solidifying DIFS’s potential as a complementary non-invasive treatment for Alzheimer’s.
  • Safe and Well-Tolerated Treatment: Importantly, the study indicated no serious side effects reported among participants. Despite undergoing twice-daily stimulation sessions over three weeks, elderly patients tolerated the treatment well, with only minor sensations such as tingling that resolved quickly. This profile is particularly critical in vulnerable populations such as Alzheimer’s patients.

With Alzheimer’s disease affecting over 50 million people globally and projections rising to over 113 million by 2050, there is an urgent need for innovative therapies that address the root causes of cognitive decline. Current treatments primarily focus on managing symptoms, but Nexalin’s DIFS technology offers the potential to modulate brain activity and restore metabolic functions, providing a new avenue for treating this debilitating disease.

This study builds on the recently announced findings from Nexalin’s DIFS research, which demonstrated similar improvements in memory and cognitive function in Alzheimer’s patients. The DIFS study revealed significant gains in Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) scores, along with increased neural activity and blood flow in the hippocampus, a region critical for memory. By confirming these cognitive improvements and extending them to broader brain networks, this new study strengthens the case for non-invasive stimulation therapies like DIFS in Alzheimer’s treatment.

Dr. David Owens, Chief Medical Officer at Nexalin, commented: “We are very encouraged by the findings of this study, which reaffirm that DIFS not only improves cognitive function but also does so in a well-tolerated manner, even in elderly populations. The connections between brain activity, blood flow, and glucose metabolism suggest that DIFS may be addressing some of the underlying causes of cognitive decline in Alzheimer’s patients, offering hope for long-term improvements.”

Mark White, CEO of Nexalin Technology, added: “This study marks another significant milestone for Nexalin’s DIFS technology. Building on our recent DIFS findings, these results further demonstrate the potential of our non-invasive brain stimulation methods to restore brain function and improve cognitive performance in Alzheimer’s patients. With the efficacy shown in these studies, we are professionally optimistic regarding the future of DIFS as a treatment option that directly targets the brain’s electrical activity to help slow the progression of this devastating disease.”

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/.

Disclaimers

This study was conducted on a limited number of participants, and larger clinical trials are needed to confirm the efficacy and safety of DIFS for Alzheimer's disease. The information in this press release is for informational purposes only and does not constitute medical advice.

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



i Wang, T., Yan, S., Shan, Y., Xing, Y., Bi, S., Chen, Z., Xi, H., Xue, H., Qi, Z., Tang, Y., Lu, J. (2024).
Altered Neuronal Activity Patterns of the Prefrontal Cortex in Alzheimer's Disease After Transcranial Alternating Current Stimulation: A Resting-State fMRI Study. Journal of Alzheimer's Disease, 101(3), 901-912. doi: 10.3233/JAD-240400.



FAQ

What were the key findings of Nexalin's (NXL) Alzheimer's disease study?

The study showed increased neuronal activity, improved cognitive function, enhanced brain connectivity, and better blood flow in Alzheimer's patients after DIFS treatment, with benefits sustained over three months.

How many patients participated in Nexalin's (NXL) DIFS study?

The study included 46 patients who were randomly assigned to receive either real DIFS or sham treatment for 30 one-hour sessions over three weeks.

What is the safety profile of Nexalin's (NXL) DIFS treatment?

The treatment was well-tolerated with no serious side effects reported, with only minor sensations such as tingling that resolved quickly.

How long did the cognitive benefits from Nexalin's (NXL) DIFS treatment last?

The cognitive benefits were sustained throughout the three-month follow-up period after the initial three-week treatment.

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