Nexalin Technology CEO Provides Letter to Shareholders
Nexalin Technology (Nasdaq: NXL) released a shareholder letter highlighting recent achievements in their Deep Intracranial Frequency Stimulation (DIFS) technology. The company reported two significant Alzheimer's research studies in October showing improvements in memory and cognitive function. They secured a key patent for frequency-based deep brain stimulation in treating Alzheimer's and dementia. Additionally, their DIFS technology demonstrated positive results in treating Major Depressive Disorder (MDD). The company announced a clinical trial collaboration with UC San Diego and San Diego VA to study their Gen-3 Halo headset for mild Traumatic Brain Injury treatment. Nexalin also received regulatory approval in Brazil for their Gen-2 15 mA neurostimulation device.
Nexalin Technology (Nasdaq: NXL) ha pubblicato una lettera agli azionisti evidenziando i recenti traguardi nella loro tecnologia di Stimolazione Frequenziale Intracranica Profonda (DIFS). L'azienda ha riportato due studi significativi sulla ricerca dell'Alzheimer in ottobre, mostrando miglioramenti nella memoria e nelle funzioni cognitive. Hanno ottenuto un brevetto chiave per la stimolazione cerebrale profonda basata sulla frequenza nel trattamento dell'Alzheimer e della demenza. Inoltre, la loro tecnologia DIFS ha dimostrato risultati positivi nel trattamento del Disturbo Depressivo Maggiore (MDD). L'azienda ha annunciato una collaborazione per una sperimentazione clinica con la UC San Diego e il VA di San Diego per studiare il loro visore Gen-3 Halo per il trattamento della lesione cerebrale traumatica lieve. Nexalin ha anche ricevuto l'approvazione normativa in Brasile per il loro dispositivo di neurostimolazione Gen-2 da 15 mA.
Nexalin Technology (Nasdaq: NXL) publicó una carta a los accionistas destacando los logros recientes en su tecnología de Estimulación de Frecuencia Intracraneal Profunda (DIFS). La empresa reportó dos estudios significativos sobre investigación del Alzheimer en octubre, mostrando mejoras en la memoria y la función cognitiva. Aseguraron una patente clave para la estimulación cerebral profunda basada en frecuencia para tratar el Alzheimer y la demencia. Además, su tecnología DIFS demostró resultados positivos en el tratamiento del Trastorno Depresivo Mayor (MDD). La empresa anunció una colaboración para un ensayo clínico con la UC San Diego y el VA de San Diego para estudiar su auricular Gen-3 Halo para el tratamiento de lesiones cerebrales traumáticas leves. Nexalin también recibió la aprobación regulatoria en Brasil para su dispositivo de neuroestimulación Gen-2 de 15 mA.
넥살린 테크놀로지 (Nasdaq: NXL)는 최근 그들의 심부 두개내 주파수 자극(DIFS) 기술에서 이루어진 성과를 강조하는 주주 서한을 발표했습니다. 이 회사는 10월에 알츠하이머 연구에 대한 두 가지 주요 연구를 발표하며 기억력과 인지 기능의 개선을 보여주었습니다. 알츠하이머와 치매 치료를 위해 주파수 기반의 심부 뇌 자극에 대한 중요한 특허를 확보했습니다. 또한, 그들의 DIFS 기술은 주요 우울 장애(MDD) 치료에서도 긍정적인 결과를 보였습니다. 이 회사는 경미한 외상성 뇌 손상 치료를 위한 Gen-3 Halo 헤드셋을 연구하기 위해 UC 샌디에고 및 샌디에고 VA와 임상 시험 협력을 발표했습니다. 넥살린은 또한 브라질에서 Gen-2 15 mA 신경 자극 장치에 대한 규제 승인을 받았습니다.
Nexalin Technology (Nasdaq: NXL) a publié une lettre aux actionnaires mettant en avant les récentes réalisations de sa technologie de Stimulation Fréquentielle Intracrânienne Profonde (DIFS). La société a signalé en octobre deux études importantes sur la recherche sur l'Alzheimer montrant des améliorations de la mémoire et des fonctions cognitives. Ils ont obtenu un brevet clé pour la stimulation cérébrale profonde basée sur la fréquence dans le traitement de l'Alzheimer et de la démence. De plus, leur technologie DIFS a montré des résultats positifs dans le traitement du Trouble Dépressif Majeur (MDD). L'entreprise a annoncé une collaboration pour un essai clinique avec l'UC San Diego et le VA de San Diego pour étudier leur casque Gen-3 Halo pour le traitement des lésions cérébrales traumatiques légères. Nexalin a également reçu l'approbation réglementaire au Brésil pour leur dispositif de neurostimulation Gen-2 de 15 mA.
Nexalin Technology (Nasdaq: NXL) hat einen Brief an die Aktionäre veröffentlicht, in dem die jüngsten Errungenschaften ihrer Technologie zur tiefen intrakranialen Frequenzstimulation (DIFS) hervorgehoben werden. Das Unternehmen berichtete im Oktober von zwei bedeutenden Alzheimer-Forschungsstudien, die Verbesserungen des Gedächtnisses und der kognitiven Funktion zeigten. Sie sicherten sich ein wichtiges Patent zur frequenzbasierten tiefen Hirnstimulation zur Behandlung von Alzheimer und Demenz. Darüber hinaus zeigte ihre DIFS-Technologie positive Ergebnisse bei der Behandlung von Major Depressive Disorder (MDD). Das Unternehmen kündigte eine klinische Studienkooperation mit der UC San Diego und dem VA San Diego zur Untersuchung ihres Gen-3 Halo-Headsets zur Behandlung von leichten Traumatischen Hirnverletzungen an. Nexalin erhielt außerdem die regulatorische Genehmigung in Brasilien für ihr Gen-2 15 mA Neurostimulationsgerät.
- Published two successful Alzheimer's studies showing cognitive improvements
- Secured patent for frequency-based deep brain stimulation treatment
- Demonstrated positive clinical results for Major Depressive Disorder
- Obtained regulatory approval in Brazil for Gen-2 device
- Established clinical trial partnership with UC San Diego and San Diego VA
- None.
Insights
The recent breakthroughs in Alzheimer's research using Deep Intracranial Frequency Stimulation (DIFS) technology represent significant progress. Two published studies in October demonstrate substantial improvements in memory and cognitive function, validating the non-invasive treatment approach. The newly issued patent for frequency-based deep brain stimulation strengthens their intellectual property position.
The expansion into Major Depressive Disorder (MDD) treatment and the collaboration with UC San Diego for mild Traumatic Brain Injury (mTBI) trials shows promising diversification. The ANVISA approval in Brazil opens a new market opportunity. However, while the research results are encouraging, more extensive clinical trials and regulatory approvals will be needed to fully validate the technology's effectiveness across multiple conditions.
The company's strategic developments across multiple fronts - from Alzheimer's research to regulatory approvals - demonstrate strong market positioning. The expansion into Brazil represents entry into a significant market, while the UC San Diego partnership adds credibility. The Gen-3 Halo headset's virtual clinic model could enable broader market penetration through home-based treatment options.
However, investors should note that despite these positive developments, commercialization and revenue generation will require significant time and resources. The company's relatively small market cap of
HOUSTON, TX, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) today released a letter to shareholders from its CEO Mark White:
Dear Shareholders,
I am pleased to provide an update on Nexalin Technologies’ recent milestones, which underscore our commitment to advancing our patented Deep Intracranial Frequency Stimulation (DIFS) technology for the treatment of neurological and mental health conditions. The past months have brought exciting developments, particularly in our Alzheimer’s research, showcasing Nexalin’s dedication to offering non-invasive treatments without the potential side effects of medication.
Alzheimer’s Research Breakthrough and Key Patent
Our Alzheimer’s research achieved an important breakthrough, with two significant studies published this October. On October 17, we announced the results of a new study using our DIFS technology, which demonstrated substantial improvements in memory and cognitive function for Alzheimer’s patients. This study confirms DIFS’s effectiveness in positively impacting cognitive outcomes, addressing Alzheimer’s disease through a non-invasive approach without the adverse effects associated with pharmaceuticals. The study’s findings support Nexalin’s goal of pioneering a potentially safer, alternative treatment for Alzheimer’s patients, thereby providing renewed hope for caregivers and families.
Furthermore, our October 28 press release highlighted a second publication in the Journal of Alzheimer’s Disease, reinforcing our prior study and validating DIFS as a promising therapy for cognitive decline. These results collectively position Nexalin as a leader in Alzheimer’s treatment innovation, bringing us closer to addressing the core challenges of neurodegenerative disease management.
In addition to these research milestones, we announced the issuance of a key patent on June 20 for using frequency-based deep brain stimulation to treat Alzheimer’s and dementia. This patent is an essential asset that strengthens our intellectual property and underscores our leadership in non-invasive neurostimulation. With this protection, Nexalin is well-positioned to expand its research and clinical applications, advancing our Alzheimer’s program with greater confidence.
Positive Clinical Data in Major Depressive Disorder
Nexalin’s DIFS technology has shown promising results beyond Alzheimer’s, notably in treating Major Depressive Disorder (MDD). As detailed in our June 26 press release, a study published in a leading scientific journal demonstrated that DIFS effectively reduces symptoms in MDD patients, potentially providing a new, non-invasive option for individuals seeking alternatives to antidepressant medications. With millions affected by depression globally, we believe Nexalin’s approach offers a safe and effective solution that could transform the mental health landscape.
Clinical Trial with UC San Diego and the San Diego VA
Expanding our clinical reach, we recently announced a collaboration with the University of California, San Diego (UCSD) and the San Diego VA to conduct a clinical trial using Nexalin’s Gen-3 Halo headset, designed to be used in a virtual clinic model and allowing patients to receive treatment from the convenience and privacy of their own home. As described in our October 22 press release, this trial will explore the effectiveness of DIFS for treating veterans with mild Traumatic Brain Injury (mTBI). This collaboration is a significant step toward validating our technology’s broader applications and addressing the unique challenges faced by veterans who suffer from these conditions.
Strategic Expansion of Regulatory Approvals
Aligned with our mission to make Nexalin’s innovative technology widely accessible, we are pursuing regulatory pathways to expand DIFS’s approved uses, including Alzheimer’s, MDD, PTSD, mTBI, and more. As we engage with regulatory agencies around the world, these approvals will be key to making safe and effective neurostimulation available for more patients globally.
As an example, we reached a major milestone in our international expansion with the approval of Nexalin’s Gen-2 15 mA neurostimulation device by the Brazilian Health Regulatory Agency (ANVISA) on June 13. This regulatory clearance follows similar approvals in China and Oman, and allows us to introduce our technology to the Brazilian market, marking Nexalin’s first approval in Latin America. Entering Brazil represents a critical step in our global growth strategy and aligns with our commitment to reaching patients in need of non-invasive alternatives for mental health and neurological treatments.
Looking Ahead
The recent Alzheimer’s studies, positive MDD data, UC San Diego and San Diego VA clinical trial, patent award, and regulatory clearance in Brazil are all significant milestones in Nexalin’s journey. Together, they reflect our commitment to providing safe, effective, and non-invasive solutions for those impacted by cognitive and mental health challenges.
I am deeply grateful to our shareholders, partners, and team for their unwavering support and confidence in Nexalin’s mission. We look forward to the journey ahead as we push the boundaries of DIFS technology, delivering life-changing solutions for Alzheimer’s, MDD, and beyond.
Warm regards,
Mark White
CEO, Nexalin Technologies
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
FAQ
What are the recent research breakthroughs for Nexalin Technology (NXL) in Alzheimer's treatment?
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