Nexalin’s Breakthrough DIFS™ Neurostimulation Device Demonstrates Reduction in Blood Pressure while Enhancing Mental Health According to New Landmark Study
Nexalin Technology (Nasdaq: NXL) has published a landmark study in the Journal of Affective Disorders showcasing the effectiveness of its Deep Intracranial Frequency Stimulation (DIFS™) technology. The study demonstrated that patients receiving 15 mA DIFS therapy experienced significant blood pressure reductions: 2.04 mmHg in systolic and 1.92 mmHg in diastolic blood pressure compared to sham stimulation.
The randomized controlled trial involved 68 first-episode, drug-naive patients with major depressive disorder (MDD), who underwent 20 sessions over four weeks. The treatment showed particular efficacy in patients with elevated baseline blood pressure and was well-tolerated with no reported adverse effects.
The DIFS technology, supported by 29 clinical trials, targets deep brain structures including the brainstem, hypothalamus, and thalamus. Currently approved in China, Brazil, and Oman, Nexalin aims to obtain CE Mark certification for European markets in 2025.
Nexalin Technology (Nasdaq: NXL) ha pubblicato uno studio innovativo nella rivista Journal of Affective Disorders che mostra l'efficacia della sua tecnologia di Stimolazione Freqenziale Intracraneale Profonda (DIFS™). Lo studio ha dimostrato che i pazienti sottoposti a terapia DIFS a 15 mA hanno registrato significative riduzioni della pressione sanguigna: 2.04 mmHg nella sistolica e 1.92 mmHg nella diastolica rispetto alla stimolazione placebo.
Il trial controllato randomizzato ha coinvolto 68 pazienti con primo episodio di disturbo depressivo maggiore (MDD), naive ai farmaci, che hanno effettuato 20 sessioni in quattro settimane. Il trattamento ha mostrato particolari effetti benefici nei pazienti con pressione sanguigna di base elevata ed è stato ben tollerato senza effetti avversi segnalati.
La tecnologia DIFS, supportata da 29 studi clinici, mira a strutture cerebrali profonde, inclusi il tronco encefalico, l'ipotalamo e il talamo. Attualmente approvata in Cina, Brasile e Oman, Nexalin punta a ottenere la certificazione CE per i mercati europei nel 2025.
Nexalin Technology (Nasdaq: NXL) ha publicado un estudio importante en el Journal of Affective Disorders que demuestra la efectividad de su tecnología de Estimulación de Frecuencia Intracraneal Profunda (DIFS™). El estudio mostró que los pacientes que recibieron terapia DIFS a 15 mA experimentaron reducciones significativas en la presión arterial: 2.04 mmHg en la sistólica y 1.92 mmHg en la diastólica en comparación con la estimulación simulada.
El ensayo controlado aleatorizado incluyó a 68 pacientes en el primer episodio, naïve a medicamentos, con trastorno depresivo mayor (MDD), quienes realizaron 20 sesiones durante cuatro semanas. El tratamiento mostró una eficacia particular en pacientes con presión arterial basal elevada y fue bien tolerado sin efectos adversos reportados.
La tecnología DIFS, respaldada por 29 ensayos clínicos, se dirige a estructuras cerebrales profundas, incluyendo el tronco encefálico, el hipotálamo y el tálamo. Actualmente aprobada en China, Brasil y Omán, Nexalin tiene como objetivo obtener la certificación CE para los mercados europeos en 2025.
넥살린 테크놀로지 (Nasdaq: NXL)는 저널 오브 애펙티브 장애(Journal of Affective Disorders)에 심층 내재파 주파수 자극(DIFS™) 기술의 효과를 보여주는 획기적인 연구를 발표했습니다. 이 연구는 15 mA DIFS 치료를 받은 환자들이 혈압이 상당히 감소했음을 보여주었습니다: 수축기 혈압에서 2.04 mmHg 및 이완기 혈압에서 1.92 mmHg로, 위약 자극과 비교했습니다.
무작위 통제 시험에는 주요 우울 장애(MDD)로 진단받은 약물 미사용 68명의 첫 에피소드 환자가 참여했으며, 이들은 4주 동안 20회의 세션을 받았습니다. 치료는 기저 혈압이 높은 환자에게 특히 효과적이었고, 보고된 부작용 없이 잘 견뎌냈습니다.
DIFS 기술은 29개의 임상 시험을 통해 뒷받침되며, 뇌간, 시상하부 및 시상과 같은 깊은 뇌 구조를 목표로 합니다. 현재 중국, 브라질 및 오만에서 승인된 상태이며, 넥살린은 2025년 유럽 시장을 위한 CE 마크 인증을 목표로 하고 있습니다.
Nexalin Technology (Nasdaq: NXL) a publié une étude phare dans le Journal of Affective Disorders démontrant l'efficacité de sa technologie de Stimulation Fréquentielle Intracrânienne Profonde (DIFS™). L'étude a montré que les patients recevant une thérapie DIFS à 15 mA ont connu des réductions significatives de la pression artérielle : 2,04 mmHg en systolique et 1,92 mmHg en diastolique par rapport à la stimulation simulée.
L'essai contrôlé randomisé a impliqué 68 patients en premier épisode, naive aux médicaments, atteints de trouble dépressif majeur (MDD), qui ont bénéficié de 20 séances sur quatre semaines. Le traitement a montré une efficacité particulière chez les patients ayant une pression artérielle de base élevée et a été bien toléré sans effets indésirables signalés.
La technologie DIFS, soutenue par 29 essais cliniques, cible des structures cérébrales profondes, y compris le tronc cérébral, l'hypothalamus et le thalamus. Actuellement approuvée en Chine, au Brésil et à Oman, Nexalin vise à obtenir la certification CE pour les marchés européens en 2025.
Nexalin Technology (Nasdaq: NXL) hat eine wegweisende Studie im Journal of Affective Disorders veröffentlicht, die die Wirksamkeit ihrer Technologie zur Tiefenintrakranialen Frequenzstimulation (DIFS™) zeigt. Die Studie hat gezeigt, dass Patienten, die eine DIFS-Therapie mit 15 mA erhielten, signifikante Blutdrucksenkungen erfuhren: 2.04 mmHg systolisch und 1.92 mmHg diastolisch im Vergleich zur Scheinbehandlung.
Die randomisierte kontrollierte Studie umfasste 68 Patienten im ersten Krankheitsfall mit einer medikamentenfreien Vorgeschichte und majorer depressiver Störung (MDD), die 20 Sitzungen über vier Wochen durchliefen. Die Behandlung zeigte eine besondere Wirksamkeit bei Patienten mit erhöhtem Ausgangsblutdruck und wurde gut vertragen, ohne berichtete unerwünschte Wirkungen.
Die DIFS-Technologie, unterstützt durch 29 klinische Studien, zielt auf tiefe Gehirnstrukturen ab, darunter den Hirnstamm, den Hypothalamus und den Thalamus. Aktuell ist sie in China, Brasilien und Oman genehmigt, und Nexalin strebt an, 2025 die CE-Kennzeichnung für die europäischen Märkte zu erhalten.
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HOUSTON, TX, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, announces the publication of a landmark study in the Journal of Affective Disorders demonstrating the potential efficacy of its proprietary DIFS technology. The research highlights the potential of DIFS to deliver meaningful reductions in systolic and diastolic blood pressure in patients with major depressive disorder (MDD), while offering a safe and non-invasive approach to addressing systemic health challenges.
Key findings include:
- Clinically Significant Blood Pressure Reductions: Patients receiving Nexalin’s 15 mA DIFS therapy experienced a 2.04 mmHg reduction in systolic blood pressure and a 1.92 mmHg reduction in diastolic blood pressure compared to sham stimulation.
- Strong Response Among Higher-Risk Patients: Participants with elevated baseline blood pressure demonstrated the greatest improvements.
- Potential Safety and Tolerability: The treatment was well-tolerated, with no reported adverse effects or patient discomfort.
Mark White, Nexalin’s CEO stated, “Everyone at Nexalin, including our clinical and engineering teams, is excited about this landmark trial demonstrating a reduction in blood pressure in depressed patients. This study is a major first step in understanding the true power of our breakthrough DIFS waveform that stimulates the entire brain. We believe that the DIFS entire brain stimulation is important for general health as well as mental health. We continue to believe that this neurostimulation technique is a breakthrough in neurostimulation and represents the future of mental health treatment.”
This study builds on Nexalin’s robust clinical research program and highlights the versatility of its patented neurostimulation technology in targeting deep brain structures critical to emotional and physical health regulation.
The study analyzed data from a randomized controlled trial involving 68 first-episode, drug-naive patients with MDD. Over four weeks, participants underwent 20 sessions of either active DIFS or sham stimulation, targeting key brain regions associated with blood pressure regulation, including the brainstem, hypothalamus, and thalamus.
Significant reductions in blood pressure were observed as early as the fourth week of treatment, with greater reductions among participants who had higher baseline blood pressure. These results underscore the ability of Nexalin’s DIFS technology to modulate critical neurological pathways that influence systemic health.
Dr. David Owens, Chief Medical Officer of Nexalin, commented: "This study is a potential game-changer, demonstrating that our innovative DIFS technology not only addresses mental health disorders but also has far-reaching potential in systemic wellness, such as improving cardiovascular health. It validates our mission to create transformative solutions that are safe, effective, and non-invasive."
DIFS technology employs a proprietary frequency-based waveform to stimulate deep brain structures, a challenge for traditional treatments. Unlike pharmaceuticals or invasive procedures, Nexalin’s approach is designed to deliver powerful therapeutic effects without side effects. These findings complement prior research that highlighted DIFS’ potential to improve conditions such as depression, insomnia, PTSD, and Alzheimer’s disease.
Nexalin’s DIFS technology is supported by 29 completed or ongoing clinical trials, including studies evaluating its efficacy in Alzheimer’s disease and PTSD among veterans. With regulatory approvals in China, Brazil, and Oman, Nexalin is poised to expand its impact, targeting CE Mark certification for European markets in 2025.
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 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
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