iHub News
3月前
Nexalin launches pivotal HALO Clarity trial to support FDA submission for insomnia treatmentFebruary 24, 2026 10:26 AM
IH Market News
Nexalin Technology, Inc. (NASDAQ:NXL) has initiated its pivotal HALO Clarity clinical trial, a key step toward a planned de novo submission to the U.S. Food and Drug Administration seeking clearance for its insomnia treatment technology.The study will evaluate the company’s non-drug Deep Intracranial Frequency Stimulation (DIFS) platform, which Nexalin is positioning as a potential alternative to pharmaceutical therapies in the multi-billion-dollar insomnia market.Insomnia affects an estimated 30 million adults in the United States, with many patients dissatisfied with existing treatment options due to concerns over dependency risks, side effects, and long-term use. Nexalin aims to address these limitations through a neuromodulation-based approach delivered via its next-generation HALO device.The HALO Clarity trial is designed as a randomized, triple-blinded, sham-controlled study expected to enroll at least 150 adult participants across the U.S. Conducted in partnership with Lindus Health, the trial will follow a fully decentralized format, allowing patients to complete treatments and evaluations remotely through Nexalin’s NeuroCare virtual clinic and integrated electronic data capture system. The company said this virtual framework is intended to remove traditional site visit requirements and expand patient accessibility.The pivotal trial builds on earlier clinical findings, including a randomized, double-blind, placebo-controlled study involving 120 patients with chronic insomnia that demonstrated clinically meaningful and statistically significant improvements in key sleep outcomes compared with placebo.Nexalin noted that its Gen-2 15 mA device has already received regulatory approvals in international markets for insomnia and related indications.The company said the HALO Clarity study marks an important milestone in its broader strategy to expand the DIFS platform into high-prevalence neuropsychiatric disorders. Data from the trial are expected to support the planned FDA submission.NXL shares have traded between $0.36 and $2.80 over the past 12 months. The stock closed Monday at $0.49, down 1.63%, and rose 16% to $0.56 in pre-market trading Tuesday.Nexalin Technology stock price
Original: Nexalin launches pivotal HALO Clarity trial to support FDA submission for insomnia treatment
georgie18
8月前
NXL...All out $1.96 to $2.00...🥳...from my .85 range shares...
georgie18
Member Level
Re: georgie18 post# 105
Wednesday, October 08, 2025 3:47:00 PM
Post#
107
of 107
NXL...$1.84...🥳...Pushing up into the close...
georgie18
Member Level
Re: georgie18 post# 701523
Wednesday, October 08, 2025 9:37:00 AM
Post#
701538
of 701662
NXL...$1.71...🥳...Off my .85 Alert...
georgie18
Member Level
Re: georgie18 post# 100
Wednesday, October 08, 2025 8:42:44 AM
Post#
103
of 104
NXL...$1.22...🥳...Off my .85 Alert... Hit $1.62 this morning...https://finviz.com/news/186815/nexalin-technology-announces-additional-positive-clinical-results-in-alzheimers-disease-with-gen-2-sync-neurostimulation-device
georgie18
Member Level
Re: georgie18 post# 99
Friday, August 29, 2025 10:02:38 AM
Post#
100
of 103
NXL...🥳...14,000 share by at .95...Hit .99 this morning...
georgie18
Member Level
Re: georgie18 post# 98
Friday, August 29, 2025 8:50:29 AM
Post#
99
of 99
NXL...95...🥳...Off my .85 Alert...
georgie18
Member Level
Re: georgie18 post# 696154
Thursday, August 28, 2025 1:47:29 PM
Post#
696169
of 696249
NXL...90s clearing ...🥳
georgie18
Member Level
Re: georgie18 post# 96
Thursday, August 28, 2025 12:53:12 PM
Post#
97
of 97
NXL...8731...🥳...Break/Hold .89 and she will run... imo...we sall see...
georgie18
Member Level
Re: georgie18 post# 695576
Tuesday, August 26, 2025 10:27:59 AM
Post#
695719
of 696153
NXL...86...🥳...27K bidder at 8499
georgie18
Member Level
Re: georgie18 post# 94
Monday, August 25, 2025 12:46:11 PM
Post#
95
of 95
NXL....84...Been adding all morning...🥳...https://schrts.co/EciBWAwf ...Fill Open Gap at $1.02 and run...imo...we shall see...
georgie18
Member Level
Re: georgie18 post# 664756
Monday, August 25, 2025 9:37:44 AM
Post#
695510
of 695576
NXL...85...🥳...Zero Borrow...Hit $1.23 this past Friday...
georgie18
8月前
NXL...$1.84...🥳...Pushing up into the close...
georgie18
Member Level
Re: georgie18 post# 701523
Wednesday, October 08, 2025 9:37:00 AM
Post#
701538
of 701662
NXL...$1.71...🥳...Off my .85 Alert...
georgie18
Member Level
Re: georgie18 post# 100
Wednesday, October 08, 2025 8:42:44 AM
Post#
103
of 104
NXL...$1.22...🥳...Off my .85 Alert... Hit $1.62 this morning...https://finviz.com/news/186815/nexalin-technology-announces-additional-positive-clinical-results-in-alzheimers-disease-with-gen-2-sync-neurostimulation-device
georgie18
Member Level
Re: georgie18 post# 99
Friday, August 29, 2025 10:02:38 AM
Post#
100
of 103
NXL...🥳...14,000 share by at .95...Hit .99 this morning...
georgie18
Member Level
Re: georgie18 post# 98
Friday, August 29, 2025 8:50:29 AM
Post#
99
of 99
NXL...95...🥳...Off my .85 Alert...
georgie18
Member Level
Re: georgie18 post# 696154
Thursday, August 28, 2025 1:47:29 PM
Post#
696169
of 696249
NXL...90s clearing ...🥳
georgie18
Member Level
Re: georgie18 post# 96
Thursday, August 28, 2025 12:53:12 PM
Post#
97
of 97
NXL...8731...🥳...Break/Hold .89 and she will run... imo...we sall see...
georgie18
Member Level
Re: georgie18 post# 695576
Tuesday, August 26, 2025 10:27:59 AM
Post#
695719
of 696153
NXL...86...🥳...27K bidder at 8499
georgie18
Member Level
Re: georgie18 post# 94
Monday, August 25, 2025 12:46:11 PM
Post#
95
of 95
NXL....84...Been adding all morning...🥳...https://schrts.co/EciBWAwf ...Fill Open Gap at $1.02 and run...imo...we shall see...
georgie18
Member Level
Re: georgie18 post# 664756
Monday, August 25, 2025 9:37:44 AM
Post#
695510
of 695576
NXL...85...🥳...Zero Borrow...Hit $1.23 this past Friday...
georgie18
8月前
NXL...$1.71...🥳...Off my .85 Alert...
georgie18
Member Level
Re: georgie18 post# 100
Wednesday, October 08, 2025 8:42:44 AM
Post#
103
of 104
NXL...$1.22...🥳...Off my .85 Alert... Hit $1.62 this morning...https://finviz.com/news/186815/nexalin-technology-announces-additional-positive-clinical-results-in-alzheimers-disease-with-gen-2-sync-neurostimulation-device
georgie18
Member Level
Re: georgie18 post# 99
Friday, August 29, 2025 10:02:38 AM
Post#
100
of 103
NXL...🥳...14,000 share by at .95...Hit .99 this morning...
georgie18
Member Level
Re: georgie18 post# 98
Friday, August 29, 2025 8:50:29 AM
Post#
99
of 99
NXL...95...🥳...Off my .85 Alert...
georgie18
Member Level
Re: georgie18 post# 696154
Thursday, August 28, 2025 1:47:29 PM
Post#
696169
of 696249
NXL...90s clearing ...🥳
georgie18
Member Level
Re: georgie18 post# 96
Thursday, August 28, 2025 12:53:12 PM
Post#
97
of 97
NXL...8731...🥳...Break/Hold .89 and she will run... imo...we sall see...
georgie18
Member Level
Re: georgie18 post# 695576
Tuesday, August 26, 2025 10:27:59 AM
Post#
695719
of 696153
NXL...86...🥳...27K bidder at 8499
georgie18
Member Level
Re: georgie18 post# 94
Monday, August 25, 2025 12:46:11 PM
Post#
95
of 95
NXL....84...Been adding all morning...🥳...https://schrts.co/EciBWAwf ...Fill Open Gap at $1.02 and run...imo...we shall see...
georgie18
Member Level
Re: georgie18 post# 664756
Monday, August 25, 2025 9:37:44 AM
Post#
695510
of 695576
NXL...85...🥳...Zero Borrow...Hit $1.23 this past Friday...
georgie18
8月前
NXL...$1.22...🥳...Off my .85 Alert... Hit $1.62 this morning...https://finviz.com/news/186815/nexalin-technology-announces-additional-positive-clinical-results-in-alzheimers-disease-with-gen-2-sync-neurostimulation-device
georgie18
Member Level
Re: georgie18 post# 99
Friday, August 29, 2025 10:02:38 AM
Post#
100
of 103
NXL...🥳...14,000 share by at .95...Hit .99 this morning...
georgie18
Member Level
Re: georgie18 post# 98
Friday, August 29, 2025 8:50:29 AM
Post#
99
of 99
NXL...95...🥳...Off my .85 Alert...
georgie18
Member Level
Re: georgie18 post# 696154
Thursday, August 28, 2025 1:47:29 PM
Post#
696169
of 696249
NXL...90s clearing ...🥳
georgie18
Member Level
Re: georgie18 post# 96
Thursday, August 28, 2025 12:53:12 PM
Post#
97
of 97
NXL...8731...🥳...Break/Hold .89 and she will run... imo...we sall see...
georgie18
Member Level
Re: georgie18 post# 695576
Tuesday, August 26, 2025 10:27:59 AM
Post#
695719
of 696153
NXL...86...🥳...27K bidder at 8499
georgie18
Member Level
Re: georgie18 post# 94
Monday, August 25, 2025 12:46:11 PM
Post#
95
of 95
NXL....84...Been adding all morning...🥳...https://schrts.co/EciBWAwf ...Fill Open Gap at $1.02 and run...imo...we shall see...
georgie18
Member Level
Re: georgie18 post# 664756
Monday, August 25, 2025 9:37:44 AM
Post#
695510
of 695576
NXL...85...🥳...Zero Borrow...Hit $1.23 this past Friday...
georgie18
9月前
NXL...🥳...14,000 share by at .95...Hit .99 this morning...
georgie18
Member Level
Re: georgie18 post# 98
Friday, August 29, 2025 8:50:29 AM
Post#
99
of 99
NXL...95...🥳...Off my .85 Alert...
georgie18
Member Level
Re: georgie18 post# 696154
Thursday, August 28, 2025 1:47:29 PM
Post#
696169
of 696249
NXL...90s clearing ...🥳
georgie18
Member Level
Re: georgie18 post# 96
Thursday, August 28, 2025 12:53:12 PM
Post#
97
of 97
NXL...8731...🥳...Break/Hold .89 and she will run... imo...we sall see...
georgie18
Member Level
Re: georgie18 post# 695576
Tuesday, August 26, 2025 10:27:59 AM
Post#
695719
of 696153
NXL...86...🥳...27K bidder at 8499
georgie18
Member Level
Re: georgie18 post# 94
Monday, August 25, 2025 12:46:11 PM
Post#
95
of 95
NXL....84...Been adding all morning...🥳...https://schrts.co/EciBWAwf ...Fill Open Gap at $1.02 and run...imo...we shall see...
georgie18
Member Level
Re: georgie18 post# 664756
Monday, August 25, 2025 9:37:44 AM
Post#
695510
of 695576
NXL...85...🥳...Zero Borrow...Hit $1.23 this past Friday...
georgie18
9月前
NXL...95...🥳...Off my .85 Alert...
georgie18
Member Level
Re: georgie18 post# 696154
Thursday, August 28, 2025 1:47:29 PM
Post#
696169
of 696249
NXL...90s clearing ...🥳
georgie18
Member Level
Re: georgie18 post# 96
Thursday, August 28, 2025 12:53:12 PM
Post#
97
of 97
NXL...8731...🥳...Break/Hold .89 and she will run... imo...we sall see...
georgie18
Member Level
Re: georgie18 post# 695576
Tuesday, August 26, 2025 10:27:59 AM
Post#
695719
of 696153
NXL...86...🥳...27K bidder at 8499
georgie18
Member Level
Re: georgie18 post# 94
Monday, August 25, 2025 12:46:11 PM
Post#
95
of 95
NXL....84...Been adding all morning...🥳...https://schrts.co/EciBWAwf ...Fill Open Gap at $1.02 and run...imo...we shall see...
georgie18
Member Level
Re: georgie18 post# 664756
Monday, August 25, 2025 9:37:44 AM
Post#
695510
of 695576
NXL...85...🥳...Zero Borrow...Hit $1.23 this past Friday...
georgie18
9月前
NXL...90s clearing ...🥳
georgie18
Member Level
Re: georgie18 post# 96
Thursday, August 28, 2025 12:53:12 PM
Post#
97
of 97
NXL...8731...🥳...Break/Hold .89 and she will run... imo...we sall see...
georgie18
Member Level
Re: georgie18 post# 695576
Tuesday, August 26, 2025 10:27:59 AM
Post#
695719
of 696153
NXL...86...🥳...27K bidder at 8499
georgie18
Member Level
Re: georgie18 post# 94
Monday, August 25, 2025 12:46:11 PM
Post#
95
of 95
NXL....84...Been adding all morning...🥳...https://schrts.co/EciBWAwf ...Fill Open Gap at $1.02 and run...imo...we shall see...
georgie18
Member Level
Re: georgie18 post# 664756
Monday, August 25, 2025 9:37:44 AM
Post#
695510
of 695576
NXL...85...🥳...Zero Borrow...Hit $1.23 this past Friday...
georgie18
9月前
NXL...8731...🥳...Break/Hold .89 and she will run... imo...we sall see...
georgie18
Member Level
Re: georgie18 post# 695576
Tuesday, August 26, 2025 10:27:59 AM
Post#
695719
of 696153
NXL...86...🥳...27K bidder at 8499
georgie18
Member Level
Re: georgie18 post# 94
Monday, August 25, 2025 12:46:11 PM
Post#
95
of 95
NXL....84...Been adding all morning...🥳...https://schrts.co/EciBWAwf ...Fill Open Gap at $1.02 and run...imo...we shall see...
georgie18
Member Level
Re: georgie18 post# 664756
Monday, August 25, 2025 9:37:44 AM
Post#
695510
of 695576
NXL...85...🥳...Zero Borrow...Hit $1.23 this past Friday...
georgie18
2年前
NXL...$4.02...🥳...Hit Double Top at $4.05...Looking for all time highs here...at $4.15 plus...
georgie18
Member Level
Re: georgie18 post# 664395
Tuesday, November 12, 2024 1:36:30 PM
Post#
664650
of 664755
NXL...$3.70...🥳...Like to see it Break $4...
georgie18
Member Level
Re: georgie18 post# 85
Monday, November 11, 2024 10:17:19 AM
Post#
88
of 88
NXL...$3.10 on the dip...🥳still looking for $4 Break...🥳
georgie18
Member Level
Re: georgie18 post# 664228
Friday, November 08, 2024 7:09:05 PM
Post#
664325
of 664394
NXL...$3.80...Hit my $4 Target...🥳... I think we set an ALL TIME HIGH on Monday Breaking the $4.15 point...I will be out of this on Monday from my .78 range buys...setting my sells at $4.18...$4.28...$4.58...
georgie18
2年前
NXL...$3.85...Off my .78 Alert...Getting close to my $4 target...🥳
georgie18
Member Level
Re: georgie18 post# 664040
Thursday, November 07, 2024 1:34:12 PM
Post#
664083
of 664227
NXL...$3.48...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 76
Thursday, November 07, 2024 11:51:39 AM
Post#
82
of 82
NXL...$3.22...HOD...🥳50/100 Cross will happen later today or tomorrow...I am still looking for the $ 4 Break off my .78 alert...
georgie18
Member Level
Re: georgie18 post# 662745
Friday, October 25, 2024 12:25:40 PM
Post#
662765
of 664040
NXL...$2.77...Looking for $4 Break...off my .78 Alert...🥳
georgie18
Member Level
Re: georgie18 post# 384848
Friday, October 25, 2024 11:14:48 AM
Post#
384869
of 384874
NXL...13,000 Buy @ $2.65...🥳
NXL...$2.50s clearing here...Off my .78 Alert...🥳
georgie18
Member Level
Re: RIGATONI post# 384255
Tuesday, October 08, 2024 4:07:24 PM
Post#
384266
of 384847
NXL...78s clearing here on A/H Volume...🥳
georgie18
2年前
NXL...$3.48...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 76
Thursday, November 07, 2024 11:51:39 AM
Post#
82
of 82
NXL...$3.22...HOD...🥳50/100 Cross will happen later today or tomorrow...I am still looking for the $ 4 Break off my .78 alert...
georgie18
Member Level
Re: georgie18 post# 662745
Friday, October 25, 2024 12:25:40 PM
Post#
662765
of 664040
NXL...$2.77...Looking for $4 Break...off my .78 Alert...🥳
georgie18
Member Level
Re: georgie18 post# 384848
Friday, October 25, 2024 11:14:48 AM
Post#
384869
of 384874
NXL...13,000 Buy @ $2.65...🥳
NXL...$2.50s clearing here...Off my .78 Alert...🥳
georgie18
Member Level
Re: RIGATONI post# 384255
Tuesday, October 08, 2024 4:07:24 PM
Post#
384266
of 384847
NXL...78s clearing here on A/H Volume...🥳
georgie18
2年前
NXL...$3.22...HOD...🥳50/100 Cross will happen later today or tomorrow...I am still looking for the $ 4 Break off my .78 alert...
georgie18
Member Level
Re: georgie18 post# 662745
Friday, October 25, 2024 12:25:40 PM
Post#
662765
of 664040
NXL...$2.77...Looking for $4 Break...off my .78 Alert...🥳
georgie18
Member Level
Re: georgie18 post# 384848
Friday, October 25, 2024 11:14:48 AM
Post#
384869
of 384874
NXL...13,000 Buy @ $2.65...🥳
NXL...$2.50s clearing here...Off my .78 Alert...🥳
georgie18
Member Level
Re: RIGATONI post# 384255
Tuesday, October 08, 2024 4:07:24 PM
Post#
384266
of 384847
NXL...78s clearing here on A/H Volume...🥳
georgie18
2年前
NXL...$2.80s starting here...🥳...still looking for the $4 Break...Off my .78 Alert...
NXL...$2.65s clearing here...🥳...still looking for the $4 Break...Off my .78 Alert...
georgie18
Member Level
Re: georgie18 post# 662745
Friday, October 25, 2024 12:25:40 PM
Post#
662765
of 663093
NXL...$2.77...Looking for $4 Break...off my .78 Alert...🥳
georgie18
Member Level
Re: georgie18 post# 384848
Friday, October 25, 2024 11:14:48 AM
Post#
384869
of 384874
NXL...13,000 Buy @ $2.65...🥳
NXL...$2.50s clearing here...Off my .78 Alert...🥳
georgie18
Member Level
Re: RIGATONI post# 384255
Tuesday, October 08, 2024 4:07:24 PM
Post#
384266
of 384847
NXL...78s clearing here on A/H Volume...🥳
georgie18
2年前
NXL...$2.65s clearing here...🥳...still looking for the $4 Break...Off my .78 Alert...
georgie18
Member Level
Re: georgie18 post# 662745
Friday, October 25, 2024 12:25:40 PM
Post#
662765
of 663093
NXL...$2.77...Looking for $4 Break...off my .78 Alert...🥳
georgie18
Member Level
Re: georgie18 post# 384848
Friday, October 25, 2024 11:14:48 AM
Post#
384869
of 384874
NXL...13,000 Buy @ $2.65...🥳
NXL...$2.50s clearing here...Off my .78 Alert...🥳
georgie18
Member Level
Re: RIGATONI post# 384255
Tuesday, October 08, 2024 4:07:24 PM
Post#
384266
of 384847
NXL...78s clearing here on A/H Volume...🥳
georgie18
2年前
NXL...$2.77...Looking for $4 Break...off my .78 Alert...🥳
georgie18
Member Level
Re: georgie18 post# 384848
Friday, October 25, 2024 11:14:48 AM
Post#
384869
of 384874
NXL...13,000 Buy @ $2.65...🥳
NXL...$2.50s clearing here...Off my .78 Alert...🥳
georgie18
Member Level
Re: RIGATONI post# 384255
Tuesday, October 08, 2024 4:07:24 PM
Post#
384266
of 384847
NXL...78s clearing here on A/H Volume...🥳
tw0122
2年前
New Study Shows Nexalin’s Deep Intracranial Frequency Stimulation (DIFS) Significantly Improves Memory and Cognitive Function in Alzheimer’s Patients
Source: GlobeNewswire Inc.
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.”
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