Then on the other hand I can see while Helius Medical Technologies Inc sent in their NDA for PoNS Device because they use Patients 12 months after their injuries and not before. IMO the reason why the FDA did not have enough evidence to support Helius study of the PoNS. Maybe if they would've started the study from start of traumatic injuries mild to moderate injuries, in both physical therapeutic to using the PoNS Device and a study of Patient using PT without PoNS device. Helius Medical Technologies inc would probably have an FDA Approval for the PoNS neurostimulation Device.
Please, Correct me if I'am wrong.
Recent HSDT News
- Helius Medical Technologies, Inc. Expands Stroke Clinical Program with Participation of Shepherd Center • GlobeNewswire Inc. • 04/24/2024 01:05:00 PM
- Helius Medical Technologies, Inc. Announces Partnership with Lovell® Government Services to Expand Reach of PoNS Therapy™ • GlobeNewswire Inc. • 04/03/2024 11:05:00 AM
- Helius Medical Technologies, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results • GlobeNewswire Inc. • 03/28/2024 08:05:00 PM
- Helius Medical Technologies, Inc. to Release Fourth Quarter and Full Year 2023 Financial Results on March 28, 2024 • GlobeNewswire Inc. • 03/15/2024 11:05:00 AM
- Helius Medical Technologies, Inc. Initiates Open-Label Study for Registrational Program in Stroke • GlobeNewswire Inc. • 03/12/2024 12:59:22 PM
- Helius Medical Technologies, Inc. to Present at the 36th Annual ROTH Conference • GlobeNewswire Inc. • 03/07/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/04/2024 12:30:51 PM
- Helius Medical Technologies, Inc. Secures HCPCS Codes for Portable Neuromodulation Stimulator (PoNS®) Mouthpiece and Controller • GlobeNewswire Inc. • 03/04/2024 12:00:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 12:09:07 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/09/2024 09:15:49 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/06/2024 03:22:13 PM
- Helius Medical Technologies, Inc. Announces Alignment with FDA on Registrational Program for Treatment of Stroke Patients • GlobeNewswire Inc. • 02/06/2024 12:00:00 PM
- Helius Booth and Special Event at APTA Combined Sections Meeting Will Highlight Physical Therapists’ Ability to Customize PoNS Therapy® to Improve Gait in People with MS • GlobeNewswire Inc. • 02/05/2024 12:05:00 PM
- Helius Medical Technologies, Inc. Announces Further Expansion of Stroke Clinical Program with the Addition of Brooks Rehabilitation Hospital • GlobeNewswire Inc. • 01/11/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/04/2023 02:00:31 PM
- Helius Medical Technologies to Present at NobleCon19 Annual Conference • GlobeNewswire Inc. • 11/30/2023 12:47:23 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 09:15:22 PM
- Helius Medical Technologies, Inc. Reports Third Quarter 2023 Financial Results • GlobeNewswire Inc. • 11/09/2023 09:05:00 PM
- Helius Medical Technologies, Inc. Announces Study Results Demonstrating That PoNS Therapy™ Helps Patients with Traumatic Brain Injury Return to Work • GlobeNewswire Inc. • 11/06/2023 12:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/02/2023 09:15:18 PM
- Helius Medical Technologies, Inc. to Release Third Quarter 2023 Financial Results on November 9, 2023; Announces Extended Cash Runway into Q2 2024 • GlobeNewswire Inc. • 11/02/2023 09:05:00 PM
- Helius Medical Technologies, Inc. Receives Letter of Intent from the Québec Ministry of Health and Social Services to Purchase 30 PoNS® Devices • GlobeNewswire Inc. • 10/12/2023 11:05:00 AM
- Helius Medical Technologies to Participate at Two Upcoming Healthcare Conferences • GlobeNewswire Inc. • 10/02/2023 11:05:00 AM
FEATURED Cannabix's Breath Logix Alcohol Device Delivers Positive Impact to Private Monitoring Agency in Montana, USA • Apr 25, 2024 8:52 AM
Bantec Reports an Over 50 Percent Increase in Sales and Profits in Q1 2024 from Q1 2023 • BANT • Apr 25, 2024 10:00 AM
Kona Gold Beverages, Inc. Announces Name Change to NuVibe, Inc. and Initiation of Ticker Symbol Application Process • KGKG • Apr 25, 2024 8:30 AM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM