Welcome to our dedicated page for Helius Med Technologies news (Ticker: HSDT), a resource for investors and traders seeking the latest updates and insights on Helius Med Technologies stock.
About Helius Medical Technologies Inc. (HSDT)
Helius Medical Technologies Inc. is a pioneering neurotechnology company dedicated to improving the lives of individuals with neurological impairments. Headquartered in Newtown, Pennsylvania, Helius focuses on developing, licensing, and acquiring innovative, non-invasive medical devices that address balance and gait deficits caused by neurological diseases or trauma. The company’s flagship product, the Portable Neuromodulation Stimulator (PoNS®), represents a breakthrough in therapeutic neuromodulation by leveraging the science of neuroplasticity to promote functional recovery.
Core Product: PoNS® Device
The PoNS device is a non-implantable, orally applied therapeutic device that delivers mild electrical stimulation to the tongue, targeting cranial nerves to stimulate the brain’s ability to adapt and recover. It is used in conjunction with supervised physical therapy to treat gait deficits in adults with mild-to-moderate symptoms of multiple sclerosis (MS) and balance deficits due to mild-to-moderate traumatic brain injury (mmTBI). In Canada, the PoNS device is also authorized for stroke rehabilitation, where it has demonstrated significant improvements in gait and balance. This unique approach positions PoNS as an innovative solution for patients seeking to regain mobility and independence.
Market Focus and Applications
Helius Medical Technologies operates at the intersection of neurotechnology, rehabilitation, and medical devices. Its primary market focus includes:
- Multiple Sclerosis (MS): PoNS Therapy® is indicated as a short-term treatment for gait deficits in MS patients, addressing a critical need for mobility improvement.
- Traumatic Brain Injury (TBI): Authorized in Canada for chronic balance deficits due to mmTBI, PoNS Therapy offers a non-invasive alternative to traditional rehabilitation methods.
- Stroke Rehabilitation: The company is conducting a stroke registrational program in the U.S. to expand PoNS’ indications, leveraging its success in Canada.
Helius has also established partnerships with key institutions, including the U.S. Department of Veterans Affairs (VA), enabling veterans with MS and other neurological conditions to access PoNS Therapy through the VA Healthcare System.
Scientific Basis: Neuroplasticity
The PoNS device is grounded in the principle of neuroplasticity, the brain’s ability to reorganize and form new neural connections in response to stimulation. By delivering targeted neuromodulation through the tongue, PoNS Therapy enhances the brain’s compensatory mechanisms, facilitating improvements in motor control, balance, and gait. This science-backed approach sets Helius apart in the competitive neurotech landscape.
Regulatory Achievements and Market Access
Helius has achieved significant regulatory milestones, including FDA clearance for PoNS as a Breakthrough Device for MS-related gait deficits and authorization for sale in Canada and Australia for multiple indications. The company continues to advocate for broader reimbursement coverage, including Medicare approval, to make PoNS Therapy accessible to a wider patient population.
Competitive Positioning
In the rapidly evolving neurotech industry, Helius differentiates itself through its innovative oral neuromodulation platform and focus on non-invasive therapies. While challenges such as reimbursement delays and regulatory complexities persist, the company’s clinical evidence, partnerships with leading healthcare institutions, and commitment to patient-centered innovation underscore its potential to transform neurorehabilitation.
Conclusion
With its groundbreaking PoNS device and dedication to advancing neurological wellness, Helius Medical Technologies Inc. is at the forefront of neurotechnology. By addressing critical unmet needs in balance and gait rehabilitation, the company continues to make strides in improving the quality of life for individuals with neurological conditions.
Helius Medical Technologies (HSDT) announced its participation in several upcoming investor conferences. Management will present at the Investor Summit Group’s Virtual Fall Summit on November 17 at 1:00 p.m. ET. Additionally, they will engage in virtual 1x1 meetings at the Alliance Global Partners’ Virtual Healthcare Symposium on November 19, with no formal presentation. Furthermore, they will present at the Sidoti & Co. Virtual Fall Microcap Conference on the same day at 9:15 a.m. ET. Live webcasts will be available on Helius’s investor relations website.
Helius Medical Technologies has announced the expansion of its clinic network to 27 locations across Canada, enhancing access to PoNS Treatment for individuals with gait and balance deficits due to multiple sclerosis and traumatic brain injury. The initiative targets established neurorehabilitation providers in Ontario with existing referral networks. Helius aims for further clinic authorizations to support PoNS Treatment accessibility as it recovers from pandemic impacts. The PoNS device is currently under regulatory review in the U.S., EU, and Australia.
Helius Medical Technologies, Inc. (NASDAQ:HSDT) announced that it will release its third quarter fiscal year 2020 financial results on November 12, 2020, after market close. A conference call is scheduled for 5:45 p.m. ET the same day to discuss these results. Interested parties can join the call or access a live webcast via the company’s investor relations website. Helius focuses on developing non-invasive neurotechnology aimed at enhancing neurological wellness, with its leading product, the Portable Neuromodulation Stimulator (PoNS™), currently authorized for sale in Canada but still investigational in other markets.
Helius Medical Technologies (Nasdaq:HSDT) has successfully closed a private placement raising approximately $3.4 million through the sale of 6,567,868 Class A Common Stock shares and warrants. Each unit was sold at $0.52, with warrants exercisable at $0.452 per share for three years. Notably, affiliates of Helius' CEO and CFO participated under the same terms. The funds will support operations and general corporate purposes. These securities are subject to resale restrictions and the company will file a registration statement with the SEC for their resale.
Helius Medical Technologies (Nasdaq:HSDT) announced a private placement agreement to sell 6,664,022 shares of Class A Common Stock and warrants to purchase 3,332,013 shares at $0.52 per unit, totaling approximately $3.4 million. The closing is anticipated around October 23, 2020, pending customary conditions. Proceeds will fund operations and general corporate purposes. The placement includes related-party transactions but adheres to TSX exemptions, with the company intending to file a resale registration statement with the SEC. The PoNS™ device is under regulatory review in multiple regions.
Helius Medical Technologies (Nasdaq:HSDT) has received a request for additional information from the FDA regarding its Portable Neuromodulation Stimulator (PoNS™) device aimed at treating gait deficits in Multiple Sclerosis patients. The request, which occurred 75 days post submission, requires further clinical data analysis and labeling modifications. This follows the FDA granting Breakthrough Designation in May 2020, allowing for an expedited review process. Helius aims to respond promptly to ensure the continuation of FDA’s review process.
Helius Medical Technologies (NASDAQ: HSDT) announced a partnership with Berlin-based Breakthrough Health to conduct research on Multiple Sclerosis (MS) therapy options. The study will utilize Breakthrough's Emilyn application, engaging over 10,000 U.S. MS patients to gather anonymized data. This initiative aims to enhance the development of Helius's Portable Neuromodulation Stimulator (PoNS™) device, which aids in treating gait deficits in MS. Current PoNS™ status includes FDA review, with no commercial availability yet in the U.S. or other regions.
Helius Medical Technologies has formed a Multiple Sclerosis (MS) Scientific Advisory Board to enhance its U.S. launch strategy for its PoNS technology. The board, comprising nine leading MS experts, will advise on commercial, reimbursement, and market access strategies, focusing on the treatment of gait deficits due to MS. Their objectives include validating the positive effects of neuromodulation, guiding the launch strategy, and reviewing existing clinical data. The PoNS device is currently under FDA review and is not yet available in the U.S.
Helius Medical Technologies (NASDAQ:HSDT) announced the publication of a peer-reviewed study demonstrating that translingual neural stimulation (TLNS) with the PoNS device may facilitate structural brain changes leading to functional recovery in patients with mild-to-moderate traumatic brain injury (TBI). The study showed significant increases in grey matter volume in brain regions associated with balance and movement after treatment. This suggests TLNS combined with physical therapy may enhance recovery. The findings contribute to the growing body of evidence supporting the therapeutic potential of PoNS technology.
Helius Medical Technologies (HSDT) announced a peer-reviewed study published in EMJ Radiology highlighting the effectiveness of its Portable Neuromodulation Stimulator (PoNS) in treating balance issues after mild-to-moderate traumatic brain injury (TBI). The study evaluated 9 patients and demonstrated significant increases in grey matter volume within the cerebellum and temporal regions, correlating with improved functional assessments. The research indicates that TLNS combined with physical therapy may effectively address balance disorders.
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