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.
Helius Medical Technologies, Inc. (symbol: HSDT) is a pioneering neurotechnology company headquartered in Newtown, Pennsylvania, dedicated to developing, licensing, and acquiring non-invasive technologies for the treatment of symptoms caused by neurological diseases or trauma. The company’s flagship product, the Portable Neuromodulation Stimulator (PoNS®), is a novel medical device approved in Canada for the treatment of chronic balance deficits due to mild-to-moderate traumatic brain injury (mTBI) and gait deficits related to multiple sclerosis (MS). The PoNS® device works by delivering gentle electrical stimulation to the tongue's surface, which helps improve balance and gait through enhanced neuromodulation.
Recently, Helius Medical Technologies has achieved significant milestones, including expanding its clinical development program in collaboration with renowned institutions like the Shepherd Center and Brooks Rehabilitation. This expansion aims to further validate PoNS®'s efficacy for treating gait and balance deficits in chronic stroke survivors, highlighting the company’s commitment to broadening therapeutic applications.
In terms of partnerships, Helius has secured a meaningful collaboration with Lovell Government Services to introduce the PoNS® device to the U.S. Department of Veterans Affairs (VA) and other federal healthcare providers. This partnership aims to enhance the quality of life for veterans suffering from MS by providing access to innovative treatments. Real-world studies have shown that PoNS® Therapy can lead to clinically meaningful improvements in gait for all MS patients after 14 weeks of therapy.
Financially, Helius Medical Technologies is focusing on securing widespread reimbursement for the PoNS® device. The company recently received its first third-party reimbursement from a major insurance carrier, a crucial step towards establishing market pricing and expanding access. This follows the Centers for Medicare & Medicaid Services’ (CMS) establishment of unique Healthcare Common Procedure Coding System (HCPCS) codes for the PoNS® components.
Additionally, the PoNS® device is now available for purchase via the VA’s Federal Supply Schedule (FSS) and the GSA Advantage marketplace, ensuring quicker access for veterans and federal employees. The inclusion of PoNS® in these platforms underscores its potential as a game-changing therapy for those affected by neurological conditions, promoting neuroplasticity and improving patients' lives.
For more information about the PoNS® or Helius Medical Technologies, please visit www.heliusmedical.com.
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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