Welcome to our dedicated page for Helius Medical Technologies news (Ticker: HSDT), a resource for investors and traders seeking the latest updates and insights on Helius Medical 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 (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.
Helius Medical Technologies (Nasdaq: HSDT) has announced its participation in upcoming investor conferences in September. Key presentations include the LD 500 Virtual Investor Conference on September 1 at 1:20 p.m. ET, the Wall Street Investor Forum Virtual Conference on September 10 at 9:20 a.m. ET, and the H.C. Wainwright 22nd Annual Global Investment Conference from September 14-16, with its presentation on September 16 at 12:00 p.m. ET. Webcasts will be available on their investor relations website.
Helius Medical Technologies (NASDAQ:HSDT) announced that Philippe Deschamps has resigned as President and CEO, effective August 23, 2020. Dane C. Andreeff and Blane Walter have been appointed as Interim President and CEO, and Chairman, respectively. The Board expressed gratitude for Deschamps' leadership during his seven-year tenure, highlighting the company's transition to a public entity. Andreeff, a board member since 2017, is recognized for his extensive experience in healthcare and is expected to drive Helius' regulatory and operational progress. The PoNS device is currently awaiting FDA clearance.
Helius Medical Technologies (HSDT) reported Q2 2020 financial results, with revenue of $0.1 million, down from $0.5 million in Q2 2019. The operating loss narrowed to $3.7 million from $5.8 million. Net loss was $3.4 million, compared to a $0.2 million loss a year prior. Cash on hand was $5.3 million as of June 30, 2020. Recent developments include receiving Breakthrough Designation for the PoNS™ device and the submission for FDA review. The company anticipates ongoing challenges due to COVID-19 affecting clinic operations in Canada.
Helius Medical Technologies (NASDAQ: HSDT) will announce its second quarter fiscal year 2020 financial results on August 12th, after market close. A conference call, scheduled for the same day at 5:00 p.m. ET, will provide insights into the quarterly performance. Participants can join via phone or through a live webcast available on the investor relations website. The company focuses on neurological wellness, with its first product, the Portable Neuromodulation Stimulator (PoNS), aimed at treating gait deficits from mild to moderate neurological conditions. PoNS is currently under FDA review.
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