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 participation in the H.C. Wainwright Annual Global Life Sciences Conference from September 13-15, 2021. Management's presentation will be available on-demand starting September 13 at 7:00 a.m. Eastern Time, with investor meetings scheduled during the conference. Helius focuses on neurological wellness and develops the Portable Neuromodulation Stimulator (PoNS™), an innovative device for treating gait deficits associated with multiple sclerosis and mild traumatic brain injuries. For more information, visit heliusmedical.com.
Helius Medical Technologies (Nasdaq:HSDT) announced its voluntary delisting from the Toronto Stock Exchange (TSX), with the last trading day expected on September 9, 2021. The decision comes as the company believes that the trading volume does not justify the costs and efforts associated with maintaining the TSX listing, especially since it is already listed on Nasdaq. This move aims to redirect resources towards business advancement while ensuring good liquidity for stockholders. No shareholder approval is required for this delisting.
Helius Medical Technologies (Nasdaq:HSDT) announced that its PoNS™ device has received Breakthrough Designation from the U.S. FDA for treating dynamic gait and balance deficits due to stroke. This device aims to assist patients aged 22 and older as part of a supervised therapeutic exercise program. Strokes affect approximately 7 million Americans, with over 80% experiencing gait impairment. The Breakthrough designation enables more efficient interactions with the FDA and prioritized review, which could enhance patient access to this non-drug treatment option.
Helius Medical Technologies (Nasdaq:HSDT) reported a net loss of $6 million for Q2 2021, compared to a $3.4 million loss in Q2 2020. Revenue fell to $71,000 from $133,000 year-over-year. The operating loss increased 66% to $6.2 million, driven by a $1.9 million rise in non-cash stock-based compensation. The company ended the quarter with $7.4 million in cash, up from $3.3 million in December 2020. Despite challenges, Helius is focused on U.S. commercialization of its PoNS device, targeting MS patients with gait deficits, and aims to begin operations in early 2022.
Helius Medical Technologies, Inc. (HSDT) announced the approval of an equity award for a new employee under its 2021 Inducement Plan, effective August 10, 2021. The award grants an option to purchase 2,000 shares of Class A common stock at an exercise price of $15.39 per share, which is the closing price on the grant date. The options will vest over four years, contingent upon the new hire's ongoing employment. This announcement complies with Nasdaq Listing Rule 5635(c)(4), which mandates public disclosure of non-stockholder approved equity awards.
Helius Medical Technologies (Nasdaq:HSDT) has launched a new website to enhance resources for U.S.-based patients and physicians regarding its PoNS Treatment. As part of its pre-commercial activities, the company aims to raise awareness and educate key clinicians about the PoNS device, which is designed for treating gait deficits associated with multiple sclerosis. The device is expected to be commercialized in Q1 2022. The company faces several challenges, including securing Medicare coverage and building a commercial infrastructure.
Helius Medical Technologies (Nasdaq:HSDT) announced its upcoming participation in two virtual investor conferences in July 2021. The first is the Ladenburg Thalmann Healthcare Conference, where management will present on July 14 at 11:30 a.m. Eastern Time. The second is the Alliance Global Partners Virtual MedTech Summer Conference, where management will engage in virtual 1x1 meetings on July 29. A webcast of the presentation will be available on their investor relations website for replay after the conference.
Helius Medical Technologies (Nasdaq:HSDT) announced the appointment of Dr. Antonella Favit-Van Pelt as Chief Medical Officer. Dr. Favit-Van Pelt brings over 20 years of experience in neurology and medical program leadership. Her expertise will support the advancement of PoNS technology, highlighted by recent U.S. regulatory clearance for treating multiple sclerosis. As part of her induction, she received options for 18,000 shares, priced at $16.45 with a four-year vesting schedule. Helius aims to enhance awareness and expand its clinical and regulatory strategies under her leadership.
Helius Medical Technologies has announced its participation in the Annual World Congress of the Society for Brain Mapping and Therapeutics from July 8-11, 2021, in Los Angeles. The company will receive the Pioneer in Technology Award, recognizing its innovative contributions to neurotechnology. Co-Founder Dr. Jonathan Sackier will present on the PoNS™ device, highlighting its role in treating gait deficits associated with conditions like multiple sclerosis. This non-surgical device delivers electrical stimulation through the tongue, showing promise in enhancing neurological wellness.
Helius Medical Technologies (NASDAQ:HSDT) announced that it will release its second quarter fiscal year 2021 financial results on August 12, 2021, after market close. Management will host a conference call at 5:00 p.m. ET to discuss the results, accessible via phone and a live webcast. The PoNS™ device is currently authorized for treatment of gait deficit from multiple sclerosis in the U.S. and is available for similar conditions in Canada. For more details, visit the company's investor relations website.
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