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 (Nasdaq:HSDT) announced the pricing of an underwritten public offering, raising approximately $9.6 million before expenses. The offering consists of 647,772 units, each priced at $14.82, and includes one share of common stock along with a warrant for 0.5 shares at an exercise price of $16.302. The closing is expected around February 1, 2021. Ladenburg Thalmann & Co. Inc. is the sole bookrunning manager. The company has also granted underwriters a 45-day option for over-allotments.
Helius Medical Technologies (Nasdaq:HSDT) responded positively to the Centers for Medicare & Medicaid Services' (CMS) new Medicare Coverage of Innovative Technology (MCIT) pathway established on January 12, 2021. This initiative enables national Medicare coverage for FDA-designated breakthrough devices from the date of market authorization for up to four years. Should Helius secure FDA clearance for its Portable Neuromodulation Stimulator (PoNS), immediate coverage for beneficiaries could enhance access for approximately 60 million Medicare enrollees.
Helius Medical Technologies (Nasdaq:HSDT) has announced that it has cured its minimum bid price deficiency, allowing its stock to remain listed on The Nasdaq Capital Market. The scheduled hearing for a non-compliance appeal has been canceled following this compliance confirmation from Nasdaq. Helius focuses on developing non-invasive technologies aimed at neurological wellness, with its first product being the Portable Neuromodulation Stimulator (PoNS™), currently under review by the FDA in the U.S. and the Australian Therapeutic Goods Administration.
Helius Medical Technologies, a neurotech company, will participate in the Noble Capital Markets 17th Annual Small & Microcap Investor Conference on January 19-20, 2021. Management's presentation is scheduled for January 19 at 11:15 a.m. ET. A live audio webcast will be accessible following free registration on the Noble conference website. Helius focuses on developing non-invasive technologies for neurological wellness, including the Portable Neuromodulation Stimulator (PoNS™), currently under FDA review.
Helius Medical Technologies has formally responded to the FDA's request for additional information regarding the de novo classification of its Portable Neuromodulation Stimulator (PoNS™) for treating gait deficits due to Multiple Sclerosis (MS). This response aims to resume the FDA's review process, which was on hold following a previous request from the agency. The company anticipates a decision from the FDA in the first half of the year. Helius previously obtained Breakthrough Designation for PoNS™ in May 2020.
Helius Medical Technologies, Inc. (Nasdaq:HSDT) reported unusual trading activity for its Class A Common Stock on the Toronto Stock Exchange and The Nasdaq Capital Market. The company confirmed it is unaware of any undisclosed material changes impacting its business that could explain the recent trading price increase. In conjunction, Helius has made available an investor presentation in anticipation of its participation in upcoming investor conferences this January, previously announced on January 4, 2021.
Helius Medical Technologies (Nasdaq:HSDT) has announced participation in several virtual investor conferences during January 2021. Key events include:
- The Demy-Colton Digital Medicine and Medtech Showcase from January 11-15, with on-demand access starting January 6th.
- The H.C. Wainwright BioConnect Conference from January 11-14, with presentations available on January 11th.
- The Sidoti Winter 2021 Conference on January 13-14, where management will present on January 13th.
- The ICR Conference from January 11-14, with management presenting on January 14th.
Helius Medical Technologies (HSDT) announced a 1-for-35 reverse stock split effective December 31, 2020, aimed at complying with Nasdaq listing requirements. Consequently, the outstanding shares will decrease from approximately 51.9 million to 1.5 million, while the number of authorized shares remains at 150 million. The common stock will trade on a split-adjusted basis starting January 4, 2021. Shareholders will receive cash for any fractional shares. More details can be found in the definitive proxy statement filed with the SEC.
Helius Medical Technologies (HSDT) reported its Q3 2020 financial results. Revenue was $131K, down from $150K in Q3 2019. Operating loss decreased to $3.7M from $5.7M year-over-year. The company closed a $3.4M private placement to support operations into Q1 2021. Following a leadership change, Helius continues to pursue FDA clearance for its Portable Neuromodulation Stimulator (PoNS) device to treat Multiple Sclerosis symptoms. Authorized clinics for PoNS treatment increased from 7 to 27 in Canada amid ongoing challenges from the COVID-19 pandemic.
Helius Medical Technologies (NASDAQ:HSDT) will present at the virtual Fall Investor Summit from November 16-18, 2020. This summit aims to connect smallcap and microcap companies with over 300 investors.
Helius focuses on developing non-invasive neurotech solutions, particularly the Portable Neuromodulation Stimulator (PoNS™). Currently authorized for sale in Canada, the PoNS™ is aimed at treating gait deficits associated with multiple sclerosis and mild traumatic brain injury. The device is under FDA review for potential use in the U.S.
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