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 (HSDT) has announced a partnership with Dr. Steve Kautz for a study on cranial-nerve non-invasive neuromodulation (CN-NINM) using its PoNS device, aimed at improving dynamic gait balance in stroke survivors. The study will be conducted at the Medical University of South Carolina (MUSC) and will start enrolling participants in early 2022. Dr. Kautz emphasizes the significance of reducing falls, a major post-stroke complication, while Helius's Chief Medical Officer states this collaboration will enhance their clinical research and registrational program.
Helius Medical Technologies has received a significant boost with the issuance of U.S. Patent No. 11,197,994, enhancing its Portable Neuromodulation Stimulator (PoNS) device. This patent allows for wired communication between the mouthpiece and the controller, paving the way for next-generation PoNS therapy. Currently, Helius holds 34 U.S. and 46 foreign patents, and PoNS is approved for treating gait deficits in MS patients in the U.S., while authorized for use in Canada and Australia for similar conditions. The advancements position Helius strongly in the neurotech market.
Helius Medical Technologies announced that Dr. Antonella Favit-Van Pelt will present at the 4th International Brain Stimulation Conference from December 6-9, 2021, in Charleston, S.C. She will discuss the research leading to FDA authorization of translingual nerve stimulation for gait disturbance in multiple sclerosis. Helius received FDA marketing authorization for its Portable Neuromodulation Stimulator (PoNS) in March 2021 and Breakthrough Designation for stroke treatment in August 2021. This symposium highlights innovative brain stimulation treatments advancing patient care.
Helius Medical Technologies (Nasdaq: HSDT) announced participation in 1x1 meetings at the 12th Annual Craig-Hallum Alpha Select Conference on November 16, 2021. CEO Dane C. Andreeff and CFO Jeffrey S. Mathiesen will represent the company. Interested investors should contact their Craig-Hallum representative for meeting arrangements.
Helius focuses on neurologic wellness using its non-implantable technologies, including the Portable Neuromodulation Stimulator (PoNS), aimed at improving lives affected by neurologic diseases.
Helius Medical Technologies, Inc. (Nasdaq: HSDT) closed its underwritten public offering of 1,385,031 shares of Class A common stock at $8.00 per share, generating approximately $11.1 million in gross proceeds. This includes the full exercise of the underwriter's over-allotment option. The company will utilize the net proceeds for funding operations, working capital, and other corporate purposes. The offering was conducted under a shelf registration statement declared effective by the SEC in 2020.
Helius Medical Technologies (Nasdaq:HSDT) reported its Q3 2021 financial results, with revenue of $109K, down from $131K in Q3 2020. Operating loss increased to $4.4M, compared to $3.7M in the prior year. The net loss was $4.7M, or $(2.01) per share. Helius received FDA Breakthrough Designation for its PoNS device for stroke-related gait deficits and launched a Therapeutic Experience Program with NYU. The company secured a $15 million equity line of credit and announced a $9.6 million public offering. Cash balance stood at $4.7 million as of Sept 30, 2021.
Helius Medical Technologies, Inc. (Nasdaq: HSDT) announced a public offering of 1,204,375 shares of common stock at $8.00 per share, aiming to raise approximately $9.6 million in gross proceeds. The offering will close around November 12, 2021, subject to customary conditions. The company plans to use the net proceeds for operations, working capital, and general corporate purposes. Ladenburg Thalmann & Co. Inc. serves as the sole book-running manager for the offering, which is conducted under an effective shelf registration statement.
Helius Medical Technologies (HSDT) announced a proposed underwritten public offering of its common stock. The company will sell all shares, with a potential additional 15% option for the underwriter. Proceeds from the offering will be directed towards funding operations, working capital, and general corporate purposes. This offering is contingent on market conditions and follows a shelf registration statement effective since February 6, 2020. Ladenburg Thalmann & Co. Inc. is the sole book-running manager for this offering.
Helius Medical Technologies (Nasdaq: HSDT) has launched its Therapeutic Experience Program (TEP) in partnership with NYU Langone Health to assess adherence to PoNS therapy in patients with multiple sclerosis (MS). The study aims to evaluate the effectiveness of the PoNS device in improving gait deficits, enrolling 50-60 patients across 10-12 Centers of Excellence in the U.S. Enrollment is expected to begin in Q4 2021 and continue through mid-2022. This program is pivotal for understanding the relationship between treatment adherence and therapeutic outcomes in a real-world setting.
Helius Medical Technologies (Nasdaq:HSDT) announced receiving market authorization from the Australian Therapeutic Goods Administration for its PoNS device as a Class IIa medical device. This authorization allows PoNS to be sold in Australia to aid patients in improving balance and gait when used alongside therapeutic exercises. The company is preparing for commercialization in Australia, marking the third country to authorize PoNS, following the U.S. and Canada. CEO Dane C. Andreeff expressed enthusiasm for this development.
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