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) has launched its Portable Neuromodulation Stimulator (PoNS®) in the U.S. to assist Multiple Sclerosis (MS) patients with gait deficits. Approved by the FDA, PoNS is a non-surgical device designed for individuals aged 22 and over, complementing physical therapy. Approximately 70% of the one million MS patients in the U.S. experience gait-related mobility issues. Helius aims to enhance patient mobility through innovative neuromodulation therapy. The company is also advancing research partnerships to further validate PoNS Therapy effectiveness.
Helius Medical Technologies (HSDT) reported a 35% increase in Q4 2021 revenue, reaching $258,000, compared to $191,000 in Q4 2020. However, total revenue for the full year decreased to $522,000 from $661,000 in 2020. Operating expenses rose to $4.2 million, leading to an operating loss of $4.1 million in Q4. The company closed a public offering with $11.1 million in gross proceeds and is preparing for the U.S. commercial launch of PoNS for multiple sclerosis. Guidance for Q1 2022 projects revenue of $150,000 to $170,000.
Helius Medical Technologies (HSDT) announced the approval of equity awards to two new employees as part of its 2021 Inducement Plan, effective February 16, 2022. This follows Nasdaq Listing Rule 5635(c)(4), requiring public announcements for non-stockholder approved equity awards. The new hires received options to purchase a total of 2,000 shares at $4.68 each, valid for ten years, with a four-year vesting period. Helius specializes in neurotech solutions and is focused on improving neurologic conditions through its innovative PoNS device.
Helius Medical Technologies (HSDT) projects Q4 2021 revenue between $250,000 and $260,000, up over 30% year-over-year. The company ended 2021 with an unaudited cash balance of $11 million and aims for the U.S. commercial launch of its PoNS device for multiple sclerosis in Q1 2022. Key milestones include ongoing pivotal trials for stroke recovery using PoNS and expansion of Therapeutic Experience Program centers. Helius raised $24 million to fund these developments and add experienced leadership.
Helius Medical Technologies (HSDT) announced the approval of equity awards under its 2021 Inducement Plan for two new employees, effective December 16, 2021. The independent directors sanctioned options to purchase 7,500 shares of Class A common stock at an exercise price of $5.12. These options will vest over four years, with quarterly vesting tied to continued employment. Helius focuses on neurological wellness through its Portable Neuromodulation Stimulator (PoNS), aimed at treating gait deficits in multiple sclerosis patients.
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.
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