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) announced that its independent directors have approved the issuance of equity awards as part of its 2021 Inducement Plan, effective May 23, 2022. Four new employees, not previously associated with Helius, received options to purchase a total of 21,000 shares at an exercise price of $1.40 each, which reflects the closing stock price on the date of the grant. These options will vest over four years, providing Helius with a strategic advantage in attracting talent while adhering to Nasdaq regulations.
Helius Medical Technologies has expanded its Therapeutic Experience Program (TEP) by adding Shepherd Center in Atlanta as a second Center of Excellence. This multi-center observational trial aims to assess the effectiveness of Portable Neuromodulation Stimulator (PoNS) therapy for gait improvement in patients with multiple sclerosis (MS). Led by Dr. Deborah Backus, the program will provide valuable data on treatment adherence and outcomes, with enrollment expected to begin in Q2 2022.
Helius Medical Technologies (HSDT) reported a 126% increase in Q1 2022 revenue to $190,000, up from $84,000 in Q1 2021. The U.S. commercial launch of PoNS for multiple sclerosis began, with 23 prescriptions written. Operating loss widened to $4.6 million compared to $3.5 million in Q1 2021. Cash used in operations rose to $4.7 million from $2.9 million. The company anticipates being cash flow positive by Q4 2023, projecting sequential revenue growth beyond the first quarter.
Helius Medical Technologies (NASDAQ: HSDT) will release its Q1 2022 financial results on May 12, 2022, before market opening. CEO Dane C. Andreeff and CFO Jeffrey S. Mathiesen will lead a conference call to discuss the results and provide insights into Helius' plans for the U.S. commercialization of PoNS®, its first medical device aimed at improving neurological wellness. The call is scheduled for 9:00 a.m. ET, with details available via the webcast.
Helius Medical Technologies (HSDT) announced the fulfillment of the first prescriptions for its Portable Neuromodulation Stimulator (PoNS) therapy aimed at treating gait deficits in multiple sclerosis (MS) patients. Following its commercial launch in the U.S., there have been 19 PoNS prescriptions written, with two patients commencing therapy. The device, previously available in Canada, is marketed on a cash pay basis as the company seeks reimbursement from insurers. This launch marks a significant step in addressing the needs of nearly one million MS patients in the U.S.
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.
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