Helius Med Technologies Inc Stock Price, News & Analysis

Helius Medical Technologies (Nasdaq:HSDT) announced positive preliminary results from its PoNSTEP study, evaluating the impact of adherence to Portable Neuromodulation Stimulator (PoNS) Therapy on gait deficit due to multiple sclerosis (MS). The study met its primary endpoint, showing a statistically significant mean improvement in Dynamic Gait Index (DGI) scores and a linear relationship between PoNS Therapy adherence and DGI improvement.

Key findings include:

• Average therapy adherence of 67% in Phase 2, with a mean incremental improvement of 2.8 points in DGI scores
• Overall 14-week treatment led to a mean improvement of 5.0 points in DGI
• 66% of participants gained a clinically meaningful improvement of at least 4 points in DGI
• 50% of participants with 85-100% therapy adherence achieved over a 6-point improvement in DGI

The study confirms the therapeutic benefits of PoNS Therapy for gait deficit improvement in people with MS, emphasizing the importance of consistent adherence to the recommended therapy regimen.

Helius Medical Technologies (Nasdaq: HSDT), a neurotech company focused on neurological wellness, has announced the approval of equity awards under its 2021 Inducement Plan. These awards, approved by independent directors on August 14, 2024, serve as material inducements for three new employees joining the company.

The equity awards, granted in accordance with Nasdaq Listing Rule 5635(c)(4), consist of options to purchase a total of 23,500 shares of the Company's Class A common stock. The options have an exercise price of $0.6802 per share, matching the closing price of Helius' common stock on the grant date. These options have a ten-year term and vest over four years, with 25% vesting annually, subject to continued employment and potential acceleration or forfeiture under certain conditions.

Helius Medical Technologies (Nasdaq: HSDT) reported Q2 2024 financial results, highlighting key developments in its PoNS device commercialization. The company secured the first third-party reimbursement at $23,900 and received preliminary CMS payment determination. Q2 2024 revenue was $182,000, up 35% from Q1 2024 but down from $256,000 in Q2 2023. The company completed site enrollment for its U.S. stroke registrational program and secured contracts with the VA and DoD.

Financially, Helius reported an operating loss of $3.3 million and a net loss of $1.6 million for Q2 2024. The company closed a $6.4 million public offering, raising net proceeds of approximately $5.5 million. As of June 30, 2024, Helius had $6.4 million in cash with no debt, projecting a cash runway into 2025.

Helius Medical Technologies (NASDAQ: HSDT), a neurotech company focused on innovative therapeutic neuromodulation for balance and gait deficits, has announced its plans to release second quarter 2024 financial results on August 12, 2024, after market close. The company will host a conference call and webcast on the same day at 4:30 p.m. Eastern Time to discuss the results and provide an expanded business update.

The call will feature Dane C. Andreeff, President and CEO, and Jeffrey S. Mathiesen, CFO, who will share insights on Helius' progress and plans for the U.S. commercialization of PoNS®. Investors and interested parties can access the audio call via registration and join the webcast through the provided link. The webcast will be archived in the Newsroom section of Helius' investor relations website for future reference.

Helius Medical Technologies (Nasdaq:HSDT) has completed site participation enrollment for its stroke registrational program in the U.S., incorporating top neurorehabilitation centers such as REHABOLOGYM, Neurology Center of New England, and MGH Institute of Health Professions. The program aims to evaluate the efficacy of PoNS Therapy® on gait and balance in chronic stroke survivors. Additionally, a supporting study has commenced in Canada to aid in Canadian reimbursement and U.S. approval processes. Helius plans to enroll at least 30 patients by Q3 2024 in the U.S. study, with an FDA submission expected in 2025.

The Canadian study, led by Neuro-Concept Rehabilitation Center, aims to enroll 60 subjects by the end of 2024. This multi-center research trial leverages PoNS Therapy's potential to induce neuroplasticity, thereby improving stroke recovery outcomes.

Helius Medical Technologies (Nasdaq: HSDT), a neurotech company, announced its participation in the Spring MicroCap Rodeo Conference on June 6, 2024, in NYC. CEO Dane Andreeff will discuss key topics including the pursuit of U.S. FDA authorization for its Portable Neuromodulation Stimulator (PoNS) device for stroke patients, and a partnership with Lovell Government Services to provide PoNS to federal healthcare systems like the VA and DoD. Helius has also received a preliminary determination for reimbursement from the CMS for the PoNS mouthpiece and controller, with a final price decision expected on October 1, 2024. The presentation will be webcast live and management will be available for one-on-one meetings with approved investors.

Helius Medical Technologies announced that it secured its first third-party reimbursement for its Portable Neuromodulation Stimulator (PoNS) device from a major insurance carrier. The reimbursement rate is set at $23,900, slightly below the list price due to a 7% rebate. This milestone follows the Centers for Medicare & Medicaid Services’ (CMS) establishment of unique codes for the PoNS mouthpiece and controller. Helius is actively negotiating with additional third-party payers and assisting multiple sclerosis (MS) patients in submitting claims. The reimbursed rate is broken down to $16,554 for the controller and $7,347 for the mouthpiece.

Helius Medical Technologies (NASDAQ: HSDT) will exhibit at the 2024 CMSC Annual Meeting, highlighting significant advancements in making their Portable Neuromodulation Stimulator (PoNS) more accessible for individuals with multiple sclerosis (MS). Over the past year, Helius has focused on increasing accessibility and reimbursement for PoNS therapy, a non-implantable, orally applied electrical stimulation therapy that improves gait in MS patients when combined with physical exercise. Key milestones include the assignment of HCPCS codes by the Centers for Medicare & Medicaid Services (CMS) in March, a partnership with Lovell Government Services in April to provide PoNS to the VA and federal healthcare providers, and training a critical mass of physical therapists to ensure broad availability of the therapy. The CMS's final decision on pricing will be effective October 1, 2024. These efforts aim to remove barriers for MS patients, enabling them to benefit from PoNS therapy.

Helius Medical Technologies has announced that its Portable Neuromodulation Stimulator (PoNS®) device has been approved for inclusion on the Veterans Affairs (VA) Federal Supply Schedule (FSS) and General Services Administration (GSA) Advantage contracts. This approval allows U.S. veterans and federal employees access to the PoNS® device for treating gait and balance impairments associated with multiple sclerosis (MS). Priced at $23,843.72 for the device and $7,344.97 for the mouthpiece, the PoNS® device is now available for purchase through the VA's FSS Medical Equipment and Surgical Contract and the GSA Advantage online catalog.

The VA estimates that 55,000 to 70,000 U.S. veterans live with MS. The PoNS® device is designed to induce neuroplasticity, aiding in the modification and adaptation of brain activity. Helius's partnership with Lovell Government Services aims to streamline the availability of this therapy through federal healthcare systems.