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.
Overview
Helius Medical Technologies Inc (Nasdaq: HSDT) is a specialized neurotechnology company dedicated to addressing neurological deficits through innovative, non-invasive solutions. With a core focus on neuromodulation and neurostimulation, Helius leverages its proprietary technology to promote neuroplasticity—the brain's capacity to adapt and rewire—in order to improve gait, balance, and motor functions in individuals affected by neurological trauma and disease.
Core Technology and Therapeutic Approach
The company’s flagship product, the Portable Neuromodulation Stimulator (PoNS), is a medical device that delivers mild electrical impulses via a tongue-placed mouthpiece. This unique mode of delivery is designed to activate cranial nerves and stimulate neural pathways, facilitating physiologic compensatory mechanisms. The therapeutic approach is used primarily in conjunction with supervised rehabilitation, merging physical therapy with targeted neuromodulation to restore lost function and improve overall mobility in patients coping with conditions such as multiple sclerosis, mild-to-moderate traumatic brain injury, and stroke-induced gait deficits.
Clinical Applications and Market Position
Helius Medical Technologies stands at the intersection of advanced clinical neuroscience and practical medical technology. Its technology is underpinned by robust clinical research and regulatory milestones, demonstrating significant improvements in balance and gait through measurable neuroplastic changes. The company has navigated complex reimbursement landscapes and regulatory frameworks in key markets, ensuring that its therapeutic solutions are accessible for patient populations in both Canada and the United States.
Business Model and Revenue Generation
Helius employs a multifaceted business model focused on development, licensing, and strategic acquisitions. Revenue generation primarily stems from the commercialization of its PoNS device, which is integrated within existing medical and therapeutic frameworks. The company’s approach involves building partnerships with federal healthcare systems, such as the Veterans Administration, and negotiating reimbursement arrangements with third-party payers. This model aligns technical innovation with market access initiatives, targeting a well-defined niche in the neurological rehabilitation market.
Strategic Collaborations and Industry Impact
Through strategic collaborations with clinical research centers and governmental contracting entities, Helius Medical Technologies has established critical validation of its technology with real-world applications. The integration of PoNS into prominent clinical trials and its inclusion on federal supply schedules underscore the company’s commitment to addressing unmet patient needs in neurorehabilitation. Moreover, its work in achieving reimbursement from major insurers further solidifies its role as a pivotal player in the neurotechnology space.
Research, Development, and Regulatory Engagement
The company has consistently demonstrated its commitment to research and development, investing significantly in studies that underscore its technology’s efficacy. Ongoing clinical registrational programs including those focused on stroke recovery exemplify the company’s dedication to gathering comprehensive clinical data. Regulatory engagement continues to be a cornerstone of its strategy as it works closely with agencies to secure approvals and reimbursement adjustments, which are essential for widespread clinical adoption.
Market Significance and Competitive Landscape
Operating in the highly specialized field of neurotechnology, Helius Medical Technologies distinguishes itself by targeting therapeutics that facilitate neuroplasticity—a key differentiator that underpins its market positioning. By addressing critical symptoms associated with neurological impairments through a non-invasive, easily accessible device, Helius satisfies a crucial need within the broader healthcare ecosystem. Its competitive edge is maintained through continuous research, strategic partnerships, and a clear focus on providing tangible improvements in patient mobility and quality of life.
Conclusion
Helius Medical Technologies Inc embodies innovation in neurotech, blending advanced scientific concepts with practical applications to offer a transformative therapeutic modality for patients suffering from neurological deficits. The company’s dedication to neuromodulation through its PoNS device, comprehensive clinical validation, and proactive engagement with regulatory bodies collectively establish it as a noteworthy entity in the field of medical devices and neurological rehabilitation.
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.
Helius Medical Technologies (Nasdaq: HSDT) reported its Q1 2024 financial results. Revenue rose to $135,000 from $111,000 in Q1 2023, driven by higher product sales in the U.S. and Canada. Operating loss decreased to $3.4 million, down from $3.8 million in the prior year. Net loss remained stable at $2.5 million, with a net loss per share improving to $3.08, compared to $4.42 previously. The company successfully closed a $6.4 million public offering, netting $5.6 million. Helius received HCPCS codes for its PoNS device, with final reimbursement rates to be determined by October 1, 2024. The company expanded its stroke registrational program and partnered with Lovell Government Services to access federal healthcare systems.
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