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 announced agreements with existing warrant holders to exercise warrants for 4,971,110 shares at a reduced price of $0.751 per share, expecting to generate approximately $3.7 million in gross proceeds. In exchange, the company will issue new warrants in a private placement.
The new warrants will be exercisable for up to 6,213,888 shares at $0.751 per share, subject to stockholder approval. Of these, 3,728,333 warrants will be exercisable for five years and 2,485,555 for two years after stockholder approval. Roth Capital Partners is acting as financial advisor for this transaction.
The company plans to file a resale registration statement with the SEC to register the shares underlying the new warrants. The existing warrant shares are already registered under Form S-1.
Helius Medical Technologies (NASDAQ:HSDT) has exceeded its initial enrollment target for its stroke registrational program, reaching 128 participants by December 31, 2024, surpassing the original goal of 90 participants. The company expects to reach maximum enrollment of 150 participants by January 2025.
The program aims to demonstrate the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS®) for improving balance and gait deficits in stroke survivors. The FDA granted Breakthrough Designation for PoNS in stroke in 2021, and Helius remains on track for FDA submission in Q2 2025.
The registrational program consists of three studies: a randomized placebo-controlled trial at MUSC, a company-sponsored open-label study across five U.S. Centers of Excellence, and another randomized placebo-controlled trial across sites in Canada and the U.S. The studies focus on gait and balance improvement, reduced risk of falling, and maintenance of effect at 12 weeks post-treatment.
Helius Medical Technologies (NASDAQ:HSDT) announced its first PoNS System sale to the VA Healthcare System through distributor Lovell Government Services. The sale, priced at $23,844 ($16,499 for Controller, $7,345 for Mouthpiece), marks the operational implementation through VA Federal Supply Schedule Contract.
The PoNS System, indicated for treating gait deficit in adults with mild-to-moderate MS symptoms when used with physical therapy, targets a potential market of 55,000 to 70,000 veterans living with MS in the U.S. The company has sales professionals covering VA locations along the east coast and southeast, with plans to expand coverage to all VA MS Centers of Excellence network facilities.
Helius Medical Technologies (NASDAQ:HSDT) provided updates on reimbursement challenges for its Portable Neuromodulation Stimulator (PoNS) device. The company disagrees with CMS's proposed pricing for both the PoNS Mouthpiece and Controller, stating it reflects incomplete information and incorrect technology assessment. The pricing decisions have delayed access to PoNS Therapy for Multiple Sclerosis patients with balance and gait deficits. The company has requested a meeting with CMS before the January 1, 2025 Mouthpiece pricing implementation and is seeking to align Controller pricing implementation with the same date instead of April 1st.
Helius Medical Technologies (Nasdaq:HSDT) has initiated a strategic alternatives review process to maximize stockholder value. The company's decision follows challenges stemming from CMS's deferral of reimbursement payment determination for the PoNS Controller and inadequate PoNS Mouthpiece pricing in October, which has restricted operational advancement and traditional financing access. B. Riley Securities has been engaged as financial advisor to explore options including acquisition, merger, reverse merger, business combination, asset sale, and licensing opportunities.
Helius Medical Technologies, a neurotech company focused on innovative treatments for balance and gait deficits, has announced its participation in the 2024 ThinkEquity Conference. The event, scheduled for October 30, 2024, will take place at the Mandarin Oriental Hotel in New York.
Helius management will be presenting at 4:30pm ET and conducting one-on-one investor meetings throughout the day. The ThinkEquity Conference is a platform that brings together institutional investors, corporate clients, and industry professionals to showcase groundbreaking innovations and financial strategies.
Interested investors can register to attend the conference and schedule meetings with Helius representatives. This event provides an opportunity for Helius to highlight its novel therapeutic neuromodulation approach and engage with potential investors.
Helius Medical Technologies (Nasdaq:HSDT) announced updates on CMS reimbursement determinations for its Portable Neuromodulation Stimulator (PoNS®) device. The PoNS Mouthpiece (HCPCS code A4594) reimbursement was set at $2,963.30 as a lump sum payment, effective January 1, 2025. Helius plans to challenge this determination, arguing it's based on discontinued temporary pricing and doesn't reflect current market rates.
CMS deferred the national reimbursement payment determination for the PoNS Controller (HCPCS Code A4593) to the next cycle. A preliminary rate of $519.80 was published, comparing it to TENS devices. Helius disagrees with this comparison and will present its case at the November 8, 2024 HCPCS public meeting.
CEO Dane Andreeff expressed strong disagreement with CMS' methods and pricing, emphasizing the company's significant R&D investment and the FDA's Breakthrough Device designation for PoNS. Helius aims to establish fair reimbursement to improve access for MS patients with gait deficits.
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.
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