Welcome to our dedicated page for Solana Company news (Ticker: HSDT), a resource for investors and traders seeking the latest updates and insights on Solana Company stock.
Solana Company (NASDAQ: HSDT) generates news across two distinct but connected areas: its neurotech medical device operations and its Solana-focused digital asset treasury strategy. Company press releases and SEC filings highlight developments in clinical research, regulatory submissions, capital markets transactions, and digital asset management.
On the medical device side, Solana Company describes itself as a neurotech company focused on neurologic deficits using an orally applied technology platform to promote neuroplasticity. News items include announcements of positive clinical data related to the PoNS® device and submissions to the U.S. Food and Drug Administration, such as a 510(k) filing for a stroke-related label expansion.
On the digital asset treasury side, Solana Company reports on its efforts to build and manage a treasury of Solana (SOL) tokens. Recent updates have covered a large private investment in public equity (PIPE) financing, the launch of an at-the-market (ATM) program, the approval of a stock repurchase plan, and partnerships with Pantera Capital and Summer Capital. The company also issues news about its SOL holdings, staking performance, and relationships with staking and custody providers, including Helius, Twinstake, Anchorage Digital Bank, and BitGo.
Investors following HSDT news can expect coverage of quarterly financial results, changes in auditors and board composition, applications affecting its reporting status in Canada, and initiatives such as the planned tokenization of HSDT shares on Superstate’s Opening Bell platform. This news page aggregates these disclosures so readers can review Solana Company’s operational, financial, and treasury-related updates in one place.
Helius Medical Technologies (HSDT) has achieved a significant milestone with its first reimbursement from a major healthcare provider for its Portable Neuromodulation Stimulator (PoNS®) Device. Anthem Blue Cross Blue Shield approved the claim at an out-of-network adjusted list price.
The reimbursement payment, including patient co-payment, amounted to $15,420 for the PoNS controller and mouthpiece. This out-of-network total lump sum payment, typically 30-40% below in-network contracted rates, establishes a important benchmark for future negotiations with major commercial insurance carriers.
The company views this development as validation of PoNS's therapeutic benefit and economic value for payers, particularly significant as Helius appeals current CMS payment rates.
Helius Medical Technologies (NASDAQ:HSDT) has announced positive results from their PoNS Therapeutic Experience Program (PoNSTEP) study for multiple sclerosis (MS) patients. The study demonstrated significant long-term benefits of PoNS Therapy on gait deficit improvement.
The study involved 43 MS patients who underwent 14 weeks of physical rehabilitation with PoNS Therapy, including 2 weeks in clinic (Phase 1) and 12 weeks at home (Phase 2), followed by a 6-month observation period (Phase 3). Of 41 patients who started, 38 completed the study.
Key findings include a statistically significant total mean improvement of 5.00 points in Dynamic Gait Index (DGI) at week 14. Phase 2 showed 71% therapy adherence with a linear association between adherence and improvement. Notably, participants with ≥85% adherence improved by mean 3.7 points compared to 2.0 points for those with lower adherence. At 6-months post-treatment, only 1 of 28 reassessed participants showed ≥30% decline in DGI.
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.
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