NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) this week announced promising developments in its first quarter financial and operational update for 2024. The company reported progress on several fronts, including key regulatory milestones and strategic partnerships aimed at broadening access to its Portable Neuromodulation Stimulator (PoNS®) device.
In a significant step forward, Helius received preliminary Medicare reimbursement codes from the Centers for Medicare & Medicaid Services (CMS) for its PoNS mouthpiece and controller. This development is critical as it lays the groundwork for final pricing set to be determined on October 1, 2024. Achieving this milestone opens the door to broader insurance coverage for the innovative device, designed to assist patients with neurological symptoms of various conditions.
Additionally, Helius expanded its stroke registrational program in the U.S. and Canada, fine-tuning its development plan in alignment with FDA recommendations. This expansion signifies the company’s commitment to advancing treatment options for stroke survivors, leveraging the PoNS device’s potential to improve quality of life.
The company also announced a partnership with Lovell® Government Services to distribute the PoNS device across federal healthcare systems, including the VA and DoD. This collaboration underscores Helius’ dedication to supporting veterans and military personnel in need of rehabilitative care.
Financially, Helius reported a modest increase in Q1 2024 revenue, climbing to $135 thousand from $111 thousand in the same period last year. This growth reflects rising product adoption in both the U.S. and Canada. Furthermore, a successful public offering closed in May 2024 raised net proceeds of approximately $5.6 million, bolstering the company’s financial position and extending its operational runway into 2025.
“We marched one step closer to an important milestone when CMS released its preliminary Medicare payment determinations for the PoNS Controller and Mouthpiece earlier this month,” said Helius’ CEO, Dane Andreeff. He highlighted the company’s efforts to secure higher reimbursement rates, emphasizing the potential impact on expanding third-party payer reimbursement and achieving positive cash flow.
With regulatory submissions for stroke authorization anticipated in early 2025 and new sites added to its registrational program, Helius is poised for significant strides in neuromodulation therapy. These developments not only signify Helius’ growth but also represent a broader shift towards innovative treatments in healthcare, promising enhanced support for patients with neurological challenges.
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