NEWTOWN, PA — In a market landscape dominated by titans in the biotech and healthcare technology sectors, Helius Medical Technologies, Inc. (Nasdaq: HSDT) found themselves in a David versus Goliath scenario. The Pennsylvania-based company has made remarkable strides in the fourth quarter and the entire fiscal year ended December 31, 2023.
One of their most notable accomplishments involves securing Healthcare Common Procedure Coding System (HCPCS) Level II codes for its pioneering Portable Neuromodulation Stimulator (PoNS) mouthpiece and controller. The granting of these codes by the Centers for Medicare & Medicaid Services (CMS) represents an integral step towards reimbursement, paving the way for broad third-party reimbursement and establishing the potential for a wider market reach.
Helius’ strategic steps indicate the company’s commitment to revolutionizing stroke treatment. They expanded their registrational program in stroke by including a second site and initiating an open-label study, and achieved a critical alignment with the U.S. Food and Drug Administration (FDA) on optimizing the stroke development plan. This significant development places Helius on the brink of potential U.S. authorization, with a projected target for regulatory submission by early 2025 and possible commercialization by the end of that year.
The company’s innovative PoNS Therapy, designed to improve gait and balance in stroke patients, is already making waves. In collaboration with Pacific Blue Cross and HealthTech Connex, Helius publicized study results demonstrating the effectiveness of PoNS Therapy in drastically improving return-to-work outcomes for patients suffering from traumatic brain injury – a much-needed breakthrough in the field.
However, Helius is not without its financial trials. The Q4 2023 revenue took a hit, dropping to $134 thousand from $282 thousand the previous year. This was majorly attributed to the expiration of PTAP in the United States and lower product sales in Canada.
Operating expenses for the same quarter saw a decrease from $2.8 million in Q4 2022 to $2.3 million in Q4 2023.
In an effort to bolster their financial runway and counteract these setbacks, Helius secured $1.3 million from the sale of company common stock under its At-The-Market program in Q1 2024. This strategy will extend their cash runway into Q3 2024 and provides the company with a lifeline to continue progressing their stroke registrational program and secure widespread reimbursement.
Helius ended 2023 with a reduced net loss of $1.0 million for Q4 2023, compared to a net loss of $4.9 million in Q4 2022. The loss per share for the full year also decreased from $52.13 in 2022 to $14.56 in 2023 – a small yet worthy victory for the company.
Overall, while Helius Medical Technologies has faced fiscal challenges, its resolute stride forward in the healthcare sector makes it a compelling player to watch. With their innovative PoNS Therapy and pivotal maneuvers towards reimbursement, Helius may well be on the way to making a significant impact on the lives of stroke patients worldwide.
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