Helius Medical Technologies Reports $11.7 Million Net Loss and Revenue Decline for Fiscal Year 2024

Helius Medical Technologies, Inc. reported a net loss of $11.7 million for the fiscal year ending December 31, 2024, compared to a loss of $8.9 million in the previous year. The company's total revenue decreased to $520,000 from $644,000 in 2023, primarily due to a decline in U.S. sales of its Portable Neuromodulation Stimulator (PoNS) device, which was affected by the termination of its Patient Therapy Access Program in June 2023. The company generated approximately $0.5 million in revenue from product sales, with $181,000 from the U.S. and $295,000 from Canada. The cost of revenue remained relatively stable, resulting in a gross loss of $62,000 for 2024, compared to a gross profit of $61,000 in 2023.

In terms of operational developments, Helius has made significant strides in its commercialization efforts. The company received marketing authorization for the PoNS device in Canada for multiple indications, including gait deficits due to multiple sclerosis (MS), mild-to-moderate traumatic brain injury (TBI), and stroke. In the U.S., the device is authorized for use as a short-term treatment for gait deficits due to MS. Helius has also established a partnership with Lovell Government Services to make the PoNS device available to federal healthcare systems, including the Department of Veterans Affairs. The company is actively pursuing reimbursement coverage for the PoNS device, with recent developments including the assignment of Healthcare Common Procedure Coding System (HCPCS) codes for the device, effective April 1, 2024.

The company has faced challenges in maintaining compliance with Nasdaq listing requirements, receiving notifications regarding its stock price and stockholders' equity. Helius is currently appealing a determination regarding its compliance with the minimum bid price requirement and has presented a plan to regain compliance. The company has also undergone a transition in manufacturing, moving production from Key Tronic Corporation to Minnetronix, Inc., which is expected to enhance its operational capabilities.

Looking ahead, Helius plans to continue its commercialization efforts and expand its clinical trials, particularly for stroke indications. The company has enrolled over 150 participants in its stroke registrational program and aims to submit for FDA authorization by mid-2025. However, Helius acknowledges the need for additional financing to support its operations and clinical trials, raising concerns about its ability to continue as a going concern. The company had $1.1 million in cash as of December 31, 2024, and anticipates requiring further funding to sustain its operations beyond the second quarter of 2025.