NEWTOWN, Pa. - Helius Medical Technologies, Inc. (NASDAQ:HSDT), a neurotech company with a market capitalization of $2.8 million, has surpassed its initial enrollment target for its stroke registrational program, aimed at demonstrating the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS®) for improving balance and gait deficits in stroke survivors. According to InvestingPro analysis, the stock is currently trading at $0.75 and appears undervalued based on Fair Value metrics, with shares showing strong momentum, gaining over 8% in the past week. The company announced today that it has randomized 128 participants as of December 31, 2024, exceeding the original goal of 90 participants. Helius is on track to reach the maximum enrollment of 150 participants by the end of January 2025. While the company maintains a healthy current ratio of 3.61, InvestingPro data reveals the company is experiencing rapid cash burn, a critical factor for investors to monitor. For deeper insights into Helius's financial health and 15+ additional ProTips, consider exploring InvestingPro's comprehensive analysis tools.
The PoNS device is a non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller. It is currently indicated in the United States for the short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS) and is used as an adjunct to supervised therapeutic exercise programs for patients 22 years of age and over by prescription only.
The stroke registrational program consists of three studies, including an investigator-initiated randomized placebo-controlled trial (MUSC-RCT) and two company-sponsored trials (HMI-OLS and HMI-RCT), with shared design and endpoints. These studies aim to establish the device's efficacy in decreasing the risk of falling and maintaining therapeutic effects post-treatment.
The enrollment for the program began in August 2023, with the MUSC-RCT at the Medical (TASE:PMCN) University of South Carolina and Brooks Rehabilitation. Subsequent enrollments across five U.S. Centers of Excellence for Neurorehabilitation and additional sites in Canada and the U.S. have contributed to the current enrollment success.
Helius Medical's President and CEO, Dane Andreeff, expressed excitement about the opportunity to make PoNS available to the over 7 million U.S. patients living with disability from stroke. Dr. Antonella Favit-Van Pelt, Helius Chief Medical Officer, highlighted the timely enrollment as a significant step towards providing stroke patients with a new therapeutic tool.
The company is on track for FDA submission for stroke authorization in the second quarter of 2025, a crucial milestone given the company's revenue decline of 36.62% over the last twelve months. The information in this article is based on a press release statement. For a complete understanding of HSDT's potential and risks, access the detailed Pro Research Report available on InvestingPro, offering expert analysis of the company's financials and growth prospects among 1,400+ US equities.
In other recent news, Helius Medical Technologies has secured final Medicare payment rates from the Centers for Medicare and Medicaid Services (CMS) for its Portable Neuromodulation Stimulator (PoNS) device, marking a significant milestone for the company. However, Helius has expressed concerns over these determinations, arguing that the pricing does not reflect the technology's value. The company has been downgraded by Maxim (NASDAQ:MXIM) Group due to these reimbursement rate concerns. Despite facing a revenue decline of 36.62% over the last year, Helius has extended its financial stability into 2025 following a successful public offering.
In the midst of these challenges, preliminary results from Helius's ongoing PoNSTEP study show significant improvement in Dynamic Gait Index scores for multiple sclerosis patients using the PoNS Therapy. The company is also preparing for FDA submission for stroke authorization and exploring the expansion of PoNS therapy for traumatic brain injury patients. These are among the recent developments at Helius Medical Technologies.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.