Helius Medical Technologies (HSDT) FDA Approvals

Helius Medical Technologies' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Helius Medical Technologies (HSDT). Over the past two years, Helius Medical Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as PoNS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

PoNS FDA Regulatory Timeline and Events

PoNS is a drug developed by Helius Medical Technologies for the following indication: Dynamic gait and balance deficits due to symptoms from stroke. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

positive Outcome - July 21,2025

• Drug: PoNS
• Announced Date: July 21, 2025
• Indication: Dynamic gait and balance deficits due to symptoms from stroke
• Other Companies Involved: TSE:HSM

Helius Medical Technologies, announced positive outcome from the PoNS (Portable Neuromodulation Stimulator) Stroke Registrational Program (SRP) supporting a planned FDA submission seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under the current Breakthrough Device Designation.

Helius Medical Technologies announced positive results from its PoNS (Portable Neuromodulation Stimulator) Stroke Registrational Program (SRP). The SRP tested PoNS therapy, a non-implantable device that sends mild electrical signals through a mouthpiece to improve gait and balance when paired with physical therapy.

In a double-blind, randomized trial, patients using active PoNS therapy showed statistically significant improvements in walking and balance compared to sham treatment. Researchers also found few adverse events and high patient tolerability, supporting the device’s safety profile.

These findings mark an important step toward offering stroke survivors a new rehabilitation option. By enhancing neuroplasticity, PoNS therapy could help people regain functional mobility and reduce the risk of falls after chronic stroke.

Helius plans to submit an FDA application under its current Breakthrough Device Designation in the third quarter of 2025, seeking approval for the PoNS device to treat chronic gait and balance deficits after stroke.

Provided Update - June 16,2025

• Drug: PoNS
• Announced Date: June 16, 2025
• Indication: Dynamic gait and balance deficits due to symptoms from stroke
• Other Companies Involved: TSE:HSM

Helius Medical Technologies, Inc. announced an additional authorized claim for payment for the PoNS Device from CignaHealth. CignaHealth becomes the fifth major payer to authorize claims for payment for the PoNS Device following the recent authorization by Anthem MultiPlan.

Helius Medical Technologies, Inc. announced on June 16, 2025, that CignaHealth approved a claim for payment for its PoNS Device at an out-of-network negotiated price of about $19,161. This approval makes CignaHealth the fifth major payer to offer reimbursement for the device, following the recent authorization by Anthem MultiPlan. The PoNS Device is designed to improve balance and walking ability in patients with multiple sclerosis when used along with a supervised physical therapy program.

The growing support from major healthcare payers highlights the increasing recognition of the device’s value. Although these authorized claims may not immediately lead to a device sale due to individual patient deductibles and out-of-pocket costs, this move is expected to strengthen Helius’s efforts to expand reimbursement options, possibly including broader coverage from CMS in the future.

Highlights - May 20,2025

• Drug: PoNS
• Announced Date: May 20, 2025
• Indication: Dynamic gait and balance deficits due to symptoms from stroke
• Other Companies Involved: TSE:HSM

Helius Medical Technologies, Inc announced it will highlight the results of a new study confirming the therapeutic regimen and sustained efficacy of its Portable Neuromodulation Stimulator (PoNS®) device for people with multiple sclerosis (MS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting.

Helius Medical Technologies, Inc. announced that it will present key findings from a new study at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. The study confirms that the Portable Neuromodulation Stimulator (PoNS®) device delivers a therapeutic regimen that improves gait and balance for people with multiple sclerosis (MS). In the study, participants who adhered closely to the prescribed PoNS Therapy, which combines non-invasive cranial nerve stimulation with physical exercises, experienced statistically significant benefits. Deborah Backus, PT, Ph.D., a leading investigator, highlighted that patients maintained improved walking function from the supervised phase into their at-home treatment, with gains sustained six months later. The presentation, scheduled for May 29 at the Phoenix Convention Center, will share full results and discuss how regular use of the PoNS device can drive lasting therapeutic outcomes for those with gait deficits in MS.

Positive Results - January 22,2025

• Drug: PoNS
• Announced Date: January 22, 2025
• Indication: Dynamic gait and balance deficits due to symptoms from stroke
• Other Companies Involved: TSE:HSM

Helius Medical Technologies, Inc. announced positive results from the PoNS Therapeutic Experience Program, or PoNSTEP, study for people with multiple sclerosis (MS).

Helius Medical Technologies, Inc. reported promising outcomes from its PoNS Therapeutic Experience Program (PoNSTEP) study in people with multiple sclerosis. The study focused on PoNS Therapy, a innovative treatment that uses mild electrical stimulation on the tongue combined with physical exercise, aiming to improve gait and balance in MS patients.

The research involved 43 patients with mild-to-moderate MS, of which 38 completed the 14-week treatment. Results showed significant progress, with participants recording an average improvement of 5.00 points on the Dynamic Gait Index. The study also found that better adherence to the therapy, especially during the unsupervised at-home phase, was associated with more marked improvements. Additionally, the benefits were durable, with most participants maintaining their gains six months after treatment. These findings support PoNS Therapy’s potential role in enhancing neuroplasticity and long-term gait function in people with MS.

Provided Update - January 21,2025

• Drug: PoNS
• Announced Date: January 21, 2025
• Indication: Dynamic gait and balance deficits due to symptoms from stroke
• Other Companies Involved: TSE:HSM

Helius Medical Technologies, announced it has completed and far exceeded the initial target enrollment for its stroke registrational program.

Helius Medical Technologies has completed and far exceeded the initial enrollment target for its stroke registrational program. The program, which evaluates the Portable Neuromodulation Stimulator (PoNS®) for improving balance and gait deficits in stroke survivors, enrolled 128 participants by December 31, 2024—well above the goal of 90 participants. The company expects to reach its maximum enrollment target of 150 participants by the end of January 2025.

This strong enrollment progress is a key step toward demonstrating the safety and effectiveness of PoNS Therapy. Helius is on track to submit its findings to the FDA for stroke authorization by the second quarter of 2025, aiming to provide a new therapeutic tool for over 7 million stroke survivors in the U.S. who struggle with mobility issues.

Provided Update - September 30,2024

• Drug: PoNS
• Announced Date: September 30, 2024
• Indication: Dynamic gait and balance deficits due to symptoms from stroke
• Other Companies Involved: TSE:HSM

Helius Medical Technologies, Inc. announced that The study treatment phase is complete, and the ongoing post-treatment follow-up phase will be completed by the end of the year, with full results expected to be released in early 2025.

Helius Medical Technologies, Inc. announced an important update regarding its ongoing study on PoNS Therapy for improving gait deficits in people with multiple sclerosis. The company confirmed that the treatment phase of the study is now complete, marking a significant step forward. Participants have transitioned to the post-treatment follow-up phase, which will continue until the end of the year.

Full study results are anticipated to be released in early 2025. This timeline underscores Helius’ commitment to thoroughly evaluating the therapy’s effectiveness and the role of patient adherence in achieving better gait outcomes. The update highlights the progress made in the study and the importance of consistent at-home physical therapy as part of the treatment regimen.

Preliminary Results - September 30,2024

• Drug: PoNS
• Announced Date: September 30, 2024
• Indication: Dynamic gait and balance deficits due to symptoms from stroke
• Other Companies Involved: TSE:HSM

Helius Medical announced positive preliminary results from its Therapeutic Experience Program open-label observational study (PoNSTEP) which evaluates the impact of subjects' adherence to the Portable Neuromodulation Stimulator (PoNS®) Therapy program that treat gait deficit due to multiple sclerosis ("MS"). Technologies, Inc.

Helius Medical Technologies announced positive preliminary results from its PoNSTEP study, which examined how well patients with multiple sclerosis adhere to the Portable Neuromodulation Stimulator (PoNS®) Therapy program and its effect on gait deficits. The study’s primary endpoint was met, showing a clear linear relationship between therapy adherence and improvement in Dynamic Gait Index (DGI) scores over a 14‐week period. During the initial two-week clinic phase, patients improved in gait performance, but the home-based phase demonstrated that consistent use of the PoNS device led to even greater gains. For example, participants with at least 70% adherence experienced significant cumulative improvements in DGI scores, indicating that regular and sustained use of PoNS Therapy may enhance functional rehabilitation. These promising results support the benefits of combining supervised treatment with at-home neuromodulation exercises for patients with MS-related gait deficits.

Foreign Approval - May 20,2024

• Drug: PoNS
• Announced Date: May 20, 2024
• Indication: Dynamic gait and balance deficits due to symptoms from stroke
• Other Companies Involved: TSE:HSM

Helius Medical Technologies, Inc. announced the Company's Portable Neuromodulation Stimulator (PoNS®) device has been approved for inclusion on Lovell Government Services' ("Lovell") Veterans Affairs (VA) Federal Supply Schedule (FSS) and General Services Administration (GSA) Advantage contracts.

Helius Medical Technologies, Inc. announced that its Portable Neuromodulation Stimulator (PoNS®) device has been approved for inclusion on Lovell Government Services' Veterans Affairs Federal Supply Schedule (FSS) and General Services Administration (GSA) Advantage contracts (contract #V797D-50450). This approval allows the VA and other Federal agencies to purchase the device at pre-approved prices through established government channels.

The PoNS device is designed as a short-term treatment for gait deficits in adults with mild-to-moderate multiple sclerosis (MS), used alongside physical therapy. With between 55,000 and 70,000 veterans estimated to live with MS in the US, this inclusion means quicker, easier access to an innovative therapy that may help promote neuroplasticity. Helius is proud to offer PoNS to veterans and Federal employees who suffer from balance and gait impairments.

Helius Medical Technologies FDA Events - Frequently Asked Questions

Has Helius Medical Technologies received FDA approval?

As of now, Helius Medical Technologies (HSDT) has not received any FDA approvals for its therapy in the last two years.

What drugs has Helius Medical Technologies submitted to the FDA?

In the past two years, Helius Medical Technologies (HSDT) has reported FDA regulatory activity for PoNS.

What is the most recent FDA event for Helius Medical Technologies?

The most recent FDA-related event for Helius Medical Technologies occurred on July 21, 2025, involving PoNS. The update was categorized as "positive Outcome," with the company reporting: "Helius Medical Technologies, announced positive outcome from the PoNS (Portable Neuromodulation Stimulator) Stroke Registrational Program (SRP) supporting a planned FDA submission seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under the current Breakthrough Device Designation."

What conditions do Helius Medical Technologies' current drugs treat?

Currently, Helius Medical Technologies has one therapy (PoNS) targeting the following condition: Dynamic gait and balance deficits due to symptoms from stroke.