What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2025-03-25 compared with 2024-03-28 · 285 added, 136 removed, 574 unchanged (42% of the section changed)

25 unchanged sentences

During each clinic visit and at the end of the 14-week therapy, the clinic downloads and reviews the PoNS usage data from the device.

This usage data in combination with the detail of the completed treatment assessments gives the clinician and the patient a unique and powerful method to assess treatment progress.

This usage data in combination with details of completed treatment assessments gives the clinician and the patient a unique and powerful method to assess treatment progress.

The patient initiates their PoNS Therapy sessions with the PoNS device initially under the supervision of the clinicians, then through regular check-ins.

19 unchanged sentences

There are a variety of treatments available for MS, some of which are experimental, including pharmaceutical, dietary, and surgical, which may or may not be covered by government or private health insurance.

Findings from a National MS Society study estimate that nearly 1 million people in the U.S.

are living with MS of which approximately 25-30% are on Medicare and 93,000 people in Canada are living with MS.

Findings from a 2019 National MS Society study (Wallin et al, 2019) estimate that nearly 1 million people in the U.S.

are living with MS of which approximately 25-30% are on Medicare.

The National MS Society estimates that 2.9 million people live with MS globally.

and Canada have the highest rates of MS, with 337.9 to 362.6 cases per 100,000 in the U.S., and 291 cases per 100,000 in Canada.

and Canada have the highest rates of MS, with 337.9 to 362.6 cases per 100,000 in the U.S.

In Canada, 93,000 people are living with MS with 290 cases per 100,000 in Canada (Statistics Canada, Gilmour et al, 2018).

Given the nature of this neurodegenerative disease, these individuals and their caretakers are active in exploring treatment options that may resolve or delay the progression of symptoms.

There is also a well-established advocacy framework.

Mobility disability and walking impairment are among the most debilitating consequences of MS with approximately 85% of individuals diagnosed with MS reporting gait impairment as a major limitation in their daily lives.

Mobility disability and walking impairment are among the most debilitating consequences of MS with approximately 72% of individuals diagnosed with MS reporting gait impairment as a major limitation in their daily lives (Williams et al, 2014).

Gait is one of the most important bodily functions for MS patients and gait parameters, such as walking speed and stride length, have been shown to be significant predictors of patient’s independence in daily activities.

A survey of 436 patients found that 45% reported a mobility disability in the first month following diagnosis, with upwards of 90% of patients reporting a mobility disability within 10 years of their diagnosis.

Additionally, 50-80% of MS patients suffer from balance and gait dysfunction and over 56% fall at least once within a three-month period.

It has also been reported that unemployment rates in MS patients range from 24-80% with higher rates associated with decreased ambulation and mobility.

Additionally, 50-80% of MS patients suffer from balance and gait dysfunction (Cameron et al, 2018) and over 56% fall at least once within a three-month period (Carlin et al, 2018).

It has also been reported that unemployment rates in MS patients range from 24-80% with higher rates associated with decreased ambulation and mobility (Julian et al, 2008).

The Centers for Disease Control, or CDC, reports that individuals with disabilities, like MS, that result in limited mobility are at greater risk for health problems including injury, mental health and depression, overweight and obesity, pain, pressure sores or ulcers and other issues.

A 2016 economic analysis of MS found the total lifetime costs per person with MS to be $4.1 million, with average yearly healthcare costs ranging from $30 thousand to $100 thousand based on the severity of the disease, and averaging $65 thousand more in yearly healthcare costs than that of someone without MS.

In 2019, the total economic burden attributed to MS in the U.S was $85.4 billion and the average annual cost of living with MS was $88.5 thousand.

A 2016 economic analysis of MS found the total lifetime costs per person with MS to be $4.1 million (Owens, 2016), with average yearly healthcare costs ranging from $57 thousand to $93 thousand based on the severity of the disease, and averaging $65 thousand more in yearly healthcare costs than that of someone without MS (Bebo et al, 2022).

In 2019, the total economic burden attributed to MS in the U.S was $85.4 billion and the average annual cost of living with MS was $88 thousand (Bebo et al, 2022).

Since the exact cause of MS is still unknown, there is no known prevention.

3 unchanged sentences

Overview of TBI and Current Available Treatments

There are an estimated 49.0 million people globally, with over 5.3 million in the U.S.

and 760,000 in Canada, who have sustained a TBI.

Every year there are 27.2 million newly diagnosed TBIs globally, of which 2.8 million and 165,000 occur in the U.S.

There are an estimated 49.0 million people globally (Guan et al, 2023), with 5.3 million in the U.S.

(Centers for Disease Control and Prevention, 2015) and 2% of Canadians estimated to be 760,000 (Brain Injury Canada, N.D.), living with a TBI-related disability.

Every year there are 27.2 million newly diagnosed TBIs globally (Guan et al, 2023), of which 2.8 million (Taylor et al, 2017) and 165,000 (Brain Injury Canada, N.D.) occur in the U.S.

and Canada, respectively.

This condition often has a significant impact on one’s quality of life, negatively affecting independence, employability, productivity, mental health and participation in the community.

This condition often has a significant impact on one’s quality of life, negatively affecting independence, employability,

productivity, mental health and participation in the community.

Rehabilitation is often required following a TBI for resulting motor, cognitive and behavioral impairments.

Approximately 80% of individuals who sustain a TBI report balance impairment.

Approximately 80% of individuals who sustain a TBI report balance impairment (Dever et al, 2022).

The current standard of care to address balance issues following a TBI is supervised therapeutic exercise.

While supervised therapeutic exercise can help to

promote balance recovery, individuals are often unable to return to their full function and are left living with a balance deficit.

While supervised therapeutic exercise can help to promote balance recovery, individuals are often unable to return to their full function and are left living with a balance deficit.

Prior to the development of the PoNS device, there were no cleared treatments that were clinically indicated to treat balance deficit.

4 unchanged sentences

Overview of Stroke and Current Available Treatments

According to the World Health Organization, there are more than 101 million people across the globe who have experienced a stroke, and over 12 million new strokes occur each year.

In the U.S., approximately 650,000 people survive a new stroke each year and an estimated 7 million Americans live with ongoing complications of stroke.

According to the World Stroke Organization, there are more than 101 million people across the globe who have experienced a stroke, and over 12 million new strokes occur each year (Feigin et al, 2022).

In the U.S., approximately 650,000 people survive a new stroke each year and an estimated 7 million Americans live with ongoing complications of stroke (Dobkin, 2013).

The Canadian Chronic Disease Surveillance System states that stroke is the third leading cause of death in Canada and the tenth largest contributor to disability-adjusted life years (the number of years lost due to ill-health, disability or early death).

About 878,500 Canadian adults aged 20+ have experienced a stroke (2018-2019) and with the population aging, more and more Canadians are at risk.

This condition often has a significant impact on the ability on one’s functionality, negatively affecting independence, employability, productivity, mental health and participation in the community.

In addition, more than 80% of the survivors have a gait impairment.

About 878,000 Canadian adults aged 20+ have experienced a stroke (Heran et al, 2022) and with the population aging, more and more Canadians are at risk.

This condition often has a significant impact on one’s functional ability, negatively affecting independence, employability, productivity, mental health and participation in the community.

In addition, more than 80% of the survivors have gait impairment (Carmen, 2020).

Rehabilitation is required following a stroke for resulting motor, cognitive and behavioral impairments.

Most province public health systems in Canada offers stroke rehabilitation services along with private establishments.

The potential for commercial opportunity for PoNS in order to support all these public and private establishments is wide.

The potential for commercial opportunity for PoNS to support all these public and private establishments is wide.

PoNS Therapy offers new opportunities for this type of service by enhancing physical rehabilitation and helping attain the desired goals.

6 unchanged sentences

● The study was designed as a between-group comparison of the Dynamic Gait Index (DGI) score improvement in 10 subjects treated with active PoNS, in conjunction with two weeks of treatment in clinic under supervision of a registered PoNS trainer, and, individually, at home over 12 weeks, as compared to 10 subjects treated with placebo PoNS and the same physical therapy regimen, after a total of 14 weeks of treatment.

● The primary endpoint demonstrated a statistically significant improvement greater that 4 points in the DGI score from baseline in the active PoNS group as compared to placebo at endpoint (Week 14) (p<0.005).

● The DGI improvement was already clinically meaningful at 2 weeks of treatment and continued to increase over the following 8 weeks of therapy with an average improvement of 7,7 point, which was then maintained (slightly increased) through week 14.

● The primary endpoint demonstrated a statistically significant improvement greater than 4 points in the DGI score from baseline in the active PoNS group as compared to placebo at endpoint (Week 14) (p<0.005).

● The DGI improvement was already clinically meaningful at 2 weeks of treatment and continued to increase over the following 8 weeks of therapy with an average improvement of 7.7 points, which was then maintained (slightly increased) through week 14.

Summary results from the Leonard study in 14 patients treated with mild and moderate MS:

7 unchanged sentences

● An analysis of the surveillance safety database demonstrated an excellent safety profile supporting a positive benefit-risk ratio in the real-world clinical utilization setting.

Summary of PoNS Therapeutic Experience Program (PoNSTEP) study in MS.

● PoNSTEP study assesses the adherence to on-label PoNS® Therapy for improvement of gait in people with multiple sclerosis (MS) in a real-world clinical setting, and aims at understanding the utilization, treatment compliance, and the short/long-term clinical benefits of PoNS Therapy.

● The study enrolled 43 patients with gait deficit due to mild-to-moderate MS into the study who were receiving standard clinical care for their medical condition.

The recommended dose of PoNS Therapy was 100-120 min per day for 14 weeks, performed 5 days/week in the clinic for the first 2 weeks (Phase 1), followed by a 12-week unsupervised therapy at home (Phase 2).

Participants were also evaluated after a 6-month post-treatment observation period (Phase 3).

● The primary endpoint was maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject’s adherence to PoNS therapy.

Secondary endpoints included, among others, maintenance of improvement of gait and balance deficit over time.

● 41 patients started treatment, 38 completed the 14-week treatment protocol, and 29 of 38 were evaluated at the 6-month follow-up.

Participants who declined 30% or more in their functional improvement from the end of Phase 2, were eligible for an additional 12-wk course of PoNS Therapy at home.

● The mean improvement in DGI during Phase 1 and Phase 2, among the 38 subjects completing the protocol, was 5.00 points (4.1 to 5.9, p<0.001) at week 14.

Average therapy adherence was almost 90% in Phase 1 (with no significant association with DGI improvement [r=0.14;

p=0.42]), whereas in Phase 2, adherence was over 67% with a significant linear correlation with DGI improvement (r=0.345;

The mean changes [SD] in Phase 2 for subjects with ≥85% and <85% adherence were 3.7 [1.8] and 2.0 [1.8] points, respectively (p=0.008).

● 70.7% participants were evaluated Week 26 and the mean percentage decline in DGI was -4.1% (95% CI -9.4% to 1.1%) with only 1/28 (3.6%) experiencing at least a 30% decline in DGI (95% exact binomial confidence interval:

0.09% to 18.4%).

No correlations between the mean decline from Week 14 to Week 26 and the treatment adherence metrics was observed (0.16 for Phase 1, 0.20 for Phase 2, and 0.20 for the whole 14-wk treatment period, all with p>0.30).

PoNS Clinical Trials and Scientific Support in mmTBI

13 unchanged sentences

According to published clinical trial data, balance impaired TBI subjects treated with physical therapy alone reached an average improvement of 10-13 points in their SOT composite score over a short-term treatment period, an improvement that trended back towards baseline values upon physical therapy discontinuation.

In both PoNS studies, participants entered the trial with an average SOT composite score of 40 (1-100 range) indicative of compromised functional balance and were randomized to treatment with PoNS devices that delivered either a high-frequency pulse, or HFP, (25.7 million pulses per 20 minute treatment) or a low-frequency pulse, or LFP, (13,728 pulses per 20 minute treatment).

In both PoNS studies, participants entered the trial with an average SOT composite score of 40 (1-100 range), indicative of compromised functional balance, and were randomized to treatment with PoNS devices that delivered either a high-frequency pulse ( HFP) (25.7 million pulses per 20 minute treatment) or a low-frequency pulse (LFP) (13,728 pulses per 20-minute treatment).

In both studies, the primary efficacy endpoint was constructed for a between-group (HFP-treated and LFP-treated cohorts) comparison based on a greater than 15-point SOT composite score improvement at endpoint.

The statistical

plans also provided for a key secondary efficacy endpoint that established the treatment response (> 15 points on SOT composite score) from baseline in the pooled HFP and LFP groups at endpoint(s), should the primary measure failed to establish a significant difference between the HFP and LFP treatment groups.

The statistical plans also provided for a key secondary efficacy endpoint that established the treatment response (> 15 points on SOT composite score) from baseline in the pooled HFP and LFP groups at endpoint(s), should the primary measure failed to establish a significant difference between the HFP and LFP treatment groups.

Summary results of the registrational study (Ptito et al.

8 unchanged sentences

● No device-related serious adverse events were observed.

Summary of the results of the 26-week long-term treatment study (2019) in people with mmTBI:

Summary of the results of the 26-week long-term treatment study (Tyler et al, 2019) in people with mmTBI:

● The study, performed to evaluate the durability of response to the PoNS Therapy over a 26-week period (14-week therapy followed by 12-week washout period) conducted at the Tactile Communication & Neurorehabilitation Laboratory at the University of Wisconsin-Madison and sponsored by the U.S.

19 unchanged sentences

Summary of RWE database analysis in stroke patients treated with PoNS in Canada:

● The adjusted mean improvement in the Functional Gait Assessment (FGA) was 6.74 (95% CI:

● The adjusted mean improvement in the FGA was 6.74 (95% CI:

4.85 to 8.63) among 30 subjects.

12 unchanged sentences

Furthermore, there were reductions from baseline in fall rate and in the Headache Disability Index (“HDI”) and improvements in sleep quality were also reported in the TBI studies.

The PoNS device has been used in clinical rehabilitation settings with over 480 patients since March 4, 2019 to treat balance and gait disorders with more than 180,000 patient sessions recorded.

An exhaustive search of the HMI complaint records for 33 patients identified with a diagnosis of stroke yields a total of 13,960 patient sessions and no serious device-related events have been recorded along with zero reportable adverse events.

The PoNS device has been used in clinical rehabilitation settings with over 798 patients since March 4, 2019 to treat balance and gait disorders with more than 247,000 patient sessions recorded, no serious device-related events have been recorded along with zero reported adverse events.

Regulatory Status Worldwide

14 unchanged sentences

On March 26, 2021, we received marketing authorization from the FDA of the PoNS device for use as a short-term treatment of gait deficit due to mild-to-moderate symptoms of MS and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

On February 29, 2024, we received Healthcare Common Procedure Coding System (HCPCS) codes for the PoNS controller and for the PONS mouthpiece, which will become effective on April 1, 2024.

We will continue monitoring the development by Centers for Medicare & Medicaid Service (“CMS”) of a

new pathway for coverage of innovative new devices, Transitional Coverage of Emerging Technology (“TCET”), which is replacing the repealed Medicare Coverage of Innovative Technologies (“MCIT”) rule.

CMS is expected to share more about TCET with the public for comments in 2024.

As we follow the evolution of TCET, we will continue to assess our evidence generation strategy to maximize the potential to gain CMS reimbursement benefits as a result of our Breakthrough designation in MS.

While we will continue to monitor this, we will also remain focused on building out our reimbursement strategy for both commercial and government payers.

On February 29, 2024, we received Healthcare Common Procedure Coding System (HCPCS) codes for the PoNS controller and for the PONS mouthpiece, which became effective on April 1, 2024.

We also intend to provide broad access and reimbursement for the PoNS Therapy over time through commercial insurers.

Prior to the initiation of CMS or broad commercial payer coverage, the primary source of sales have been self-pay patients.

Prior to the initiation of CMS or broad commercial payer coverage, the primary source of sales has been self-pay patients.

We expect to continue to support the cost of the PoNS Therapy by collaborating with third parties to provide self-pay patients with financing options as well as working with advocacy groups and charitable organizations to help self-pay patients access our technology.

In general, we anticipate that it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers once HCPCS codes become effective.

In September 2021, we started activities to set up and implement a new study as part of a Therapeutic Experience Program, or PoNSTEP, with NYU Langone Health as our first Center of Excellence clinical site.

Since then, we have added five additional clinical sites to the program.

Recruitment site information can be found on clinicaltrials.gov.

PoNSTEP is a Helius-sponsored, open label observations, interventional multi-center outcome research trial designed to assess adherence to on-label PoNS Therapy for improvement in gait deficits with MS in a real-world clinical setting.

study measures subjects’ adherence to PoNS Therapy, which combines the PoNS device with physical therapy, to better understand the relationship between adherence to the treatment regimen and therapeutic functional outcome.

The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject’s adherence to PoNS Therapy.

The secondary endpoints are improvement of gait and balance deficit over time, and clinical global impression of change.

Enrollment commenced in the second half of 2022 and is expected to be completed in 2024 with targeted participation of approximately forty to fifty patients with MS.

In general, we anticipate that it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers.

Regulatory Status:

In August 2021, we received Breakthrough Designation for the PoNS device as a potential treatment for dynamic gait and balance deficits due to symptoms from stroke, to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over.

With Breakthrough Designation received, a clinical trial of PoNS Therapy in stroke participants in collaboration with Medical University of South Carolina commenced in 2023 with initial patient enrollments beginning in the second half of 2023.

An open label study to evaluate the therapeutic benefit of PoNS in chronic stroke subjects will start enrolling participants in the first quarter 2024 in three sites in the U.S.

and Canada as part of our registrational program for gait and balance deficit due to stroke.

Enrollment for both studies is expected to be completed by the end of 2024 with a submission to FDA targeted for mid-to-late 2025.

With Breakthrough Designation received, we have started a stroke registrational program (SPR) including two company sponsored pivotal studies, a randomized controlled double blinded trial (HMI-RCT) and an open label study (OLS) of PoNS Therapy in people with gait and/or balance deficit due to chronic stroke, at 10 clinical sites across the US and Canada.

In addition, the SPR includes an investigator-initiated pilot study, sharing the same study design, patient population, study treatment, endpoints, and statistical analysis of the pivotal studies, conducted at the Medical University of South Carolina and at Brooks Rehabilitation (FL).

All studies are fully enrolled and we are targeting a submission to FDA in mid-to-late 2025.

Regulatory Status:

12 unchanged sentences

During the second quarter of 2019, we engaged with our notified body in Europe to answer questions that we received from them as part of the conformity assessment of our PoNS device for CE certification.

In August 2019, we withdrew our application to be CE certified due to uncertainty in Europe caused by the switch from the Medical Device Directive, or MDD, to the Medical Device Regulation, or MDR, Brexit, and the withdrawal of Lloyd’s Register Quality Assurance, our notified body, from the EU

notified body business.

We have engaged G-MED NA (North America) as our ISO registrar and will reconsider submitting to the EU when conditions stabilize.

11 unchanged sentences

Product Development, Manufacturing and Logistics Services

The commercial design of the PoNS device is currently manufactured and assembled by Key Tronic Corporation (“Key Tronic”), our contract manufacturing partner since 2017, at its facility located in Oakdale, Minnesota.

Key Tronic manufactures devices for engineering and design verification testing and for our FDA submission as well as commercial devices for launch inventory.

During the third quarter of 2023, the Company began implementing the transition of the manufacturing of PoNS device controllers and mouthpieces from Key Tronic to Minnetronix, Inc in St.

The Company expects this transition to be fully completed by mid-2024.

We remain ultimately responsible for the compliance of our submissions and products and for the activities performed on our behalf.

The commercial design of the PoNS device was originally manufactured and assembled by Key Tronic Corporation (“Key Tronic”), our contract manufacturing partner since 2017, at its facility located in Oakdale, Minnesota.

During the third quarter of 2023, the Company began implementing the transition of the manufacturing of PoNS device controllers and mouthpieces from Key Tronic to Minnetronix, Inc (“Minnetronix”) in St.

The Company has completed the transition during the fourth quarter of 2024.

Minnetronix now manufactures devices for engineering and design verification testing and for our FDA submissions as well as commercial devices for inventory.

We place an emphasis on protecting our patented technology, trade secrets and know-how and only share confidential information on an as-needed basis.

Both Minnetronix and Key Tronic are registered as medical device manufacturers in good standing with the FDA and along with Cambridge Consultants, our design services supplier, are certified in accordance with International Organization for Standardization, or ISO, 13485, a comprehensive quality management system for the design and manufacture of medical devices.

HMI maintains a compliant quality management system certified to ISO 13485:2016 and compliant with MDSAP requirements for the U.S., Canada and Australia.

Minnetronix is registered as a medical device manufacturer in good standing with the FDA and along with Cambridge Consultants, our design services supplier, are certified in accordance with International Organization for Standardization, or ISO, 13485, a comprehensive quality management system for the design and manufacture of medical devices.

HMI maintains a compliant quality management system certified to ISO 13485:2016 and is compliant with MDSAP requirements for the U.S., Canada and Australia.

During 2021, we contracted with Healthlink International Inc.

1 unchanged sentence

Healthlink began fulfilling orders in the United States effective with the commencement of commercial sales in the United States in April 2022 and in Canada during the fourth quarter of 2022.

Healthlink is a life science solutions company, specializing in logistics, temperature-controlled warehousing, fulfillment and freight management as well as back-office services, including multilingual customer service, financial services and VAT management.

Healthlink is a life science solutions company, specializing in

logistics, temperature-controlled warehousing, fulfillment and freight management as well as back-office services, including multilingual customer service, financial services and VAT management.

Commercialization

Canadian Commercialization Efforts

In March 2019, we commenced the commercialization of our PoNS Therapy in Canada, where PoNS became the first and only device authorized by Health Canada for the treatment of balance deficit due to mmTBI.

Throughout 2019, we made important progress in advancing and refining our commercialization strategy in Canada building access, awareness and credibility for the PoNS Therapy, including the acquisition of the Heuro Canada, Inc.

(“Heuro”) operating entity of

These efforts, which were led by our local Canadian commercial team, included the establishment of our authorized clinic network throughout Canada, launching digital marketing campaigns, and building key opinion leader and advocacy networks.

On March 18, 2020, the Company received notification that its Canadian Class II license amendment application for the treatment of gait deficit in patients with mild and moderate symptoms from MS, when used in conjunction with physical therapy, was successful and received marketing authorization for PoNS from Health Canada.

On March 9, 2023, we announced the authorization from Health Canada to market PoNS Therapy for the treatment of gait deficit due to mild and moderate symptoms from stroke.

This indication is instrumental as it is one of the most significant indications impacting balance and gait in Canada, and it provides the opportunity to extend options for coverage through government and third-party payers.

Following in-depth market analysis and field intelligence, our Canadian commercial team began an expansion plan to increase the number of authorized PoNS clinics.

During the year ended December 31, 2023, we authorized 22 new clinical locations to have 81 clinic locations across Canada as of December 31, 2023.

In addition to continuing to increase the number of clinic locations, we have shifted our focus to driving patient throughput to these clinics.

The value dossiers for mmTBI, stroke and MS that were created in mid-2020 to fully demonstrate in both scientific and financial terms, the merits of PoNS Therapy for claimants are now being utilized along with submissions from clinics on behalf of their patients.

The dossiers are provided to our clinics across Canada to submit as part of treatment plans with reimbursement applications to the payer community.

Our reimbursement strategy for mmTBI is focused on the auto collision insurance and workers’ compensation (“WC”), market as well as long-term disability cases.

Our reimbursement strategy for MS is focused on commercial insurers/extended health benefits and charitable foundations that support these patient conditions .

Our reimbursement strategy for stroke is focused on private payers while also demonstrating to public health organizations the benefits and potential PoNS Therapy could provide within their respective networks.

As part of our overall PoNS Therapy strategy, we are also gathering comprehensive health economic assessments of treatment outcomes.

These data will, in-turn, be used to support our applications for WC, auto insurance and commercial insurance reimbursement initiatives in Canada, the U.S.

and other markets around the world.

The real-world results from the collective experience of our patients that have completed the 14-week PoNS Therapy, in Canada thus far, have been encouraging.

Consistent with what we observed in our two clinical trials, one for 5 weeks and the other for 14 weeks, commercial MS and mmTBI patients demonstrated improvements in balance and gait within the first two weeks followed by continued improvement over the following twelve weeks.

The majority of patients had a mean patient adherence to treatment of over 90% and showed significant improvement in their balance and gait with a meaningful clinical difference at the end of their treatment.

Similar results were observed in the treatment of patients with symptoms from stroke.

The consistency of the patient results from our initial commercial experience supports our plans to expand access PoNS Therapy in Canada.

Commercialization Activities

6 unchanged sentences

in the first quarter of 2022, and our first commercial sales began in April 2022.

Presently, PoNS Therapy is not covered by the Medicare program or reimbursed by any other payors in the US.

We have targeted specific Key Opinion Leaders (i.e., neurologists and physiatrists) and their associated neurorehabilitation centers, where selected physical therapists will be trained to deliver the PoNS Therapy.

Importantly, this focused strategy will also allow us to measure patient outcomes to determine if they are similar to those observed in our clinical trials.

Importantly, this focused strategy will also allow us to measure patient outcomes to determine if they are comparable to those observed in our clinical trials.

In June 2022, we launched the Patient Therapy Access Program (“PTAP”) program, which provided qualifying patients access to PoNS Therapy at a significantly reduced price.

9 unchanged sentences

We are pursuing commercial insurance coverage and Medicare reimbursement for PoNS within the Durable Medical Equipment (“DME”), benefit category.

Effective in 2025, the list price for the PoNS Device is $28,270, comprised of $19,580 for the controller and $8,690 for the mouthpiece.

We initially applied for unique Healthcare Common Procedure Coding System (“HCPCS”) codes during the third quarter of 2021.

In order to address CMS’s request for additional information to “further understand the PoNS device indication for use”, we decided to monitor real-world utilization of PoNS Therapy and collect additional clinical evidence through our ongoing PoNSTEP study and our registry program.

Based on consistent reports of positive therapeutic benefits experienced by MS patients through our commercial programs, we reapplied for HCPCS codes in the second quarter of 2023 leveraging new information, addressing their questions and providing further support in favor of obtaining unique HCPCS codes for PoNS.

In February 2024, CMS assigned HCPCS Level II codes A4593, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime” to describe the PoNS controller and A4594, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime, mouthpiece each” to describe the PoNS mouthpiece.

The new HCPCS codes will be effective April 1, 2024.

We expect to interact again with CMS in the second half of 2024 – to seek Medicare final payment determinations for both codes to be effective at the next scheduled date of October 1, 2024.

The new HCPCS codes became effective April 1, 2024.

On May 2, 2024, CMS published a proposed fee schedule payment rates for the PoNS controller and PoNS mouthpiece to be discussed at CMS' bi-annual Healthcare Common Procedure Coding System (“HCPCS”) public meeting to be held on May 29, 2024.

For the PoNS Controller (HCPCS Code A4593), CMS preliminarily set pricing by mapping reimbursement to existing code E0745, (Neuromuscular stimulator, electronic shock unit), resulting in a capped fee of $1,206.53.

For the PoNS Mouthpiece (HCPCS code A4594), CMS based pricing on the previously offered, temporary, cash pay price of $4,500, resulting in a total capped payment of $3,075.53.

The Company subsequently provided CMS additional information to support reimbursement economics and presented that information at the public meeting with CMS on May 29, 2024 for consideration by CMS for determination of the final reimbursement amount for each of the PoNS controller and mouthpiece.

On October 7, 2024, CMS posted the final payment rate for the PoNS Mouthpiece (HCPCS code A4594) at $2,963.30, which will be effective January 1, 2025 and deferred final national determination of the payment rate for the PoNS Controller (HCPCS Code A4593) to the next payment cycle.

At the Company’s request, Company management subsequently met with CMS in December 2024 prior to PoNS Mouthpiece pricing taking effect on January 1, 2025 to request that they revisit the starting point for the gap filling process to more appropriately use the market pricing established through negotiation with the VA and an insurance carrier.

On October 8, 2024, CMS published the preliminary rate for the PoNS Controller (HCPCS Code A4593) at the capped total payment of $519.80, based on its view that the product is comparable to devices reported with HCPCS code E0730 (transcutaneous electrical nerve stimulation (TENS) device, four or more leads, for multiple nerve stimulation) to be effective April 1, 2025.

On January 13, 2025, CMS posted final Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies fee schedule payment rates for the PoNS Controller (HCPCS Code A4593) at the capped total payment of $532.27 and no changes to the previous final determination for the PoNS Mouthpiece (HCPCS code A4594) were made.

The Company continues to disagree with CMS’ pricing determinations for both the Controller and Mouthpiece and plans to continue to challenge the pricing decisions through avenues available including the individual claims appeal process.

During the first quarter of 2024, the Company partnered with Lovell Government Services (“Lovell”), an SBA-certified Service-Disabled Veteran-Owned Small Business, to make the PoNS device available to federal healthcare systems.

In May 2024, PoNS became available on the Veteran Affairs Federal Supply Schedule and General Services Administration Advantage Contracts at $23,843.72 for the PoNS device and $7,344.97 for the PoNS mouthpiece.

In July 2024, PoNS became available to the Department of Defense and U.S.

Military facilities on the Distribution and Pricing Agreement at $23,724.50 for the PoNS device and $7,308.25 for the PoNS mouthpiece.

In December 2024, the first PoNS System sale to the VA Healthcare System through Lovell was delivered at the contracted price of $23,844, comprised of $16,499 for the PoNS Controller and $7,345 for the PoNS Mouthpiece.

Concurrently, we will be approaching various third-party payers to negotiate coverage under these codes.

In general, we anticipate that it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers once the HCPCS codes become effective.

In general, we anticipate that it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers.

Canadian Commercialization Efforts

(“Heuro”) operating entity of HTC.

On March 9, 2023, we announced the authorization from Health Canada to market PoNS Therapy for the treatment of gait deficit due to mild and moderate symptoms from stroke.

Following in-depth market analysis and field intelligence, our Canadian commercial team began an expansion plan to increase the number of authorized PoNS clinics.

In addition to continuing to increase the number of clinic locations, we have shifted our focus to driving patient throughput to these clinics.

The value dossiers for mmTBI, stroke and MS that were created in mid-2020 to fully demonstrate, in both scientific and financial terms, the merits of PoNS Therapy for claimants are now being utilized along with submissions from clinics on behalf of their patients.

The dossiers are provided to our clinics across Canada to submit as part of treatment plans with reimbursement applications to the payer community.

Our reimbursement strategy for mmTBI is focused on the auto collision insurance and workers’ compensation (“WC”), market as well as long-term disability cases.

Our reimbursement strategy for MS is focused on commercial insurers/extended health benefits and charitable foundations that support these patient conditions .

As part of our overall PoNS Therapy strategy, we are also gathering comprehensive health economic assessments of treatment outcomes.

These data will, in-turn, be used to support our applications for WC, auto insurance and commercial insurance reimbursement initiatives in Canada, the U.S.

and other markets around the world.

The real-world results from the collective experience of our patients that have completed the 14-week PoNS Therapy in Canada, thus far, have been encouraging.

Similar results were observed in the treatment of patients with symptoms from stroke.

The consistency of the patient results from our initial commercial experience supports our plans to expand access PoNS Therapy in Canada.

Commercialization in Other Markets

5 unchanged sentences

In November 2021, we received market authorization from the TGA for the sale of PoNS as a Class IIa medical device.

In Australia, PoNS is authorized as a non-implantable neurostimulator intended for short term used by

healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

In Australia, PoNS is authorized as a non-implantable neurostimulator intended for short term used by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

PoNS is not intended to be used alone without an exercise program.

11 unchanged sentences

Canadian Reimbursement

We believe that traditional life and health payers may be among the earliest to provide coverage and reimbursement for the PoNS Therapy, and therefore, we are focusing on gaining coverage for the PoNS Therapy through them.

We believe that traditional life and health payers may be among the most relevant to provide coverage and reimbursement for the PoNS Therapy, and therefore, we are focusing on gaining coverage for the PoNS Therapy through them.

Life and health encompass long- and short-term disability claims.

1 unchanged sentence

As part of our commercial treatment program in Canada, we will collect both outcomes and return to work data, which we plan to utilize with life and health, provincial workers compensation insurance programs, and property and casualty insurers to demonstrate both the clinical and economic value associated with the PoNS Therapy.

In addition to private and public payers, we are pursuing in-patient hospital utilization with submissions to hospital formularies to encourage the use of PoNS in acute treatment especially in post-Traumatic Brain Injury and Stroke patients.

Reimbursement

2 unchanged sentences

Significant uncertainty exists regarding the coverage and reimbursement status of products approved by the FDA and other government authorities.

In the United States, sales of our products depend in significant part on the availability and adequacy of coverage and reimbursement from third party payors for our product and for services that use our products.

Third-party payors include government authorities such as Medicare and Medicaid, managed care providers, private health insurers, and other organizations.

The process for determining whether a payor will provide coverage may be separate from the process for setting the reimbursement rate that the payor will pay for the product or service.

Moreover, a payor’s decision to provide coverage does not imply that an adequate reimbursement rate will be approved.

Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

Third-party payors are increasingly challenging the prices charged for, examining the medical necessity, safety, and efficacy of, and assessing the cost-effectiveness of medical products.

In the United States, sales of our products depend in significant part on the availability and adequacy of coverage and reimbursement from third party payers for our product and for services that use our products.

Third-party payers include government authorities such as Medicare and Medicaid, managed care providers, private health insurers, and other organizations.

The process for determining whether a payer will provide coverage may be separate from the process for setting the reimbursement rate that the payer will pay for the product or service.

Moreover, a payer’s decision to provide coverage does not imply that an adequate reimbursement rate will be approved.

Adequate third-party

reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

Third-party payers are increasingly challenging the prices charged for, examining the medical necessity, safety, and efficacy of, and assessing the cost-effectiveness of medical products.

government and state legislatures have shown significant interest in implementing cost containment programs to limit the growth of government-paid health care costs, including price controls and restrictions on reimbursement.

Any such downward pressure on the

reimbursement for our products could limit our ability to realize an appropriate return on our investment in product development.

Any such downward pressure on the reimbursement for our products could limit our ability to realize an appropriate return on our investment in product development.

CMS has indicated that it is developing a program that would provide a pathway for expedited transitional coverage of emerging technologies under the Medicare program, though that rule has yet to be released.

While we will continue to monitor this, we will also remain focused on building out our reimbursement strategy for both commercial and government payers.

While we continue to monitor this, we will also remain focused on building out our reimbursement strategy for both commercial and government payers.

We continue to work with Medicare requirements and policies for coverage, coding, and payment of durable medical equipment and assess how the PoNS device may be treated with respect to coding, coverage, and reimbursement under the Medicare program.

18 unchanged sentences

● Unlike deep brain stimulation devices, implantable vagal nerve devices and other invasive forms of electrical stimulation, the tongue allows for neurostimulation to be delivered via a portable, non-implantable device.

allows for the concomitant utilization of portable neurostimulation with a wide range of pharmacological therapies and non-pharmacological interventions previously unexplored for neurological rehabilitation.

This allows for the concomitant utilization of portable neurostimulation with a wide range of pharmacological therapies and non-pharmacological interventions previously unexplored for neurological rehabilitation.

Intellectual Property

15 unchanged sentences

Non-invasive neurostimulation of a subject’s oral cavity or skin while the subject engages in a physical or cognitive exercise in order to enhance the subject’s proficiency in the exercise

Non-invasive neurostimulation of a subject’s oral cavity or skin while the subject engages in a physical or cognitive exercise and while the patient is not engaged in the exercise in order to enhance the subject’s proficiency in the exercise

(Provisional)

5 unchanged sentences

Therefore, though the two provisional applications have expired, they establish a priority date for U.S.

and 11,285,325, U.S.

and 12,064,629, and U.S.

Application No.

25 unchanged sentences

Company Owned Intellectual Property

As of February 14, 2024, we have filed 36 U.S.

As of February 23, 2025, we have been granted 36 U.S.

patent applications related to various technical and ornamental aspects of the PoNS device:

15 non-provisional patent applications that describe various technical features in the current version device and 21 design patent applications describing various ornamental designs.

15 patents that cover various technical features in the current version device and 21 design patents describing various ornamental designs.

We have also filed two U.S.

provisional patent applications related to aspects of our next generation neurostimulation technology.

We are the sole assignee for these 38 U.S.

patent filings.

In addition to the first issued patent (U.S.

9,072,889), the USPTO has issued 14 utility patents and 21 design patents.

Our current U.S.

patent portfolio consists of the following:

Application No.

Subject Matter

Utility patent covering overall system design, including controller and mouthpiece

Utility patent covering strain relief mechanisms for the connection between the mouthpiece and the controller

Utility patent covering shape of the mouthpiece

Utility patent covering center of gravity of the mouthpiece

Utility patent covering structural support of the mouthpiece

Utility patent covering glue wells of the mouthpiece

Utility patent covering overall system design, including controller and mechanical details of the mouthpiece

Utility patent covering aspects of the controller

Utility patent covering authentication techniques

Utility patent covering the locators of the mouthpiece

Utility patent covering methods of manufacturing the mouthpiece

Utility application covering overall system design, including controller and mechanical details of the mouthpiece

Utility application covering methods of manufacturing the mouthpiece

Utility patent application covering methods of placing a mouthpiece in a patient’s mouth prior to engaging in NINM

Utility patent application covering overall system design, including controller and mechanical details of the mouthpiece, where controller and mouthpiece communicate wirelessly

Provisional patent application covering next generation neurostimulation technology

Design patent covering an alternative version of the current PoNS device -over-ear double boom design

Design patent covering an alternative version of the current PoNS device -overhead minimal interference design

Design patent covering system design used in the current PoNS device

Design patent covering an alternative mouthpiece not used in the current PoNS device

Design patent covering the controller used in the PoNS device

Design patent covering an alternative controller not used in the current PoNS device

Design patent covering an alternative mouthpiece not used in the current PoNS device

Design patent covering mouthpiece used in the current PoNS device

Design patent covering an alternative controller not used in the current PoNS device

Design patent covering alternative system design used in the current PoNS device

Design patent covering mouthpiece retainer case design used in the current PoNS device

Design patent covering carry case design used in the current PoNS device

Design patent covering alternative system design used in the current PoNS device

In addition to our U.S.

patents, we have been granted 22 foreign utility patents (nine in Australia, five in Russia, two in Canada, two in Israel, two in Europe (validated in France, Germany, Italy, UK and Spain), one in UK and one in Eurasia, or EA (validated in all eight Eurasian member-states), and 33 foreign design patents (three in Australia, nine in Canada, six in Russia, and fifteen registered community designs in Europe).

Further, we have 11 foreign utility patent applications that are currently pending:

three in Europe, two in each of Australia, Canada and Russia and one in each of China and Israel, and one design patent application that is currently pending in Canada.

patents, we currently own 17 foreign utility patents (nine in Australia, two in Canada, two in Israel, three in Europe (validated in France, Germany, Italy, the UK and Spain), and one in the UK and 34 foreign design patents (three in Australia, ten in Canada, six in Russia, and fifteen registered community designs in Europe).

Further, we have six foreign utility patent applications that are currently pending:

two in Europe, and one in each of Australia, Canada, China and Israel.

Our current owned foreign utility patent portfolio consists of the following:

Foreign patents/

PCT application

US Priority document(s) (filing date)

*patent applications

WO2016/089751A1

14/559,080 (3 December 2014)

AU2015355211B2

(PCT/US2015/062950)

14/559,123 (3 December 2014)

AU2017218934B2

14/559,118 (3 December 2014)

AU2017276270B2

14/559,105 (3 December 2014)

AU2018204184B2

Systems and Methods for

AU2018247259B2

Providing Non-Invasive

Neurorehabilitation of a Patient

WO2016/089752A1

14/557,787 (3 December 2014)

AU2015355212B2

(PCT/US2015/062953)

14/557,789 (3 December 2014)

AU2017228517B2

14/559,045 (3 December 2014)

AU2019200175B2

AU2019246836B2

Devices for Delivering Non-

Invasive Neuromodulation to a

EP19190373.1A*

WO2016/089795A1

14/559,080 (3 December 2014)

(PCT/US2015/063059)

14/559,123 (3 December 2014)

14/559,118 (3 December 2014)

14/559,105 (3 December 2014)

Methods of Manufacturing

Devices for the Neurorehabilitation

WO2020/176954

62/812,185 (28 February 2019)

AU2020228618A1*

(PCT/US2020/019853)

CN113728393A*

Computer Systems and

EP20712806.7A*

Methods for Enhancing

Neurorehabilitation

Our current owned Australian design patent portfolio consists of the following:

Australian Design

Application No.

Subject Matter

Design patent covering system design used in the PoNS device

Design patent covering the controller design used in the PoNS device

Design patent covering the mouthpiece design used in the PoNS device

Our current owned Canadian design patent portfolio consists of the following:

Canadian Design

Application No.

Subject Matter

Design patent covering system design used in the current PoNS device

Design patent covering an alternative mouthpiece not used in the current PoNS device

Design patent covering mouthpiece used in the current PoNS device

Design patent covering an alternative controller not used in the current PoNS device

Design patent covering the controller used in the PoNS device

Design patent covering system design used in the current PoNS device

Design patent covering alternative system design used in the current PoNS device

Our current owned Russian design patent portfolio consists of the following:

Russian Design

Application No.

Subject Matter

Design patent covering the system design currently used in the PoNS device

Design patent covering the mouthpiece design currently used in the PoNS device

Design patent covering the controller design currently used in the PoNS device

Design patent covering alternative system design used in the current PoNS device

Our current owned EU design patent portfolio consists of the following:

EU Community Design

Application No.

Subject Matter

002712026-0001 - 002712026-0007

Design patents covering several aspects of the system design currently used in the PoNS device

006753877-0001 – 006753877-0008

Design patents covering the controller design used in the PoNS device

Currently, we own rights in five trademarks:

2 unchanged sentences

We are also the owner of the rights in the PoNS Therapy, Helius, Helius Medical, and Helius Medical Technologies marks.

We are the owner of the trademark registrations for the Helius and PoNS Therapy marks in the U.S.

as well as the trademark registration for the Helius mark in Canada and the trademark registrations for the PoNS mark in Europe, Israel, and New Zealand.

We have also applied for the PoNS trademark in Russia, China and Australia along with the Helius trademark in Australia, and the Helius Medical trademark in the U.S.

We are the owner of the trademark registrations for the Helius, Helius Medical, PoNS, and PoNS Therapy marks in the U.S.

as well as the trademark registrations for the PoNS mark in Australia, Europe, Israel, New Zealand, and Russia.

We have also applied for the Helius trademark in Canada.

Below is a listing of our active trademark registrations or pending trademark applications:

Registration Number

Application Number

HELIUS MEDICAL

Government Regulation

24 unchanged sentences

Classification of a device is important because the class to which a device is assigned determines, among other things, the necessity and type of FDA review required prior to marketing the device.

QSR, facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.

Class I devices are those for which safety and effectiveness can be assured by adherence to FDA’s “general controls” for medical devices, which include compliance with the applicable portions of the FDA’s Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.

Some Class I devices also require premarket clearance by the FDA through the 510(k) premarket notification process described below.

16 unchanged sentences

To obtain 510(k) clearance for a medical device, an applicant must submit to the FDA a premarket notification submission demonstrating that the proposed device is “substantially equivalent” to a legally marketed device, known as a “predicate device.” A legally marketed predicate device may include a device that was legally marketed prior to May 28, 1976 for which a PMA is not required (known as a “pre-amendments device” based on the date of enactment of the Medical Device Amendments of 1976), a device that has been reclassified from Class III to Class II or Class I, or a device that was found substantially equivalent through the 510(k) process.

A device is substantially equivalent if, with respect to the predicate device, it has the same intended use and has either (i) the same technological characteristics, or (ii) different technological characteristics, but the information provided in the 510(k) submission demonstrates that the device does not raise new questions of safety and effectiveness and is at least as safe and effective as the predicate device.

device does not raise new questions of safety and effectiveness and is at least as safe and effective as the predicate device.

A showing of substantial equivalence sometimes, but not always, requires clinical data.

3 unchanged sentences

Once the 510(k) submission is accepted for review, by regulation, the FDA has 90 days to review and issue a determination.

As a practical matter,

clearance often takes longer.

As a practical matter, clearance often takes longer.

The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence.

22 unchanged sentences

All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption, or IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

If the device presents a “significant risk,” as defined by the FDA, to human health, the FDA requires the device sponsor to submit an IDE application to the FDA, which must

become effective prior to commencing human clinical trials.

If the device presents a “significant risk,” as defined by the FDA, to human health, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials.

A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject.

22 unchanged sentences

● clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices;

device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

● medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

● correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

13 unchanged sentences

Practices that involve remuneration to those who prescribe, purchase, or recommend medical devices, including discounts, providing items or services for free or engaging such individuals as consultants, advisors, or speakers, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor and would be subject to a facts and circumstances analysis to determine compliance with the Anti-Kickback Statute.

Violations of this law are punishable by up to ten years in prison, criminal fines, administrative civil money penalties, damages, disgorgement and exclusion from participation in federal healthcare programs.

Violations of this law are

punishable by up to ten years in prison, criminal fines, administrative civil money penalties, damages, disgorgement and exclusion from participation in federal healthcare programs.

In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it.

Various states have adopted laws similar to the Anti-Kickback Statute, and some of these state laws may be broader in scope in that some of these state laws extend to all payors and may not contain safe harbors.

Various states have adopted laws similar to the Anti-Kickback Statute, and some of these state laws may be broader in scope in that some of these state laws extend to all payers and may not contain safe harbors.

The federal civil False Claims Act imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities (including manufacturers) for, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment of government funds or knowingly presenting or causing to be presented a false statement or record material to payment of a false claim or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government.

Penalties for a False Claims Act

violation include three times the actual damages sustained by the government, plus significant mandatory civil penalties for each separate false claim and the potential for exclusion from participation in federal healthcare programs.

Penalties for a False Claims Act violation include three times the actual damages sustained by the government, plus significant mandatory civil penalties for each separate false claim and the potential for exclusion from participation in federal healthcare programs.

The government may deem manufacturers to have “caused” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label.

2 unchanged sentences

Conduct that violates the False Claims Act also may implicate various federal criminal statutes.

Various states have adopted laws similar to the False Claims Act, and many of these state laws are broader in scope and apply to all payors, and therefore, are not limited to only those claims submitted to the federal government.

Various states have adopted laws similar to the False Claims Act, and many of these state laws are broader in scope and apply to all payers, and therefore, are not limited to only those claims submitted to the federal government.

The federal Health Insurance Portability and Accountability Act (“HIPAA”) imposes criminal liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payers, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

60 unchanged sentences

any failure to honor promises, such as the statements made in a privacy policy or on a website, may also constitute unfair or deceptive acts or practices in violation of the FTC Act.

The FTC has the power to enforce promises as it interprets them, and events that we cannot fully control, such as data breaches, may be result in FTC enforcement.

The FTC has the power to enforce promises as it interprets them, and events that we cannot fully control, such as data breaches, may be

result in FTC enforcement.

Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.

5 unchanged sentences

Failure to comply with the CCPA may result in, among other things, significant civil penalties and injunctive relief, or statutory or actual damages.

In addition to the CCPA, numerous other states’ legislatures are

considering similar laws that will require ongoing compliance efforts and investment.

In addition to the CCPA, numerous other states’ legislatures are considering similar laws that will require ongoing compliance efforts and investment.

For example, Virginia, Colorado, Utah, Indiana, Iowa, Tennessee, Montana, Texas, and Connecticut have enacted privacy laws similar to the CCPA that impose new obligations or limitations in areas affecting our business and we continue to assess the impact of these state legislation, on our business as additional information and guidance becomes available.

19 unchanged sentences

A lack of valid transfer mechanisms for GDPR-covered data could increase exposure to enforcement actions and may affect our business operations and require commercial cost (including potentially limiting our ability to collaborate/work with certain third parties and/or requiring an increase in our data processing capabilities in the EU/UK).

Further, the European/UK data protection laws (including laws on data transfers) may also be updated/revised, accompanied by new guidance and/or judicial/regulatory interpretations, which could entail further impacts on our compliance efforts and increased cost.

Further, the European/UK data protection laws (including laws on data transfers) may also be updated/revised,

accompanied by new guidance and/or judicial/regulatory interpretations, which could entail further impacts on our compliance efforts and increased cost.

Additionally, other countries outside of Europe/UK have enacted or are considering enacting similar cross-border data transfer restrictions and laws requiring local data residency, which could increase the cost and complexity of delivering our services and operating our business.

5 unchanged sentences

(formerly known as 0922327 B.C.

Ltd.) and 0995162

Ltd.) and 0995162 B.C.

to reorganize the business structure of such three entities in such a manner which would allow Boomerang Oil, Inc.

2 unchanged sentences

On July 20, 2018, we reincorporated from the state of Wyoming to the state of Delaware.

On March 11, 2025, we obtained a Certificate of Formation for Revelation Neuro with the Secretary of State of Texas.

Acquisitions, Mergers and Dissolutions

On June 13, 2014, we acquired NeuroHabilitation Corporation (“NHC”) and on December 21, 2018, NHC changed its name to Helius Medical, Inc.

3 unchanged sentences

HMC is our operating subsidiary in Canada.

On September 12, 2024, Helius NeuroRehab, Inc., a wholly owned and dormant subsidiary of HMTI, was merged into HMTI pursuant to a Certificate of Ownership and Merger certified by the State of Delaware.

On September 20, 2024, Heuro was dissolved pursuant to a Certificate of Dissolution issued under the Canada Business Corporations Act.

On September 23, 2024, Helius Canada Acquisition Ltd., a wholly owned Canadian subsidiary of HMC, was dissolved pursuant to a Certificate of Dissolution issued under the Canada Business Corporations Act.

Corporate Information

Our principal executive offices are located at 642 Newtown Yardley Road, Suite 100, Newtown, PA 18940 and our telephone number is 215-944-6100.

We maintain a corporate webs ite at www.helius medical.com.

We maintain a corporate website at www.heliusmedical.com.

We make available free of charge through our Internet website our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and any amendments to these reports, as soon as its reasonably practicable after we electronically file such material with, or furnish such material to the SEC.

16 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business