What changed in Solana Co's 10-K — 2024 vs 2025

Clinical research has shown that translingual neurostimulation activates two major cranial nerves – the trigeminal nerve, and the facial nerve, which creates a flow of neural impulses that are delivered directly into the brain stem and cerebellum – the main control centers for multiple functions including sensory perception and movement.

From the brain stem, these impulses travel throughout the brain and may activate or reactivate signaling pathways involved in human function.

Researchers believe that supervised therapeutic exercise with neurostimulation can modulate neural activity and initiate adaptive changes in the brain that lead to restructuring and reorganization (neuroplasticity) processes in specific areas of the brain. 6 Table of Contents Design The PoNS device is ergonomically designed for patient comfort, is relatively light, contains a replaceable hygienic mouthpiece and a rechargeable battery with built-in technology to allow for tracking of the patient’s usage, including time and intensity of treatments.

See Figure 1. Figure 1 The Portable Neuromodulation Stimulator, PoNS device The mouthpiece of the PoNS device sits on the front third of the tongue and is held in place by the lips and closed mouth. See Figure 2. Figure 2 A rechargeable lithium polymer battery with built-in charge safety circuitry provides power.

While the voltage and pulse timing to each electrode are programmed into the device and cannot be altered, the user can adjust the stimulus intensity, which is achieved by adjusting the electrical pulse width. The sensation produced by the mouthpiece is similar to the feeling of drinking a carbonated beverage.

The patented waveform is specifically designed to minimize the potential for tissue irritation. 7 Table of Contents Overview of MS and Current Available Treatments MS is currently classified as an autoimmune disease of the central nervous system.

The disease attacks the myelin, the protective covering of the nerve necessary for the transmission of nerve impulses through nerve fibers, causing inflammation and often damaging the myelin. Damage to the myelin is variable, depending on the course of the disease, which influences the type and severity of symptoms.

MS is unpredictable and can cause symptoms such as extreme fatigue, lack of coordination, weakness, tingling, impaired sensation, vision problems, bladder problems, cognitive impairment and mood changes. Its effects can be physical and emotional with a substantial financial burden. Currently there is no cure and patients with MS experience a progressive decline in health over time.

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 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.

The U.S. 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 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 (Baird et al, 2019).

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 (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.

Although there is no cure for MS yet, immunotherapy can provide disease-modifying effects, and other pharmacological and non-pharmacological treatments can manage symptoms. MS medications are designed to lessen the frequency of relapses and slow the progression of the disease, but none have been proven to halt progression of the disease.

While there are several disease-modifying medications approved by the FDA to treat MS, only one drug approved by FDA and Heath Canada, Ampyra® (dalfampridine), which is indicated for the improvement of gait speed in conjunction with physical therapy in patients with MS, offers the closest, albeit limited only to speed, comparison to PoNS Therapy on improvement in gait.

Overview of TBI and Current Available Treatments 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, 8 Table of Contents 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 (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.

Prior to the development of the PoNS device, there were no cleared treatments that were clinically indicated to treat balance deficit. A few studies have suggested that supervised therapeutic exercise aimed at improving balance and gait may be mildly effective for rehabilitation in the mmTBI population.

Given the small number of published studies, the small number of patients enrolled in the studies of which we are aware, the varying range of interventional protocols employed in such studies and the lower levels of study design, it is difficult to draw any conclusions regarding the effectiveness and dosing parameters of using supervised therapeutic exercise alone for the treatment of balance deficit following mmTBI.

Consequently, we believe that there is a large potential commercial opportunity for the PoNS Therapy in the treatment of balance deficit due to mmTBI. Our goal is to establish the PoNS Therapy as the standard of care for this condition all over the world.

Overview of Stroke and Current Available Treatments 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 878,000 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 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.