Axis

We develop portable neuromodulation devices for Alzheimer's Disease (AD) and Parkinson’s Disease (PD). Our devices incorporate precise transcranial current stimulation (tCS) technology for the treatment of AD and PD.

Alzheimer's Disease and Parkinson's Disease are the two large neurodegenerative disorders that are pervasive throughout the world. Over 60 million individuals are suffering from one or both of these disorders worldwide and the current treatment regimes are ineffective and costly. Treatments include pharmacological intervention or invasive surgery techniques. Furthermore, the caregiving costs that we need to provide for these patients are high leading to a $305 billion economic burden emerging from these disorders. To continue, the main factors that contribute to these problems are the cost, accessibility, and invasiveness of current treatments.

In regard to costs, at U we have developed tCS neuromodulation units whose costs of parts are underneath $100. This is highly disruptive in the field of neuromodulation as current technologies, such as TMS and DBS, require advanced and expensive manufacturing procedures to produce units.  Healthcare workers, patients, and hospitals resort to TMS and DBS technologies to advance neuromodulation in their treatment regimes. Precision noninvasive neuromodulation has yet to be explored with advanced tCS waveforms and that is what makes U highly innovative. Furthermore, we are developing out an electroencephalography (EEG) component to our tCS technologies which allows for subsequent measurements of brain activity pre-, during-, and post-stimulation sessions. We then develop a treatment protocol for specific patients' brains while being reimbursed by patients for each stimulation session. We have modeled costs of stimulation to be around $0.5-2 per session and the average number of sessions needed for a Stage II PD patient will be 15 sessions every 3 months.

To continue on the second factor that fuels the prominence of Parkinson's and Alzheimer's Disease, we will turn to the accessibility and invasiveness of current treatment modalities. In Africa, it has been cited by the World Health Organization (WHO) that less than 2% of the drugs consumed in Africa are produced in Africa and that 50% of children under five who die of pneumonia, diarrhea, measles, HIV, tuberculosis and malaria are in Africa. This means that 1) the medical supply chain infrastructure in Africa is dependent upon global forces leading to expensive imported medications and 2) the lack of accessibility of medicine leads to unwarranted deaths in the pediatric population resulting in shortened average lifespans on the continent.

On the last factor of invasiveness, globally, major treatments for Parkinson's Disease and Alzheimer's Disease involve the usage of implantable electrodes into deep cortical regions to electrical reactivate degenerated circuits, dubbed Deep Brain Stimulation (DBS). Although effective, the surgical costs for DBS render it to be an impractical treatment in countries where sanitary medical facilities is scarce.  Furthermore, the neurosurgical training needed to implant electrodes are a major barrier of entry in developing countries' nations further diminishing the access of quality treatments of PD and AD.

A noninvasive and cost-effective device for PD and AD is a breakthrough innovation that will change the current state of care in the neurodegenerative economy. With over 44 million cases worldwide and with the total healthcare costs for Alzheimer’s Disease totaling over $305 billion, we expect U’s novel neuromodulation technology to be integrated into the current healthcare system to enhance current treatment regime efficacy with combined precision neuromodulation and pharmacotherapy. Our vision is to incorporate non-invasive neuromodulation into the standard practice of care in both developed and developing nations. Furthermore, we envision hospitals and medical schools incorporating training protocols to allow nurse practitioners, physician assistants, and physicians to select, optimize, and tract stimulation protocols and montages remotely through telehealth services and/or remote monitoring.

At U, we have engineered a device that modulates and detects neural oscillations in a closed-loop transcranial current stimulation (tCS) and electroencephalogram (EEG) device. This device, called Axis, utilized several types of stimulation modalities to that were selected for each specific disease. The tCS paradigm sends small electrical packets through current drivers to generate voltage gradients inside the brain and the devices are used for 20 minutes. This can excite and/or inhibit regions of the cortex to modulate the subject’s endogenous neural oscillations. By modulating the endogenous neural oscillations of the brain, we can guide the brain to a desired state of activity, arousal, and/or plasticity that is indicative of a healthy brain.

Traditionally, the way to modulate endogenous neural oscillation of the brain is through transcranial direct current stimulation (tDCS) paradigm. The tDCS paradigm delivers weak electrical currents to the brain via noninvasive electrode contacts to prime underlying brain regions to higher states of excitability or inhibition. Higher states of excitability come from the anode (negative) tDCS electrode contact and higher states of inhibition come from the cathode (positive) tDCS electrode contact. This is due to the fact that the voltage gradient generated by the two electrode contacts moves in one direction, from the cathode to the anode, and the voltage gradient carries the ions that excite the neurons from the cathode region of interest to the anode region of interest. This means the ions that excite the neurons are near to the anode electrode contact, causing higher states of excitability, and further away from the cathode electrode contact, causing lower states of excitability, or rather, higher states of inhibition. The application of tDCS is often safe, at low currents, however, it is incapable of inducing repeatable neurophysiological effects.

Transcranial Alternating Current Stimulation (tACS) is another noninvasive neuromodulation tool and it has been shown to modulate endogenous brain activity in a frequency-dependent manner to treat memory and neurodegenerative diseases. By applying a weak alternating current to the scalp, tACS can entrain natural neural oscillations in the range of the stimulation frequency. It is important to note that the frequency of the tACS being applied is correlated to the frequency it entrains over the regions in which the electric field passes. A downside of tACS is that it does not provide a sufficient current level to depolarize neurons to efficiently induce myelination of axonal branches and increase functional connectivity between regions to induce greater interhemispheric coherence. In summary, tACS is a tool to entrain brain oscillations without substantially directly affecting neural circuits.

Transcranial Pulsed Current Stimulation tPCS is a new neuromodulation treatment. It is of high interest for its quality in safety and higher effectiveness than traditional tDCS by sending discrete current pulses with intervals rather than a continuous current like tDCS.  A new noninvasive stimulation paradigm named anodal-Transcranial Pulsed Current stimulation has shown better enhancement of cortical excitability than traditional tDCS as well as showing increased interhemispheric coherence of brain oscillatory activity, mainly in the fronto-temporal regions. Being able to modulate activity in the prefrontal cortex with transcranial pulsed current stimulation allows for altering and enhancing higher cognitive functions, including impulse control and increased attention.

At U: The Mind Company, we utilize different waveform modalities (tDCS, tACS, tPCS) to customize specific waveforms for Parkinson's Disease and Alzheimer's Disease. Furthermore, our technology is adaptable for different head-shapes to customize the electric field delivery to specific tracts and/or regions inside the brain. Different pathologies have highly correlated abnormalities in 1 or more specific tracts and/or regions inside the brain. By using different stimulation and montage patterns, our adaptable technology is even configurable for neurodegenerative disorders outside of PD and AD. Lastly, the development of a closed-loop electroencephalogram (EEG) and tCS system will allow the technology to go one step deeper and adapt waveforms to specific physiological biomarkers.

We have 3 targeted populations who we aim to directly improve lives for which we have listed in the timely order of impact: patients, healthcare workers, and the community. We are focused on the commercialization of our technology in health sectors across Africa

For patients, we provide a cost-effective, non-invasive, and efficacious solution to their neurodegenerative disorder. Our devices allow patients to pay for the number of stimulation sessions they need as the devices are stationed in the hospital which allows for treatment costs to not exceed more than $40 a month for 20 days of stimulation (~$2 per 20-minute stimulation session). Furthermore, the portability and non-invasive of Axis allow for more time-efficient set-up, monitoring, and removal of the tCS treatment which allows for parallel treatments of patients at scale. Our technologies have shown, in 2 pilot studies, the ability to mitigate specific symptoms of Parkinson's Disease and Alzheimer's Disease. More specifically, we have video evidence of reduction of resting tremor in several PD patients and fMRI data showcasing the slowing down and reversal of frontal degeneration in terms of activity for AD patients.

For healthcare workers, we provide effective, safe, and portable treatment to be used in their clinics to reduce patient overflow in their medication sparse countries. First, our company will provide certifications programs to train healthcare workers on the deployment of tCS technologies on their patient population as well as educate them on the biophysical mechanisms of the electrical field on neuronal tissue. This will empower physicians to expand their clinics' services in their country as well as provide the hospitals with reusable devices to be used in their patient population.  Second, our devices provide a new neuromodulation platform in their hospital for which we will use to expand the medical internet-of-things (MIoT) ecosystem over the years ahead. Our neuromodulation technologies have the capabilities to be updated in real-time to provide novel stimulation parameters personalized to each patient's brain. By collecting, securing, and analyzing the big data from our technology, we are able to have an asset that appreciates over time. Namely, our device's ability to provide more personalized treatment increases the more the devices are used which greatly benefits patients, as well as healthcare workers looking to expand the repository of services in their clinics.

For communities, our technologies provide hope that medications and care are being highly prioritized in these nations where economic development is low. In Africa, the WHO cited that 1.1 billion people lack regular access to even the most essential medicines. By providing efficacious technologies to these medicine scare countries, we empower communities by providing them the health they need to develop stable economies. Furthermore, we will aim to measure an indirect increase in mental health levels of community members due to a restoration of health infrastructure to ensure their communities and countries' position in the global healthcare supply chain. This will minimize healthcare-related poverty due to extreme medical conditions like PD and AD that render the individual to work to support the community and their family.

Mohammed Abouelsoud is the Founder and CEO of U: The Mind Company. Mohammed has over 6 years of deep experience in the fields of neuroscience, neuromodulation, and neurotechnology and he has over 10,000+ hours of engineering, reading, and clinical experience with electrical stimulation waveforms. Mohammed studied Computational Neuroscience and Applied Physics at The Ohio State University prior to founding U. Mohammed is directly involved in grant writing, engineering development, clinical trial management, intellectual property writing, and business networking to expand U’s presence and collaborative opportunities. Mohammed Abouelseoud sits on the board at U and is the Chief Executive Officer.

Dr. Jeffrey Spitzner PhD has over 20 years’ experience as a founder and executive of nine Life Sciences, Software, Investment, Bio-Technology, and Healthcare companies that contributed over $35 Million to the Columbus, OH community. Dr. Spitzner has numerous publications, invited conference presentations and interviews, and industry awards. He completed his Ph.D. at The Ohio State University in molecular cancer research with a postdoc at the Massachusetts Institute of Technology (MIT). Dr. Spitzner is directly involved in grant and intellectual property writing as well as setting up the corporate foundation at U: The Mind Company. Dr. Jeffrey Spitzner PhD sits as the Chairman at U.

Dr. David Mishelevich MD PhD received an M.D. and a Ph.D. in Biomedical Engineering from The Johns Hopkins University and, at The University of Texas Southwestern Medical School in Dallas, was Professor and Chair of the first Department of Medical Computer Science in the U.S.  At Sparton/Aubrey Group, contract medical device development/manufacturing firm, he was VP of Engineering and Chief Medical Officer.  Dr. Mishelevich has been a team member in a number of startups including being a founder of NeoStim (over $25M invested prior to its unfortunate demise).  During the initial development of NeoStim’s stereo Transcranial Magnetic Stimulation (sTMS) IP, he was Consulting Professor of Neurosurgery at Stanford. He was an inventor on 44 granted patents with 18 in deep-brain neuromodulation  (sTMS, optogenetics, ultrasound).  He serves on the Board of Directors at U.

Dr. Sam Khozin MD is a battle-tested entrepreneur who happens to be a doctor.  Through his experience in medical school, internal medicine residency, as a patient and as an entrepreneur, he has become keenly aware of the most valuable limited resource we have - time. Sam’s goal is to compassionately optimize the way our healthcare system thinks about and uses time for people on both sides of the exam table. He has been developing the initial prototypes at U and aiding with physician networking.

Nick Knudson is an established Electronic Engineering Consultant with a degree from The Ohio State University and has deep experiences in the industries of robotics, consumer electronics, and wearable devices such as EEGs and EMGs. Other engineering expertises from Nick are developing electronics prototypes, minimum viable products, industrial design, products design, firmware development, software development, electronics design, schematic capture, PCB layout, design for manufacturing, contract manufacturing, volume manufacturing, manufacturing test fixtures, manufacturing test software, secure device provisioning, device authenticity, genuine hardware, and regulatory certifications. Nick Knudson and his firm are developing the PCB layout, electrode design, and minimum viable product for Axis at U.

Dr. Nicholas Peatfield PhD has a PhD in Psychology, and Postdoctoral Training from Bangor University in electrophysiology (EEG/MEG), neurostimulation (TMS), and new neurotechnologies (OPMs). He has 24 publications in the neurotechnology field with 250+ citations on these publications. He founded ProtoMe Technologies Inc. which is a company specializing in diagnostic systems for brain health using their own machine learning software data analytics platform.

In 2020, we applied to the Horizion Prize when the company's technology was in an initial stage of development. We have greatly expanded our data, team, and technology to be able to deploy our technology at a higher scale. Due to the work that MIT has done with previous horizon winners, we hope to learn and be led by the Challenger Leaders to adapt from their past experiences navigating different problems that we have not anticipated at scale. We hope that the quality of professionals at MIT will allow us to develop our company on a legal, technological and business front as well. The success of MIT comes from various domains at the university like in engineering, research, and philanthropic works which we hope to integrate our work with.

At U, we developed a closed-loop transcranial current stimulation (tCS) and an electroencephalogram (EEG) device, called Axis, to be used for the treatment of neurodegenerative disorders. What makes our technology unique comes from three major variables: cost, portability, and effectiveness. Our technology will be priced around $500 with a $10 monthly subscription which is several magnitudes lower in comparison to antidepressants and/or pharmacological intervention, TMS, and DBS. Because Axis is noninvasive and portable, we can reduce the cost of hospital visits as well as open the opportunity for telehealth services to be more utilized in the mental health economy. We have pioneered a novel transcranial pulsed current stimulation (tPCS) technology that shows to be highly advantageous to other transcranial stimulation methods in modulating excitability in the cortex. U has developed a wide variety of waveform parameters for different applications in both therapeutic and consumer markets. Our approach utilizes an electrical stimulation waveform that turns on and off repetitively,  allowing the cerebral cortex to achieve higher states of plasticity. At U, we have collected hundreds of thousands of minutes of recording device use with positive safety and effectiveness data. This combination of cost, portability, and effectiveness makes our technology highly novel and disruptive in the neuromodulation space compared to the current state of the art. 

A noninvasive and cost-effective device for Alzheimer’s Disease is a breakthrough innovation that will change the current state of care in the Dementia economy. With over 44 million cases worldwide and with the total healthcare costs for Alzheimer’s Disease totaling over $305 billion, we expect U’s novel neuromodulation technology to be integrated into the current healthcare system to enhance current treatment regime efficacy with combined precision neuromodulation and pharmacotherapy. Our vision is to incorporate non-invasive neuromodulation into the standard practice of care. Furthermore, we envision hospitals and medical-schools to incorporate training protocols to allow nurse practitioners, physicians assistants, and physicians to select, optimize, and tract stimulation protocols and montages remotely through tele-health services and/or remote monitoring. Furthermore, we expect to have transcranial stimulation technology be expanded into other neurological disorders such as in the psychiatric, oncological, and epilepsy domains.

Outside of the medical fields, the neuromodulation technologies being developed at U will widen a developing economy called performance optimization or often called biohacking. Whether a police officer, first responder, business executive, medical surgeon, or professional athlete, optimizing peak performance metrics down to a physiological level will open the floodgates of biohacking trends to the mainstream public. Since our technology can record neuronal endogenous oscillations from a single and group of endogenous individuals, we can develop pulses customized to a person, group of people, or an entire organization to optimize and synchronize how decisions are made on a person, group, and total-group levels. Group level neural-optimization is called hyperscanning recording+stimulation

In the short, 1 year term, U will further expand its clinical trial platform to continue recruiting patients with PD and AD to investigate transcranial stimulation under proper regulatory settings. The technology that is developed will go through a regulatory approval process which is different in countries across the globe. In the Democratic Republic of Congo, Cameroon, and Mali, we have partnering hospitals that will aid in the documentation of getting device approvals in their associated countries which we expect to take around 6 months. The technology is manufactured under good manufacturing practices (GMP) and we have HIPAA-secured medical portals (MP) where physicians can log on and input patient information associated with device use. The MPs will also allow us to generate early revenue, once devices are approved, for payment of sessions needed for a given patient.

In the medium 2-3 year term, we will solidify an advanced machine learning device that has EEG and tCS capabilities allowing for concurrent brain activity recording and eclectic field modulation. We have software engineering experts that will further refine our predictability algorithms to showcase an advanced medical device that we will extend across the medical community. To continue off this point, the technology will start investigations outside PD and AD, for example, epilepsy and major depressive disorder, to further expand the U pipeline of treatment. Furthermore, as we station out units in more hospitals across the globe, we will create an interconnected pipeline of information flow to allow for inter-continent collaboration through our company to treat patients at scale.

In the long term, in 4-5 years, as we find our technology and presence in more hospitals across the globe, we will also release consumer technology for cognitive enhancement for the general public. We will build two main pillars in our company, medical and consumer, that will be collaborative in terms of their neurological epidemiology analysis, stimulation personalization, and smart city applications will be based on big-data analysis. As the expansion of the company continues over the years ahead, we will find partnerships with leading organizations, universities, institutions, companies, federal agencies, and non-profits to be an integral part of our successes. We hope that with a collaboration with MIT, they can lead us on building great partnerships all over the globe.

The impact goals on an internal company level is listed in two major domain: engineering and clinical.

In an engineering setting, there are 4 main KPIs, with sub-KPIs which are listed below. First, we are evaluating whether the electrodes we are developing are sufficient to produce the high-frequency pulsed waveforms we intend to deliver in specific regions of the brain. Second, we are measuring whether or not the EEG capabilities of the device are 1) sufficient to pick up brain activity differences before/during/after stimulation 2) the signal-to-noise ratio of the signals, and how to maximally reduce interference from skin/skull/sweat and pulses 3) compare the brain activity data to standard EEG’s on the market today and 4) develop the software analysis to match current medical EEG standards.

In a clinical/medical setting, KIPs are specific quantitative data points that are collected via our Neuroimaging machines (MRI, EEG, fNIRS, MEG, etc.). For example, patients with Dementia after using our technology should see an increase in BOLD responses in the frontal cortex following prolonged periods of stimulation with our portable devices. With patients suffering from neuromuscular disorders, motor responses/changes/modulations are the KPI endpoints we are observing; whether it be a reduction of a tremor or increased mobility in a wheelchair. Furthermore, we will use big-data machine learning methods to refine more quantitative biomarkers to support waveform delivery as well as for general public knowledge on different medical statistics all over the globe; this is fueled by major and continuous epidemiology studies.

Out of all the 17 UN sustainable development goals, our primary focus with this application will be goal 3: ensure healthy lives and promote well-being for all at all ages. As of today, our company creates portable, cost-effective, and non-invasive technology for different neurodegenerative disorders. In the near term future, we will further expand the technologies capabilities for more disorders and with more applications in the field of medicine. Due to the portability and cost of our technology, we will rightly serve many developing countries' medical ecosystems through a technology that can be adopted in communities will medicine scarcity. Furthermore, the empowerment of portable tCS devices in the community will be reflected in the empowerment of healthcare workers deploying tCS devices. We will make sure to equip healthcare care workers with the proper training, education, and certifications for the management, care, and deployment of our current and future technologies in their hosptials.

In the short term, our theory of change revolves around educating, training, and certifying new health care workers on electrical stimulation in the brain. We are developing our a course platform with key opinion leaders teaching classes on specific subjects about electrical stimulation and its mechanism of actions on network, cellular, and subcellular processes in the brain. Furthermore, these classes will talk about the management and implementation of transcranial stimulation technology in a clinical setting, how to identify inclusion+exclusion criteria for patient populations for prescription, and dealing+reporting any adverse event reactions. Lastly, we showcase to physicians the interpretation of waveform parameters on behavioral, psychological, and imaging biomarkers to determine the optimal course of treatment for a given diagnosis.

In the medium term, the educating, training, and certifying process developed in short term will start to emerge more commonly in clinics in both developing and developed countries. We will start to see more research around the interaction of electrical fields in medicine with rare diseases, pharmacological synergy, and biological optimization where research will be done in vivo, in vitro, and in silico. Electrical fields and their applications will then extend outside of just the neurological field and find its place in other body systems to treat more complex disorders like using electrical fields for tumor impression, muscle fiber activation, and spinal cord injury rehabilitation to name a few.. This will open many research pathways in the future of different waveforms, medications, and mechanisitic studies for disorders in the field of medicine.

In the long term, as electrical stimulation finds a comfortable seat in research communities and hospitals, we will start to see pharmaceutical companies, medical schools, and undergraduate programs revolve around this new field of medicine. Training for all healthcare workers entering the field  will have, at a minimum, knoweledge on electrical stimulation in the medical field. A new opening on research grant, fellowships, and hospital departments will start to emerge as electrical stimulation becomes more foundational to precision medicine next to pharmacological application. We, at U, we will be integral in this expansion of medicine to this new desired state and we are committed to this work over the following decades ahead.

Transcranial current stimulation (tCS) studies how weak electrical current passes through a given brain region of interest to modulate neuronal activity. There are many different forms of tCS depending on how one chooses to pass the electrical waveform. These different forms are named after the shape of the electrical waveform which includes: direct, alternating, random-noise, and pulsed. Each waveform has a different mechanism of action on a neuronal level which can lead to different treatment outcomes. 

The main mechanisms of action transcranial direct current stimulation (tDCS) will be briefly outlined before summarizing the main literature findings. The basis of tDCS is through the application of one small continuous pulse through two electrodes positioned on the head. Direct current stimulation (DCS) does not induce cerebral activity directly but rather is focused on subthreshold modulation of neuronal membranes to alter spontaneous brain activity. The membrane voltage gradient values induced by standard 2-4 mA noninvasive direct current stimulation is <1 mV/mm which is insufficient in inducing effective spike firing in a neuronal population. 

The physics of transcranial alternating current stimulation is through the application of an alternating sinusoidal pulse between two electrodes on the head. tACS is similar to DCS in the fact that it does not induce cerebral activity directly and that its induced voltage gradient is <1 mV/mm. However, tACS focuses on entraining endogenous oscillations by guiding the spike frequency rate and direction on a single neuron to large neuronal tracts rather than the excitation/inhibition of a region of interest through anodal/cathodal direct current stimulation.

Transcranial random noise stimulation (tRNS) uses a sinusoidal alternating current between two electrodes positioned on the head. However, unlike tDCS, tRNS stimulation is randomly generated between a frequency range. Other parameters related to the stimulation electrodes, like position and size, are similar to tDCS. Although the specific mechanism of actions of tRNS is not established, it has been observed that repeated opening of sodium channels in a neuronal ensemble generated by a random frequency field leads to robust excitability upon the targeted region of interest. Furthermore, due to the random distribution of frequencies, it is speculated that tRNS induces a temporal summation of charge which leads to larger voltage gradients >1 mV/mm.

There are two main mechanisms of actions of pulsed current stimulation that have been theorized and observed electrophysiologically: pulsed current can summate charge to induce higher voltage gradients along a neuronal ensemble and that pulsed current stimulation can induce phasic subthreshold modulation along a region of interest. First, this induction of higher voltage gradients (>1 mV/mm) from charge current summation is achieved by sending high-frequency pulses faster than 5-20 ms which is the time integrity constant of the neuron. High Voltage gradients lead to great neuronal excitability and possibly suprathreshold depolarization. Secondly, phasic effects of stimulation are caused by the successive on/off nature of the pulsatile currents which subsequently attribute to the opening and closing Ca 2+ or Na+ channels which is unlike DCS. This leads to a gradual increase in the firing of action potentials in the targeted region of interest.

We at U: The Mind Company are a group of international neuromodulation experts making an impact on various neurodegenerative disorders. We have leaders on 6 continents and embrace the identity of diverse cultures. More deeply, we infuse the inter-continental relationships into our engineering, clinical, and marketing verticals. For engineering, we look to develop technologies that can be easily shipped, handled, and implemented in different countries, especially where the internet and medicine are scarce. For clinical verticals, we prioritize treatment indications that are prevalent in different geographies. PD and AD are prevalent disorders globally; in Africa specifically, the treatments for these diseases are scarce. Furthermore, we focus on the reusability of our technology so it can be crossly sterilized for different people. The leaders working with U speak several different languages which allows us to broaden our horizons into niche sectors in countries where English is not the most used language.

Due to the strong association between diverse identities in different countries with the accessibility of resources for people in those countries, we at U work on developing infrastructure not just for the growth of our technology. We focus on developing leaders through the initial lens of electrical stimulation by providing classes, connections, and communication of our future goals to our collaborators. The infrastructure we develop with our tCS devices allows physicians to expand the scope of their clinics to empower the healthcare workers to offer more services to the community. In short, we focus on leadership. Leaders that have the emotional intelligence to see the bigger picture while staying focused on the details at U.

Lastly, we offer our technologies globally not only as a service to provide health to other. We do it on a basis of respect for different countries that are not often linked to the global medical supply chain. We are aware that the diseases in the USA is required with diseases in Congo. We treat all of our connections with the highest standards of respect and professionalism. We develop leaders through growth-minded environments, open communication of ideas, efficiency on project tools, and accountability on goals as set up by team members individually. We at U build leaders and we work to develop all the necessary tools to continue on this value.

Our business model is two-fold: medical devices and consumer devices. As medical devices, we will go through the FDA 510 (k) process and other international regulatory agencies with a medical device indicated for Parkinson's Disease and Alzheimer's Disease. We have a regulatory expert assisting with this process. The device, once cleared, will be prescribed to patients through the traditional medical process. We will be attempting to have the device insured concurrently to this, however, due to the cost-effective nature of the device, we hope to make initial sales immediately. We are focused on commercializing our technology in developed and developing nations concurrently to serve both populations all done with good manufacturing practices (GMP).

As to continue with the medical device, our devices will have variable treatment lengths that will be predicted for each patient. For example, some patients with Stage II PD, low amplitude tremors, and normal gait shall use the tCS treatment for 5 days with recurring treatment every 3 months. while a patient with Stage IV PD, high amplitude tremors, and wheelchair-bound may need 1-month stimulation every other month. Patients, hospitals, and insurance groups will finance the number of sessions a specific patient as determined through clinical trials whose endpoints revolve around prognosis modulation through tCS treatment, for example, $1 each session/day of stimulation. This moves into the large big-data platform that U will collect, secure, and analyze for both internal and external use. Due to the large amount of data that U collects, we will utilize the data for support of other institutions and as well package personalized analysis models for case seniors to sell to interested parties (i.e. hospitals interested in patient response metrics to electrical stimulation). We have built and continue to perfect different short-,mid-, and long-term treatment protocols for a variety of patients to quantitatively determine the most optimal treatment length, waveform delivery, and post-stimulation period for patients.

As consumer devices, we will build an EEG component into the unit to record, track, and analyze neural activity derived from our stimulation and sell the device for an estimated $500. We will offer consumers a subscription pulse model where we will update their device for $10 a month with a new pulse to further enhance brain plasticity. Machine learning software will be embedded into the unit for real-time pulse modulation. Customers will unlock different optimization tools for them to use in their day-to-day schedules. The data collected on the consumer devices will be utilized to enhance medical device operations and vice versa by determining the optimal response curves for healthy and non-healthy individuals.

Aside from the revenue coming from one-time sales through selling equipment and subscription sales from using the equipment, our path to financial sustainability is through both non-dilutive and dilutive sources of funding. Proper funding will advance the engineering and research + development of the project described herein and it will be further outlined in later sections. In regard to other non-dilutive sources, U will submit grants for animal trials to study the mechanism of action of tPCS on different subcellular, cellular, and network processes in the brain for different neuropsychiatric, neurodegenerative, and neuromuscular disorders. Federal grants, strategic partnerships with non-profits, and crowdfunding platforms are all viable non-dilutive funding sources that we are embarking on at U. For dilutive sources, working with strategic investors who are well-versed in the neuromodulation space is critical to us as we are building a advisor and directory board filled with Key Opinion Leaders (KOL). Our expectations for investors are timely communication, long-term focus, and domain expertise in neuroscience. Whether through angel investors, venture capital, and/or high-net-worth individuals, we will welcome negotiations with these leaders for dilutive funding to scale the services at our company.

As of today, we have submitted 2 SBIR NIH animal grants as explained below. We are currently working with a principal investigator from the Mayo Clinic on an NIH R01 grant on the study of novel waveform parameters, dubbed amplitude modulation spinal cord pulsed current stimulation (ams-PCS) in spinal cord injury rats. In short, we will deliver a variety of novel pulsed waveforms in different rat groups and compare them to traditional spinal cord stimulation (SCS) parameters in rats suffering from spinal transection at T9 while they train to walk again on a customized treadmill. The 3 major aims of the project are, 1: Quantify the effect of different SCS waveforms on the recovery of motor functions and related neuronal changes after complete SCI with a comparison of pre-training stimulation and in-training stimulation, 2:  Identify the role of ams-PCS on spinal cord plasticity and sprouting after complete spinal cord injury, 3: Differentiate brain activation patterns and brain plasticity biomarkers as a result of different SCS waveforms.

Furthermore, with our current animal grants, we are working with a researcher at Marshall University on a SBIR grant to study the effects of different anodal tPCS waveforms on smoking cessation in nicotine-addicted mice and the physiology in midbrain processes. The 3 major aims of the project are, 1: Determine the differences between a-tPCS monophasic waveforms (5, 50, 500 ms with 50 ms Inter-Pulse-Interval (IPI) or Sham monophasic pulses) on nicotine e-Vape® self-administration, 2: Correlating nAChR upregulation with a-tPCS in mice alongside e-Vape self-administration, 3: Correlating changes in neuronal excitability and dopamine release to a-tPCS alongside e-Vape Administration. We are networking with more researchers to submit a variety of different grants to further elucidate the mechanism of action of tPCS on subcellular, cellular, and network actions in the central nervous system.

There are many ways to study the effects of tCS in animals through Non-dilutive grants, the goal combined tCS+Pharmacology and their mechanisms of action. This will open many research pathways in the future of different waveforms, medications, and mechanistic studies for different neurological disorders using electrophysiological, behavioral, and biochemical measuring methods to create multi-dimensional pulse profiles. At U, we will continue hypothesizing, writing, and submitting SBIR grants in the USA, and other grants internationally, to determine to optimize response curves for different tCS waveforms.

Other non-dilutive sources of funding that U is currently embarking on in with Parkinson's Disease non-profit groups. We have reached out and connected with different PD organizations in the past few months and we are presenting information about our current data and future technology plans to receive funding contracts for device manufacturing, clinical trial development, and commercialization potential in both developed and developing nations. We anticipate more collaborative efforts with non-profit groups over the months and years ahead as we collected more data, serve more patients, and expand our current list of KOL at our company. To close, we are U are interested in dilutive capital from angel investors, high-net-worth individuals, and/or venture capital partners; we have not made the right connections yet to initiate negotiations.