Parkinson's Remote Interactive Monitoring System

Parkinson’s is the fastest-growing neurological disease, affecting more than 10 million people worldwide. Clinicians face considerable challenges in tracking PD severity and progression. Clinicians evaluate patients yearly by testing their motor skills and cognitive functions during clinic visits. These infrequent and semi-subjective tests are skewed by many factors, including the need for patients to travel long distances to the clinic. Over 40 percent of individuals with Parkinson’s are never treated by a neurologist or Parkinson’s specialist because they live too far from an urban center or have difficulty travelling. PD is a chronic and progressive disorder characterized by a loss of neurons in the brain. PD does not affect everyone similarly due to the variability in neuronal loss. Many non-motor symptoms are also associated with PD creating a complex web of symptoms that need to be treated.  

We operate in Maine, USA, and will run a pilot project in collaboration with MaineHealth. We have been accepted into the Founder Residency program at the Roux Institute in Portland, Maine. The Roux Institute offers a one-year program that supports high-growth technology ventures and founders who are out to solve the world’s most pressing challenges related. The value proposition is that the pilot trial will determine the benefit of PRIMS in a US State with a primarily rural aging demographic. Facts regarding Maine and why it is an ideal test-bed location:

• 61.3% of Maine’s population lives in rural areas.
• Maine has one of the highest disability-adjusted life year rates in the US.
• In 2019, 210 Mainers died from PD (10 deaths per 100,000 population).
• Maine claims the oldest median age of any state.
• Maine has the highest share of the population aged 65 and older at 21.2%, estimated to grow to 37% by 2026.
• In Maine, telehealth is viewed as particularly beneficial for rural communities.

PRIMS will improve access and make the clinician's job of assessing Parkinson's Disease more effective and efficient than is currently possible. Disease progression results provided by intelligent software are available to patients and clinicians from separate web-accessible dashboards. Patients can view summary statistics on progress, and the medical team can see trends, details, and red-flagged issues that might require follow-up. PRIMS uses cost-effective depth cameras for capturing all movement data following a widely accepted testing format enabling a thorough assessment without requiring wearable sensors. The cameras are fixed in position on a specially designed preassembled frame surrounding a touchscreen computer for use in a hub clinic near where patients live. Patients can schedule monthly motor assessments at the clinic through the patient portal. The hardware captures all motor data as users are guided through the testing procedures via instructions on the screen. Data is stored in the database for disease status analysis and rating by our software.

Along with motor assessments, patient-reported data is essential in determining disease progression. PRIMS has an online survey tool that patients log into weekly to complete questionnaires which, like motor data, are stored in the database for analysis and rating. Both motor and survey data are used in the overall scoring of each patient. The raw motor and survey data is stored in the cloud and scored by our proprietary algorithms according to an internationally accepted rating scale. In addition,  an essential aspect of the motor assessments is that they are self-managed by patients who follow on-screen instructions for various tests involving hand and leg movements, posture, tremors, speech and gait. Scores and details of each test as well as overall trends and flagged issues of significance, give the care team a complete picture of a patient's status regularly so that treatment decisions can be made based on solid evidence.   

Parkinson’s Disease (PD) affects ten million people worldwide and is one of the fastest-growing neurological disorders. There is no cure; treatments reduce symptom severity but do not slow disease progression. Globally, disability and death due to PD are increasing faster than any other neurological disorder. The prevalence of PD has doubled in the past 25 years. Estimates in 2019 suggest that PD resulted in 5.8 million disability-adjusted life years, an increase of 81% since 2000, and caused 329,000 deaths, an increase of over 100% since 2000. PD is a clinical diagnosis that not only can be made by neurologists but also by trained non-specialists. Despite the significant impact, there is global inequality in the availability of neurological resources to manage the disease, with poor availability in rural areas. Assessing PD by trained non-specialized healthcare workers in primary care is critical in areas where specialist neurological services are unavailable. Few specialists work in rural areas. The WHO estimates that 0.03 neurologists per 100,000 people are located in low-income countries, 4.74 per 100,000 in high-income countries, and only 23% of countries worldwide have neurologists in rural areas. Assessment of PD by non-specialized healthcare workers and simplified treatment guidelines could offer better management in primary care where specialist neurological treatment teams are unavailable. PRIMS would dramatically reduce travel requirements; having PRIMS in rural communities in both high-income and low to middle-income countries with internet access at home or a local health centre would enable people with Parkinson’s to perform assessments at the centre, close to where they live. Local health workers would have access to the clinician portal data and scores and can use the data to make treatment decisions to alleviate symptoms. Neurologists in urban areas would also have access to the clinician portal and can discuss treatment plans with the local health workers. PragmaClin’s technology-based model will transform care to reach people in every corner of the world with neurological issues by digitally connecting patients with the care team. 

PRIMS is the right solution to the problem of detecting and managing Parkinson's Disease in underserved areas of the world, and our team is the right group to deliver the solution. The two founders grew up in rural communities, and the company originated in a remote city in eastern Canada. Therefore, the founders are familiar with healthcare issues in underserved areas. Gord Genge, the COO, was diagnosed with Parkinson's Disease in 2019. His journey from sensing something wrong to finally being diagnosed was highly frustrating. In his hometown of St. John's, the wait time to see a neurologist was a year or more, so he travelled to a major urban centre to be diagnosed. Post-diagnosis, he found that visits to his local neurology clinic were annual only, which left huge gaps in progression monitoring. PD progression is highly individualistic due to the complex pattern of neuronal loss. Weekly patient surveys and monthly motor assessments are critical to implementing an effective treatment plan. Gord and Bronwyn decided to radically change the process by introducing PRIMS to support PD assessments by the health team. The priority for PragmaClin is to demonstrate that PRIMS can be deployed successfully in a test-bed rural setting that is representative of isolated communities globally where few specialists are available to treat patients. We operate in Maine. We will run a pilot project in collaboration with MaineHealth. We have been accepted into the Founder Residency program at the Roux Institute in Portland, Maine. MaineHealth is partnering with Roux to pilot technologies developed in the program. The value for us is that running a pilot in rural Maine will determine the benefit of PRIMS to rural areas worldwide.

Monitoring Parkinson's by non-specialized healthcare workers could offer better management in rural primary care clinics where specialist neurological treatment teams are unavailable. Although diagnosis is not the job of direct care teams, assessment and even diagnosis may be possible with accurate, supportive tools such as PRIMS available in primary care facilities or pharmacies. Having PRIMS in rural communities would enable people with Parkinson's to perform assessments at a facility in their home communities, significantly reducing travel and thus benefiting the environment. Local health workers would have access to the clinician portal data and scores and can use the data to make treatment decisions to alleviate symptoms. Neurologists in urban areas would also have access to the clinician portal and can discuss treatment plans with the local health workers. PragmaClin's technology-based model will reshape care to reach people in every corner of the world with neurological issues by digitally connecting patients with the care team. The solution provides a more comprehensive clinical evaluation than traditional practice, empowering patients to monitor their disease progression consistently. PRIMS will give the world a more accurate and objective assessment solution for Parkinson's Disease to improve treatment decisions and benefit patients and the environment.

Bronwyn lives and works in Portland, Maine and has developed an extensive list of contacts with healthcare teams, regulatory consultants and business mentors while participating in the Founder Residency program at the Roux Institute. The program will continue for much of 2023. It will not only help embed us into the Maine healthcare community, but it will also open the door to the entire northeastern region of the United States, where a sizeable rural population exists.

Parkinson’s Disease (PD) affects ten million people worldwide and is one of the fastest-growing neurological disorders. There is no cure; treatments reduce symptom severity but do not slow disease progression. Globally, disability and death due to PD are increasing faster than any other neurological disorder. The prevalence of PD has doubled in the past 25 years. Two thousand nineteen estimates suggest that PD resulted in 5.8 million disability-adjusted life years, an increase of 81% since 2000, and caused 329 000 deaths, an increase of over 100% since 2000. PD is a clinical diagnosis that not only can be made by neurologists but also by trained non-specialists. Despite the significant impact, there is global inequality in the availability of neurological resources to manage the disease, with poor availability, especially in low- and middle-income countries (LMIC) and rural areas. Assessing PD by trained non-specialized healthcare workers in primary care is critical in areas where specialist neurological services are unavailable. An urgent response is necessary to meet the health requirements of people with PD, improve functioning and quality of life and prevent disability as global longevity increases. While specialists with expertise in movement disorders best diagnose PD, few specialists work in LMIC, and even fewer in rural areas. The WHO estimates that 0.03 neurologists per 100,000 people are located in low-income countries, 4.74 per 100,000 people in HIC, and only 23% of countries worldwide have neurologists in rural areas. PRIMS will change lives by connecting isolated neurology patients to a care team which was not possible in an effective way before our solution.

PRIMS will be transformational. It will impact rural communities and LMICs worldwide in five years. Although diagnosis is not the job of primary care teams, diagnosis may be possible with accurate, supportive tools such as PRIMS available in primary care facilities. Self-management is essential, as PD progression requires the management of symptoms, such as lack of balance, a propensity to fall, and cognitive and behavioural problems. Having PRIMS in rural communities in both high-income and low to middle-income countries where internet access is available at home or at a local health centre would enable people with Parkinson’s to perform assessments at the centre. They could complete the survey component from home if the internet is in the home. Local health workers would have access to the clinician portal data and scores and can use the data to make treatment decisions to alleviate symptoms. Neurologists in urban areas would also have access to the clinician portal and can discuss treatment plans with the local health workers. PragmaClin’s technology-based model will reshape care to reach people in every corner of the world with neurological issues by digitally connecting patients with the care team. The solution provides a more comprehensive clinical evaluation than traditional practice, empowering patients to monitor their disease progression consistently. PRIMS will give a more accurate and objective assessment solution for Parkinson’s Disease to improve treatment decisions.

Measurements of progress and how that relates to SDGs:

• The number of users signing on to use PRIMS - The more users on our system, the more rural communities we help to achieve equitable healthcare and the lower the carbon footprint.
• The number of PD patients who found life-changing benefits from PRIMS - The more PD patients we have accessing our solution, the lower the DALYs. One Disability-Adjusted Life Year (DALY) represents the loss of the equivalent of one year of full health. DALYs for a disease or health condition are the sum of the years of life lost due to premature mortality and the years lived with a disability due to prevalent disease or health condition cases in a population.
• Number of practitioners in primary care settings who adopted PRIMS - The more practitioners on board, the higher the acceptance rate and adoption rate, which means more patients served.
• The number of rural communities and LMICs adopting PRIMS - The more communities adopting the technology, the deeper the spread of the benefits of PRIMS on a global basis.

PragmaClin's remote patient monitoring solution (PRIMS) aims to improve access to neurological care in rural areas by leveraging technology to bridge the geographical gap between patients and healthcare providers. Here's a simplified explanation of how and why this solution can have a positive impact:

1. Activities:

   • PragmaClin develops and implements remote patient monitoring systems specifically designed for neurological care.
   • They establish partnerships with healthcare providers, clinics, and hospitals in rural areas to facilitate the adoption of the solution.
   • PragmaClin trains healthcare professionals on effectively using PRIMS.
   • They provide ongoing technical support and assistance to ensure smooth operations.

2. Outputs:

   • Healthcare providers in rural areas are equipped with the necessary tools and knowledge to use PRIMS effectively.
   • Patients in rural areas have access to the necessary equipment and are trained on how to use them correctly.
   • PRIMS is integrated into the existing healthcare infrastructure in rural areas.

3. Short-term outcomes:

   • Reduced travel burden: Patients in rural areas no longer need to travel long distances to access neurological care. They can receive monitoring and consultations remotely, saving time, effort, and expenses.
   • Timely intervention: Healthcare providers can monitor patients' neurological conditions remotely and detect any early changes or complications. This allows for timely intervention, preventing potential health deterioration.
   • Improved patient engagement: Patients become more actively involved in their healthcare, as they can monitor their condition regularly and communicate with healthcare providers through the remote system. This engagement can lead to better treatment adherence and overall health outcomes.

4. Long-term outcomes:

   • Enhanced access to care: By overcoming geographical barriers, PragmaClin's solution increases access to specialized neurological care for patients in rural areas. This can help address disparities in healthcare access between urban and rural populations.
   • Improved health outcomes: The timely monitoring, early intervention, and increased patient engagement facilitated by PRIMS contribute to improved health outcomes for patients with neurological conditions in rural areas.
   • Cost savings: Reducing travel costs for patients and preventing severe health complications can lead to overall cost savings for both patients and the healthcare system.

It's important to note that the strength of the links in this theory of change will depend on the effectiveness of PragmaClin's solution, the availability and reliability of internet connectivity in rural areas, the support and engagement of healthcare providers, and the willingness of patients to embrace remote monitoring technologies.

PRIMS uses depth cameras for capturing all movement data following a widely accepted testing format enabling a thorough assessment without requiring wearable sensors. The cameras are fixed in position on a specially designed preassembled frame surrounding a touchscreen computer for use in a hub clinic near where patients live. Patients can schedule monthly motor assessments at the clinic through the patient portal. The hardware captures all motor data as users are guided through the testing procedures via instructions on the screen. Data is stored in the database for disease status analysis and rating by our software.

Along with motor assessments, patient-reported data is essential in determining disease progression. PRIMS has an online survey tool that patients log into weekly to complete questionnaires which, like motor data, are stored in the database for analysis and rating. Both motor and survey data are used in the overall scoring of each patient. The raw motor and survey data is stored in the cloud and scored by our proprietary algorithms according to an internationally accepted rating scale. In addition, an essential aspect of the motor assessments is that they are self-managed by patients who follow on-screen instructions for various tests involving hand and leg movements, posture, tremors, speech and gait. Scores and details of each test as well as overall trends and flagged issues of significance, give the care team a complete picture of a patient's status regularly so that treatment decisions can be made based on solid evidence.   

We have surveyed over 80 patients, neurologists, nurses, therapists and health authority staff, and the feedback has been that over 90% feel that PRIMS will significantly benefit the healthcare community. The feedback also indicated that stakeholders are excited about seeing a commercial system soon. We have performed in-house alpha testing of the portals and the motor data collection hardware, as well as user testing with a small sample to determine functionality, and we have improved upon the software and hardware based on feedback. We are currently pursuing beta testing with patients and expect to have the system fully operational by mid-July.

We have 11 people working at PragmaClin. 

• Co-founders: Bronwyn Bridges, CEO, and Gord Genge, COO, have worked at PragmaClin since 2020. 
• Software: CTO, and four developers, two back-end and two front-end.
• Business Development: One Director and one Marketing Lead.
• Research: One Director and one Researcher.
• Part-time: One software developer.

The co-founders, Bronwyn Bridges and Gord Genge, have worked at PragmaClin since 2020. Bronwyn is the CEO and is pursuing a Ph.D. in pharmacy. Gord is the COO and holds degrees in Biology and Architecture. Colin Taylor is the CTO. Charlie Reid is the Business Development Director. Amanda Ricketts is the Director of Operations and Research. Chris Arns is the Marketing Lead. There are four full-time software developers on the team. We fill gaps like regulatory and IP by hiring consultants. We have three neurologists, two scientists, a product engineer, and two IT specialists on the advisory team. 

Here is an overview of PragmaClin's DEI policy:

Introduction and Purpose:

The policy begins with an overview of the organization's commitment to diversity, equity, and inclusion. 

Definitions:

This section clarifies key terms related to diversity, equity, and inclusion, ensuring a shared understanding of diversity, equity, inclusion, bias, and discrimination.

Guiding Principles:

The policy establishes guiding principles that inform the organization's approach to DEI. These principles include fostering respect, embracing diversity, eliminating discrimination and harassment, promoting fairness, and creating an inclusive and accessible environment.

Responsibilities:

The policy outlines the responsibilities of all organization members, from leadership to employees at all levels. It emphasizes the shared responsibility of upholding DEI principles, including creating an inclusive workplace, treating all individuals with dignity and respect, and actively challenging discriminatory practices.

Recruitment and Hiring:

This section focuses on ensuring fair and inclusive recruitment and hiring practices. It encourages diverse candidate pools, objective evaluation criteria, and the elimination of biases. 

Training and Development:

The policy highlights the importance of regular DEI training for all employees, promoting awareness, understanding, and empathy. It may cover unconscious bias, cultural competency, inclusive communication, and allyship. 

Retention and Promotion:

This section addresses the need to create a supportive environment that values and retains diverse talent. It emphasizes equitable career growth and promotion opportunities, fair performance evaluations, and transparent processes. 

Inclusive Workplace Culture:

The policy emphasizes creating an inclusive workplace culture that respects diversity and encourages collaboration. It also highlights the organization's commitment to providing reasonable accommodations for individuals with disabilities.

Reporting and Accountability:

The policy establishes mechanisms for reporting incidents of discrimination, harassment, or other violations of the DEI policy. It assures employees of protection against retaliation and outlines the investigation and resolution processes. It also emphasizes the organization's commitment to regularly reviewing and assessing the effectiveness of the DEI initiatives.

Communication and Transparency:

The policy stresses the importance of transparent communication regarding DEI efforts, goals, and progress. It may include provisions for public disclosure of diversity metrics, annual reports on DEI initiatives, and mechanisms for gathering feedback from employees and the broader community.

External Engagement:

The policy recognizes the organization's responsibility to contribute positively to the community. It may include partnerships with diverse organizations, community outreach programs, and support for initiatives promoting social justice and equity.

Continuous Improvement:

The policy emphasizes the organization's commitment to continuous learning, improvement, and adaptation. It encourages regular review of DEI practices, outcomes assessment, and feedback integration to foster an increasingly inclusive and equitable environment.

The global Remote Patient Monitoring (RPM) market is projected to reach $175.2 Billion by 2027 from $53.6 Billion in 2022, achieving a CAGR of 26.7%. The factors driving growth include the reduction of the burden on resources, the monetary benefits of RPM services, increasing geriatric populations, and the growing need to expand healthcare access. The total addressable market for PRIMS for PD is $9.0 Billion. The annual addressable market for the initial target markets of MENA, the UK, the US, and Canada is $1.4 Billion. The goal is to acquire a 6% global market share. Scaling to Huntington’s Disease, Multiple Sclerosis, stroke, and traumatic brain injury/concussion, increases the projected global market value to $5.9 Billion. Customers include healthcare providers such as systems, hospitals (non-profit and for-profit), and private clinics. Pharmaceutical companies will be interested in PRIMS for clinical trials. The near-term plan is to sign a purchase agreement in the UAE after validation and regulatory approval in 2023/2024. The exact process will be followed in the US, the UK, and Canada in 2024/2025. Beachheads will be the teaching hospitals that have expressed interest in being early adopters, which will de-risk commercialization. PRIMS will be sold B2B as a SaaS product per patient in the buyers' clinics. Pricing is set at $75 per patient based on applicable reimbursement codes. Hardware costs will be charged separately from the software. Based on the B2B SaaS subscription model and commercial timelines, PragmaClin's financials reflect profitability by the end of 2027 and shows a CAGR of 120%.

Go-to-market strategy:

Funding via grants, pitch competitions, VC and angel investment and accelerator/incubator programs. Raised $1.2 million to date and seeking an additional $1.5 million.

Initial distribution will be via procurement partnerships with teaching hospitals participating in validation studies.

Onboarding other providers will be aided by promotional activities at conferences and through published papers by renowned clinical collaborators participating in validation studies.

PragmaClin will present its overall strategy, including clinical validation results at neurological conferences and through social media marketing. The CEO, Bronwyn Bridges, is pursuing a Ph.D. in Pharmacology, and she will present the findings at conferences such as the World Neurology Congress and the World Parkinson’s Congress, among others.

The strategy for the US market is to develop relationships with Northern Light Health and MaineHealth through a residency program for health startups at the Roux Institute in Portland. The program will allow PragmaClin to partner with the health systems and assist with the FDA approval process. Maine will enable us to launch into the broader US market. 

Launch Plan:

• Deployment and completion of Clinical Trial in Dubai UAE – Q4 2023.
• Commercial launch in the UAE via Kings College Hospital London in Dubai – Q4 2024. 
• Deploy CRM to manage the sales process.
• Initiate FDA Approval in the US using UAE study results – Q4 2023.
• Start clinical Trial at Kings College Hospital London – Q4 2023.
• Pilot study agreement with Maine Health – Targeted for Q3 2023.

Non-dilutive: 

• Genesis Pitch & Pick - $25,000.00 
• Fry Family Foundation - $2,500.00 
• Mel Woodward Cup - $25,000.00 
• Bounce Health Embryo Grant - $47,500.00 
• Volta Labs - $300.00 
• Global Student Entrepreneur Awards National Championships - $25,000.00 
• Ready2Launch - $9,800.00 
• Startup Global Canada Rural Award - $5,000.00 
• Startup Global Canada - $15,000.00 
• AGE-WELL National Impact Challenge - $20,000.00 
• University Startup World Cup - $13,800.00 
• NU Community Board Award - $25,000.00 
• LearnSphere - $16,500.00 
• IET Province NL - $65,025.00 
• NRC IRAP #969478 - $75,000.00 
• NRC IP Assist - $8,490.00 
• CanExport - $40,423.50 
• JobsNL28 -$13,760; SSEP - $2,592; JobsNL28 - $16,352.00 
• ACOA Strategic Fund - $50,000.00 
• CAS - ACOA - $5,000.00 
• IET SIEP Funding - $100,000.00 
• NL IET Wage Subsidy - $11,760.00 
• NRC YEP - $29,831.00 
• Compusult loan - $40,671.00 
• IET Province NL - $149,000.00 
• Entrepreneur World Cup - $70,000.00 
• NRC-IRAP - $231,660.00 

SUBTOTAL - $1,123,612.50 

Dilutive: 

• Volta Convertible Note - $25,000.00 
• Genesis Centre - $50,000.00 
• Roux Institute Note - $65,000 

SUBTOTAL $140,000.00 

GRAND TOTAL $1,339,000.00 (rounded)