PRIMS

Current State: Parkinson’s Disease (PD) affects ten million people worldwide and is one of the world’s fastest growing neurological disorders. There is no cure and treatments reduce symptom severity but do not slow disease progression. Despite the impact, there is global inequality in the availability of resources to manage the disease, with poor availability in low- and middle-income countries (LMIC). While PD is best diagnosed by specialists, very few such specialists work in LMIC. Assessment of PD by trained, non-specialized health-care workers and simplified treatment guidelines could offer better management in primary care where specialist teams are unavailable. 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.

Solution: PragmaClin has developed PRIMS, a digital tool for assessing PD following recognized standards. Self-managed motor assessments are performed by patients using computer connected depth cameras in a clinic or nearby health centre, and survey assessments are completed on any internet connected device. Smart software assesses and grades the severity of disease. Clinicians’ dashboards show red-flags, assessment details, trend graphs, and have report printing tools. Patient dashboards enable patients, family members, and caregivers to access surveys, as well as assessment summaries to help with disease management at home. The patient dashboard also has a motor assessment appointment scheduling feature to schedule a motor assessment in a nearby centre.

Benefits: PRIMS will improve accessibility and will help the health team assess PD patients more easily and accurately than is currently possible. Patient benefits include, improved quality of care, control over personal health, and reduced travel. Rural communities where internet access is available at a local community centre would enable people with Parkinson’s without internet to perform all assessments at the centre. Local health workers would have access to the clinician portal data as well as scores and can use the data to help patients 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 compared with traditional practices and empowers patients to consistently monitor their own disease progression. PRIMS will provide the world with a more accurate and objective assessment solution for Parkinson’s Disease that will improve treatment decisions. Finally, as large amounts of data become available, the databank will be significantly valuable by offering the world a unique big-data repository for use by pharmaceutical companies, systems/hospitals, researchers, and other stakeholders which are seeking ways to cure.

Future: In the future we will scale the technology to other neurological conditions including stroke, concussion, Multiple Sclerosis, and Huntington’s Disease to name a few. We will deploy the solution worldwide so that even the most isolated communities have access to PRIMS.  

PRIMS will improve access and will make the clinician’s job of assessing Parkinson's Disease more effective and efficient than is currently possible. Disease progression results provided by smart software is available to both 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. Recently introduced technologies for assessing Parkinson's patients include smartphone apps such as KenesiaU, Mont4t’s EncephaLog, the PKG watch by Global Kinetics, An App for Apple watch by Rune Labs, a wearable called Biostamp nPoint, and wearable sensors for clinical trials by SHIMMER and APDM. These and other motor data capture technologies cover a limited range of symptoms, or provide data on daily living activities only and not specific tests, or use expensive wearable sensors. 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. All motor data is captured by the hardware as users are guided through the testing procedures via instructions on the screen. Data is stored in the database for analysis and rating of disease status by our software. Along with motor assessments, an important component in determining disease progression is patient-reported data. PRIMS has an online survey tool that patients log into weekly to complete questionnaires which like motor data is 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 important aspect of the motor assessments are that they are self-managed by patients who follow on-screen instructions for various tests involving hand and leg movements, posture, tremor, 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 on a regular basis 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 world’s fastest growing neurological disorders. There is no cure and treatments reduce symptom severity but do not slow disease progression. Globally, disability and death due to PD are increasing faster than for any other neurological disorder. The prevalence of PD has doubled in the past 25 years. Current estimates suggest that, in 2019, 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). Assessment of PD by trained non-specialized healthcare workers in primary care is particularly important in areas where specialist neurological services are unavailable, such as in some LMIC. An urgent response is necessary to meet the health requirements of people with PD and to improve functioning, quality of life and prevent disability as global longevity increases. While PD is best diagnosed by specialists with expertise in movement disorders, very few such 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 and 4.74 per 100,000 people in HIC, and only 23% of countries worldwide had neurologists in rural areas. Assessment of PD by non-specialized health-care workers and simplified treatment guidelines could offer better management in primary care where specialist neurological treatment teams are unavailable. 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 important, as PD progression requires management of symptoms, such as lack of balance with a propensity to falls and cognitive and behavioural problems. Having PRIMS in rural communities in both high income countries and low to middle income countries where internet access is available either at home or at a local health centre would enable people with Parkinson’s to perform assessments at the centre. If internet is in the home, they could complete the survey component from home. Local health workers would have access to the clinician portal data as well as 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 compared with traditional practice and empowers patients to consistently monitor their own disease progression. PRIMS will provide the world with a more accurate and objective assessment solution for Parkinson’s Disease that will improve treatment decisions.

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 both grew up in rural communities and the company originated in a remote city in eastern Canada. Therefore, the founders are familiar with the issues surrounding healthcare in underserved areas. Gord Genge, the COO, was diagnosed with Parkinson's Disease in 2019. His journey from sensing that something was 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 ended up travelling 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 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 through the introduction of 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 intend to establish a presence in Maine and 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. We are one of 10 early-stage startups to join the Roux Institute. Located in Portland, Roux is a hub of Northeastern University’s global network. MaineHealth is partnering with Roux to pilot key technologies developed in the program. The value for us is that rural Maine will determine the benefit of PRIMS to rural areas and LMICs where there is an urgent need for a new care paradigm. 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%, and this is estimated grow to 37% by 2026.
• In Maine, tele-health is viewed as particularly beneficial for rural communities.

We have developed a functional MVP (Minimum Viable Product) over a two year period that is sitting at Technology Readiness Level 7 (TRL-7) and the next phase to reach TRL-8/9 is to run validation work in an operational setting prior to final commercialization. This work will be carried out in Maine. We have developed and tested a patient portal, and work on a clinician portal, and a researcher portal is nearly complete. The motor assessment component has been tested in its basic format and will be updated/improved in April and May 2023 so that the system can be beta tested in its final form prior to the pilot testing in Maine with MaineHealth. The system will be a fully functional prototype by June 1, 2023. 

We do not have a commercial system operating at this point.

 Assessment of PD by non-specialized health-care workers and simplified treatment guidelines could offer better management in primary care where specialist neurological treatment teams are unavailable. 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 important, as PD progression requires management of symptoms, such as lack of balance with a propensity to falls and cognitive and behavioural problems. Having PRIMS in rural communities in both high income countries and low to middle income countries where internet access is available either at home or at a local health centre would enable people with Parkinson’s to perform assessments at the centre. If internet is in the home, they could complete the survey component from home. Local health workers would have access to the clinician portal data as well as 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 compared with traditional practice and empowers patients to consistently monitor their own disease progression. PRIMS will provide the world with a more accurate and objective assessment solution for Parkinson’s Disease that will improve treatment decisions.

Parkinson’s Disease (PD) affects ten million people worldwide and is one of the world’s fastest growing neurological disorders. There is no cure and treatments reduce symptom severity but do not slow disease progression. Globally, disability and death due to PD are increasing faster than for any other neurological disorder. The prevalence of PD has doubled in the past 25 years. Current estimates suggest that, in 2019, 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). Assessment of PD by trained non-specialized healthcare workers in primary care is particularly important in areas where specialist neurological services are unavailable, such as in some LMIC. An urgent response is necessary to meet the health requirements of people with PD and to improve functioning, quality of life and prevent disability as global longevity increases. While PD is best diagnosed by specialists with expertise in movement disorders, very few such 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 and 4.74 per 100,000 people in HIC, and only 23% of countries worldwide had 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 prior to our solution.

PRIMS will be transformational. It will impact rural communities and LMICs all over the world in five years time. 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 important, as PD progression requires management of symptoms, such as lack of balance with a propensity to falls and cognitive and behavioural problems. Having PRIMS in rural communities in both high income countries and low to middle income countries where internet access is available either at home or at a local health centre would enable people with Parkinson’s to perform assessments at the centre. If internet is in the home, they could complete the survey component from home. Local health workers would have access to the clinician portal data as well as 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 compared with traditional practice and empowers patients to consistently monitor their own disease progression. PRIMS will provide the world with a more accurate and objective assessment solution for Parkinson’s Disease that will improve treatment decisions.

1. Number of users signing on to use PRIMS
2. Number of PD patients who found life-changing benefit from PRIMS
3. Number of practitioners in primary care settings who adopted PRIMS
4. Number of rural communities and LMICs adopting PRIMS

Change is inevitable and technology paves the way for radical and rapid change for the benefit of the world. Our technology will transform neurological care worldwide and will improve the lives of everyone facing the challenges of living with Parkinson's Disease.

Depth cameras, computers, software and AI.

We can solve the problem. We have made significant progress to date: Developed MVP to TRL 7 with non-dilutive funding support. Accomplishments:

• Added a researcher, business director, marketing lead and tech people to the team. 
• Raised $1.10 million in non-dilutive funding. 
• Won over $190,000 in pitch awards (part of $1.1m). 
• Accepted to several incubators/accelerators, including one in Maine.
• First place in Canada-wide entrepreneur contest. 
• Preparing for four validation studies (US, UAE, UK, Canada). 
• Accepted by Ontario Bioscience Innovations Organization for funding one validation study. 
• Concluded phase 1 of UX testing. 
• Concluded customer response survey with over 95% of respondents showing strong support. 
• Secured the collaborative support of a world-renowned PD specialist in the UK. 

We have surveyed over 80 patients, neurologists, nurses, therapists and health authority staff people, and the feedback has been that over 90% feel that PRIMS will be of significant benefit to the healthcare community. The feedback also indicated that stakeholders are very excited about the prospect of seeing a commercial system in operation soon.

We have a DEI policy in place.

The TAM for PD is $10.0 billion. A pricing analysis is underway. Our SaaS model assumes a patient fee of US$5/patient/month for at-home use and an annual subscription fee for US healthcare organizations of US$70/patient/month based on reimbursement codes CPT 1400F and CPT 4325F which cover US$70/test for in-office tests. The forecast in USD millions assumes year 1 revenue at US$2.37, year 2 at US$7.46, year 3 at US$29.83, year 4 at US$67.55, and year 5 at US$147.30 for a CAGR of 128% by Year 5.

We expect to obtain regulatory approval and a procurement contract in the UAE by January/February 2024 followed by the UK and the US in late 2024 or early 2025. Launch in Canada will depend on how quickly we can secure a validation study with a Canadian health authority.

The TAM for PD is $10.0 billion. A pricing analysis is underway. Our SaaS model assumes a patient fee of US$5/patient/month for at-home use and an annual subscription fee for US healthcare organizations of US$70/patient/month based on reimbursement codes CPT 1400F and CPT 4325F which cover US$70/test for in-office tests. The forecast in USD millions assumes year 1 revenue at US$2.37, year 2 at US$7.46, year 3 at US$29.83, year 4 at US$67.55, and year 5 at US$147.30 for a CAGR of 128% by Year 5. First revenue is expected from the UAE on completion of the Dubai study.

We expect to obtain regulatory approval and a procurement contract in the UAE by January/February 2024 followed by the UK and the US in late 2024 or early 2025. Launch in Canada will depend on how quickly we can secure a validation study with a Canadian health authority.

– Developed MVP to TRL 7 with non-dilutive funding support.
– Added a researcher, business director, marketing lead and tech people to the team.
– Raised $1.10 million in non-dilutive funding.
– Won over $190,000 in pitch awards (part of $1.1m).
– Accepted to several incubators/accelerators, including one in Maine.
– First place in Canada-wide entrepreneur contest.
– Preparing for three validation studies (UAE, UK and Canada).
– Accepted by Ontario Bioscience Innovations Organization for funding one validation study.
– Concluded phase 1 of UX testing.
– Concluded customer response survey with over 95% of respondents showing strong support.
– Secured the collaborative support of a world-renowned PD specialist in the UK.