Inflammatory Neuropathy MOnitoring Devices(INMODE)

Current international guidelines recommend the periodic use of outcome measures to monitor patients with chronic inflammatory neuropathies in the absence of a biomarker that accurately reflects disease activity and response to treatment. Treatment optimization in these patients remains a process driven by clinical metrics. Individualized maintenance treatment using the minimum effective dose and periodically attempting dose reduction or interval lengthening trials are recommended to establish the need for ongoing therapy. Failing to objectify treatment response (or absence of response) is one factor that contributes to both the overtreatment and overdiagnosis of chronic inflammatory neuropathies, as well as to delayed treatment escalation for patients without benefit to first-line therapies. Traditional outcome measures, currently used in routine clinical practice and clinical trials for patients with inflammatory neuropathies, have various drawbacks that limit their sensibility, reliability and usability. For instance, they do not allow measurement of the daily fluctuations of symptoms in the patients’ home-environment. Current means of assessing chronic inflammatory neuropathies are largely limited to episodic in-person assessments conducted in the clinic. Recent studies that assessed the daily home monitoring of grip strength in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN) on maintenance treatment, showed that the frequent assessment of grip strength may provide information that cannot be obtained by fixed-point observation, such as at outpatient visits.

Digital tools, such as smartphones and wearable devices, offer clear advantages over traditional outcome measures with regard to sensitivity, passive data collection, possibility to gather large amount of sharable data, capture daily fluctuations. Our solution will use peripheral devices & wearable technologies connected to a software platform which will collect and analyze various symptom-related objective measurements.  The platform will provide rich data sets for users (patients, medical professionals, and researchers) many orders of magnitude larger than the data sets which exist today.  Through a real time analytics engine, this information will revolutionize our collective understanding of symptom response in patients with CIDP, MMN and other forms of inflammatory peripheral neuropathies.

Our aim is to provide real time data, build predictive response models and to seamlessly link patients to medical and research professionals.  This objective symptom data can capture patient condition on a spectrum spanning “symptomless” to “disabled” where current methods capture subjective data only when patients are very near to functional disability.

Having a vast data set for a broad portion of people who suffer from these rare diseases will provide many benefits to patients themselves, medical professionals and to society at large.

First, our solution serves those people who are diagnosed with a rare peripheral nerve disease like CIDP or MMN.  

Symptoms can be very different from person to person.  Symptoms also can be difficult to describe & interpret when filtered through human language.  Finally, individual response to therapies can vary widely and are difficult to objectively measure.  Individuals may even lack the skills to effectively articulate or communicate their symptom responses to their doctors.  At best, this communication chasm between patient and doctor can be a source of frustration on both sides of the conversation.  At worst, this breakdown of communication may lead to inaccurate diagnosis, poorly optimized therapy volumes and increased suffering for all involved.   Our solution will provide a voice that will speak clearly to medical professionals and to patients themselves.  For patients, seeing an objective measurement firsthand which truly reflects their own perception is comforting.

Second, our solution serves medical professionals and research academics at large.

Even today, research studies for treatment and interactions (life choices, diet, environment) are expensive, extremely long and collect only sparse and largely subjective data.  This method of research is slow, expensive and rarely results in meaningful breakthroughs.  Our solution will put a vast dataset in the hands of medical professionals and researchers that richly describes the daily life and symptom response of people with these rare diseases.  This symptom response data may be overlaid with life events, lifestyle choices, sickness, diet, treatment details including volumes, frequency & changes as well as with clinical assessments.  Over time, research may evolve into retroactive and real time analysis of a dataset that already exists.  This approach may represent a paradigm shift in the way research is performed on rare diseases like CIDP.  

Finally, our solution reduces the strain on society in general.  

For every person treated with blood products, there are 20 blood donations required to produce the therapy drugs.  These treatments occur ever 3-4 weeks (13 to 18 times per year).  This means that treating one person with a rare nerve disease like CIDP requires up to 360 blood donations per year.  The average hero who frequently donates blood, can do so only once every 6 months.  This means that nearly 200 heroes are required to support every person suffering from a rare disease like CIDP.  Since not everyone is a hero, those who give selflessly represent a much larger population.  Less than 2% of people who are eligible to donate blood do so, this means that a population of ~10,000 eligible blood donors from society are supporting each person receiving this therapy.

Our solution aims to optimize treatment volumes.  Optimization will save costs for medical systems.  Fewer therapy sessions mean lower costs and less waste in the form of disposable plastics used widely in all aspects of medical therapies.  Lower therapy volumes further reduce costs and consumption of disposable plastics being produced and incinerated into the environment.  Most importantly, this optimization of therapy frequency & volume means more efficient use donated human blood.

A unique opportunity exists!

As the team lead I am uniquely positioned to lead our solutions.  As a person diagnosed with a rare disease (CIDP).  I have been treated for the disease in 2 (almost 3!) countries and have experienced several rounds of diagnosis, therapies & clinical trials.  I experienced first-hand the communication chasm, inefficiencies of data collected (from me!) during clinical trials as well as the subjective nature of symptom measurement in Neurology in a broad sense. For this project I will collaborate with the Italian CIDP and MMN database study groups, coordinated by Prof. Nobile Orazio and Dr. Pietro Doneddu of the Humanitas University of Milan. The Italian CIDP database is currently the largest database of this disease in the world, containing data on approximately 700 patients included from approximately 30 centres. The data contained in this database led to the publication of 13 scientific articles in peer reviewed journals. The MMN database has more than 100 patients included. Through collaboration with the Italian network it will be possible to enroll patients interested in participating in the study.

The value of our solution has data at its core.  Following the successful outcome of our first clinical trial, together with our partner research hospital, we will seek funding likely from the EU government to build a commercial platform and integrate existing wearable devices and other peripherals that help us to measure symptom intensity in patients. 

Prior to full funding, all data compilation and analysis is completed manually..  The horizon prize would help us to create a prototype application to collect & analyze symptom data & fine tune our analysis engine.

Having CIDP myself, I am part of the primary community that this project aims to serve.

Our solution potentially represents a paradigm shift in the way neurological symptoms are measured as well as fundamentally how some neurological research is performed.  We recognize the fleeting nature of situational data as well as its fundamental value.  By distilling information from data that would otherwise be neglected we are both providing patients an objective voice as well as equipping researchers to develop knowledge that otherwise would be lost.

By demonstrating that relatively high-frequency non-clinical measurements are relevant and even significant we will allow treatment to be adjusted with precision and provide a vastly improved data set for research analytics.

The resulting adjustment will optimize therapies, reduce hospital stays, decrease supplies and packaging needs as well as conserve human energy in the form of blood donations.

Impact goals for the next 5 years (10:100:1000):

• Reduce overall treatment drug volumes by 10% from baseline year (in target population)
• Increase available data set size for research by 100x.
• Reach 1000+ patients daily through daily platform access.

We will measure our progress through our own operational information and though our partnership with the medical research community that will publish results in peer reviewed journals  

Our solution is not exactly tech based but does apply technology broadly available today in a specific and unaddressed space.

By having higher frequency and more precise measurement of a system (our patient) we can better understand the system itself.  This concept is widely accepted and has been demonstrated in even the simplest of inputs (ex. Nyquist theorem) for more than a century.  This concept has yet to be applied to research of rare diseases and essentially represents our logical framework.

Our solution is not exactly tech based but does apply technology broadly available today in a specific and unaddressed space.

4 people, all part time.

Approximately 2 years

Diversity, equity and inclusivity have not yet been formally addressed but these will certainly be part of our core principles in the future.

Our business model is to cover operational costs while providing a net cost savings for health care systems.  Leveraging our initial clinical trial, we will seek government funding to fully develop our software platform, supply chains and operating interface with the target health care system.  We have avoided financial investors to date because we want to provide the lowest cost operating model post commercialization.

Our organization will not be non-profit but may be considered minimum-profit as our goal is not to reward investors but to improve the lives of those with rare disease and serve society in general through the reduction of costs and human energy required for treatment.

In order to have broad based endorsement by health care systems, our solution needs to be low cost, easy to adopt and have obvious financial impact.

Our 10 year operating budget is quite conservative and our initial target grant size has been deemed feasible by our research partner.  The grant funded start-up model will allow us to implement a very low-cost subscription revenue model for health care systems.  Part of our value statement will be to provide health care systems with a net savings for the treatment of rare diseases like CIDP through the adoption of our solution.

No historical data to share.  We are specifically self-funded to date.