Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - PARK-IT (Unobtrusive, continuous and quantitative assessment of Parkinson’s disease: hard evidence foroptimal disease management with information technologies)

Teaser

Parkinson’s Disease (PD) is a chronic, incurable, neurodegenerative disease that affects approximately 1,2 million people in Europe. It is possible to effectively treat PD so that the symptoms are significantly reduced, but only when an accurate diagnosis of disease...

Summary

Parkinson’s Disease (PD) is a chronic, incurable, neurodegenerative disease that affects approximately 1,2 million people in Europe. It is possible to effectively treat PD so that the symptoms are significantly reduced, but only when an accurate diagnosis of disease progression has been made. The current methodologies for monitoring PD progression are based on patient interviews, activity diaries and patient observation. These methods have significant weaknesses as they are expensive and fail to accurately diagnose the patient’s state, meaning that treatment is not optimal. This has a significant cost, both economically and on the patient’s quality of life.
Sense4Care are the owners of a proprietary sensor, PARK-IT, that was developed and verified during the FP7 REMPARK project. This sensor accurately monitors PD progression through patient movements. The sensor contains algorithms that specifically identify a patient’s status and can support neurologists to make a more accurate diagnosis of the patient’s state and the appropriateness of their current treatment regime.
Sense4Care have applied to the SME instrument to bring this sensor to the market, for the benefit of neurologists and PD patient’s and their families. The aim of the phase 1 project is confirm the feasibility of successfully launching the product on the market. As the technical aspects of the sensor have been verified during the REMPARK project, achieving over 90% sensitivity and over 90% specificity, the key for the phase 1 project is to confirm that there is sufficient market demand for the PARK-IT product.

Work performed

The phase 1 project has been undertaken including 3 main tasks:
- Task 1.1: Sound market and stakeholder analysis: in order to determine the key market and its size, market drivers, routes to market and to identify the key stakeholders and establish partnerships with them
- Task 1.2: Detail Plan for regulatory and IP Management, including a CE medical device certification plan
- Task 1.3: Drafting an elaborated business plan, including target and value proposition, distribution channels, price strategy, market penetration and sales forecast, manufacturing cost and gross margin, marketing strategy, changes in the company structure and organization, profit and losses accounts and sensitivity analysis.

Final results

The market analysis has confirmed, after holding discussions with patients and neurologists, that there is a significant market demand and that our product has significant advantages over the competitors’.
PARK-IT device needs to be certified according European Council directive 93/42/EEC. Within the category of non-invasive active device for diagnosis, the PARK-IT product can be considered as a Class IIa device (see task 1.2, Detail Plan for regulatory and IP Management).
The financial projections demonstrate that, 3 years after the end of the phase 2 project, PARK-IT will generate a return on investment of 75%, achieving fast growth (sales of 4M€) and a strong operating margin of 34%.
It has also been confirmed that there are several final and vital steps that must be completed by a PARK-IT phase 2 project, including final design of the sensor, appropriate registration as a medical device and undertaking pre-marketing activities. This tasks were already envisaged by the grant agreement and the overall objectives of the SME instrument project remain the same. What this feasibility study has demonstrated is that, once the project is completed, that PARK-IT is the market leading solution, has a significant target market and a clear business strategy to achieve a successful market launch. Doing so will not only have a significant impact on SENSE4CARE as a company but also the estimated 60,000 patients who will be using the device three years after the project has been completed.
The conclusion of the action is therefore that SENSE4CARE should submit an application for PARK-IT to the Phase 2 of the SME Instrument.

Website & more info

More info: http://www.sense4care.com/en/about-us/parkinson.