Technology to improve the assesment and treatment of Parkinson\\\'s disease
Sense4Care is an ICT company created in 2012 in Barcelona, Spain, due the interest of the Universitat Politècnica de Catalunya (UPC) to exploit the IP generated by researchers from the Technical Research for Dependency Care and Autonomous Living (CETpD).
Our 8 team members have experience in different IT sectors, health, electronics, and also in growing high-tech SMEs, and launching products on the market.
Due to a technology transfer agreement, we have the exclusive use and the full exploitation rights for the technology developed by the UPC concerning the IP generate in the European projects FATE and REMPARK. Thanks to this agreement, we were able to launch Angel4 to the market in the fall of 2015. Angel4 is a high-sensitive automatic fall detector device that we developed as a result of the FATE European project. We have already signed distribution agreements with several companies, including Safe Concept (Hong Kong) and Smart Family Caregivers (Puerto Rico). These two companies are distributors that will ensure a minimum sales of 4,000 Angel 4 units in 2018.
At the moment, our goal is to build on the success of our first product, by commercializing PARK-IT: the result of the REMPARK European Project. PARK-IT: the first medical device available on the market allowing a reliable, extensive, continuous, direct, interoperable, and cost-effective monitoring of Parkinson’s disease (PD) in ambulatory conditions.
PARK-IT is a wearable device that is placed on the patient’s waist within a comfortable belt. Firstly, using a set of sensors, advanced algorithms and signal processing methods, this device identifies and records the patient’s PD motors symptoms (ON/OFF fluctuations, bradykinesia, dyskinesias, freezing of gait, falls). Secondly, when this information is collected and thanks to a mobile application, the information is accessible to patients and their health care professionals. The knowledge provided by PARK-IT helps doctors and patients to make informed and improved decisions on how to treat the individual’s changing PD. Receiving the information provided by PARK-IT helps patients to:
Previously, it has not been possible to continuously monitor a patient’s ON and OFF periods in real time. So far, current solutions have focused on analyzing PD’s specific symptoms, rather than paying attentions to ON/OFF fluctuations. Furthermore, they are based on the reports made by the patients. Moreover, according to a recent study (2016) published on Parkinsonism & Related Disorders, “the home monitoring solutions using body worn accelerometers methods used today are not sufficient to monitor the ON/OFF fluctuations of PD patients at home, and they are only able to monitor dyskinesia”.
As a consequence of the promising results obtained in the FP7 REMPARK project that confirmed the market interest in our device, we performed a feasibility study funded by the European Comission under an SME-Instruments Phase 1 project. This study confirmed that we have the main elements to transform our idea into a business opportunity, namely:
Sense4Care was granted in November 2016 an SME-Instruments phase 2 project whose goal is to produce the commercial version of the PARK-IT device, to carry out a usability study with patients and neurologists, to complete its medical device (class IIa) certification process and to promote it among stakeholders. The project has officially started on February 1st, 2017, and will run until Jaunary 31st, 2019. The overall budget of the project is 1.000.000 €, from which 700.000 € will be provided by the European Commission.
The current fundung needs of the project are estimated in 300.000 €, and will be addressed in two funding rounds:
The exit strategy will consist in selling the participation acquired through the funding rounds to interested stakeholders.
Juan Manuel Moreno (CTO), PhD in Telecommunications Engineering: He was the overall project coordinator of the Reconfiguragle POEtic tiussue project (POETIC, IST-2000-28027) whose main results was a new family of integrated programmable devices with bio-inspired capabilities. He has participated in several european projects related to artificial neural networks (Enhanced Learning for Evolutive Neural Architectures, ELENA, Esprit IV RTD, No. 6891), Field-Programmable Architectures (FIeld Programmable System On a Chip, FIPSOC, Esprit V RTD, No. 21625), dynamically reconfigurable programmable architectures (Design methodology and environment for dynamically reconfigurable FPGA, RECONF2, IST-2001- 34016), bio-inspired systems (Pervasive Comuting Framework for Modeling Complex Virtually-unbounded Systems, PERPLEXUS, IST-2006-034632) and e-health (Personal Health Device for the Remote and Autonomous Management of Parkinson's Disease (REMPARK) – FP7 – ICT – 287677, Fall Detector for the Elder (FATE) – FP7 – CIP – 297178). His research interests include analog and digital VLSI design, neural networks models, architectures for programmable devices and systems on chip, bio- inspired computing techniques, and electronic systems for e- health infrastructures.
Alejandro Rodríguez, MD, PhD (medical advisor of Sense4Care): He graduated in medicine at Universidad Autónoma de Madrid (UAM), in 2001. In 2005, he attended the Academic Program in the Medical Specialties in Geriatric Medicine and Paliative Care at the Brookdale Department of Geriatric and Adult Development, Mount Sinai School of Medicine, New York. In 2006, he completed the specialisation in Geriatrics at the Hospital Central de la Cruz Roja in Madrid. In 2009 he was awarded the PhD degree in Preventive Medicine and Public Health at the UAM, Spain. In 2010 he was appointed Adjunct Professor in Gerontechnology at the School of Engineering and Informatics, NUI Galway, Irelend. He has devoted his clinical work and research to the care of the elderly. As a clinician he is on duty physician at the Geriatric Acute Unit of the Hospital Clínico, Barcelona and he works as an attending physician in the Geriatrics service of the Fundación Hospital Comarcal Sant Antoni Abat, where he also manages the Gerontechnology research line. As researcher he has worked in 4 European research projects (FP6, FP7, AAL). He has leaded the application of kinematic sensors to symptoms detection in Parkinson’s patients.
Joan Cabestany, PhD in Telecommunication Engineering: He is a Professor at the Department of Electronic Engineering (UPC) and one of the founders of S4C. About of 10% of his time is allocated to S4C. He received his degree in Telecommunication Engineering in 1976, and the PhD in 1982, both from the Technical University of Catalonia (UPC). He is the responsible of the AHA (“Advanced Hardware Architectures”) research group, with expertise on reconfigurable hardware, electronic system design, advanced hardware architectures, microelectronics and VLSI design. He is member of the CETpD staff structure since 2005. He has been the UPC responsible in several EU funded projects, and their main interest topics are artificial intelligence and electronic technology applied to different topics (aging and dependent people issues, in particular). He was the coordinator of the REMPARK and FATE projects.
Andreu Català, PhD in Physics: He was Head Director of the Engineering School of Vilanova i la Geltrú (UPC 2000-2006). Director of the Research Centre for Dependency Care and Autonomous Living (UPC) since 2010. Cordinator of the Thematic Network: E-NOFALLS European Network for Fall Prevention Intervention and Security CIP-PSP. Cordinator UPC of the Erasmus Mundus Joint Doctoral Program on Interactive and Cognitive Environments. Coordinatior of the Action Area 4 on Governance and Scaling up of the European Innovation Partnership on Healthy and Active Aging. Action Group 2 on Fall prevention. His research interests include Assistive Technologies and Artificial Intelligence.
Francesc Masana, PhD in Electronic Engineering: has a great experience working with high tech start-ups. He’s currently CEO of Barcelona Semiconductors, a microenterprise dedicated to the design and manufacture of advanced semiconductors. He has great experience in taking research results to the market, being a key person in the development of the business plan of Sense4Care.
Xavier Castillo, PhD in Telecommunications Engineering: He is the partner of the team with a greater experience in business growth and development. He is currently the Barcelona Branch Manager for AMETIC, the Spanish Information & Communications Technology (ICT) trade association and leads courses on technology transfer and entrepreneurship in La Salle Business school and at the Universitat de Pompeu Fabra. Previously he served as the CEO of Tempos 21, a Start Up devoted to the conception, development and commercialization of enterprise mobile applications and in 2008, he successfully negotiated its sale to Atos Origin.
Carlos Pérez, PhD in Electronic Engineering: He is actually, under contract by Universitat Politecnica de Catalunya, developing the technical supervision of the electronic design laboratory at CETpD. He is the main responsible of the design and upgrades of the developed system for movement analysis. His main expertise is on electronic design, electrical signal acquisition, noise and interferences prevention and microprocessor programming.
Albert Samà, PhD in Computer Science: He participated in the Spanish Project ‘AURA’ whose goal was to develop soft-computing techniques for marketing purposes. He participated in the Spanish-funded project ‘MoMoPa’ with the objective of monitoring Parkinson’s patients by using inertial sensors, and he is also cooperating in FP7 project CAALYX-MV, which aims to validate a tele-health monitoring solution named CAALYX. His main research interests consist on Intelligent Signal Analysis, Support Vector Machines and Parkinson’s disease symptoms detection. He has a good value for the team due to his skill (maths and computer science) and signal treatment and processing experience.
The participation of the team members in international research and pilot projects related to movement analysis has permitted them to establish alliances with strategic stakeholders. Among them, it is worth mentioning:
The PARK-IT solution is composed of 3 main parts:
Based on this symptom evaluation, PARK-IT has three main applications:
Very few alternatives have been developed to diagnose symptoms of PD. The identified available commercial products for monitoring of PD are Kinetigraph, Kinesia, Kinesia 360 and the Objective Movement Disorder Measurement 2.0 (all of them from companies outside Europe). The attributes of PARK-IT are clearly more suitable than those of the competitors, going beyond a naïf concept of movement monitoring to tackle an effective PD monitoring. The scope of PARK-IT reaches both hospital and home monitoring; offers continuous assessment during long periods of time; delivers automatic identification of motor symptoms; is unobtrusive, simple and easy to wear; customisable and interoperable.
|Solution||Components||Ambulatory?||Continuous?||Bradykinesia||Dyskinesia||Freezing of gait||Gait disorders||Falls||Monitoring period||Drawbacks|
|Kinetigraph||Wristband||Y||Y||Y||Y||N||N||N||7-10 days||No real-time measurements|
|Y||Y||Y||Y||N||N||N||Continuous||Detects only 2 symptoms|
|Y||Y||Y||Y||Y||Y||Y||Continuous||Weak detection when seated|
The attributes of PARK-IT are clearly more suitable than those of the competitors, going beyond a basic concept of movement monitoring to develop an effective PD monitoring. The scope of PARK-IT reaches both hospital and home monitoring; offers continuous assessment during long periods of time and delivers automatic identification of more symptoms, including the assessment of on/off stages; while being unobtrusive, simple and easy to wear; customisable and interoperable.
And, in addition to the performance, PARK-IT outpaces its competitors by being the most economical device in the market, and with a business model based only in selling the device, unlike some of its competitors such as Kinetigraph who besides selling the device, charges a fee for each generated report.
PARK-IT works with neurologists and their Parkinson’s patients to improve the effectiveness of their medication, their quality of life, and reduce the overall costs of care.
There are 6.3M people with PD worldwide, all of them are potential users of PARK-IT, and 1.2M of whom living in Europe. It is estimated that about 1-2% of people over 65 years are affected by the disease. PD is expected to double in 2030 due to aging and demographic change, particularly in Europe, Japan and North America. Although it is associated with older age groups, 10% are affected before the age of 50 years.
The Hoehn and Yahr (H&Y) scale rates 1-to-5 the severity of the PD, and defines three main groups of patients corresponding to mild (C), moderate (B) and advanced (A) stages. In Europe there are 684.000 patients at the mild stage C (57%), 420.000 moderate stage B (35%) and 96.000 at the advanced stage A (8%). The care needs of PD are different according to the stage of disease progression. As PD patient’s disease progresses, it becomes increasingly difficult to live an independent, quality and fulfilled life. PARK-IT’s value to these patients is simple, but vital because it ensures that the medication is effective when the patient needs it, and it allows PD patients to live independently, and improves quality lives for longer.
PARK-IT targets to PD patients in the moderate (B) and late mild stage (C), as they are the ones that already presented some symptoms related to motor disorders. In total these segments reach 625k of the 1.2M PD patients in Europe, growing at 8% annually. Globally, the total will reach over 15,5M by 2022.
Despite PD patients are the end-users, neurologists are our main target group in order to successfully commercialize PARK-IT, since the role of doctors (as prescribers) is critical to introduce PARK-IT into the market. Neurologist working in public and private hospitals will purchase a stock of PARK-IT devices in order to be provided to patients for short periods while their levels of OFF and ON are monitored.
During the SME-Instruments Phase 1 project we estimated that there are 21.250 neurologists in Europe, at an average rate of 4.25 neurologists per 100k inhabitants. In addition, focus groups were conducted with neurologists, and we encountered an initial resistance from the neurologists, as PARK-IT represents an important change in their ways of working, and they are not familiar to “electronic devices”, and they prefer to base their diagnosis on their perception and personal skills. However, those focus groups revealed that, once the neurologists discover that PARK-IT does not substitute their professional role but gives them objective, continuous information to support them to obtain a more accurate diagnosis and treatment, neurologists become real ambassadors of it.
Based on our feasibility study, the main advantages that neurologists have found are:
Additionally, pharmaceutical companies are willing to use PARK-IT to improve the performance of their clinical trials during the development of new drugs and treatments. Sense4Care has already some collaboration with most relevant pharmaceutical companies for PD’s products (Abbvie, producer of Duodopa, Britannia Pharmaceuticals producing Apomorphine in UK and Neuroderm in Israel).
Neurologists and the medical community in general are a key stakeholder in order to successfully commercialize PARK-IT, since they will act as prescribers either renting PARK- IT devices to their patients, or recommending the purchases of PARK-IT to their patients to our website or retail stores.
The best way to influence this target group will be through publishing evidence in well recognized scientific publications and by distributing samples to hospitals and clinics for trials. Also, conferences and workshops at professional congresses and hospital medical sessions will be critical. These efforts will become an important part of our marketing budget. Once the medical community accept this innovation, they will prescribe to their patients who are already absolutely in favour since they have recognized that PARK-IT will improve their quality of live by making it much easier to monitor and record the PD symptoms (market research with patients).
We do not plan to develop the large commercial sales team that would be required to visit neurologists and convince them of the benefits of our product. We plan instead to work with distributors who already have these sales networks and experience in working with health professionals. Therefore it is key that we demonstrate and convince distributors of the benefits of PARK-IT and the impact it can have on the market. This is a key aspect of the PARK-IT project.
It is important for us to continue to work alongside patient’s to understand how they view PARK-IT, how it helps them in their lives and therefore how to communicate this message to future users. We will continue to listen to patients throughout the project, in particular through the Hospitals of Bellvitge, Teknon, Maccabi Health Services and the Fondazione Santa Lucia, who will all take part in the PARKT-IT training activities.
Since the materials required for the production of the PARK-IT sensor and the belt are available from many suppliers, they are not considered as strategic partners. During our feasibility study we found many companies that can supply us with such components that fulfil our requirements, so this means that suppliers do not have the sufficient negotiating force that would jeopardise our profitability.
Neurologists will be our main target, concentring the majority of sales, and especially in the first year of PARK-IT commercialization. According to our feasibility study, the Total Available Market is formed by 21,250 neurologists in Europe. Thus, during the SME-Instruments Phase 2 project we will aim to reach an audience of approximately 300 neurologists through the trials of PARK-IT (based on hospitals, service providers and distributors that have already committed to the project), and a further 1500 through conferences, publications and other dissemination materials.
For this reason, and considering the above distribution, we aim that PARK-IT will have registered 276 neurologists by the first year of commercialization, and nearly 1,500 neurologists by 2023, corresponding to 7% Share of Market (SOM).
The average stock of devices per neurologists is estimated in 7 to 9. These units will be provided to patients around 6 weeks per year in average (2 to 3 weeks per patient before each visit to neurologist to ensure a good monitoring process of symptoms). With a rate of usage of 50%, it is forecasted that around 33k PARK-IT devices on the market, and more than 324k patients in Europe will have used PARK-IT through their hospital by 2023.
Our direct sales strategy targets to PD patients, which according to our feasibility study will constitute a Total Available Market (TAM) of 1,6M patients at European level. Our goal is to reach an affordable penetration of 0,07% by first year of commercialization (2019), which will increase up to a 0.77% Share Of Market (SOM) at European level, representing 11k PARK-IT devices on the market, and more than 25k patients having used PARK-IT through by 2023.
The forecast of revenues is calculated from the total of units sold and the retail price (€ 590). All the sales revenue here come from selling medical devices. Our objective is to reach a turnover of € 13M by 2023, corresponding to 22,120 PARK-IT units sold.
As mentioned previously, it is anticipated that the vast majority of sales will come through distributors, which will account 93% of PARK-IT sales. Based on discussions with distributors on the feasibility study, we have forecasted that the distributors will require a commercial margin of 30% - 40% over the selling price when selling to hospitals or professional care providers. According to our commercial experience, PARK-IT's selling cycle through distributors will take 3 months, as first it is needed to set the first contact with the distributor, to send a sample for its evaluation and then, to sign the contract. We plan a training course to distributor’s sales forces, to support distributors with marketing materials, and, where necessary, to offer pre and post-sales support in order to help us to successfully scale PARK-IT in the targeted countries.
Two different sale channels are distinguished when selling through distributors:
We do not anticipate huge number of sales in terms of sales from our website (7% direct sales). However we will use techniques of SEO and SEM to obtain the best positioning on the net. To do this, we will allocate a community manager who will develop content and maintain relationship with users. We will also list our products in the e-commerce platforms related to geriatrics. These activities will reinforce the message activities undertaken by the distributors.
The roadmap for the PARK-IT project will be the following:
The forecast of revenues is calculated from the total of units sold and the retail price (590 €). All the sales revenue here come from selling medical devices. Our objective is to reach a turnover of € 13M by 2023, corresponding to 22,120 PARK-IT units sold.
Our cost of sales lies basically on the manufacturing costs (185 €, and including components, handling charges, costs of storage and logistics, without substantial changes in costs expected over the covered period), the commercial margin applied to distributors (set to 39% in this forecast to simplify), and the commercial margin applied to retail stores (set to 21%). Based on this structure of income and expenses, the gross margin will be around 29%, which is very much in line with products of these characteristics in the medical device sector.
The financials for the project are summarised in the following table:
|PARK-IT units sold - Neurologists||2.486||5.100||6.694||8.925||10.413|
|PARK-IT units sold - PD patients||514||1.890||4.338||7.185||11.716|
|TOTAL PARK-IT INCOMES||1.770.148€||4.124.100€||6.508.733€||9.504.900€||13.055.815€|
|Distributors and retail margin||702.455€||1.641.852€||2.615.189€||3.834.086€||5.299.141€|
|Number of personnel||7.5||9||10||11||12|
The budget of the project is distributed as follows:
|Direct personnel costs||Other direct costs||Subcontracting||Indirect costs||Total|
|418.200 €||164.150 €||270.573 €||145.587 €||998.510€|
The subcontracting costs include:
From the overall budget the European Commission is will provide 698.957 € (70 % of the total budget) through the SME-Instrruments phase 2 project. Therefore, there is a need to invest around 300.000 € in two years to complete the budget.