STAT-ON™, a medical device that monitors the motor symptoms of persons with Parkinson disease.

Barcelona, March 1, 2021 – Sense4Care, a leading company specialized in developing and producing wearable medical devices based on the identification of human movement patterns; and NordicInfu Care AB, a Healthcare provider of innovative solutions including medical devices and novel pharmaceuticals, announce a new exclusive distribution partnership in Sweden, Norway, Finland, and Denmark to distribute and commercialize Sense4Care’s Holter for Parkinson STAT-ONTM.

Still today, the lack of precise, continuous data on the clinical status of persons affected by Parkinson’s disease (PD), is one of the main difficulties faced by neurologists in charge of adapting treatment. It is estimated that 40% of diagnoses are wrong in current clinical practice [1]. This obstacle has been now overcome with the STAT-ONTM device.

STAT-ON™ consists of one small non-invasive device capable to capture and process objective data of PD motor symptoms, and automatically generate user-friendly reports easy to read. STAT-ON™ is placed on the patient’s waist using a belt and monitors the motor activity of a person with PD under normal living conditions. This allows the neurologist and other health professionals in charge of supervising the evolution and wellness of the patient, to have objective, precise, and extensive information on the person’s motor state and its evolution, which is complicated and expensive to obtain through other traditional methodologies still used today.

STAT-ON™ has been certified as a CE Class IIa medical device, according to the UE regulatory processes and exhibits the main following capabilities:

• Indication of the ON and OFF states distribution of the patient along the day using a colour code (green for ON and red for OFF)
• Severity of Bradykinesia
• Identification of Dyskinesias
• Detection of the Freezing of Gait and Falls
• Possibility of medication in-take registration and medication alarm reminder
• Detailed additional and complementary representation and analysis of Gait Parameters

STAT-ON™ makes it easy to constantly monitor the ON/OFF fluctuations experienced by patients under treatment and supervision. It also monitors other motor symptoms experienced by them (bradykinesia, dyskinesia and freezing), allowing more precise treatments in early and moderate stages, the detection of early motor fluctuations/dyskinesia, and identification of candidates for Advance Therapies. In addition, STAT-ON™ can monitor gait parameters, falls and other characteristics of movement that allow for improved management of the disease and for significantly improving patient’s quality of life. Since each individual moves differently, the STAT-ON™ is designed to adapt to each patient. To do so, it uses the information that initially receives from the patient and “learns” from their movement. Then, through embedded Machine Learning algorithms, it personalizes the parameters used to analyze and register their motor state. Once this step is completed, the STAT-ON™ works autonomously and is very easy to use. While carried by the patient, it does not require any sort of activation or connection. STAT-ON™ is the result of a full decade of research and development from Sense4Care and UPC (Technical University of Catalonia · Barcelona Tech) and it has been validated clinically in several pilots with the aim of replacing the evaluation methods used to date. Growing incidence of Parkinson’s The incidence of Parkinson’s disease has grown in recent years, largely as a result of longer life expectancies in the general population. Over 7 million individuals worldwide have been diagnosed with this neurodegenerative disease, and of these, 1.5 million live in Europe. This disease causes serious motor problems throughout its evolution and may result in freezing as well as hidden non-motor symptoms including pain, apathy, confusion, difficulty speaking, disturbed sleep and depression. Parkinson’s disease is the second most frequent neurodegenerative pathology, after Alzheimer’s. The last studies indicate that the number of patients will increase exponentially [2]. This fact, along with the high increase of the cost of a PD patient, which is rated at 8.300 € more than a healthy person in Europe on average [3], shows an unsustainable scenario where public health systems will experiment problems to afford correctly. Advantages of using STAT-ON™ In conclusion, STAT-ON™ improves the therapy adjustments by providing better information to the physician, which means improving the QoL, satisfying the patient and increasing the quality of the relationship between the neurologist and the patient. At the same time, the centre can attend more patients, as professionals will have digital tools to evaluate objectively without doing classical evaluations such as diaries, or questionnaires, meaning less saturation of centres due to COVID-19 scenario. Therefore STAT-ON™ can be perfectly considered a tool against the COVID-19 pandemic effects, minimizing the need for physical visits, and making possible the digitalization of data for the first time.

References

[1] Channa A, Popescu N, Ciobanu V (2020) Wearable Solutions for Patients with Parkinson’s Disease and Neurocognitive Disorder: A Systematic Review. Sensors 20:2713 . doi: 10.3390/s20092713

[2] Dorsey ER, Sherer T, Okun MS, Bloem BR (2018) The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis 8:S3–S8 . doi: 10.3233/JPD-181474

[3] European Parkinson’s Disease Association (2011) The European Parkinson’s Disease Standards of Care Consensus Statement. 28