Aseptika Ltd, the self-care and patient activation solutions developer, is pleased to announce that the European Patent Office has granted a patent for its medical-grade wearable, for use by patients with severe cardiovascular and respiratory diseases (EU patent number 3197354, granted 3rd July 2019 with a filing date of 9th September 2015).
The product called BuddyWOTCHTM, will continuously monitor, record and transmit the patient’s physiological signs of blood oxygen, heart rate, breathing rate and temperature for 24-hours-a-day, 7-days-a-week. With its integrated 9-axis accelerometer, BuddyWOTCH tracks in real-time the patient’s physiological signs and how these change over time as the patient goes about daily life. As well as acting as an alert in case of medical emergencies, this information is used to continuously calculate the patient’s overall health and to detect whether the wearer’s health is getting better or is declining rapidly. The BuddyWOTCH can be used to test the patient in a GP clinic using the 6-minute walk test – something usually only performed in a laboratory setting during sessions at hospital outpatient clinic appointments.
The BuddyWOTCH platform connects directly to the Company’s Activ8rlives Cloud (or can be pointed to a partner’s cloud system). Activ8rlives has portals for the patient, for family members caring for them and for clinicians, providing continuous monitoring and alerts as well as the index of tolerance to exercise, itself perhaps a better indication of overall health than simple alerts usually associated with remote monitoring systems.
The BuddyWOTCH transmits information to-and-from the wearer using an integrated 4G modem and WiFi, so that no separate home hub or even a Smartphone is required by the user.
Monitoring the most “at risk” patients can therefore be provided by care homes, as part of a ready-for-home package after being discharged from hospital or used at home to support independent living for as long as possible.
The BuddyWOTCH also acts as a Bluetooth hub, transmitting data from the Company’s other Activ8rlives Bluetooth medical devices and those from partner suppliers, to make it easier to provide reminders for medication from inhaler trackers like the PUFFClickerTM or to measure blood pressure or weight, as some examples. This means the user still does not require a Smartphone or home hub to be supplied and installed, in order to self-care and remote monitor from home.
Now in its final stages of development and transfer to production, the EU patent enables the Company to begin identifying commercialisation partners who provide healthcare services to patients or need continuous patient monitoring during clinical trials of new medication, with a particular focus on overseas markets.
The BuddyWOTCH will be CE-marked under the EU’s Regulation on Medical Devices 2017/745 as a Class IIb medical device, reflecting its role as a “life-critical medical monitor” replacing a bedside vital signs monitor for home-use, rather than a consumer-level accessory. This has been made possible through the development of Aseptika’s MediOSTM, a real-time operating system designed by the Company to be a clinically certifiable operating system for use in a range of medical monitors.
MediOS will be used in future medical devices to enable the Company’s and its future partner’s to fast-track development and quickly gain a CE-mark by using a previously certified and stable operating system, which can be strictly controlled and only updated after extensive testing to ensure security vulnerabilities and bugs have not be introduced.
BuddyWOTCH and MediOS have been developed with support from pre-procurement contracts from SBRI Healthcare and grants from UKRI (formerly Innovate UK).