VitalTracer for COVID-19 (VT-19)

There is a lack of an inexpensive, easy-to-use, accurate, and real time COVID-19 patient health monitoring device. 

VitalTracer provides an all-in-one continuous remote monitoring solution, as accurate as a medical device. It uses biomedical sensors through the wrist to continuously detect biosignals and store them in a secure cloud base environment. By using AI and machine learning algorithms, a complete assessment of vital signs will be accessible in real-time to doctors or caregivers as needed. Vital signs measured include blood pressure, heart rate, respiratory rate, blood oxygen saturation, body temperature, ECG, and PPG signals. 

Providing a cost-effective, easy-to-use, solution to all health practitioners and caregivers globally to safely and accurately monitor critical vital signs of all patients remotely and simultaneously. This contributes to reducing delays in diagnosis and community contagion. It also reduces close contact with medical personnel and hence reduces the need for personal protective equipment. 

According to the John Hopkins Corona-virus resource center, in the US alone, there are more than 1.8 million confirmed COVID cases and 109 042 COVID-related deaths. In Canada, there are a little less than 100 000 confirmed COVID cases and 7 778 COVID-related deaths. Even though there are breakthroughs in COVID testing kits, there is still a lack of an inexpensive, easy-to-use, accurate, and real-time COVID-19 patient health monitoring device. Such a device is particularly important because about 81% of confirmed COVID cases are treated as outpatients according to the CDC. Since there is a potential for some patients to rapidly deteriorate one week after illness onset, all patients require close monitoring. 

As some hospitals are already functioning at near or maximum capacity, there is a need for a monitoring solution for patients that are at higher risk of complications but that are still discharged because of a lack of hospital bed.  

VitalTracer has developed a medical wristband that continuously tracks bio-signals and enables clinical-grade vital sign monitoring in real-time and remotely to caregivers or healthcare systems. 

It measures all Vital signs through the wrist using 3 optical sensors including green, red and Infrared (IR) with integration of artificial neural networks (ANN). It measures blood pressure, oxygen saturation, heart rate, respiratory rate, blood oxygen saturation, body temperature, ECG, and PPG signals. It also has a gyroscope and accelerometer to measure sleep detection, step count, calorie burns, fall detection as well as measuring the intensity of the cough for COVID-19 patients. It has Bluetooth to transfer the data wirelessly to the online cloud via the mobile application that stores all the data within the highly secure online platform.  

By continuously monitoring the blood oxygen saturation level, heart rate, skin temperature and the intensity of cough, VitalTracer can monitor the recovery stage/level of the COVID-19 patients, more specifically for those who are treated as outpatients. With predetermined alarms setting to detect a drop in blood oxygen saturation or a fever, VitalTracer could send an alarm to caregivers and therefore decrease delays in COVID-19 complication management.  

The target population that would most benefit from our solution is COVID-19 outpatients and vulnerable uninfected people. The latter includes people aged 65 years and older and any person with at least one of the following risk factors: asthma, chronic kidney disease being treated with dialysis, chronic lung diseases, diabetes, immunocompromised, liver disease, serious heart conditions or severe obesity. One particular at-risk population are people living in nursing homes or long-term care facilities. 

By distributing VitalTracer to vulnerable uninfected people, we can help them rapidly detect the apparition of COVID-19 symptoms and alert caregivers to diagnose and treat them accordingly. Similarly, by distributing VitalTracer to COVID-19 outpatients, we can help potentially reduce hospital stay by offering a continuous and in real-time monitoring solution.   

By continuously, remotely and non-invasively monitoring the blood oxygen saturation level, heart rate, skin temperature and the intensity of cough, VitalTracer contributes to improve outpatient monitoring and to accelerate the COVID-19 diagnosis of vulnerable people by detecting the main COVID-19 symptoms and alerting caregivers in such cases. 

VitalTracer is a low-cost rapid monitoring tool that informs caregivers remotely and in real-time. Remote monitoring is highly beneficial because it protects both the most vulnerable population and health workers by reducing close contact with medical personnel. 

The first innovation is the new way to derive the beat to beat estimation of BP from the ECG and PPG signals by leveraging an advanced ML algorithm accurately. Additionally, we are working on a novel BP algorithm to use only one optical sensor and ML. The second innovation is our novel algorithm for Continuous and calibration-free SPO2 measurement from the wrist by using 3 optical sensors and ML with an accuracy of ±2%. The most important novelty is our algorithm which can early detect COVID-19 disease using ML, but this needs to be tested on COVID-19 patients to find the accuracy of the results.

1. there are improvements in the functionality of Respiratory rate and body temperature measurements through the wrist by the application of LED sensors and AI.

2. The hardware is considered a state-of-the-art product since there is no other product to have all the sensors integrated into one device. We are filing a patent portfolio regarding the novelty in algorithms and hardware.

VT-19 is a medical smartwatch that helps detect and manage COVID-19 disease by continuously monitoring vital signs and provides an alarm system in case of abnormality. VT-19 is a wearable development kit that is a low-cost alternative to current lab sensors and is just as accurate. It is a small, low-power device packed with sensors to measure vitals, such as ECG, PPG, SPO2 & Heart Rate, Body Temperature, Motion, Step count, calorie measurement, with an easy to use design. VT-19 includes 3 optical sensors of Green, Red and IR and AI which makes it special in measuring SPO2 accurately from the wrist while being calibration-free. Bluetooth capabilities, Arduino compatibility and a library of tested codes make using your board easy, even right out of the box. They could collect, store and retrieve raw ECG and PPG signals from the built-in memory and display them on the desktop and mobile app simultaneously. The signals are analyzed and vital signs are estimated continuously with the aid of AI. We have developed several AI and ML algorithms for measuring all vital signs. The input were different features extracted from ECG and PPG bio-signals and the target values are the vital signs values. The algorithm was trained and different network structures were checked until the final network structure was chosen that showed the standard accuracy.

Beat-to-Beat Estimation of Blood Pressure by Artificial Neural Network, doctoral thesis, Azadeh Dastmalchi, University of Ottawa, master thesis, 2015. 

https://www.youtube.com/watch?v=irHvn1kw6aY&feature=youtu.be

Elgendi, M., Fletcher, R., Liang, Y. et al. The use of photoplethysmography for assessing hypertension. npj Digit. Med. 2, 60 (2019)

The impact of this project is multi-fold: 1) early detection of COVID symptoms in the most vulnerable population to reduce delays in diagnosis, management and to help reduce community contagion (i.e. Cardiovascular patients, pregnant women etc.). 2) Early detection of health deterioration in COVID-positive diagnosed outpatients thereby improving outpatient monitoring which contributes to alleviate hospital bed congestion. 3) Remote diagnostic, allowing for the surveillance of health and contagion in elderly residences and private homes. 4) remote diagnosis, allowing for surveillance of patients in residences or hospitals, to reduce close contacts with medical personnel and hence reduce need for protection material, still reduce contagion within care units. 

Currently VitalTracer is 20 people based on the number of devices sold. Those 20 units are currently used in clinical research projects to help detect sleep apnea and dementia in an elderly population. 

In one year we expect to be serving 500 people.  This is based on the sum of the  estimated orders that we are expecting to receive due to our collaborations with universities. Those 500 units will be used in two separate clinical trials: i) for early COVID-19 detection and monitoring and ii) for dementia screening in an elderly population during COVID-19 pandemic time. 

Combined with company growth and the expected 25% CAGR of the global mobile health and smart sensor market (https://www.marketwatch.com/pr...), in 5 years we expect to have sold 10,000 units. These will be through sales to researchers at universities and government organizations, as well as other Commercial and public sector organizations for research and patient monitoring.

In the following year, we will run a clinical trial in partnership with University of Calgary to detect and monitor COVID-19 cases in the elderly population. Meanwhile, we will finalize the commercial design of the watch before starting manufacturing it in the next 6 months. Within the following year, our goal is to obtain certifications for medical devices from the FDA and Health Canada. Once we obtain these approvals, we will scale production and sell our services directly to COVID-19 treatment centers and to senior homes and long-term facilities. 

There are a few barriers that we are encountering.

While continuously monitoring the patient’s respiratory rate from the wrist, if the person moves this tends to cause additional signal noise and affect accuracy.  Also, currently, optical sensors have a common issue with motion artifacts when measuring the patient’s vital signs.  Since the wristband is in close contact with the skin, it is possible to have problems in collecting signals from the wrist of the persons who have thin and sensitive skin. Further studies need to be made to determine the accuracy of measurement from people with different skin pigmentations and ages. 

There are also some challenges regarding the certification process (CE and ISO-13485) which is required for medical device manufacturers to show certified evidence of compliance to the appropriate regulatory quality systems.

Since VitalTracer is a start-up that has a limited financial budget for salaries.  Most resources are dedication to R&D and technology, and not to business growth and development. Also, Intellectual property rights could cause an issue if patents are not taken care of soon.

1- It is possible to use supervised learning such as ANN to train the algorithm while the person is in steady-state and add a couple of filters for motion artifacts to find the accurate breathing rate.

2- Our manufacturing partner will provide guidance, training, and support to make sure that the engineering documents and development of the prototype are in line with the certification process.

3- As a potential solution to this issue, we are developing an Ultrasound sensor that could solve this issue and estimate BP more accurately in comparison to optical sensors. However, it needs to be tested.

4- This could be done by adding an algorithm to change the power intensity of the light for different pigmentation and skin thickness.

5- If we get this grant, we will be able to hire more qualified experts as well as being a partner with other SMEs to accelerate the project development.

6- We already got our Canada FTO letter regarding our technology. We are filing a patent portfolio with our law firm Fasken regarding our hardware, SpO2, and BP algorithms. However, we have to move fast since this technology has lots of small and big competitors globally such as other start-ups and big players like apple and google.

full-time staff 5 (Ali, Abouzar, Azadeh, Zahra, Seyed)

part-time staff (3 MBA students)

4 contractors : 

A- Saimen as our manufacturer, 

B- Vagabond & Marketers as our marketing firm,   

C-LOK North America as our regulatory consultation and health certifications for health canada and FDA clearance

D- Kobi Kor Design, a professional medical device industrial designer

VitalTracer is a medical start-up whose focus is on personalized medicine and our value proposition is measuring blood pressure continuously and without the cuff. The co-founder and CEO, Azadeh Dastmalchi, has Ph.D., MSc and BSc all in biomedical engineering and has been working on the concept of cuffless blood pressure measurement for about 10 years. She is also an expert in machine learning as well as signal processing. Azadeh Did her master and Ph.D. thesis in the topic of Beat-to-Beat Estimation of Blood Pressure by Artificial Neural Network at the University of Ottawa. Zahra is the Chief Operating Officer and co-founder of VitalTracer, who has a Ph.D. in project management and is an expert in AI. She is doing the AI algorithm for blood pressure and other vital signs. These founders are supported by a team of experienced people, as well. Ali Ghorbani, who has an MSc in Electronic engineering, is the hardware designer with more than 15 years of experience in design and implementation in medical devices and has 3 patents in this area. Abouzar Dastmalchi has an M.Sc in computer since Focus on Software Project Management and Information Security at Johns Hopkins University and responsible for secure online clouding as well as the Business Development lead and is taking care of the business side of the start-up, especially  in the middle east and US. Rachel Cohen who has a BSc in biomedical engineering, is the Quality Assurance lead.

• Calgary University and McGill University Health Center will each pilot a clinical trial, to detect and monitor COVID-19 symptoms and dementia in an elderly population, respectively. 

• University of Waterloo, University of Ottawa and Laval University are currently contributing to technology development, namely researching to improve blood oxygen saturation measurement, to improve the AI algorithm and to optimize power utilisation, respectively. 

Yes, our product is using AI and ML algorithms to develop a personalized health assessment report for each individuals based on the collected bio-signals through the wrist. We have used data from over 10,000 patients to train our algorithm to calculate vital signs based on the ECG and PPG signals.

As of now, all of the founders of VitalTracer are women and visible minorities. The culture of our startup gives priority to women, youth, people with disabilities and minorities for recruitment. We will definitely work hard to create diversity within our workforce and to support the participation of under-represented groups such as women, minorities and youth. We will allocate 50% of our job vacancies to minorities especially women since we want to create an atmosphere in which all people feel valued and respected and have access to the same opportunities. 

One of our target market is the pregnant women. Most pregnenet women experience high blood pressure during their pregnancy which result in permanent hypertension if not taken care of. VT-19 could let them know their health report daily in addition to alarming if the symptoms of COVID-19 appear on them.