Slide 1: Continuous Temperature Monitoring – Use in Fever Detection and Other Areas
Continuous Temperature Monitoring – Use in Fever Detection and Other Areas Stephen Willmor – Head of Regulatory Affairs March 2020 NASDAQ: NMRD
Slide 2: Forward-looking Statements
2 Forward - looking Statements Certain statements made in this presentation that are not historical facts constitute forward - looking statements within the mean ing of the Private Securities Litigation Reform Act of 1995. Reliance should not be placed on forward - looking statements because they i
Slide 3: Body Temperature - Background
Body Temperature - Background • A person’s body temperature says a lot about their health! • Several diseases including COVID - 19 are characterised by fever (an increase in body temperature) meaning that temperature monitoring is a vital tool in detection / diagnosis and consequently in preventing
Slide 4: Body Temperature - Background
Body Temperature - Background • The temperature of the human body can vary depending on a number of factors including the age of the person, their level of (recent) physical activity, the time the measurement is taken and importantly where on the body the measurement is taken from. • As such and con
Slide 5: Current ways to measure body temperature
Current ways to measure body temperature • There are number of relatively simple ways to monitor temperature at a ‘point in time’ and these are outlined below with some of their advantages / disadvantages [1] : 5 Site of Measurement Advantages Disadvantages Forehead (Temporal) Easy of use Highly ina
Slide 6: Temperature changes in response to a fever
Temperature changes in response to a fever • Thermoregulation is a vital function of the autonomic nervous system in response to cold and heat stress. Thermoregulatory physiology sustains health by keeping body core temperature within a degree or two of 37 ° C [1] . • Our bodies have evolved to func
Slide 7: Temperature changes in response to a fever
Temperature changes in response to a fever • For practical clinical purposes a person is considered febrile or pyrexical if their body temperature rises above the following values: 7
Slide 8: Current Diagnosis of COVID-19
Current Diagnosis of COVID - 19 (Corona) • Currently there are two main ways to initially detect or screen people for the contagious virus COVID - 19 without performing a formal test: • Elevated temperature due to fever i.e. temperature above the values provided in previous table. • Persistent dry c
Slide 9: Detection of COVID-19
Real time temperature monitoring – Detection of COVID - 19 • A CTM that provides accurate temperature readings / trends over an extended period of time would have multiple advantages over the current systems including: • A trend over time would allow the user to see if their body temperature is (gra
Slide 10: Detection of COVID-19
Real time temperature monitoring – Detection of COVID - 19 • Global travel is now the norm with airports like London Heathrow having nearly 220,000 passengers land or depart every day [5] . • During viral outbreaks, attempts have been made to screen passengers showing signs of fever using infrared t
Slide 11: Detection of COVID-19
Real time temperature monitoring – Detection of COVID - 19 • In the detection / diagnosis of COVID - 19, a non - invasive device providing ‘real time’ temperature monitoring data and trends could be a powerful tool for: • Users : An accurate up to date temperature chart would allow them to see if th
Slide 12: Diagnosis of other diseases
Real time temperature monitoring – Diagnosis of other diseases • COVID - 19 may be at the front of the world’s mind at this time but there are many other infectious diseases which are characterised by fever and diagnosis of many of these could benefit greatly from continuous rather than ‘point in ti
Slide 13: Diagnosis of other diseases
Real time temperature monitoring – Diagnosis of other diseases • In hospital settings, medical workers check the temperature frequently to form the temperature curve that doctors then interpret. If this function was performed by a simple non - invasive device which transmitted the readings to a mobi
Slide 14: Diagnosis of other diseases
Real time temperature monitoring – Diagnosis of other diseases • Febris intermitens (Intermittent Fever) [8] : Temperature rises to 39 / 40 ° С, with fluctuations resulting in drops below even 37 ° С sometimes for a day or more. Febris intermittens is a typical temperature curve for malaria but also
Slide 15: Diagnosis of other diseases
Real time temperature monitoring – Diagnosis of other diseases • Febris undulans (Undulating Fever) [8] : Temperature gradually rises every day, sometimes reaching 39 / 40 ° С and then slowly falls, followed by a period of afebrile days until the onset of a new wave of febrility. Characteristic of l
Slide 16: Diagnosis of other diseases
Real time temperature monitoring – Diagnosis of other diseases • All of the above fever states and others including septic fever (seen in sepsis and osteomyletis ) and hectic fever (seen with tuberculosis and sepsis) display fluctuating temperature profiles. • Continuous temperature monitoring provi
Slide 17: Pregnancy
Real time temperature monitoring – Pregnancy • It is well known that checking and plotting basal (‘at rest’) body temperature is helpful to predict when a woman will ovulate. • Before a woman ovulates, her basal body temperature will usually be about 36.1 - 36.4 ° C (97 - 97.5 ° F). • During ovulati
Slide 18: Pregnancy
Real time temperature monitoring – Pregnancy • Current methods require women to take their temperature every morning before getting out of bed and charting this themselves or using an App. • This ‘point in time’ measurement approach has a number of limitations / disadvantages: • Inaccurate readings
Slide 19: Pregnancy
Real time temperature monitoring – Pregnancy • Combine this accurate temperature dataset with data such as heart rate, sleep quality etc from other wearable devices plus information from user input and the potential to create using predictive analytics / artificial intelligence, a personalised datas
Slide 20: Foot complications in diabetes
Real time temperature monitoring – Foot complications in diabetes • People with diabetes can develop many different foot problems often caused by nerve damage (neuropathy) but also by poor blood flow or changes in the shape of the feet or toes [9] . • These foot problems can range from the minor (ca
Slide 21: Foot complications in diabetes
Real time temperature monitoring – Foot complications in diabetes • As the window to identify an increase in foot temperature indicating a potential ulcer is wide – 37 days prior to ulceration [14] , patients do not need to monitor their temperature every day but do need to do it regularly. As such
Slide 22: Device Regulations in the US
Device Regulations in the US • Any medical device will be regulated by FDA if it meets the definition in Section 201(h) of the Food, Drug, and Cosmetic Act [15] : 22
Slide 23: Device Regulations in the US
Device Regulations in the US • Medical Devices in the US currently fall into three categories: • Class I – Low risk to user. General controls are adequate to control it. • Class II – Medium risk to user. General controls plus special (specific) controls required • Class III – High risk to user. Gene
Slide 24: Summary – Uses and Benefits of a Continuous Temperature Monitoring Device?
Summary – Uses and Benefits of a Continuous Temperature Monitoring Device? • Monitoring body temperature has multiple uses from the (self) - diagnosis of fever in diseases like COVID - 19 to helping to predict ovulation date in order to increase the chances of conception. • Currently available and e
Slide 25: References
References • [1] Thermoregulatory disorders and illness related to heat and cold stress; Cheshire W P; Autonomic Neuroscience: Basic and Clinical 196 (2016) 91 – 104 • [2] Hausfater P, Zhao Y, Defrenne S, Bonnet P, Riou B. Cutaneous infrared thermometry for detecting febrile patients. Emerging Infec