Gleaning reliable population-level temperature data routinely has been a key component of the more successful efforts in several Asian countries for containing the emerging, novel coronavirus. But these often have required highly time and labor-intensive coordinated efforts to screen people manually as they access various services such as public transportation and grocery stores.
Remotely monitoring people for the early signs of COVID-19, as well as determining disease progression for infected patients virtually, would offer huge potential advances in better protecting the populace, as well as lessening the burden on swamped health care providers.
Into the gap
Zurich-based startup Ava Science Inc. hopes to step into that gap. The company recently issued a public call for partners and funding to further research the potential usefulness of its fertility wearable, known as Ava Bracelet, during the COVID-19 pandemic.
The effort is not unprecedented; the primary COVID-19 treatment center in Shanghai, the Shanghai Public Health Clinical Center, has been using continuous temperature monitoring in hospitalized patients using wearable technology from Campbell, Calif.-based startup Vivalnk Ltd., which also has a China office. This freed health care staff from routine temperature checks.
“Given the current pandemic, we have looked as a company at how we could repurpose our device to help combat the spread of COVID-19,” Ava Chief Medical Officer and head of clinical development Maureen Cronin told BioWorld. Cronin was previously the Head of Women´s Medical Affairs at Bayer Schering Pharma.
The Ava Bracelet provides the highly accurate temperature readings necessary for this application, as well as other vital sign monitoring. It is already in widespread use throughout the U.S. and Europe and has aided more than 30,000 women in getting pregnant. Ava, which has a U.S. headquarters in San Francisco, is starting to coordinate with various governments, nonprofits, academics and companies to explore the application of its Ava Bracelet for systematic COVID-19 monitoring.
“We believe our device, the Ava Bracelet, could be used to detect early symptoms known to be associated with COVID-19 and are seeking funding to test our hypothesis directly,” said Cronin. “We know that our medical-grade device, worn nightly while the user sleeps, can pick up subtle changes in breathing rate, heart rate, and temperature; the user syncs the device each morning with a smartphone app that shows them how their physiological parameters have changed over the last days, weeks and months.”
“The nightly log of changes in biophysical data could provide critical insights for first responders and/or people with known or suspected exposure quarantining at home, indicating when they may want to seek medical advice,” she continued. “Additionally, this data could be shared with health care professionals at time of triaging to demonstrate the trajectory and/or severity of the disease. We believe the Ava bracelet could even serve as a remote surveillance tool in hospital wards, reducing the need for health care professionals to take in-person vitals and thereby minimizing the risk of additional transmission.”
In Europe, the device has a CE mark to measure the physiological parameters to facilitate conception and to provide general health and wellness information. In the U.S., where it launched in 2016, the device is listed with the FDA as a class I device for use in conception and physiological changes in subsequent pregnancies. Ava aims to submit to European regulators later this year for a contraception indication.
Remote monitoring priorities
The Ava Bracelet is a wrist worn device that is worn nightly to track breathing rate, pulse rate, skin temperature, heart rate variability, perfusion as well as sleep quality and quantity. Its initial fertility aim was to replace the common fertility practice of monitoring basal body temperature every morning prior to leaving bed to predict when ovulation is most likely to occur.
The most common COVID-19 symptoms are fever, dry cough and shortness of breath, according to the World Health Organization. These occur at a rate of 88%, 68% and 19%, respectively. Ava anticipates that it can detect a fever with both its body temperature and pulse rate monitors, which should both increase, while shortness of breath can be measured as an increased breathing rate. There is obviously no physiological reason why the wearable couldn’t be used across genders.
The Ava Bracelet data is analyzed via machine learning to predict a five-day fertile window with 89% accuracy. It’s been evaluated in several clinical trials and peer-reviewed manuscripts. The company said that it is currently evaluating data from its users for COVID-19 related trends, but declined to disclose anything further.
The FDA is prioritizing the expansion of “the availability and capability of noninvasive remote monitoring devices to facilitate patient monitoring while reducing patient and health care provider contact and exposure to COVID-19 during this pandemic.” It released guidance late last week that is designed to enable the smooth repurposing of existing devices – and remove potential penalties for repurposing of these devices.
“FDA does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared non-invasive remote monitoring devices that are used to support patient monitoring during the declared public health emergency,” the FDA stated in the new guidance.
Ava declined to name any specific potential partners in its COVID-19 efforts, but did say that it has the capacity to make 50,000 bracelets available “shortly” with the capacity to further ramp up production. The company has started offering a non-fertility version of the Ava Bracelet for $100 off the standard $249 price to individuals, researchers and medical professionals for physiology tracking.
“We have had numerous requests for information and several requests for discussions,” said Cronin. “The requests have come from current users, potential users, governmental and non-governmental organizations, academics and industries. We are investigating several options as we speak.”
“We are working towards submitting a grant application for a public-private (academic and industry) grant proposal in Europe by the end of this week,” she added. “We are a very small organization, but we understand the need to act fast. We are investigating several other proposals in different regions throughout the world and remain open to other proposals.”