In a recent clinical trial, which Ava conducted in collaboration with University Hospital of Zurich, the Ava bracelet was shown to capture the physiological changes known to occur in early pregnancy. These changes include differences in heart rate variability, pulse rate, and temperature between the late luteal phase in conceptive and non-conceptive cycles.
Based on these findings, scientists concluded that Ava could potentially be able to show the users in the future an indicator of pregnancy based on the changes of the physiological parameters reported at the late luteal phase.
The new findings have been presented to the American Society of Reproductive Medicine 2017 conference, which was held at San Antonio, Texas in early November. To find out more about the device Digital Journal spoke with Ava Co-Founder Lea von Bidder.
Digital Journal: Thanks for the interview Lea. Please can you explain what the Ava bracelet does?
Lea von Bidder: Ava is a sensor bracelet that uses new technology to precisely detect the fertile days during a woman’s monthly cycle in real time. Worn only at night while sleeping, Ava measures nine physiological parameters including pulse rate, breathing rate, heart rate variability, temperature that – in combination – help indicate a rise in reproductive hormones estradiol and progesterone.
The impact of the rise of these hormones on the physiological parameters is used to detect a five-day fertile window in a woman’s cycle. Because users simply wear the Ava bracelet at night and sync it with the Ava app in the morning, they avoid the hassles, mess and invasiveness of other fertility tracking methods like ovulation strips and BBT thermometers.
An FDA Class 1 medical device, the Ava bracelet was proven in a recently concluded clinical study at the University Hospital of Zurich to detect an average of 5.3 fertile days per cycle with 89 percent accuracy.
DJ: How did you go about developing the technology?
von Bidder: Every woman knows there are several things that change over the course of a woman’s menstrual cycle. Her hair, her skin, her basal temperature. Three years ago, we decided to explore if other physiological parameters also change as a result of the hormonal influences during the cycle. The result of that research is Ava.
The Ava technology was developed together with several research partners, most prominently the University hospital in Zurich, Switzerland. The Ava founders have a background in medical devices, medical devices manufacturing and sensor technology, which came in very handy to tackle this challenge.
DJ: Has the Ava device been subject to clinical trial?
von Bidder: Ava is clinically tested in a first trial which ended in Spring 2016. We are currently in a much larger clinical study that is ongoing since summer 2016.
DJ: Are any further trials planned?
von Bidder: The ongoing trial currently underway will finalize our research for the time-being. This research includes various sub-groups.
DJ: How is data captured and displayed?
von Bidder: The data is captured via the Ava bracelet, a medical device Class I registered with the FDA and CE marked. Women wear it continuously during the night. The data is then displayed on their mobile phone after synchronization in the morning.
DJ: How did you address any data security concerns?
von Bidder: Ava complies with the gold standards of data security. It is a topic we are very serious about.
DJ: What has been the response from the medical community?
von Bidder: The medical community is very positive about Ava. It has been frustrating for OB/Gyns to have to recommend women tedious and imprecise methods of cycle tracking while those same women are used to 21st century technology.
DJ: What has been the response from consumers?
von Bidder: We’ve had overwhelmingly positive response and interest from consumers around the world. Even more exciting: We have had at least 1,000 pregnancies among users since we first launched in July 2016.
DJ: What is your marketing strategy going forwards?
von Bidder: Ava is already now a product that grows strongly organically, either through recommendations or through women finding our content on our blog, AvaWorld. That is something we expect to grow further.
DJ: What else are you working on?
von Bidder: We are working on sub-groups of fertility such as PCOS and highly irregular cycles as well as on different ideas regarding pregnancy monitoring, menopause management and contraception.
DJ: What other types of healthcare technology interest you?
von Bidder: Ava is and will be focused on women’s health. Our mission is to be a woman’s companion over 20-30 years in her life and give her all insights she needs about each exciting stage of her reproductive life.
The first findings from Ava’s clinical study have been published in the peer-reviewed journal Scientific Reports (“Pulse Rate Measurement During Sleep Using Wearable Sensors, and its Correlation with the Menstrual Cycle Phases, A Prospective Observational Study”).