A Personal Fertility Sensor Coming Soon
Priya is an intravaginal ring being developed to help your patients who are interested in their fertility to wirelessly capture their continuous core body temperature. Currently undergoing testing in clinical trials, the intravaginal ring transmits temperature data directly to the Priya App on the patients smartphone. When the Priya app detects the subtle changes in core temperature that occur PRIOR to ovulation, it sends an alert.
What is Priya:
Priya - For the next generation of patients seeking precise personal monitoring
Priya is an intravaginal ring with the same dimensions and flexibility as Estring®. We use the same medical-grade silicone form-factor and have inserted a wireless continuous temperature sensor. Priya is intended to be an over-the-counter product that a woman can insert while in the comfort of her home. We have developed the technology for the data to be automatically transferred to the iOS Priya App and are testing the app to send an alert to the phone when Priya detects a dip in temperature. Temperature is continuously monitored and all the data are transferred to the Priya app on her iPhone. An algorithm is being tested to detect the DIP in temperature prior to ovulation.
There are no monitors, attachable extra sensors, urine strips, or replacement parts. All that is required is to pair the Priya Ring with the Priya App on the smartphone and then insert the ring. Your patients can then go about their normal daily activities. The Priya Ring is being designed vaginal use only.
Unlike oral temperatures which measure Basel Body Temperature (BBT), Priya is an internal, continuous, core temperature sensor. Core temperature monitoring has been shown to be a more precise method for identifying ovulation compared with a once-daily oral thermometers or skin measurements (1,2,3).
The Science Behind Priya
It is well know that a pre-ovulatory decline in core temperature takes place 24-48 hours prior to ovulation (2,3). When measured accurately, this decline provides an important tool for predicting ovulation (see figure below). Having intercourse during these pre-ovulatory days significantly increases the probability of conception (6).
Women’s bodies tightly control body temperature and exhibit a striking diurnal temperature pattern. This temperature pattern has been well studied and has been established as a highly reliable marker for circadian rhythm (8). Continuous core temperature monitoring can be used to precisely predict impending ovulation by identifying a dip in body temperature (circamensal nadir) as detected with multiple continuous temperature readings in the 48 hour period prior to ovulation. Based on continuous core temperature monitoring during clinical trials, the algorithms developed for Priya have been shown to achieve a 99% sensitivity for detection of ovulation, with a 99% percent accuracy.
In the published study conducted by Mary Coyne et al, "Circadian rhythm changes in core temperature over the menstrual cycle: method for noninvasive monitoring", core temperatures were measured every minute over the course of an entire menstrual cycle. The results of this study showed a beautiful circadian rhythm could more-reliably identify the temperature changes that precede ovulation. Even more impressive was that circadian rhythm could better-detect the important DIP in temperature that precedes the surge of luteinizing hormone by one or two days (2).
Therefore, oscillating temperature patterns can be measured accurately and precisely using a vaginal rings that are similar to those that women have been wearing for several years.
- Validation of the ingestible VitalSense temperature capsule. Phillips – Respironics, 2009.
- Coyne et al. (2000). Circadian Rhythm Changes in Core Temperature over the Menstrual Cycle: Method for Noninvasive Monitoring Physiol Regulatory Integrative Com Physiol. AM J 279:1316-132.
- Cagnacci et al. (1997). Regulation of the 24-hour Rhythm of Body Temperature Cycles with Spontaneous and in Menstrual Gonadotropin-induced Ovulation.Fertility and Sterility 68:421-425.
- Johnson SR, Shaw R. (2009). Success of detection of LH surge by home ovulation tests. Fertil Steril : 92(3):S101.
- American Pharmacists Assoc. (2007). Selection and Use of Home Diagnostic Products.
- Wilcox et al. (1995). American Pharmacists Assoc NEJM 333(23):1517-1521 5.
- Consumer Report (2009).
- Brown et al. (2000). A statistical model of the human core-temperature circadian rhythm. Am J Physiol Endocrinol Metab 279: E669–E683.
Who is Behind Priya?
Lauren Costantini, PhD, CEO. Lauren has held executive positions in life science companies focusing on driving products from discovery through launch. She has lead products from research though clinical, regulatory, marketing and commercialization stages, with 20+ years developing therapeutics for several indications. She plays a key role connecting early-stage companies with potential partners, venture capital and investors, as well as directing due diligence for in- and out-licensing activities. Roles include Vice President at Colorado Institute for Drug, Device and Diagnostic Development (CID4) and former faculty at Harvard Medical School.
Don Kirkpatrick, Chairman of the Board, Prima-Temp Inc. Don is the founder and Chairman of Cadre Technologies, the largest software provider to the third-party logistics in warehouse management and distribution technology. Don is an engineering graduate of Princeton University and Director of Denver School of Science and Technology.
Rich Pollack, CTO and Co-Founder. Rich’s engineering team developed the temperature/pressure sensor in tires for Goodyear that later evolved into Phase IV Engineering in Boulder, CO. His engineering career spans 25 years experience including wireless temperature sensors for a variety of applications and is named in over 15 patents. He founded Phase IV and three other companies.
Wade W. Webster, MD, CMO and Co-Founder. Dr. Webster is a practicing Emergency Physician at Evergreen Hospital Medical Center, Kirkland, Washington for 21 years. He received his Medical Degree from Albany Medical College in Albany, New York. Wade is currently the Chief Science Officer for DVM Systems, LLC, a system for early disease detection and reproduction that uses temperature monitoring in dairy cattle and ruminants.