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Below is our recent interview with Jackie Dayton, Director of Product Marketing at Prima-Temp:
Q: Jackie, tell us something more about your platform and Prima-Temp’s mission?
A: Prima-Temp’s mission is to address a variety of physiological health challenges using a patented wireless continuous core body temperature (Circadian Rhythm) monitoring system. Prima-Temp has accomplished the first ever transmission of data from inside a woman’s body to her smartphone. Our technologies will transform many of healthcare’s challenges with continuous core temperature sensors and machine learning algorithms.
Prima-Temp’s platform technologies will empower users to engage in their own health with sophisticated and individualized fertility diagnosis, early infection or sepsis detection, organ rejection, timing of therapy, called precision medicine (including chemotherapy), weight loss, and sleep disorders. Our first product, Priya, effortlessly and precisely predicts a woman’s most fertile window, 2-3 days sooner than current methods, helping her to get pregnant. Priya will empower women and their partners with greater control over their fertility patterns and bring fertility to the 21st century.
Q: Your first product, Priya, is currently under development; how are things going so far? Any ETA?
A: We have had an exciting year thus far. We are on track for our global partner Gedeon Richter’s soft launch November of this year. We plan to launch in the U.S. the first quarter of 2019.
Our CEO, Alene Campbell, in addition to preparing for our product launch, spearheaded acquisition of the assets of the fertility company Kindara. We are thrilled to expand our product offering and work with an incredibly loyal customer base and celebrated App. Additionally, we have accomplished two exciting milestones: The first is the submission of our tech file for the EU regulatory clearance, the CE Mark. Second, we have started enrolling participants in our clinical study.
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Q: How exactly is it supposed to work?
A: Priya harnesses the power of wearable sensors and machine learning to create the first effortless method to pinpoint a woman’s fertile window. Priya is a self-inserted vaginal ring, a proven safe form factor identical to those on the market for decades (NuvaRingTM, EstringTM). The Priya ring continuously and passively monitors her core body temperature, identifying the patterns that occur 2 –3 days prior to ovulation when a woman is most fertile. This real time alert comes days before other methods, and during her most viable time for conception. Only 13% of women can accurately identify their fertile window, as sophisticated tools have not been available to help the majority of women who have irregular cycles. When the Priya app detects the subtle shifts in temperature, it then sends an alert to her smartphone notifying her when she is most fertile. By combining a proprietary algorithm with wireless technology, Priya will help couples improve their chances of conceiving.
Q: Can you provide some real word use-cases that we can expect to see?
A: Allow for me to introduce you to Jenny and Chris. Jenny is a 36-year-old woman trying to conceive with her partner Chris, who is 38 years of age. They have been trying to get pregnant for 5 months. Aware of Jenny’s advanced maternal age, they are getting anxious about the prospect of the fertility testing which was recommend if they had not conceived after trying for 6 months. Jenny’s is aware that IVF is around $12,000 per cycle and may take several rounds and desperately hopes to not have to go down that path.
She has tried LH predictor kits, but they can be confusing to read, and she doesn’t feel confident that she is using them correctly. While LH test kits mostly let her know when she should try to conceive the following month, the information is not helpful because she is irregular. She met with her doctor to start discussing next steps when her doctor recommended that Jenny checks out Priya. Jenny was thrilled to learn all that is required of her is to download the Priya app and insert the ring at home. From there she can go about her life as normal and she will be notified the first month of use when she is most fertile.
She orders the ring and inserts it on the last day of her period as instructed. She gets a notification 2-days later, which is much earlier than the clinical guidelines had predicted when she would ovulate. Clinical guidelines to predict the fertility window are inaccurate for 70% of women (Wilcox 2002), so this is not an unusual result. At the end of her cycle she shows her doctor her Priya temperature chart in the app and her doctor confirms that Jenny was indeed ovulating a few days after the PRIYA alert, as indicated by a rise in temperature shown by the app 3 days after Priya notified her of her fertile window. Jenny and Chris decide to try another month of Priya before seeking IVF. Jenny is surprised that she ovulated 3 days later than the previous month. Her doctor explained that it’s perfectly normal for women to vary cycle to cycle, even with a regular cycle. This time her period does not arrive, and Jenny is pregnant.
Additional real-world use cases include women who have irregular cycles, which is more than 1 in 10 women. Ovulation predictor kits typically do not work as well for these women, as well as women of advanced maternal age in which the Luteinizing Hormone is a less reliable biomarker. Priya will also help women who have been diagnosed as sub-fertile as well as those with unexplained infertility. Priya will not only be able to help women determine when they most fertile, but also confirm whether they ovulated or not.
Q: What sorts of challenges have you faced in the process of developing Priya?
A: Anyone who has developed a new innovation is aware that there are many hurdles and challenges to face. We are no exception and have yet to overcome things that we have been told, at times, are impossible. Since Priya is both a physical product and an app, we have had to address the individual challenges one would expect from each. For the physical ring, we had to overcome creating a working design, manufacturing delays and having it work consistently with the Priya App. For the application, we had to tackle bugs, design challenges and having the ring work with two different operating systems. We have overcome these challenges and have recently submitted the tech file for the CE Mark. By keeping the needs of our customer at the forefront of the product design, our team is beyond excited to launch Priya and help couples achieve their goal of growing their family.
Q: Do you have any plans for some products other than Priya?
A: The Nobel prize was won last year for Chronobiology, and with our patented approach to showing distinctive patterns in real-time circadian rhythm, we enable this “window” on an individual’s physiology in many ways. Chronobiology analysis can predict infection & sepsis, help with timing of chemotherapy, enable sleep cycle analysis for better therapeutic approaches, and aid in weight loss management.
In the fertility area, analysis of an individual’s specific Circadian Rhythm pattern can signal a short luteal phase. This shows a woman is at risk for miscarriage, and early awareness can allow her MD to prescribe Progesterone (which can help prevent some of the 900,000 miscarriages in the US per year). Her physician could see evidence she is not ovulating well, so they could prescribe Clomid or other ovulation enhancement therapies. PRIYA may provide a diagnostic tool for healthcare professionals to diagnose and monitor patients suffering from unexplained infertility, miscarriage and conditions such as Polycystic Ovarian Syndrome (PCOS). With multiple applications across the fertility market, Priya is a comprehensive fertility sensor that will shift the entire fertility picture to help couples achieve their dream of having a child of their own.
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Beyond fertility, the Prima-Temp technology could save lives. Death from infection and sepsis (currently killing 200,000 individuals in the US every year, more than most cancers) could be reduced significantly through real time monitoring. Similar to when in the hospital, an EKG measures your heart function, Circadian rhythm measures full body function and specific patterns indicate problems like infection or sepsis, often before a patient even spikes a fever.
In addition, by measuring continuous core temperature, doctors can learn more about patient’s circadian rhythm for precision medicine application. This will allow the doctor to administer treatment at the right time for the patient, which will maximize the treatment results and reduce side effect. Studies have shown this to be especially helpful in Chemotherapy administration.
Additionally, combining Priya with actigraphy, (our ring has been called a Fit-Bit on the inside by some MD’s) we can tap into and help solve two major health challenges, sleep and weight loss. Sleep clinics currently do not have a way to diagnose insomnia aside from Sleep Apnea (largely a men’s issue) effectively. By combining the Priya ring with an actigraphy, Priya creates a powerful integrative physiological tool to properly diagnose sleep and have potential to reduce the need for harmful sleep drugs as well as monitor drug therapy when required. This powerful combination of Priya and an actigraphy can also be used to measure actual Basal Metabolic Rate. This will help measure total calories burned rather than what is currently available, which is just an estimate of activity.
So in summary, with sophisticated technology like PRIYA, it is a new day, especially for women’s health, and Prima-Temp is poised to have a real and important impact on well-being.
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