Even as science continues to unravel countless mysteries of the world, some remain. One of them is how to protect unborn infant from the tragedies associated with preterm birth. Unfortunately, every year approximately 11% of all babies are born too soon (a statistic that has not improved in over forty years). The grim statistics reveal that largely due to our inability to keep the fetus in the womb one million babies do not survive, and two million will be forced to live with severe lifelong disabilities.
To date, there is no safe and effective therapy to prevent preterm contractions. It is critically important to keep the baby in the womb because with each passing day the chances of survival increase. This is reflected in the fact that while less than 30 percent of the babies born before 24 weeks survive versus 99 percent at full term.
Discovering the right intervention to prevent spontaneous preterm contractions and address this significant unmet medical need was the driving force for Prena. “Our sole mission is to reduce the tragedies associated with preterm birth,” said Don Rosenkoetter, Chairman of Prena.
The company’s founding was driven by curiosity about what causes labor. Professor James Olcese, the inventor of the Prena’s core solution, is a researcher at Florida State’s College of Medicine and leading authority in circadian rhythms. Wondering why 80+ percent of babies were born at night he believed that the circadian clock and the nightly release of melatonin could be the trigger and that inhibiting melatonin could stop contractions using photo biomodulation, e.g., light.
Our sole mission is to reduce the tragedies associated with preterm birth
In two proof of concept trials, in over 70% of the cases the contractions of the pregnant women were reduced to a level where they would not deliver a baby or even stopped labor altogether.
However, it is infeasible to sleep facing a bright light panel. So the Prena team, working with NASA scientists, determined the optimum wavelength, intensity, and cycling time of light to stop contractions. The science was encapsulated into a light-emitting sleep mask that pregnant women can wear at night, turning it on before sleeping. After 45 minutes, a low intensity cerulean blue light will be emitted twice during the night.
A low-intensity light passes through the eyelids and should not disrupt sleep in most nor have any adverse impact on the fetus.
The company has enlisted Professor Anna David of University College London and Dr. Michael Paidas of the University of Miami, two globally recognized leaders in the women’s perinatal care, to lead small multicenter trials in both the U.S. and the UK in the coming months, which should prove two claims. “The first will be to stop premature contractions in pregnant women who come to the hospital. The second application is for preventative home healthcare. If a woman is identified as being at risk of preterm birth she would wear the mask every night from the 20th – 24th week on until the doctor deems that the fetus is ready to be born,” explains Rosenkoetter.
Prena’s current focus is on conducting pivotal trials globally to gain regulatory approvals. Longer term; “The commercial plan is to partner with a leading company in the OB GYN segment to get the product to market quickly and ensure that it is broadly accessible to the women that need it,” concludes Rosenkoetter.