A California-based startup may finally help physicians monitor vital signs for fetuses of obese mothers, starting with heartrate. First Pulse Medical hopes to have the intrauterine device, which is noninvasive to the fetus, cleared with the FDA by the summer of 2014.
Right now, physicians use an ultrasound stomach belt to monitor fetal heartrate, which doesn’t work for mothers who weigh more than 200 pounds. The other fetal monitoring option, and what must be used if the ultrasound device isn’t a good fit, is the scalp electrode needle, a device that screws into the baby’s scalp. If the mother has hepatitis, HIV or certain other infections, the second option can’t be used either–forcing doctors to go without vital signs for the fetus during labor. If the fetus goes unmonitored, even for just a few moments, it puts the baby at risk of serious health problems and the hospital and physician in serious liability issues.
First Pulse’s device uses proprietary light-based technology to display FHR on existing bedside equipment.
The startup has tested the device in Europe, redesigned a prototype based on that feedback, was accepted (and moved in) to the incubator at the Fogarty Innovation Institute earlier this year, has earned several patents and should have its first in man trial finished by mid-September 2013. (Shwoosh.) It’s closed a round of seed funding and is currently courting investors who have presence in the women’s health space for its next round of $2 to $3 million.
But it doesn’t stop there. First Pulse CEO Nathan Bachtell said the company plans to use this platform technology to go way beyond the bounds of fetal heartrate monitoring.
“If any of us walks into an emergency room, physicians can get 20 pieces of information on us in 10 minutes. The physician takes all that information and processes it together to make an initial assessment of what is going on with us,” Bachtell said. “We want to begin to try and allow for that type of monitoring for the fetus–to begin to give the physician an array of diagnostic information on the fetus.”
The company hopes to move quickly into monitoring fetal circulatory, respiratory and oxygen statuses.
Bachtell has a background in critical care and continues to moonlight in emergency rooms to maintain a clinical presence.
“I think it’s really important that there are physicians working in the industry that develop new devices and drugs because it’s really important that those things aren’t developed in a vacuum,” he said. In fact, the idea for First Pulse came from an obstetrician who had delivered more than 15,000 babies. Bachtell heard about the company because of a presentation at Mass General and was an early investor. So, in some ways, becoming CEO brought the project full circle.
He plans to use the time the company has at the Fogarty Institute to seek mentors and advisers in regulatory and legal areas, as well as continuing to strengthen its intellectual property position. Currently, the company is working with the team at WSGR.
Hi Dr. Curtis,
Thank you so much for your comment. You bring up a very good point--there are two people involved in labor, and the mother's health and well-being are just as important as the fetus's. I've changed the headline to reflect that.
I am an Ob/Gyn who has been practicing for more than 20 years so let me first say that I think this is an improvement for fetal heart rate monitoring that is overdue. However, it is simply incorrect to label this is noninvasive in the headlines and later, buried in the text, acknowledge that it is noninvasive to the fetus. It IS invasive to the mother and as such, carries the associated risks of any form of intrauterine monitoring. To brush that aside is to act as though any risks to the mother are insignificant if there is a promise of 'improved care' for the fetus. Which, quite frankly, is debatable- the evidence is clear that fetal monitoring does NOT improve neonatal outcomes overall but the reality is that the lawyers have clear evidence that not doing it will worsen outcomes for obstetricians overall. I shudder at the thought that we are going to allow excitement over an improvement in fetal monitoring permit further advancement of the idea the only form of invasive therapy during pregnancy or labor that matters is if it is fetal.