A new medical device startup is working on a non-invasive fetal heart monitor it says can detect tiny fluctuations in fetal heartbeats and potentially reduce the number of Caesarian sections pregnant women undergo.
MindChild Medical Inc. inked a royalty-sharing agreement with Tufts Medical Center to help launch, license and share any profits derived from a belt studded with embedded electrodes for fetal electrocardiograms.
Tufts will act as the licensing agent for the device and share a sales royalty with MIT, where some of the technology was developed, according to a Tufts spokeswoman.
The technology stems from a collaboration between Dr. Adam Wolfberg, a Tufts Medical Center fellow, and North Andover-based E-Trolz Inc.
Wolfberg, looking to create a more precise fetal heart monitor, wasn’t getting the results he wanted. That’s where the E-Trolz signal acquisition and data management platform came in, Vice President Jay Ward told MassDevice.
Gari Clifford, an MIT researcher had been working with E-Trolz on the company’s signal acquisition technology, when he met Wolfberg it occurred to him that E-Trolz and the physician should be working together. Using their combined expertise they went to work developing a heart monitor that could separate the signals from the heartbeat of a fetus from its mother’s. As Ward described it to us, E-Trolz provided the ability to acquire the two signals and Clifford helped develop the ability to parse and analyze them.
The device is currently in the investigative phase at two hospitals, Ward said, and an official clinical trial could start as soon as next year. E-Trolz has its own licensing agreement with MindChild that includes royalties and an equity stake in the startup.
There are only two ways to listen to a fetal heartbeat, he explained — ultrasound or a fetal scalp electrode. Although ultrasound is the most common and non-invasive practice, it’s not accurate enough to distinguish between small variations in the unborn child’s heartbeat because it only listens for blood flow and the movements of the fetus require the physician to constantly readjust the device.
The second method, a fetal scalp electrode, can only be applied when the mother is fully dilated during labor.
Ward said the new, non-invasive technology is even more accurate than a fetal scalp electrode because it provides a three-dimensional picture of the health of the baby’s heart.
Clifford described the technology as “like going from a one-dimensional slice of an image to a hologram” in a March article for MIT’s Innovations Report.
The ability to listen more closely and more accurately to fetal heartbeats could have a big impact on the amount of C-section births performed every year, Ward added.
“You get a lot of false positives [with current fetal monitoring], so [physicians] do a C-section to be on the safe side,” he explained.
According to Tufts, MindChild is seeking outside investment to fund the project.