FDA Gives Nod to SonarMed Device For Monitoring Newborns

Xconomy Texas — 

Houston-area biotech SonarMed has received FDA clearance to sell its non-invasive medical device that can monitor, in real-time, endotracheal tube position in newborn babies—and help guard against suffocation.

The company previously received regulatory approval for a version of the device used on adult patients since 2012. Executives didn’t disclose details on sales. “We wanted to establish the need, and interest, and then to move on to the neonate and pediatric market, where need is more urgent,” David Gunn, SonarMed’s vice president for strategy and business development, tells me

The issue is that endotracheal tubes, which are inserted into the windpipe to assist a patient in breathing, can move around and get clogged with mucus and other moisture. About 10 percent of the tubes come out entirely, says Tom Bumgardner, SonarMed’s president and CEO. “This can cause brain damage … 90 seconds for a baby, two to three minutes in adults,” he adds. “They can suffocate.”

SonarMed’s device uses sonar technology that sends sound pulses down the breathing tube. A sensor picks up echoes in the tube and relays that information to a monitor through which healthcare providers can see if the tube has moved or is blocked. The device can be used in both the intensive care and surgical environments, the company says.

In the last year, SonarMed has conducted pilots among adult patients at the University of Texas MD Anderson Cancer Center in Houston, and it plans a second one at Stanford University. (SonarMed executives declined to provide the number of patients in the studies or other details.)

“Having the device in patients allowed us to make some small tweaks in the product,” says Laura Lyons, the company’s vice president for clinical, quality, and regulatory affairs. “Our microphone technology helps us overcome the issue” of clogging from mucus or humidity.

With the FDA clearance, SonarMed will start marketing and ramping up production for its pediatric device, as well as the one designed for adults. SonarMed is targeting the top 10 children’s hospitals in the United States initially, Bumgardner says.

“For a neonate, a tiny baby, a small amount of movement can be catastrophic; it’s a brand new life,” Lyons says. “We want to do everything at all costs to protect it.”

SonarMed’s technology came out of research done by Jeffrey Mansfield, Eduardo Juan, and George Wodicka at Purdue University. The company, which was founded in 2005 in Carmel, IN, licensed the technology from the Purdue Research Foundation and joined the Research Valley Innovation Garage, a co-working space located at Texas A&M University in College Station, TX, in 2014 as it was applying to the the Texas Emerging Technology Fund. (Upon entering office, Texas Gov. Greg Abbott abolished the fund—one of his campaign promises—and SonarMed did not end up receiving money.)

The company has raised just over $2.4 million from a variety of angel groups, including the Central Texas Angel Network, the Baylor Angel Network, and the Texoma Angels, among others.