Device Helps Babies Breathe Easier

SonarMed President and Chief Executive Officer Tom Bumgardner spends a lot of time in neonatal intensive care units (NICUs) and says the tiny patients sometimes fit in the palm of your hand. The fragile infants are often connected to ventilators to help them breathe, but even the slightest movement can cause the tiny endotracheal tube that extends into the baby’s trachea, or windpipe, to slip out of place, or even come out entirely. Carmel-based SonarMed says its device monitors these critical tubes, providing immediate feedback to alert medical staff before a baby becomes short of breath.

“Neonates are so delicate to begin with,” says Bumgardner, “and about 18 to 30 percent of the time, they have complications with the endotracheal tube. The breathing tubes come out or get clogged a lot of times in the NICU—when the baby moves around or [the staff] changes its diaper, for example.”

And the results can be devastating, says SonarMed, noting that when such complications occur with premature babies, 31 percent suffer serious harm.

“When the tube comes out, sometimes you can’t get it back in right away,” says Bumgardner. “It’s easy for babies’ oxygen level in their blood to drop very quickly. Things can turn on a dime with a neonate.”

The company is striving to protect babies with its AirWave Monitoring System, which involves a tiny, high-tech sensor just 2.5 centimeters long that attaches to the end of an endotracheal tube. Using piezoelectric film, the disposable sensor monitors the tube’s opening, which can be as tiny as 2.5 millimeters, and alarms if any sort of obstruction begins to block even a fraction of the opening.

Bumgardner says locating and positioning the tube in babies can also be extremely challenging, so the device has a second feature that monitors the tube’s location; sliding deeper toward the baby’s lungs, for example, can cause complications. The AirWave Monitoring System also displays the size of the anatomical structure it’s sitting inside; skewed values will alert medical staff if the tip of the tube has slid up or down.

Characterizing current methods as “antiquated,” SonarMed says the device provides medical staff, for the first time, real-time monitoring of endotracheal tubes in babies. Bumgardner notes the current standard method is to take an X-ray of the infant’s chest to see the tube’s location, but that’s only “a snapshot in time,” not constant, real-time monitoring. He says even the jostling associated with obtaining the X-ray can cause the endotracheal tube to move.

The startup has sold about 30 systems in a “controlled rollout” of the product. SonarMed recently completed its Series C financing, totaling $3 million, and says it is seeing “phenomenal results” from its clients, mostly in California and Texas. While the company doesn’t have any Indiana clients yet, much of its funding is connected to Indiana. In addition to providing early funding, BioCrossroads, Spring Mill Venture Partners and VisionTech Partners invested again in the most recent round.

The AirWave Monitoring System actually began as an adult product in 2010, but Bumgardner says “we always knew the NICU market had the greatest need.” SonarMed no longer sells the adult AirWave system.

The startup has two other pediatric products in its pipeline: a device that monitors tracheostomy tubes, which are inserted through an incision, rather than the mouth, and a second technology the company cannot yet discuss publicly.

Bumgardner says the startup is now evaluating whether to raise additional funds and “go it alone” or find a strategic partner to expand its market rollout nationally, and later, internationally. SonarMed is having discussions with corporations now and expects to make a decision in the first half of 2018.

“We’re excited about the feedback we’re getting clinically right now and the possibility of one of these major multi-national companies picking up our product and getting it on as many children as possible,” says Bumgardner. “The results we’re seeing are really phenomenal. We’ve always said, if we could save just one baby, it’s worth it. We’re hearing story after story after story of how our device has made a huge difference.”