Devices & Diagnostics

FDA clearance in hand, SonarMed plans Q4 launch of breathing tube device

SonarMed Inc. celebrated the biggest milestone in its nearly five-year history earlier this year when its breathing-tube-monitoring device was cleared by the U.S. Food and Drug Administration. Now it just needs to start selling the device, which is used for patients on ventilators. But before the company rolls it out, Indianapolis-based SonarMed wants to ensure […]

SonarMed Inc. celebrated the biggest milestone in its nearly five-year history earlier this year when its breathing-tube-monitoring device was cleared by the U.S. Food and Drug Administration.

Now it just needs to start selling the device, which is used for patients on ventilators. But before the company rolls it out, Indianapolis-based SonarMed wants to ensure that it’s ironed out any potential problems with its device, called the Airway Monitoring System (AMS), president Andy Cothrel said.

“You only get one chance at a first impression,” he said. “More than one company has foundered on the rocks of premature launch and we don’t want to be one of those.”

To avoid those figurative rocks, SonarMed is making small tweaks to the device’s design as the company readies for a fourth-quarter launch. For example, the company has begun using a stronger resin for the device’s monitoring screen, after some fears that the previous iteration would struggle to stand up to the rigors of being dropped in a bustling intensive care unit, Cothrel said.

Also high on Cothrel’s priority list is rounding up some venture capital, though he declined to say how much since the company is in the midst of fundraising. “Like all companies at this stage, we’re seeking to finance our go-to-market strategy,” he said.

The six-employee company plans to use the funding to help build a sales team and establish partnerships with third-party companies that will also sell the AMS device.

SonarMed has raised about $6 million since its founding in 2005 by licensing technology developed by three Purdue University scientists, the company’s founders. (Cothrel joined in late 2008 after about 20 years in the medical industry, including stints with drugmakers Roche and Abbott Laboratories.) The company’s funding so far has come from the National Heart, Lung, and Blood Institute; the state-supported Indiana Seed Fund and Spring Mill Venture Partners of Carmel, Indiana.

“They’ve accomplished a lot on not much money,” said Dr. Ken Green, managing partner with Spring Mill.

SonarMed’s AMS device consists of a disposable adapter that contains acoustic sensors connected via cable to a handheld monitor.  The monitor contains software that interprets signals from the adapter to display information about the breathing tube’s position and possible obstruction.

The technology works by sending audible sound waves down the breathing tube and into a patient’s lungs. The device then analyzes the returning echoes to determine if the breathing tube is properly positioned and if anything is obstructing it.

Placing a patient on a ventilator involves snaking a tube down her trachea, and pushing air into through the tube into her lungs. A host of difficulties can arise during the process and its aftermath, including the tube becoming dislodged from the trachea, the tube getting pushed down too far into the trachea, or the tube being obstructed by lung secretions from the patient.

Those problems are now typically handled by visual checks, chest X-rays or monitoring blood-oxygen levels–all of which are reactionary and incomplete, according to Cothrel. SonarMed’s AMS device, which was (pdf) cleared by the FDA in April,  aims to notify health providers so they can correct the complications before they get too serious.

“They’ve got a product approved,” Green said. “Now their challenge is to get people to use it.”