According to Respiratory Motion CEO Dr. Jenny Freeman, breathing problems following surgery are highly under-reported, resulting more than 50,000 deaths per year. With a new FDA clearance in hand, Freeman said the company has several "irons in the fire" for its breath-monitoring device.
Respiratory Motion recently touted positive clinical results for its ExSpiron, presented the data at conferences across the States. The device monitors patients after surgery to warn of signs of respiratory arrest, a serious post-operative risk with a high mortality rate.
More than 80% of surgery patients who slip into respiratory depression die, and more careful monitoring can save lives and reduce costs for hospitals, according to Freeman.
"The key is patient safety, but this is something that also impacts healthcare dollars," Freeman said. "Once you start down a path toward respiratory depression, the further down the path you go the more expensive the cost and the riskier it is for the patient."
ExSpiron, which landed FDA 510(k) in 2012, is a set of chest electrodes that link to a monitor displaying breathing metrics to nurses and physicians. Precise measurements of inhalation and exhalation gases – called minute ventilation – are especially important when a patient emerges from full anesthesia after surgery. The device’s can provide these metrics even if the patient is not hooked up to a ventilator, and the ExSpiron device may have additional applications.
Clinical data suggests 3 possible future uses, Freeman told us, including close monitoring after heart surgery, early warnings for obstructive apnea and monitoring inside the operating room when patients are not fully sedated.
Respiratory Motions built the 1st prototype of the device in 2007 and has since then secured much of its funding from some kick-start grant money and a group of angel investors in New England.
The most iteration of the ExSpiron technology, currently on the market in the U.S., is called ExSpiron 1Xi. It features a more sophisticated user interface than prior models, a streamlined PAD set with only 1 connection – which is easier for nurses to apply – and a battery which allows for transportation.
"Our device isn’t complicated," Freeman told us. "Doctors already know what these metrics mean because they use them all the time."
The company is expanding is facility in Waltham to support manufacturing. It is also working on a pipeline telemetry project in collaboration with Phillips Healthcare for a patient-controlled device.