Monitored Therapeutics Inc. received Food and Drug Administration approval for its GoSpiro Home Spirometer, a device that measures the air capacity of the lungs and is used to diagnose asthma, chronic obstructive pulmonary disease and other breathing conditions.
The company said it’s the first spirometer developed as a home-use wireless connected device that works with a wide range of smartphones, tablets and PCs.
Dublin, Ohio-based Monitored Therapeutics develops telehealth technology and in-home monitoring devices for respiratory disease patients, including pulmonary drug delivery and lung function monitoring. It began as a spinout of Garden Grove-based 12th Man Technologies, which provides clinical, engineering and regulatory consulting services in areas including pulmonary and critical care medicine, and infectious disease. 12th Man Technologies remains its majority shareholder and handles product design and manufacturing.
“There are some unique characteristics of this device, [in particular] the simplicity of design,” said 12th Man Technologies President Alex Stenzler, who’s chief business officer of Monitored Therapeutics. “If you go to a hospital, before performing [spirometry], the equipment must be calibrated. Not everyone can do that. Our device you don’t need to calibrate.” All measurements and calculations are performed inside the GoSpiro, which collects data such as time-to-peak flow, cough detection and total expiratory, or exhale time.
He said GoSpiro has an avatar-based real-time patient interface named “Lisa” that walks patients through the process and can advise them to breathe more deeply or longer when the device doesn’t capture the correct result.
Founded in 2011, 12th Man Technologies was formerly the advanced technology group of Yorba Linda-based Care Fusion. It occupies a 4,000-square-foot facility in Garden Gove and has eight full-time employees in California. The company has contract manufacturers in China and the U.K.
