TORONTO – The Medipines AGM100, which was developed by Orange County, Calif.-based Medipines Corp. to detect respiratory impairment caused by chronic obstructive pulmonary disease (COPD), has been recruited in the fight against COVID-19 in Canada. Described by company CEO and coinventor Steve Lee as “the world's first noninvasive lung monitor for gas exchange measurement,” the device is undergoing advanced testing at the University of British Columbia and Alliston, Ontario’s Stevenson Memorial Hospital.

“Until we showed up, there had not been a technology that uses a noninvasive, breath-sampling method to provide an entire respiratory panel, including carbon dioxide and oxygen levels in the lung,” Lee told BioWorld. “It also provides a major innovation in respiratory impairment measurement called Oxygen Deficit that is completed in 90 seconds. We think this is revolutionary technology.”

Saves blood and time

The AGM100 has been the subject of more than a dozen experimental studies, including 10 led by the UBC over three years to validate it across a range of physiological and clinical scenarios. Those studies concluded that the device provides a safe, reproducible and valid measure of noninvasive pulmonary gas exchange and compares extremely well “with directly measured arterial blood gases."

Not to be outdone, emergency physician Oswaldo Ramirez at Stevenson Memorial Hospital has been putting the AGM100 to the test treating his own patients. Ramirez echoed study findings that showed the device stacked up well against gold standard arterial blood test results. The principal deficit using that method, said Ramirez, is time.

“We have to draw the blood, put it on ice, run it to the lab as quickly as possible to get as accurate a measurement as possible of what’s happening in the arterial blood. Then we have to wait 45 minutes to an hour to get the results back and modify treatment.”

Patients are happy to learn this can all be done faster now and without a drop of blood from their arteries. Instead, a clip is attached to the patient’s nose so that breath flow occurs via a mouthpiece to the lungs. A pulse oximeter is attached to the patient’s finger to measure pulse, heart and oxygen saturation levels. Here’s where the AGM100 proves its worth, said Ramirez.

“It has come up with a new measure called the Oxygen Deficit, something we haven’t previously had in medicine. This tells us how efficiently the lungs are working but does it from a breath sample, giving us all that information much faster and without having to poke the patient.”

The device’s monitoring speed helps almost as soon as the patient passes through the door of Ramirez’s ER to patient triage. A case in point: treating patients with COVID-19 back in March and April when testing was scarce and worries about the pandemic high. Ramirez translated what he’d learned about the AGM100’s use in COPD cases to COVID-19.

“At that time, we’d just gotten Health Canada approval for its use in respiratory patients and COVID-19 patients. It allows us to decide ‘Does this patient need to stay in hospital on oxygen? Do I have to worry about intubating them and putting them in an ICU, or can I tell the patient to wait and see how they feel in a couple of days at home?’”

Cost-effective, reimbursable

Cleared by the U.S. FDA in 2019, the AGM100 “is used in dozens of major hospital ER and respiratory departments across the U.S.,” said Lee, and should be particularly welcome in long-term care facilities where labs are nonexistent. Lee balked at disclosing how much it has cost to develop the device, however, as well as the price per unit.

Cost is a function of purchase volume and reimbursement, Lee explained. The more units a hospital chooses to buy, the lower the price per unit, an attractive discount for many institutions, he noted. “It’s also extremely competitive on a cost-per-test basis, and some procedures are reimbursable from insurers,” said Lee.

Ramirez, meantime, calculates the value of the AGM100 at his hospital in the elimination of time-consuming blood draws, lab work and fewer patients taking up valuable hospital beds and space in ICU units.

“It’s not a money-losing device, unlike a lot of our technologies,” Ramirez chuckled. “This device will actually fund itself with the current OHIP (public reimbursement) codes available here in Ontario. It’s really exciting because we’re diverting from high-cost, intensive manpower requirements.”