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Makani Science is one step closer to commercial launch.
The Irvine medtech company last month received 510(k) clearance from the Food and Drug Administration for its wireless, wearable respiratory monitor in adults.
“It shows that our device not only works as we say it does, but it shows that it’s safe, it’s accurate and at least equal to the current devices that are on the market,” Chief Executive Greg Buchert told the Business Journal.
Makani’s respiratory monitor is a small stretch sensor made of plastic sheets that shrink when heated.
The company has raised more than $3.5 million to date, including a recent $1.1 million grant from the National Institutes of Health.
With approval, commercialization could begin as early as the fourth quarter of this year, according to Buchert.
15-Month FDA Delay
It took about 15 months to get approval, Buchert said. The process was delayed due to the FDA changing its standards, forcing the company to repeat its clinical trials and meet new cybersecurity requirements.
“We performed, we executed and got the clearance,” Buchert said.
Makani was co-founded in 2019 by Michelle Khine, a biomedical engineering professor at the University of California, Irvine, and her post-doctoral student Michael Chu, who is now chief technology officer.
Its respiratory monitor is intended to be worn on the abdomen. Data is then transmitted to the user’s phone via Bluetooth, eliminating the need for wires and making it possible for people to wear on the go.
“There are continuous respiration monitors, but they don’t work well during motion,” Buchert said.
$1.1M Grant from the NIH
Makani also received a $1.1 million grant from the NIH the same month it got FDA approval.
It was awarded by the NIH’s National Heart, Lung and Blood Institute to classify and prevent apnea of prematurity, a condition where newborns suddenly stop breathing for short periods of time.
Babies rarely die from these episodes, but research shows that they’re later associated with delays in intellectual language and motor development depending on the frequency and duration of the apnea.
Nearly half of babies born before 35 weeks will experience apnea of prematurity, according to Buchert.
The grant will help fund the development of a second-generation version of the company’s device that will measure respiratory rate and volume. Many respiratory monitors measure breathing rate, but very few track volume, he said.
Makani is conducting the study in partnership with Dr. Terrie Inder, director of neonatal research, at Children’s Hospital of Orange County, which merged with Rady Children’s Hospital San Diego to create a new combined entity called Rady Children’s Health.
The second-generation device will be modified with a stimulator so that after identifying a pause in breathing, it can stop the apneic event.
Eventually, the company’s goal is to apply a machine algorithm to the device to see what’s causing apneic events and, if possible, stop them before they occur, Buchert said.
“This could be revolutionary in neonatal medicine,” he said.