A 5-year-old Kaimuki medical device company won regulatory approval last month to launch a wireless vital signs monitoring device in Europe.
Kai Medical, founded by serial entrepreneur Dustin Shindo, reached a milestone when its wireless respiration monitor — known as Kai Continuous — received a CE marking, a designation required on products sold in the European Union.
"It means they can actually begin selling products in Europe," Shindo said. "Beyond that it shows the device works."
The device’s sensor sends out a continuous wave signal that bounces off a patient’s chest, whose motion modulates the radar signal. The instrument must be pointed in a patient’s general direction within 45 degrees.
Kai Medical, whose target market is drug companies, as well as physicians in hospitals and clinics, expects to receive U.S. Food and Drug Administration clearance this summer to sell the device in the U.S., said Bob Nakata, the company’s president and CEO.
Shindo was CEO until March when he left to head Savingspoint Corp., a financial services software startup.
Separately, the business founded in 2006 received FDA clearance last year to sell its original technology: Kai Spot, which periodically checks a patient’s breathing in spot measurements.
The privately held firm does not disclose sales figures, but said it has sold the Kai Spot in the U.S. to large pharmaceutical manufacturers to monitor test subjects for reactions to new drugs. It also racked up sales from a kiosk vendor that could use the device in drugstores, workplaces or gyms, Nakata said.
Both devices currently check respiration wirelessly from a distance for a single patient, though the company is working on a version that could monitor multiple patients at a time, he said.
Kai Medical, which has 10 employees, designed the products in Hawaii and uses an FDA-registered contractor to manufacture them in California.
Besides the existing products, the company, headquartered in the Central Pacific Bank Building at 3465 Waialae Ave., has filed a patent on technology to treat sleep apnea, which "represents an untapped market," according to Nakata.
"Today there are very limited options," he said, adding that it could be a consumer alternative to wearing face masks for constant air pressure while sleeping.
In addition, the firm is negotiating with large automobile equipment suppliers to use the sensor to detect driver fatigue.
"Imagine driving and getting drowsy. Our sensor’s capable to detect whether you’re about to doze off," he said. "A very large percentage of accidents are due to driving while sleeping."
Kai Medical plans to hire a few more sales staff in the short term and eventually raise more capital as it seeks to expand its product line. The company is financed through the end of next year, according to Shindo, and is working to prepare for an initial public offering or eventual sale.
"It takes a lot of money to get devices to market. There’s not a lot of opportunities to exit right now," Shindo said. "Obviously that affects the amount of money that comes in. It takes time for these products to get adopted in the marketplace, and that delays profitability."