Startups, Diagnostics

Startup Spirometrix readies connected asthma sensors for market

Spirometrix wants to see nearly 20 percent of pulmonologists and allergists using the Fenom Pro sensor by 2020.

Sensors are everywhere — our cars, our refrigerators, our TVs and, of course, our smartphones, which generate more bits of data about us on given day than there are stars in the sky. However there is one frontier where sensors have been missing: asthma prevention.

That assessment comes from J. Dean Zikria, CEO of Spirometrix, which is developing two sensor-based devices designed to detect airway inflammation. That can help predict an attack of asthma, an incurable disease that kills nine people in the United States each day.

“Prevention. That’s the story we’re about,” Zikria said.

The Pleasanton, California-based startup has built two models of the breathalyzers. The Fenom Home, about the size of a can of soda but with a mouthpiece, is for personal home use, while the Fenom Pro, roughly the size of a toaster, is for healthcare providers who treat asthma patients.

Both measure the level of nitric oxide gas contained in a person’s breath. The gas is a unique marker that shows up in people whose asthma attacks are brought on by allergens like pollen, pollution or dust.

The simplest way to describe the breathalyzers is as a mouthpiece connected to a portable, battery-operated machine. You breathe into the mouthpiece for about 10 seconds and the machine spits out the results less than a minute later.

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The more technical version involves solid-state sensors, electrochemical reactions and millivolt outputs, the last of which get translated by an algorithm into a readout of nitric oxide levels.

The results are fed into a remote cloud-based database. The Pro uses Wi-Fi to connect to the cloud. The Home version connects via Bluetooth.

Either way, the personal data combines with information from other connected devices as well as data about the environment, such as local pollen count, local pollution index and air quality. Together, they create what Zikria called a “respiratory digital ecosystem.”

If the pollen count is particularly high that day, people with asthma can use the information to head off an attack by upping the dosage on their medication. Or they could look at patterns of inflammation to pinpoint the trigger of regular attacks.

It’s the Internet of Things meets asthma. “We’ve had pattern recognition for diabetes for years. Now we have it for asthma,” Zikria said. “We can manage those patterns, not just detect them.”

So far, Spirometrix has one major competitor, Circassia, a biopharmaceutical company headquartered in the United Kingdom. But Circassia employs different technology and a different business model, Zikria said.

However, the two companies share a target market, namely pulmonologists and allergists. Spirometrix wants to see nearly 20 percent of them using a Fenom Pro by 2020. The practitioners would lease the devices and pay monthly for the tests they use.

But the Fenom models still have to clear the U.S. Food and Drug Administration. Zikria said he expects clinical trials to begin on the Pro this fall, followed by the personal version that will sell for about $200 when it does come on the market.

They should be available sooner in European Union countries, where Spirometrix recently received a CE Mark and is lining up distributors. Zikria said he expects the products to hit the market in the EU in early 2017.

Spirometrix plans to concentrate on expanding into China and Japan after clearing U.S. regulatory hurdles.

So far, investors have injected $29 million into Spirometrix, co-founded in 2011 by Solomon Ssenyange. He helped develop a solid-state sensor for measuring nitric oxide in car exhaust while he was a doctoral student at the Ohio State University. Ssenyange, now the company president, realized in 2011 that the technology could be applied to asthma instead of cars, according to Zikria.

A Skype co-founder, Janus Friis, became one of the first investors. That first round raised $3 million.

In 2014, Ssenyange hired Zikria, whom he met at the wedding of a mutual friend in Mexico. The two men had been entrepreneurs and had cinematic life stories. Zikria picked up from his job as the head of global marketing for Animas, an arm of Johnson & Johnson, and left for Spirometrix.

Seven months later, the company raised another $8.6 million, led by NGK Spark Plug Co., a Japanese manufacturer of nitric oxide sensors for cars that will be making the sensors for Spirometrix.

In June 2016, one China’s largest pharma companies, Shanghai-based Fosun Pharmaceutical (Group) Co., led the third, and largest, round — $17.4 million.

“Lately, air pollution in China has triggered public consciousness to proactively manage health, especially in regard of respiratory health and wellness. By investing in Spirometrix, we hope to empower the public with a tool that not only better diagnoses asthma, but also actively monitors and manages this chronic disease,” Fosun Pharma’s Chairman Chen Qiyu said in a statement when Spirometrix closed the Series C funding round.

There are 30 million patients diagnosed with asthma in China. More will have asthma but not be under care.

The U.S market is smaller than China’s, but at 26 million men, women and children, it’s still considerable. That’s equal to 1-in-11 children and 1-in-12 adults,  according to the Centers for Disease Control and Prevention.

But, whereas Spirometrix is aiming at 18 percent of allergists and pulmonologists, Spirometrix expects to tap into less than 1 percent of the potential U.S. individual market, a head-scratchingly low number. However, Zikria said his company wants to stay away from unrealistic projections. “That’s the way the model grows over time.”

Photo: Spirometrix