FDA clears Spirosure's Fenom Pro Asthma Monitor

The Fenom Pro Asthma Monitor will let clinicians measure the fraction of exhaled nitric oxide in their patient's breath.
By Laura Lovett
01:50 pm
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This morning Spirosure, a health tech company focused on respiratory conditions, announced that its latest product the Fenom Pro Asthma Monitor has landed FDA clearance. The provider-facing technology enables clinicians to measure the fraction of exhaled nitric oxide (FeNO), an indicator of airway inflammation, in their patient’s breath. The technology uses proprietary algorithms to detect the concentration of exhaled nitric oxide molecules. 

The system also comes with an accompanying patient app, called Fenom Connect, which allows users to manage medications and reminders related to a care plan uploaded by the provider. 

The system works relatively quickly — the noninvasive procedure requires a patient to exhale for 10 seconds and can give the clinician results in under 30 seconds. Children as young as seven years can use the system as well as adults. 

Up next, the company said it is working on a “consumer-centric FeNO device that includes a connected smartphone app.”

Why it matters

Asthma is a fairly common medical condition impacting 8.3 percent of the US population, according to the CDC

The company is pitching the device as an alternative to spirometers and other technologies that have been in use for decades without updates. The company said the technology could help patients and clinicians manage the condition. 

“FeNO-monitoring of asthma patients at point of care not only offers significant potential to advance asthma therapy and monitor adherence to asthma-maintenance medication use, but also may reduce the risk of asthma emergency department visits and hospitalizations,” Dr. Solomon Ssenyange, chairman and CEO of Spirosure, said in a statement. 

What's the trend 

In January of 2018 the company landed $15 million in Series C-2 financing. At the time it said the new money would be put towards sales and regulatory processes in Europe, China and Japan for the Fenom Pro.

But that wasn’t the first major raise for the company it raised $8.6 million in Series B funding in 2014 and then $17.4 million in 2016

On the record 

“Successful completion of this pre-submission meeting represents a further key milestone of advancing Fenom Home toward the market,”  Ssenyange said in a statement. “We are excited at the potential benefits offered for this first-of-its-kind home FeNO monitor and accompanying smartphone app for asthma patients once approved, and we look forward to submitting this groundbreaking FeNO-measuring product for regulatory clearance within a year.”

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