Spry Health’s tight focus could have significantly beneficial implications for chronic obstructive pulmonary disease (COPD)patients. The Palo Alto, CA-based company and winner of the 2018 MedTech StartUp Showdown  said it has received FDA clearance for the Loop System, a wearable that has the ability to remotely monitor patients with chronic diseases.

While the device has the potential to look at other disease states, company executives said they want to have a tight focus on COPD, a chronic illness that claims more than 120,000 lives in the U.S. each year.

“The blessing and the curse of the type of technology we have built is that it can be useful in a lot of different conditions,” Pierre-Jean “PJ” Cobut, co-founder and CEO of Spry Health, told MD+DI. “It’s a blessing because it means that, yes, this product and this technology really do have legs to broaden the scope beyond COPD. The curse is, as a small company - you really do have to start somewhere that’s relatively specific and prove that your product actually works within that specific context - and go from there.”

The Loop System uses optical sensors located on a wristband to measure pulse oximetry, respiration rate and heart rate. This wearable doesn’t require any input or data from patients and does not require a smartphone or app. The company said the vital signs Loop measures are especially relevant for patients with COPD, because changes in respiration rate and blood oxygen are indicative of a deterioration.

The device will follow a different rollout path than other technologies in the medtech space.

“Our business model is a little bit different from the traditional med device model,” Cobut said. “We are looking to partner with remote care programs – care management type organizations within payors and providers to roll this out within their COPD programs. We think this is the fastest and most impactful way to get to these patients.”

Spry Health said it has demonstrated the efficacy of the Loop System through extensive clinical validation studies with University of California, San Francisco (UCSF). During a pilot study with a major health system to remotely monitor COPD patients with the Loop, interim results demonstrate that 92% of patients wearing the Loop followed their doctor’s monitoring recommendations, comparing favorably to the 20% rate deemed an industry success using other monitoring tools.

Cobut noted that the nod from FDA is one of the most significant goals the company has met.

"It’s just been an amazing journey to start with a vague idea in your mind and get [the idea] to the point where it’s real and it’s ready and can be deployed with organizations and patients,” Cobut said. “We definitely think this is the most meaningful milestone that we’ve reached.”