The new tool is a clinical-grade ACR test used to identify chronic kidney disease.

Healthy.io closes $60M Series C, earns second 510(k) for smartphone-based urinalysis

By Dave Muoio
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Israeli smartphone urinalysis startup Healthy.io has closed a $60 million Series C funding round led by Corner Ventures, the company announced this morning. Joy Capital Ventures and prior backers Ansonia Holdings, Aleph and Samsung NEXT each participated as well.

Furthermore, the company also announced that it has received a second FDA 510(k) clearance intended to support diagnosis of chronic kidney diseases.

WHAT THEY DO

Healthy.io’s primary product is Dip.io, a smartphone-enabled testing kit consisting of a disposable test strip, testing cups and a colored panel. Strips are dipped into urine samples and then placed into the board, whereupon the user takes a picture of the two with their smartphone camera. The diagnostic tool generates its readings by comparing the colors and patterns of these images, allowing it to quickly provide the user with their results.

While the original tool could help detect various infections, pregnancy-related complications and certain chronic illnesses, this new clearance is an albumin-to-creatinine (ACR) test kit, a type of screen used to detect kidney impairment. The EHR-friendly diagnostic tool can now be used at any pharmacy, urgent care center or health clinic.

WHAT IT’S FOR

Healthy.io said its focus is on accelerating global expansion and continue product development. Additionally, the company plans to continue further down the regulation process so that the ACR test can be used at home as well.

“The smartphone has the potential to be the great equalizer of healthcare,” Yonatan Adiri, founder and CEO of Healthy.io, said in a statement. “To unlock this potential, companies must adhere to the highest clinical standards. Our second FDA clearance and additional funding allows us to expand access to critical tests and care beyond our first 100,000 patients in Europe and Israel, making it a reality for millions of Americans suffering from diabetes and hypertension, who are at risk for chronic kidney disease.”

MARKET SNAPSHOT

Healthy.io already raised $18 million in the beginning of the year, and just a few months ago cut a deal with UK Boots pharmacies to make its UIT test kits available in stores. Then again, it’s not the only smartphone-based urinalysis provider on the market. In March, Scanwell Health announced that its tool would be playing a role in a major multicenter investigation of chronic kidney disease and other comorbid chronic conditions, while last year inui Health (formerly Scanadu) received clearance for its own take on the technology.

ON THE RECORD

“Today’s health system doesn’t make it easy for patients to get the care they need. Healthy.io is tackling this problem by meeting patients where they are, on their smartphones, and turning smartphone cameras into a clinical-grade medical device,” Michael Eisenberg, general partner at Aleph, said in a statement. “We are proud to support a company that can meet the highest FDA standards, while creating products that make life easier and more convenient for patients.”