After collecting an FDA clearance last year for its smartphone-based home kidney test, Healthy.io is letting it be known that it has the cash to help back it up.
The company disclosed a previously unannounced $45 million investment from February 2022—months before receiving its FDA blessing—plus a more recent $5 million addition, which together comprise its series D fundraising. The round was led by Schusterman Family Investments with additional backing from Aleph and other previous shareholders.
Healthy.io’s Minuteful Kidney package includes urine test strips mailed to the user’s home, with the colored results read using a smartphone camera. The test checks a person’s albumin-to-creatinine ratio to help gauge their risks of cardiovascular and kidney diseases.
The test was cleared in July 2022 as yet another example of diagnostics developers targeting remote and home use following the COVID-19 pandemic. It has also ventured further afield, hitching a ride to the International Space Station for an experiment with an astronaut-ready version of the test.
"Our mission has always been clear: to improve the lives of patients by delivering clinical grade testing at the speed of life,” Healthy.io founder and CEO Yonatan Adiri said in a release. “By reducing barriers to essential diagnostic tests, Minuteful Kidney can reduce healthcare costs, create clinical value for providers and help prevent patients of all socioeconomic backgrounds avoid costly and disruptive kidney disease treatments.”
The company paired up with the National Kidney Foundation earlier this year to make its home test available free of charge to people at risk for kidney disease.
“A whole system approach is required to tackle barriers to testing, and an easy-to-use test in the palm of so many hands is a first step to engaging Americans at risk for kidney disease with their clinicians for additional testing and care,” the foundation’s chief medical officer, Joseph Vassalotti, M.D., said in the company’s March announcement. “Additional care should include confirmatory uACR assessments and the blood test for kidney function, called the estimated glomerular filtration rate.”
Elsewhere, Minuteful Kidney has received a CE mark in Europe and has been adopted by the U.K.’s National Health Service (NHS) to screen for early kidney disease. Healthy.io said its app has enrolled more than 540,000 NHS patients in the 18 months since its launch in the country. The company has also developed computer vision- and smartphone-based apps for monitoring chronic wound healing.