The investment is set to accelerate U.S. adoption of its smartphone-powered kidney test following a landmark FDA clearance, enabling 75 million Americans at risk of chronic kidney disease to test at-home

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The recent investment will support Healthy.io's expansion across the US market. (Credit: Robina Weermeijer on Unsplash)

Healthy.io, the global leader in transforming the smartphone camera into a clinical-grade device, today announced that it completed a $50 million investment. This Series D funding round is led by Schusterman Family Investments and is joined by Aleph and other existing shareholders. This investment, together with a previously unannounced $45 million February 2022 investment, comprise the company’s Series D. The company has seen increased commercial traction in the United States since July 2022, when it became the first and only company to offer an FDA-cleared smartphone-powered, at-home kidney test.

The recent investment will support Healthy.io’s expansion across the U.S. market, where Minuteful Kidney, the company’s clinical-grade kidney test and patient engagement service, has met increased demand from leading health plans, health systems, and kidney care management groups.

As rates of diabetes and hypertension continue to rise across the U.S., more Americans are at risk for chronic kidney disease (CKD) but are otherwise untested and unmanaged. CKD is a leading cause of death in the country. Known as a “silent killer,” 90% of the 37 million Americans who have the disease – which disproportionately impacts underserved communities – don’t know they have it and often progress to having late-stage CKD or needing dialysis treatments.

Barriers such as a lack of awareness and transportation challenges prevent at-risk Americans from completing recommended testing, a urine albumin-creatinine ratio (uACR) test, that can detect kidney damage. 75 million Americans are recommended to complete uACR testing, yet 80% do not.

This has made Healthy.io’s clinical grade, at-home test solution a desired component in health plans’ kidney management programs. In tests of over 250,000 patients in the U.S. and the U.K., the solution has demonstrated unprecedentedly high adherence rates of up to 50% among previously untested populations. Promoting early diagnosis of CKD can also drastically reduce the skyrocketing costs associated with CKD, which currently costs Medicare $124 billion a year.

“Our mission has always been clear: to improve the lives of patients by delivering clinical grade testing at the speed of life. 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. In the process, we can make health care more accessible and equitable, while providing a game changing solution to one the biggest cost-drivers in healthcare. During these turbulent times, we are grateful to our investors for believing in our company, trusting our capabilities, and getting us one step closer to that goal,” said Yonatan Adiri, CEO and founder of Healthy.io.

The medical-grade innovation is a rare example of technology receiving regulatory approval across all current iOS and Android devices. Now patients can conduct the test at home at clinical grade with immediate results provided to the patient and their primary care provider.

Alongside its urinalysis services, Healthy.io also developed novel computer vision and smartphone-enabled wound image technology to digitize the management of chronic wounds. It partners with leading health groups in the U.S. and U.K. to allow clinicians to monitor their patients remotely. Providing clinicians with timely and valuable information and a visual record of the wound over time significantly lowers the risk of deterioration and amputations.

Source: Company Press Release