Healthy.io said today that it completed a Series C financing round worth $60 million and won FDA 510(k) clearance for its smartphone-based ACR test.
The funding round was led by Corner Ventures and Joy Capital, as well as previous investors Ansonia Holdings, Aleph and Samsung NEXT. The Tel Aviv, Israel-based company plans to use the funding to support global expansion and product development.
“The smartphone has the potential to be the great equalizer of healthcare,” founder & CEO Yonatan Adiri said in a press release. “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.”
Healthy.io’s smartphone-based ACR test brings lab-based testing and diagnosing of chronic kidney disease to healthcare professionals at any point of care, according to the company. Any pharmacy, urgent care center or health clinic can perform the test without a tabletop lab device. The smartphone-based technology also allows for immediate electronic medical record connectivity through its automated smartphone scan.
Gary Loveman was recently appointed to the company’s board of directors to advise Healthy.io’s work in the U.S., which has included Johns Hopkins University and Geisinger Health collaborations in the past.
“Today, too many patients face barriers to care, leading to missed appointments, undiagnosed conditions and increased visits to the emergency room or hospital. Healthy.io is establishing itself as a leader in a new world of broader, decentralized access to care without compromising on clinical quality,” Loveman said. “With this FDA clearance, Healthy.io adds a critical test to its portfolio in the U.S., which can make ACR testing dramatically more accessible and convenient, leading to a big difference in the management of at-risk populations.”
The company received FDA clearance last year for its smartphone-based 10 parameter urinalysis test kit that could be used for testing UTIs or in prenatal care. Healthy.io then inked a home kidney monitoring deal with Siemens in October last year where Siemens would provide urinalysis reagents to be integrated into Healthy.io’s smartphone-based urinalysis system for better home testing options.
“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,” general partner at Aleph Michael Eisenberg said. “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.”
