Today, Healthy.io, an Israel-based healthtech startup that turns smartphone cameras into urine-testing medical devices, has announced a $60 million Series C funding round. The company has also received FDA clearance from the U.S. Food and Drug Administration (FDA) for its smartphone-based test to be used in the aid of diagnosing chronic kidney disease (CKD), which affects over 35 million Americans.
The funding round was led by Corner Ventures with participation by Joy Capital and all previous investors: Ansonia Holdings, Aleph, and Samsung NEXT. The money will be used to accelerate Healthy.io’s global expansion and product development. The company already has a partnership with Boots UK, part of the Walgreens Boots Alliance, placing its Dip UTI test kits in hundreds of pharmacies, allowing women to test and treat common UTIs.
To compliment its CE and ISO 13485 certificates, enabling sales in the EU, Healthy.io’s latest FDA clearance now authorizes the use of the albumin:creatinine ratio (ACR) test by healthcare professionals in the U.S. at any point of care. The company has worked closely with Johns Hopkins University and Geisinger Health and now makes it possible for any pharmacy, urgent care center or health clinic to perform the test using smartphones, offering an alternative to investing in a tabletop laboratory device. Next, the company plans to continue the approval process for its test kit to be used at-home.
“The smartphone has the potential to be the great equalizer of healthcare,” said Yonatan Adiri, founder and CEO of Healthy.io. “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.
Gary Loveman, previously the executive vice president of Aetna and president of the health plan’s Consumer Health and Services business has been advising on Healthy.io’s U.S. work and now sits on its Board of Directors. He highlighted the potential for impact:
“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.”
Diagnosis and treatment are certainly moving closer towards the community and early detection measures are increasing in popularity as patients, employers, insurers and providers are all valuing prevention over cure. Fitbit’s recent roll-out to the Singapore population is more evidence that government minds might be changing around investing in community-based health initiatives and the increasing acquisitions of digital health companies by the likes of McKesson and the Walgreens Boots Alliance, shows their intent to deliver healthcare on demand outside public systems. With this in mind, it is easy to see how Healthy.io’s ACR test could ease pressure downstream and their intention to move it a stage further into patients’ homes could compound these benefits.
Healthy.io’s next challenge is to capitalise on the opportunity and Dr. Aman Gupta, an anaesthetist and healthtech startup advisor in the U.K., worked with the company during their tenure on two startup accelerators. He comments:
“CKD is progressing like a global epidemic. In the U.K. alone it costs the health service in excess of £1.45 billion ($1.8 billion) annually. By integrating point-of-care urinalysis with digital technology, Healthy.io are certainly making it easier to diagnose conditions and the addition of ACR measurement to the suite of tests is particularly interesting. The challenge will now be adoption at scale, but if successful, we could see earlier detection of CKD at population level.”