Healthy.io Files for IPO: Bringing Clinical-Grade At-Home Urine Testing to Global Markets with AI-Powered Smartphone Diagnostics

According to statistics, approximately 850 million people worldwide currently suffer from kidney disease, affecting more than 10% of the global population. The number of patients undergoing dialysis for chronic kidney disease (CKD) is continuing to grow at an annual rate of 5%–8%, and CKD is projected to become the fifth leading cause of death globally by 2040. It can be said thatEarly screening and convenient testing products for kidney disease are of particular importance to the clinical treatment of patients worldwide.

Israeli medical device company Healthy.io is dedicated to transforming smartphone cameras into medical devices, enabling clinical-grade urine analysis at home. This helps patients prevent and halt the progression of chronic kidney disease while significantly reducing healthcare system costs.

In 2013, Yonatan Adiri, former Chief Technology Officer of Israel, co-founded Healthy.io, a digital health startup that leverages artificial intelligence to provide professional-grade medical imaging services for patients with chronic kidney disease.

Healthy.io’s core product, Dip.io, is a home urine testing kit that includes a urine collection container, test strips, and a color comparison card.This product leverages colorimetric analysis, computer vision, and artificial intelligence to transform smartphone cameras into clinical-grade medical devices., completing a urine test is as simple as taking a photo.

During user testing, urine is first collected in a cup. The test strip is immersed in the urine and then placed in the slot of the color comparison card. After 60 seconds, a photo is taken with a smartphone and uploaded to the app. Subsequently,The mobile app uses artificial intelligence algorithms to analyze test markers for ketones, leukocytes, nitrites, glucose, protein, blood, specific gravity, bilirubin, urobilinogen, and pH value. These markers cover pathologies ranging from urinary tract infections to ketoacidosis, kidney disease, pregnancy health, and bladder cancer.

Healthy.io enables at-home self-testing and treatment monitoring for urinary tract infections, enabling faster and more effective treatment.

Dip.io Toolkit (Image from the Healthy.io official website)

In 2018, Dip.io received the U.S. Food and Drug Administration’s (FDA) first Class II clearance for a smartphone-based urinalysis tool.In 2019, the company’s smartphone-based urinary albumin-to-creatinine ratio (ACR) testing system also received FDA approval for the diagnosis of CKD.The FDA has approved Healthy.io’s smartphone-based ACR test as substantially equivalent to laboratory-based tests and authorized healthcare professionals to use the test at any point of care. This enables any pharmacy, urgent care center, or health clinic to perform testing without investing in desktop laboratory equipment.

Compared with similar diagnostic products, the biggest highlight of Dip.io lies in its user-friendliness and precise diagnosis, thanks toHealthy.io’s Computer Vision Algorithms and Unique Calibration Method。Typically, the wide variation in smartphone models and lighting conditions makes it extremely difficult to achieve accurate readings via mobile apps. With improvements driven by AI algorithms, Dip.io’s reading mechanism has significantly enhanced the usability of smartphone camera-based diagnostic tools. Furthermore, Healthy.io’s designers have seamlessly integrated the Dip.io toolkit into clinical workflows. After the app guides users through each step of the urine test, it automatically transmits the results to the patient’s electronic health record (EHR), facilitating clinical follow-up by physicians.

Healthy.io has gained strong momentum, raising a total of $95 million since its establishment in 2013 to accelerate product development and global market expansion.

In 2019, Healthy.io completed a $60 million Series C financing round led by Corner Ventures, with participation from Joy Capital and all previous investors—Ansonia Holdings, Aleph, and Samsung NEXT.。As part of the latest round of financing, Gary Loveman, former Executive Vice President of Aetna, has joined the board of directors of Healthy.io. Gary Loveman previously served as an Associate Professor at Harvard Business School for nine years and holds a Ph.D. in Economics from the Massachusetts Institute of Technology.

“Chronic kidney disease is a fatal condition with high treatment costs. Our research indicates that approximately 10% of the global population is affected by kidney disease. In the United States, annual spending on kidney disease treatment amounts to roughly $114 billion,” said Yonatan Adiri, Founder and CEO of Healthy.io, in a previous interview. “This round of financing will provide ample capital support for our entry into the U.S. market, and we are optimistic about Healthy.io’s growth prospects in the country.”

Last year, CNBC, one of the most influential financial media outlets globally, announced its annual “Disruptor 50 List,” with Healthy.io ranking 19th.“Disruptor” refers to disruptors and change-makers. This list aims to identify the 50 most disruptive, influential, and industry-impacting startups worldwide. These companies are poised to emerge from the COVID-19 pandemic as the next generation of billion-dollar enterprises.

Yonatan Adiri, Founder and CEO of Healthy.io, stated, “Smartphones have the potential to become a significant equalizer in healthcare. To unlock this potential, companies must adhere to the highest clinical standards. Our second FDA approval and additional funding enable us to expand coverage of critical testing and treatment beyond the initial 100,000 patients in Europe and Israel, reaching millions of Americans with diabetes and hypertension who are at risk of developing chronic kidney disease.”

Healthy.io is not the first company to transform smartphones into medical devices. However, given its relationships with hospitals and the regulatory approvals it has secured, it has gone further than most of its peers. Healthy.io officially stated that,Dip.io has obtained CE certification and ISO 13485 certification, qualifying it for sales in EU countries; it has also received FDA 510(k) Class II clearance, qualifying it for sales in the United States.

As early as 2016, Dip.io received commercialization approval in Europe and Israel. In the UK, Healthy.io was selected for the NHS Innovation Accelerator as a key technology and is sold nationwide through the G-Cloud procurement framework. In 2018, Salford Royal NHS Foundation Trust launched the NHS’s first “virtual kidney clinic” using Healthy.io, enhancing patient convenience and reducing costs.

Through Healthy.io’s strategic partners in Europe and Israel, Dip.io is currently being used by 100,000 patients.The company has also entered into a global partnership with Siemens Healthineers and announced the launch of a cystitis testing service in over 36 Boots UK stores across London, Sheffield, and Cardiff. This service enables patients with urinary tract infections (UTIs) to self-test for signs of infection, share results online with physicians, and have antibiotics delivered to their homes when clinically appropriate. In the post-pandemic era, the company is offering this service at a significant discount.

In fact, Healthy.io is emerging as a leader in the broader, decentralized landscape of healthcare services. Following the completion of its latest funding round, Healthy.io will continue its product development. In 2019, the company announced a new pharmacy evaluation project in collaboration with the UK’s National Health Service (NHS). In the United States, Healthy.io has partnered with Johns Hopkins University and Geisinger Health, achieving robust results in its prenatal care and chronic kidney disease (CKD) testing products.

On November 17, 2020, Healthy.io partnered with the National Kidney Foundation (NKF) to provide free home urine albumin-to-creatinine ratio (uACR) test kits to individuals at suspected risk of kidney disease, through a one-minute quiz developed by the NKF.These test kits help detect early signs of kidney disease, often before any symptoms appear.

In the United States, 37 million adults suffer from kidney disease, yet nearly 90% of them are unaware of their condition. Furthermore, one in three American adults is at risk of developing chronic kidney disease (CKD). The population requiring urinalysis is substantial; millions of patients with chronic conditions such as kidney disease, diabetes, and hypertension, as well as pregnant women, queue up daily for laboratory-based urinalysis, a process that is both time-consuming and labor-intensive. Traditional urinalysis must be conducted in laboratories under the supervision of professional physicians, which to some extent limits coverage for potential patients. Kidney disease treatment accounts for nearly one-quarter of all Medicare expenditures, totaling over $120 billion annually. Early detection of kidney disease enables individuals to seek timely treatment, preventing progression to end-stage renal disease (ESRD) or kidney failure, and reducing cardiovascular complications.

“Early Diagnosis of Kidney Disease Is Key to Avoiding Lifelong Complications“, if you have diabetes, you are at risk,” said Joseph Vassalotti, MD, Chief Medical Officer of the NKF. “We are pleased to partner with Healthy.io to help improve kidney disease diagnosis rates through their unique home testing solutions and to encourage patients with diabetes to work with their clinicians to take necessary follow-up steps.”

Healthy.io’s partnership with the NKF will enable tens of thousands of Americans to comfortably complete uACR testing at home. After completing the test, individuals at higher risk for kidney disease can opt to receive free kits by mail. Additionally, they can access NKF’s educational resources to help them better understand kidney disease and communicate effectively with healthcare professionals.

A joint study conducted by Healthy.io, the National Kidney Foundation (NKF), and Geisinger revealed that among high-risk populations, fewer than 50% of patients with diabetes and less than 10% of those with hypertension completed annual urine albumin-to-creatinine ratio (uACR) testing. Among those who completed the test, 71% reported having never undergone similar testing previously, and 89% indicated a preference for home-based testing over traditional methods.

Liu Erhai, Founder and Managing Partner of Joy Capital, stated, “Healthcare is a vast industry, and we have consistently been exploring the intersection of new technologies with the medical sector. Healthy.io has obtained the highest level of FDA clearance, combining artificial intelligence and machine learning to transform smartphones into clinical-grade medical devices. This brings greater efficiency and more consistent quality to the traditional healthcare industry, lowering medical costs while enhancing the patient experience. The healthcare industry is integral to everyone’s quality of life and well-being. We believe that technology will drive the industry to develop more products and services that make healthcare easier and more convenient for patients.”