Digital Diagnostics gets $75M for AI-based diagnosis of diabetic retinopathy

Steven Loeb · August 23, 2022 · Short URL:

The company is looking to expand into other areas, including cardiology, neurology, and oncology

More than thirty million Americans are living with diabetes, of which an estimated 60,000 lose their vision each year from diabetic retinopathy. There are 14,000 patients with diabetes to every one ophthalmologist that need to have their eyes tested annually for diabetic eye disease.

"With the numbers stacked against them, ophthalmologists cannot possibly see all of those in need of care before their diabetic eye disease begins to deteriorate their vision which can lead to blindness," said Seth Rainford, Co-Founder, President, and COO of Digital Diagnostics,  developer of an autonomous AI diagnostic system that allows diabetic retinopathy, including macular edema, to be diagnosed at the point-of-care in front-line care settings.

"Digital Diagnostics was founded with a mission to benefit patients by transforming the accessibility, affordability, equity, and quality of global healthcare through the application of technology in the medical diagnosis and treatment process," Rainford said.

On Tuesday, the company announced a $75 million Series B funding round led by KKR, with participation from new and existing investors, including Cedar Pine, Kinderhook, 8VC, Optum Ventures, OSF Ventures, Gundersen Health System, Edward - Elmhurst Health Venture Capital, and the University of Iowa. This brings the company's total amount raised to more than $130 million.

Along with the funding, it was revealed that Ali Satvat, Partner and Global Head of Health Care Strategic Growth at KKR and Stephen Weiss, Managing Director of Cedar Pine, joined the company's board of directors.

"Both Ali and Steve bring a wealth of knowledge and expertise to the table.  We are really excited to have them on board and to be able to tap into their years of experience in healthcare. They will support our continued growth and our efforts to develop new and innovative solutions for patients, providers, clinicians, and health plans. They are great additions to an already amazing team," said Rainford.

Digital Diagnostics' flagship product, IDx-DR, is used by primary care clinics, value-based care groups, health systems and integrated delivery networks, as well as retail pharmacies and diagnostic chains.

The company has more than 500 customers contracted in the United States, and more overseas, including the University of Iowa Hospitals and Clinics, who used IDx-DR during COVID to get through its patient backlog when all non-essential eyecare appointments were canceled. 

Another customer, Zufall Health, saw patient diabetic eye exam adherence increase 400% with the addition of IDx-DR, with 25% of those patients being identified as possibly having vision threatening eye disease due to diabetes. The company also recently announced a partnership with ArchWell Health, which made IDx-DR is available at select health centers across the southern U.S., "an area known for having the most significant doctor shortage in the country," Rainford said.

"We have had tremendous support from both public and private entities for payment and coverage that has helped spur adoption for AI in healthcare, especially from those who seek to improve patient care and close care gaps. We have especially seen risk-bearing entities and those managing at-risk populations embrace the advancements of AI in healthcare given the tremendous value that our technology can provide in those areas," he explained.

"When AI is designed and developed the right way, it provides an undeniable convenience to patients by providing increased access to low-cost, high-quality care."

Digital Diagnostics will use the funding, in part, to accelerate its product roadmap, including further testing for diseases both inside and outside of the eye; the company acquired 3Derm in 2020, which has AI technology for testing for various types of skin cancer, and it has also been working to bring AI to market in areas like cardiology, neurology, oncology, otolaryngology, and pulmonology.

The money will also be used to expand the company's distribution footprint: in July, Digital Diagnostics signed a Memorandum of Understanding with the Kingdom of Saudi Arabia’s Ministry of Investment to explore collaboration around medical services, medical technology, and digital health.

"The prevalence of diabetes in the Kingdom of Saudi Arabia is estimated to be 23.9 percent of the total population and that figure is increasing at a rapid pace. Additionally, diabetic retinopathy, the most feared complication of diabetes and the primary cause of blindness from any disease, has a prevalence of up to 44.7 percent in the Kingdom of Saudi Arabia," Rainford said.

"Despite effective treatment options, many people with diabetes go blind each year, largely because they do not undergo appropriate testing for retinopathy. Digital Diagnostics is also working with the Kingdom of Saudi Arabia’s Ministry of Health to advise them regarding the regulation of AI in healthcare."

The company is also looking to expand in the MENA region continue with a focus on UAE.

Ultimately, Digital Diagnostics' mission is to improve patient outcomes with high-quality, low-cost access to diagnostics using artificial intelligence, with success being that patients that would have otherwise had to wait months to get access to testing now receive it at their primary care office, a local retail outlet, or a diagnostic chain.   

To Rainford, this fundraise, along with accelerating our commercial traction, validates that AI in healthcare is now mainstream.

"As we saw with COVID-19, digital health is a necessary tool for healthcare providers and patient access to care. IDx-DR is a great example of how digital health and healthtech allows clinicians to diagnose diabetic eye disease at the point-of-care for people who might never have had access to the exam before in addition to prioritizing patient specialist referrals based on disease diagnosis," he said.

"To see such great momentum and support for healthtech is clearly evidence of the space’s evolving landscape in recent years. Our vision for the future is further buildout of a platform that providers and caregivers can use to more effectively democratize access to care, while enabling top-of-license practice for physicians."

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