Diagnostics, Payers

IDx raises $33M Series A after its AI-powered screening tool received an FDA nod

The company’s technology for screening diabetic retinopathy was granted “Breakthrough Device” designation and is able to provide a clinical decision, instead of simply a recommendation to the physician.

Iowa City-based IDx, which received an FDA clearance earlier this year for its AI-based system to diagnose diabetic retinopathy has raised a $33 million Series A financing round to support its continued growth and commercialization of its product.

The funding round was led by 8VC with participation from UnitedHealthcare’s Optum Ventures, Alpha Edison and Heritage Provider Network. Previously the company had received $22 million from private angel investors.

IDx CEO Gary Seamans, characterized the funding round as “Series A and expected to be series last” and said the decision to take financing from institutional investors was made to strategically help the company enter new markets and get their tool in front of more patients.

“When you have someone like UnitedHealthcare as an investor, that’s a strategic advantage, they’re an enormously important entity with great reach and presence around the country,” Seamans said in phone interview. 

IDx’s technology received FDA clearance in April as the “the first device authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results.”

The company’s technology was granted “Breakthrough Device” designation and is able to provide a clinical decision, instead of simply a recommendation to the physician.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

IDx founder president Michael Abramoff previously told MedCity that the company’s technology can be operated by “anyone with a high school degree,” given four hours of training, which makes it scalable and cost-effective as demand for screening grows.

The company was founded in 2010 by Abramoff based on his experience as a practicing ophthalmologist. He saw that patients suffering from diabetic retinopathy were regularly getting treated in a primary care setting and failing to get an eye test before it was too late.

In June, the company’s diabetic retinopathy product was deployed in its first clinical space at the University of Iowa and Seamans said the 40-person company is looking to more than triple its workforce as it continues its commercialization and sales efforts.

“The health care industry needs to accelerate its adoption of AI to reduce costs and drive efficiencies,” Sarah London, senior principal at Optum Ventures said in a statement.

“We are confident that IDx will transform health care by increasing patient access to early disease detection, which is why we look forward to helping build a bridge between IDx and the physicians and patients who would benefit from adopting this system.”

Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. It is the most common cause of vision loss among the 30 million Americans living with diabetes.

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis,” Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health said in a statement announcing the company’s FDA clearance.

“Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office. The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care.”

Seamans described IDx’s first product as tackling the “low hanging fruit” in vision disorders and added that the company is far from finished.

In the current development pipeline are tools to screen for age-related macular degeneration and glaucoma, two other vision diseases that are expected to increase in incidence as the population ages.

Photo: Jay_Zynism, Getty Images