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Trailmaker customer Optomed accelerates growth in the US market after FDA clearance

Optomed, a medical technology company and a leading provider of handheld fundus cameras, has a huge positive challenge on its hands after the United States regulator approved its revolutionary handheld AI screening device for diabetic retinopathy detection. Optomed will put its immediate focus on the US market, says CEO Juho Himberg, and adds that collaboration with Trailmaker helped clarify the Finnish company’s growth strategy.


Optomed was founded in Oulu in 2004 to improve eye screening of diabetics. For 20 years, it has designed and manufactured handheld fundus cameras for imaging the back of the eye. Fundus photography is used for the screening of eye diseases like diabetic retinopathy that cause blindness, enabling early detection and intervention.


Diabetic retinopathy is the leading cause of preventable blindness among working-age adults. In the US, there are 38.4 million diabetics, and less than 50% complete their annual eye exams. The rest are left vulnerable to diabetic retinopathy and visual impairment. Optomed’s solutions empower early detection everywhere and put eye screening within reach of everyone.


Earlier in 2024, Optomed announced it had received clearance from the United States Food and Drug Administration (FDA) to market and sell an AI camera called ‘Optomed Aurora AEYE’. The product is a “game-changer” says CEO Himberg, who adds that it will revolutionise patient care and diagnosis of diabetic retinopathy. “The AI to a large extent removes an ophthalmologist’s involvement in reading the captured images, and thus enables a more efficient screening service,” he says.


The portable camera is the first handheld AI screening solution to receive FDA clearance. It uses AI to interpret images on the spot and gives results in under 60 seconds. Optomed says that the camera will change the economics of high-quality diabetic retinopathy screening: “It enables scalable revenue growth for healthcare providers because they don’t need fixed imaging setups or cumbersome PC installations.”


Himberg says that the point of working with Trailmaker was to clarify the company’s strategy. “The process helped us see the importance of our US business operations. We realised that focusing on the US was a no-brainer given the size of the market and our FDA approval.” He adds: “It’s one of the most important innovations in medical technology in recent years. Having Optomed Aurora AEYE go through the FDA grinder and get the clearance is something to be proud of. We’ve had great results in clinical studies. It’s an amazing achievement to be the first one there.”


Looking to the future, Himberg says that Optomed will strengthen the US organisation and scale up the operation when the time is right. He says: “We have enough people on the ground at the moment, but once certain milestones are hit, we will hire more people. Trailmaker really made us examine our resources and the short and long-term objectives, so we’re in a good place. Our team is smart and agile, and we are ready for the growth challenge.”

20.6.2024