Iterative Scopes bags fivefold financing increase as its colonoscopy AI undergoes FDA review

In the past six months, the MIT artificial intelligence spinout Iterative Scopes raised $30 million in funding and secured European approval for its software to help spot the signs of colorectal cancer. Now it’s leap-frogged up to a $150 million round to help bring its computer vision programs to U.S. clinicians.

The company is also developing technologies for highlighting the characteristics of inflammatory bowel disease within endoscopic videos, in addition to spotting precancerous polyps—with the goal of supporting an AI-powered recruitment service for clinical trials that calculates a patient’s potential disease severity.

The nine-figure series B round was co-led by Insight Partners and Clearlake Capital Group. They were joined by returning participants from Iterative Scopes’ curtain-raising series A in August 2021, including Obvious Ventures, Johnson and Johnson Innovation, Breyer Capital and Eli Lilly, which has begun to use the company’s software to help screen participants for its clinical studies.

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“Patients experiencing new and chronic gastrointestinal problems have been underserved by the technology available today,” said Insight Partners’ managing director, Lonne Jaffe, who joined the company’s board of directors. “The longer-term R&D work that this latest funding will fuel is critical to advancing AI-driven precision care.”

For its first regulatory approval, Iterative Scopes obtained a CE mark last November for Skout, its AI program for colonoscopies that flags suspicious tissues in real-time. The company has also partnered with the workflow provider Provation for software that automatically translates the endoscopes’ findings into text for clinical reports and health records.

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Iterative Scopes submitted Skout to the FDA for 510(k) clearance review in November 2021. In the longer term, the company said it hopes to use its programs to help standardize the evaluation of gastrointestinal diseases and establish digital endpoints and biomarkers for use in clinical trials and drug development.

The FDA cleared its first plug-in AI colonoscopy system in April 2021. Dubbed GI Genius—developed by Cosmo Pharmaceuticals and distributed by Medtronic—the software is designed to work with video from any agency-cleared endoscope.

The program is not meant to replace lab analyses of retrieved tissue nor to help classify lesions or suggest treatments. Rather, it is meant to act as an automated second observer to help catch smaller, flatter lesions that may slip by unnoticed among the colon’s constantly shifting landscape of folds and shadows.