STAT+: For this cancer-focused digital health startup, an FDA rejection meant the end of the road

The bad news didn’t come all at once for Blue Note Therapeutics, but a final denial from the Food and Drug Administration in January proved to be the final blow.

In late 2023, after a rejection from the agency earlier in the year, Blue Note had made a last ditch attempt to convince the FDA that Attune, its mental health app for cancer patients, could fill an urgent unmet need. The January response from the agency was definitive: The clinical evidence, including data from a randomized, placebo-controlled trial, failed to show that Attune helped patients. If Blue Note wanted clearance, the company would need to present more data.

CEO Geoff Eich knew that getting new data was out of the question. In the spring of 2023, months before the FDA first rejected Attune, Blue Note had run out of money and let go all of its staff. Finding millions of dollars for another study was a nonstarter. Unlike a few years ago, venture capitalists weren’t flocking to digital health companies with the same gusto anymore. Things were especially difficult for a company like Blue Note after Pear Therapeutics, a high-profile digital therapeutics pioneer, imploded in bankruptcy in April 2023. Eich was betting on the FDA clearance to propel Blue Note forward. No clearance meant no future, and in April this year, Eich dissolved the company.

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