Blue Note Therapeutics, a digital health startup focused on cancer-related distress, has ceased operations following a final rejection from the Food and Drug Administration (FDA) for its Attune app. The app was designed to address the mental health needs of cancer patients, but the FDA determined that clinical evidence, including data from a randomized, placebo-controlled trial, did not sufficiently demonstrate its effectiveness.
In late 2023, Blue Note made a final attempt to convince the FDA that Attune could fill an urgent unmet need. However, the agency's January response was definitive: the existing clinical evidence was inadequate, and more data would be required for clearance. CEO Geoff Eich recognized that obtaining new data was not feasible. The company had already run out of funds in the spring of 2023, leading to staff layoffs. Securing millions of dollars for another study proved impossible, especially given the decreased enthusiasm from venture capitalists for digital health companies, particularly after Pear Therapeutics' bankruptcy in April 2023.
Eich had been counting on FDA clearance to propel Blue Note forward. Without it, the company had no viable path, leading to its dissolution in April. This closure underscores the difficulties digital therapeutics companies face in securing regulatory approval and financial backing, particularly in a challenging investment climate.
