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Vicore Pharma Holding AB have announced FDA Breakthrough Device Designation status for Almee, a 9-week digital cognitive behavioural therapy (CBT), to be used as an adjunct treatment of anxiety symptoms related to PF.
The FDA Breakthrough Devices Program designates those medical devices that are evaluated as providing a more effective treatment for life-threatening or irreversibly debilitating diseases. Breakthrough designation reflects the effectiveness of this new therapy compared to treatment as usual for anxiety associated with pulmonary fibrosis and demonstrates the impactful nature of this digital therapy.
Almee is a patient-facing tool based on CBT principles accessed via a smartphone or tablet.The COMPANION study on Almee demonstrated a 2.7-point improvement over control in GAD-7 (generalized anxiety disorder scale) and a 4.4 improvement in KBILD (King’s Brief Interstitial Lung Disease) total score for quality of life.
“Breakthrough designation sets Almee apart as an innovative and effective tool for PF patients, and it supports our ambition to help patients with pulmonary fibrosis by improving quality of life,” said Ahmed Mousa, Chief Executive Officer of Vicore.
Vicore plans to present Almee and the COMPANION study at a pulmonology conference in 2024.
The company is seeking to advance Almee in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis. “Almee represents the future of healthcare and is poised to deliver significant patient impact as an example of innovation in digital-molecular combination therapies,” said Jessica Shull, PhD, Director of Digital Health at Vicore.
Almee is subject to medical device regulation in the United States and Europe and is developed in partnership with Alex Therapeutics.