Rachel Klemovitch, Assistant Editor03.19.24
Vicore Pharma Holding has received FDA Breakthrough Device Designation status for Almee, a 9-week digital cognitive behavioral therapy (CBT) as an adjunct treatment for anxiety symptoms related to pulmonary fibrosis (PF).
Almee is a patient-facing tool based on CBT principles and can be accessed via a smartphone or tablet. A COMPANION study conducted earlier this year showed its effectiveness in reducing anxiety symptoms and improving health-related quality of life. The study demonstrated a 2.7-point increase 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 Vicore CEO, Ahmed Mousa.
Vicore plans to present Almee and its COMPANION study at a pulmonology conference in 2024.
The company also seeks to advance Almee in partnership with developers of late-stage and approved molecular therapies for PF treatment.
“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, director of digital health at Vicore.
Almee is a patient-facing tool based on CBT principles and can be accessed via a smartphone or tablet. A COMPANION study conducted earlier this year showed its effectiveness in reducing anxiety symptoms and improving health-related quality of life. The study demonstrated a 2.7-point increase 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 Vicore CEO, Ahmed Mousa.
Vicore plans to present Almee and its COMPANION study at a pulmonology conference in 2024.
The company also seeks to advance Almee in partnership with developers of late-stage and approved molecular therapies for PF treatment.
“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, director of digital health at Vicore.