BVP portfolio company Noah Labs has enrolled the first patients in VOICE-HF, the pivotal study intended to support FDA authorization of Noah Labs Vox™, its voice-based software for detecting worsening heart failure. Results are intended to support a De Novo request to the FDA, making this the defining clinical milestone on the company’s path to the US market.
The prospective, multicenter trial will enroll approximately 450 adults with stage C chronic heart failure across more than 15 sites in the US, Europe, and Canada. The first participants were enrolled at Brigham and Women’s Hospital in Boston and at Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital. Each participant records a short daily voice sample at home on a smartphone or tablet. The co-primary endpoints are sensitivity for worsening heart failure events and the unexplained alert rate. The National Principal Investigator is Aman Shah, MD, of Tampa General Hospital’s Heart & Vascular Institute.
The clinical problem is a monitoring gap. Most heart failure patients have no structured monitoring at home. Daily weight scales have limited sensitivity because congestion often begins with fluid redistribution before body weight rises. Implantable sensors detect congestion earlier but require an invasive procedure and reach only a small fraction of eligible patients. Congestion also affects the lungs, airways, and vocal folds, producing measurable changes in the voice. Noah Labs Vox™ analyzes these changes from recordings made at home, with no additional hardware.
Noah Labs Vox™ has received FDA Breakthrough Device Designation and is built on a proprietary dataset of more than three million heart failure voice samples. The technology has been evaluated in four clinical studies, two published and two ongoing, across more than ten hospitals in the US and EU, including Mayo Clinic, UCSF, Charité Berlin, Maastricht University Medical Center, and Hospital Clínic de Barcelona. In the TIM-HF3 study, published in the European Journal of Heart Failure, the technology detected 84% of heart failure hospitalizations up to 29 days in advance. VOICE-HF is designed to confirm performance prospectively at pivotal scale.
About Noah Labs
Noah Labs develops voice-based remote monitoring and care management for people living with heart failure. The company was founded in 2021 by Oliver Piepenstock, Marcus Hott, and Leonhard Riehle, MD, and is based in Boston and Berlin. Its portfolio includes Noah Labs Vox™, an investigational voice-based algorithm, and Noah Labs Ark, a CE-marked remote monitoring platform commercially available in Europe. Noah Labs is a portfolio company of Brightlands Venture Partners.
Noah Labs Vox™ is an investigational device, limited by United States law to investigational use. It is not available for sale in the United States.
