Ventripoint Diagnostics (TSX-V:VPT, StockForum), a Seattle Washington-based firm engaged in developing diagnostic tools that monitor heart disease patients, announced today that the company had been given clearance by the US Food and Drug Administration (“FDA”) for the company's VMS(TM) heart analysis system.
According to the news release, the system will companion all existing 2D ultrasound imaging devices to provide computation of the 3D volume and ejection fraction of the right heart in patients with Pulmonary Arterial Hypertension (“PAH”).
Ventripoint president and CEO, George Adams, commented, “We are pleased to affirm the FDA's marketing clearance today for the VMS - the first ultrasound method to give accurate right ventricle functional measurements using conventional 2D ultrasound.
He went on to explain, “People with PAH require frequent monitoring and adjustments to their treatments, which requires a detailed assessment of right heart function.”
Jim Bodtke, Vice-President Clinical Affairs, Ventripoint, concluded, “We thank the cardiology teams at The Hospital for Sick Children and Brigham and Women's Hospital for being the Core Labs on the clinical trial and the Allegheny Hospital, Mayo Clinic, Brigham and Women's Hospital, Baylor College of Medicine, University of Chicago, and the University Hospital Network (Toronto General Hospital) where the clinical testing was performed for this application.”
Ventripoint was in the news recently when the company announced its 501(k) submission for the VMS(TM) heart analysis system at the end of January.
Shares rose 20.00% on the news to $0.12 per share.
Currently there are 146.1m outstanding shares with a market cap of $17.5 million.