Perceptive Navigation, LLC, a Baltimore-based medical device company developing minimally-invasive, image-guidance solutions for the areas of cardiology, emergency medicine, and interventional radiology, has been awarded an up to $3m Phase IIB Small Business Innovation Research (SBIR) grant by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
The funding, which comes as Perceptive completes work on a $1.4 million Phase II award from the NHLBI, will be used to complete the product development and clinical work required to commercialize the company’s first product, the Vu-PathTM Ultrasound System. The NIH award will support product development, regulatory-directed safety and efficacy studies required for FDA approval, and a multi-center clinical study.
Led by Todd Chappell, CEO, Perceptive is advancing The Vu-PathTM Ultrasound System, a miniaturized, forward-viewing ultrasound probe combined with an interventional channel for needles, guide wires, and other tools, which provides health care providers with continuous real-time “always-in-plane” ultrasound guidance for safer and more efficient vascular access.
The company will seek central vascular access for its first regulatory approval.