With $3M in federal funding, Perceptive Navigation sees a path to FDA approval

A Johns Hopkins spinout was awarded $3 million in federal funding to commercialize its ultrasound system that provides medical imaging from within the body.
Perceptive Navigation plans to use the Phase IIB Small Business Innovation Research grant from the NIH’s National Heart, Lung, and Blood Institute to further develop the product and conduct studies as it works toward regulatory approval to market its device. CEO Todd Chappell said the funding would make a “huge difference” as the startup seeks FDA approval, which is a major milestone for medical device companies.
“We are embarking with this money on regulatory-directed studies in order to get FDA approval,” said Chappell, who became CEO of the company in 2015 following a stint as entrepreneur in residence at BioHealth Innovation. The grant also provides funding for a separate, multi-site clinical study that would come after FDA approval.
Perceptive Navigation is looking to bring a new tool to procedures in cardiology, emergency medicine, and image-guided diagnosis and treatment of diseases (known as interventional radiology).
The device, called VuPath, is an ultrasound probe that also contains a channel for needles, wires and other tools. The device is designed to show an image inside the body that looks forward, and shows what is happening in real-time. Chappell said the device can help make procedures safer and more efficient. The company is working toward an initial regulatory approval in 2019 to insert the device through a vein. Approvals for other points of “access” will have to follow separately.
Perceptive Navigation was founded by former Johns Hopkins cardiologist Theodore Abraham. While Abraham has since gone on to become the clinical chief of cardiology at the University of California at San Francisco, Chappell said the four-person team remains based at JHU’s FastForward East startup hub, and is committed to staying in Baltimore.
“I am delighted that Vu-Path is progressing to commercialization and look forward to seeing Vu-Path in the hands of clinicians,” Abraham said in a statement. “Vu-Path addresses a significant unmet need by reducing complication rates and increasing efficiency.”
The company previously received $1.4 million in SBIR funding. Private investors including the Abell Foundation and Maryland Venture Fund also injected $500,000 in seed funding. A larger private round could also be in the works, as an SEC form filed in March indicates the company is seeking to raise $4 million.