Brainsgate Ltd. came up short in a recent FDA advisory hearing for the company’s Ischemic Stroke System (ISS) to treat stroke despite that the panel was unanimously satisfied with the pivotal trial’s safety numbers. One of the issues with the pivotal study was the small enrollment of study subjects in the U.S., which demonstrates once again the hazards of relying on outside-U.S. study data in applications with the FDA.
New investors think Brainsgate Ltd. has some valuable new ideas, including its novel treatment for ischemic stroke, so they headed up the latest investment round. BNP Joint Capital led the $14 million round as a first-time investor along with Spero and previous investors Elron, Medtronic, Agate, Pitango, and Cipio.
