BrainScope has raised $16 million to commercialize its device for triaging patients with potential traumatic brain injury. The financing round comes one year after the FDA granted 510(k) clearance to the latest iteration of the device.
Revolution, ZG Ventures, Maryland Venture Fund and other backers who participated in the string of financings put together by BrainScope over the past decade returned for the latest fundraising, its largest venture round to date. The existing backers were joined by new investor DBL Partners as BrainScope broadened its investor base in a bid to profit from improvements to its EEG headpiece.
The BrainScope One device, formerly known as Ahead 300, shares many characteristics with its predecessor, Ahead 200. The changes BrainScope made support broader use of the device, though. BrainScope One is cleared for use in helping evaluate patients aged 18 to 85 years old who sustained a closed head injury within the past 72 hours. Ahead 200 was only cleared for use within 24 hours on patients aged 18 to 80 years old.
BrainScope One also has a label that expresses more confidence in its capabilities. The label for Ahead 200 said the device’s negative readings “may” correspond to injury-free CT scans. And that positive readings correspond to electrical brain activity “that may be present in both patients with or without a structural brain injury visible on head CT.”
The wording of the label of BrainScope One is less equivocal, while still stating the device is not a substitute for a CT scan. The overarching change is the replacement of “may” with “likely.”
BrainScope is hoping to use the broader label and $16 million to grow sales of its device. The Bethesda, Maryland-based company will also use the money to fund its R&D team, which got regulatory clearance for three iterations of the device in as many years starting late in 2014.