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| BrainPath device--Courtesy of Nico |
Nico has raised its largest financing since it was founded in 2007 with a $15 million infusion, according to a recent SEC filing. The startup specializes in creating "corridor" surgical instruments that provide access to difficult to reach places in the body through smaller openings, as well as for tools for the resection of soft tissue defects.
The financing comes just as the Indianapolis-based company is starting a trial of its BrainPath device to treat spontaneous intracerebral hemorrhage (ICH), which it notes is the deadliest, most debilitating and most expensive category of stroke. The study is slated to start this year in up to 10 centers with about a year of patient enrollment and 6 months of patient follow-up.
BrainPath offers access and visualization of lesions in the subcortical portion of the brain. It's a novel approach to how surgeons can maneuver through the folds and fibers of the brain with an atraumatic tip to minimize damage from displaced brain tissue during movement toward the targeted abnormality. After surgery, the access sheath can remain in the brain after the obturator is removed to maintain easy access for subsequent surgery.
Clot removal to remove blood clots in stroke patients who have clots obstructing the large arteries supplying blood to the brain was recommended last June by the American Heart Association and the American Stroke Association--marking the procedures' rapid progression to standard of care.
The BrainPath device enables the removal of blood and clots spilled during stroke into difficult-to-reach portions of the brain. In a pilot study of BrainPath in 35 patients, 89% had clot evacuation with no new surgical deficits or deaths. The study was on using a trans-sulcal surgical approach to hematoma evacuation following stroke.
The new study will be led by The Emory Stroke Center of Emory University hospitals and the Marcus Stroke & Neuroscience Center of Grady Memorial Hospital. It will examine early intervention using BrainPath for fluid evacuation in intracerebral hemorrhage patients.
BrainPath was cleared by the FDA last July with a design modification; its cleared indications include subcortical access to diseases such as primary or secondary brain tumors, vascular abnormalities or malformations and intraventricular tumors or cysts.
"This randomized trial will allow us to produce prospective data documenting the best course of action for patients we treat with this very deadly form of stroke," said Dan Barrow, chairman of neurosurgery, Emory University. "It underlines our commitment to partnering with other institutions in establishing a standardized minimally invasive approach and contributing to establishing a new standard of care for ICH patients."
Nico also markets several other devices including the Myriad system for tissue removal without injury to adjacent critical structures.
- here is the SEC filing and the study announcement (PDF)