CereVasc, a clinical-stage medical device company developing minimally invasive treatments for neurological diseases, announced the opening of its new manufacturing and research facility in Wilmington, Massachusetts, following completion of enrollment in its STRIDE pivotal trial and the close of an oversubscribed $85 million Series C financing.
The new facility opens as the company advances the investigational eShunt System toward potential U.S. commercialization. The new facility includes an ISO Class 7 clean room and infrastructure for assembly, inspection, testing, and manufacturing.
"This facility is an investment in CereVasc's future," said CereVasc CEO Dan Levangie in a statement. "It expands the capabilities we'll need as we prepare for potential commercialization of the eShunt System, supports our long-term growth and helps position us to bring this innovation to patients. We're proud to continue building CereVasc in Massachusetts, where the life sciences community continues to fuel innovation."
The investigational eShunt System is designed to provide a minimally invasive alternative to conventional shunt surgery for communicating hydrocephalus, including NPH, a serious and often under-recognized condition that can cause gait disturbance, cognitive decline and urinary incontinence. STRIDE Clinical Trial is intended to serve as the basis for CereVasc's anticipated Premarket Approval (PMA) submission to the U.S. Food and Drug Administration.
The eShunt System employs a percutaneous transvenous-transdural approach to the central nervous system and is intended to enable the first minimally invasive treatment for communicating hydrocephalus (CH). The patented eShunt System includes an endovascularly implantable cerebrospinal fluid shunt and delivery components designed to treat CH without invasive surgery.
