CereVasc announced today that it opened a new manufacturing and research facility in Wilmington, Massachusetts.
The new facility opening comes on the heels of two June milestones: the company’s $85 million Series C round and the completion of enrollment in the STRIDE pivotal trial of the eShunt system.
CereVasc says the new location positions it for its next phase of growth as it moves eShunt toward potential U.S. commercialization. eShunt is a minimally invasive endovascular treatment option with potential benefits. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components. Those delivery components include a self-expanding nitinol anchor.
The company hopes for the investigational system to provide a minimally invasive alternative to conventional shunt surgery for communicating hydrocephalus, including normal pressure hydrocephalus (NPH). Its STRIDE trial serves as the basis for its planned FDA premarket approval (PMA) submission.
CereVasc said its new facility at 200 Ballardvale Street sits directly off Interstate 93, within the confines of the Greater Boston medtech hub. It features a new ISO Class 7 clean room and infrastructure for assembly, inspection, testing and manufacturing.
“This facility is an investment in CereVasc’s future,” said Dan Levangie, chair and CEO of CereVasc. “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.”
