CereVasc Opens New Massachusetts Facility in Preparation for eShunt® System Commercialization
New facility expands production and R&D capabilities following completion of STRIDE Clinical Trial enrollment and recent
Wilmington facility includes an ISO Class 7 clean room supporting assembly, inspection, testing and manufacturing operations for the investigational eShunt System- Facility is designed to support expected commercial launch activity, workforce growth, supported by a Massachusetts Life Sciences Center tax incentive tied to new job creation.
The new facility positions CereVasc for its next phase of growth as it advances the investigational eShunt System toward potential
"This facility is an investment in CereVasc's future," said
"CereVasc represents exactly the type of innovative company
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.
About CereVasc, Inc.
Located in Massachusetts' healthcare hub, CereVasc, Inc. is a clinical-stage medical device company focused on developing novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, employs an innovative 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. For additional information, please visit cerevasc.com.
The eShunt System is an investigational device and has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been established.
Media Contact:
Tiffany Weil
CereVasc, Inc.
[email protected]
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SOURCE CereVasc, Inc.
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