OEM News

CereVasc Opens New Massachusetts Facility to Support eShunt Launch

The new facility includes an ISO Class 7 cleanroom and infrastructure for assembly, inspection, testing, and manufacturing.

Ribbon Cutting (L to R): Aaron Levangie, senior VP and general counsel, Adel Malek, MD, Ph.D., chief medical officer, Dan Levangie, CEO and chairman, DJ Cass, senior VP, business development and strategy. Photo: CereVasc

CereVasc has opened a new manufacturing and research facility in Wilmington, Mass.

The new facility aims to position the company for further growth as its advances its investigational eShunt system toward U.S. commercialization. It includes an ISO Class 7 cleanroom and infrastructure for assembly, inspection, testing, and manufacturing.

The investigational eShunt is a minimally invasive alternative to conventional shunt surgery for communicating hydrocephalus (CH), including NPH, a serious and under-recognized condition that can cause gait disturbance, cognitive decline and urinary incontinence. The system includes an endovascularly implantable cerebrospinal fluid shunt and delivery components designed to treat CH without invasive surgery.

The STRIDE trial aims to be the basis for CereVasc’s premarket approval (PMA) submission to the U.S. Food and Drug Administration (FDA).

In May, the company shared a first-in-human case report describing the use of its eShunt System to treat medically refractory idiopathic intracranial hypertension (IIH), formerly known as pseudotumor cerebri. The report details treatment with the eShunt system in a patient whose symptoms persisted despite medical therapy.

Comments from CereVasc and others

Dan Levangie, chairman and CEO: “This facility is an investment in CereVasc’s future. 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.”

Dr. Kirk Taylor, president and CEO, Massachusetts Life Sciences Center: “CereVasc represents exactly the type of innovative company Massachusetts seeks to support—one that is translating breakthrough science into technologies with the potential to improve patients’ lives and creating high-quality jobs here in the Commonwealth. This new Wilmington facility strengthens Massachusetts’ position as a global leader in medical technology innovation and demonstrates how investments in life sciences can drive both economic growth, job creation, and healthcare advancement.”

Eric Paley, Massachusetts Economic Development Secretary: “The best life sciences companies don’t just invent here—they build here. CereVasc’s expansion reflects the strength of Massachusetts’ life sciences ecosystem and the advantages that come from growing in the global center of innovation. Investments like this create high-quality jobs, strengthen our innovation economy, and help ensure that the next generation of breakthroughs is developed and manufactured right here in the Commonwealth.”

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