CereVasc expands US footprint with new facility in Wilmington

USA—CereVasc has opened a new manufacturing and research facility in Wilmington, Massachusetts, as the medical device company prepares for the potential commercialization of its investigational eShunt System.

The expansion comes after two key milestones: completion of patient enrollment in the pivotal STRIDE clinical trial and the close of a US$ 85 million Series C financing round.

The new site, located near Boston, will support assembly, inspection, testing, and manufacturing of the eShunt System while providing capacity for future workforce growth.

Facility supports commercial preparations

CereVasc designed the facility to meet the company’s expected operational needs as it advances the eShunt System towards potential commercialisation.

The site will support manufacturing activities and provide additional space for the company to expand its workforce and capabilities.

The company’s hiring plans have received support from the Massachusetts Life Sciences Center through a tax incentive tied to job creation in the region.

CereVasc said the incentive will help it continue expanding its presence in Massachusetts and strengthening its manufacturing operations.

CereVasc chairman and CEO Dan Levangie said the facility represents an investment in the company’s future and will expand the capabilities required to prepare for potential commercialisation of the eShunt System.

He added that the facility will support CereVasc’s long-term growth and help the company advance the technology towards patients, while allowing it to continue building its operations in Massachusetts.

The investment gives CereVasc greater control over production as it moves through clinical development.

By establishing dedicated manufacturing capacity ahead of a potential launch, the company can align facilities, staffing, and quality processes with the requirements of a regulated medical device operation in the US.

Investigational device targets hydrocephalus

CereVasc is developing the eShunt System as a minimally invasive alternative to conventional shunt surgery for communicating hydrocephalus, including normal pressure hydrocephalus (NPH).

The system uses a percutaneous transvenous-transdural approach and incorporates an endovascular, implantable cerebrospinal fluid shunt with delivery components.

The approach is designed to provide an alternative method for diverting excess cerebrospinal fluid in patients with hydrocephalus.

However, the eShunt System remains investigational and has not received regulatory approval in the US or elsewhere. Its safety and effectiveness have therefore not yet been established.

STRIDE trial advances regulatory plans

In June 2026, CereVasc completed patient enrolment in its pivotal STRIDE study, which is evaluating the safety and effectiveness of the investigational eShunt System in patients with NPH.

The company expects data from the study to support a future premarket approval application to the US Food and Drug Administration (FDA).

The regulatory submission would represent a key step towards seeking approval for the device in the US.

The completion of enrolment followed CereVasc’s $85m Series C financing, which provides additional resources as the company advances its clinical, manufacturing, and commercialisation plans.

With the new Wilmington facility now operational, CereVasc is expanding its manufacturing infrastructure while continuing to evaluate the eShunt System through clinical development.