Advancing Toward FDA Premarket Approval (PMA) for a Minimally Invasive Treatment of Normal Pressure Hydrocephalus

• STRIDE is the first and largest randomized, controlled trial conducted comparing a minimally invasive alternative to the standard-of-care ventriculo-peritoneal (VP) shunt, a treatment paradigm largely unchanged in more than 60 years
• Completion of patient enrollment marks an important milestone in developing a novel alternative for patients with normal pressure hydrocephalus (NPH)

BOSTON, June 23, 2026 /PRNewswire/ — CereVasc, Inc., a clinical-stage medical device company developing novel, minimally invasive treatments for neurological diseases, announced it has completed patient enrollment in its STRIDE pivotal trial evaluating the investigational eShunt System in patients with normal pressure hydrocephalus (NPH).

With patient enrollment complete at 32 clinical sites, STRIDE is progressing through remaining treatment and follow-up activities for consented patients, keeping the company on track toward topline data and continued progress through the FDA Premarket Approval (PMA) process.

STRIDE is a prospective, multi-center, randomized, controlled trial comparing the eShunt System head-to-head against the current standard of care, the VP shunt, in elderly patients with NPH. The results are intended to serve as the clinical basis for CereVasc’s anticipated PMA submission to the U.S. Food and Drug Administration. The investigational eShunt System is the only endovascular shunt in clinical use and the first new treatment option developed for NPH since the standard of care was introduced more than 60 years ago.

NPH is a serious, often under-recognized form of communicating hydrocephalus that affects an estimated 800,000 people in the United States, causing progressive gait disturbance, cognitive decline, and urinary incontinence. The current standard of care treatment is brain surgery to place a conventional shunt. Some older patients, particularly those with comorbidities, may not be considered suitable candidates for conventional shunt surgery, potentially leaving them untreated.

“Completing patient enrollment in STRIDE is the most important clinical milestone in CereVasc’s history and brings us closer to generating the data needed to support a PMA submission,” said Dan Levangie, Chairman and Chief Executive Officer of CereVasc. “We are grateful to the investigators, clinical site teams, patients, and CereVasc employees who have made this study possible. As consented patients complete the remaining treatment and follow-up process, our focus remains on advancing a minimally invasive option for the hundreds of thousands of people living with NPH.”

“Reaching full enrollment is an important achievement for STRIDE and reflects the clinical community’s commitment to studying less invasive treatment options for patients with NPH,” said Charles Matouk, MD, of Yale Neurosurgery. “The study will continue to follow its protocol as previously consented patients complete the remaining clinical steps.”

About the STRIDE Trial
STRIDE is a prospective, multi-center, randomized, controlled pivotal trial evaluating the safety and effectiveness of the investigational eShunt System compared with the VP shunt in patients with NPH. The trial has closed patient enrollment at all participating sites in the United States, Canada, and Argentina. Patients consented before enrollment closed will continue through screening and treatment, with remaining treatment activities to be completed by the end of July. Topline results are expected following completion of the primary endpoints. More information is available at www.nphstridestudy.com.

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 our website at www.cerevasc.com.

The eShunt System is an investigational device and has not been approved by the FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been established.

Media Contact:
Tiffany Weil CereVasc, Inc.
tiffanyweil@cerevasc.com

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SOURCE CereVasc, Inc.