CereVasc Secures $85 Million Series C to Advance Minimally Invasive eShunt System for Normal Pressure Hydrocephalus
核心洞察
CereVasc raised $85 million in Series C financing led by Piper Sandler Merchant Banking (搜索) with participation from Johnson & Johnson Innovation – JJDC and Medtronic.
Proceeds will fund the ongoing STRIDE pivotal trial comparing the eShunt System (搜索) to ventriculoperitoneal shunt in patients with normal pressure hydrocephalus (搜索).
The STRIDE trial's primary completion is estimated for December, with the company preparing for a future Premarket Approval submission to the FDA.
CereVasc, Inc. (搜索), a clinical-stage medical device company based in Massachusetts, has successfully completed the initial closing of an over-subscribed $85 million Series C financing round. The funding, led by Piper Sandler Merchant Banking (搜索) with participation from Johnson & Johnson Innovation – JJDC, Inc. and Medtronic, along with existing investors Bain Capital Life Sciences (搜索) and Perceptive Xontogeny Venture Funds (搜索), will accelerate development of the company's novel eShunt System (搜索) for the treatment of normal pressure hydrocephalus (搜索) (NPH).
"This Series C financing is a meaningful milestone for CereVasc, and more importantly, for the patients who are living with conditions for which current treatment options remain inadequate," said Dan Levangie, Chairman and Chief Executive Officer of CereVasc. "This funding supports the next critical phase for the eShunt System (搜索), including PMA submission and preparation for commercial launch — accelerating our path toward a minimally invasive surgery that we believe has the potential to meaningfully improve patient outcomes and quality of life."
STRIDE Pivotal Trial: Design and Endpoints
Proceeds from the financing will primarily support the ongoing STRIDE pivotal trial, a prospective, multi-center, randomized, controlled study designed to evaluate the safety and effectiveness of the eShunt System (搜索) compared to the current standard of care — the ventriculoperitoneal (VP) shunt. The trial is intended to support a future Premarket Approval (PMA) submission to the U.S. Food and Drug Administration.
CereVasc began the STRIDE study in 2024, with primary completion estimated for December. The trial's primary efficacy endpoint assesses change in gait impairment after six months, while the primary safety endpoint evaluates adverse events over the same six-month period. Patients in the eShunt cohort will stay overnight at the hospital, though the company has indicated the approximately one-hour procedure could eventually support outpatient use.
Addressing Unmet Needs in Hydrocephalus Treatment
Normal pressure hydrocephalus (搜索) is characterized by blockages to the flow of cerebrospinal fluid (CSF) after it exits the ventricles, leading to symptoms such as mild dementia and difficulty walking. Current treatment involves surgically inserting a ventriculoperitoneal shunt to drain CSF from the ventricles into the abdominal cavity. While these shunts are well established and can effectively alleviate symptoms, the procedure requires drilling a hole in the skull, and post-surgical complications are common. An analysis of U.S. claims data found that 25% of patients had complications or were readmitted within 30 days of the procedure.
CereVasc's eShunt System (搜索) employs a percutaneous transvenous-transdural approach to the central nervous system, using femoral venous access to deliver an endovascularly implantable cerebrospinal fluid shunt. The company designed the device to address issues associated with traditional VP shunts, including overdrainage of CSF, post-procedure pain, and infection.
Board Strengthening and Commercial Preparation
In conjunction with the financing, CereVasc strengthened its Board of Directors with the addition of Kevin Conroy as Lead Independent Director, Christopher Geyen as independent director and Chair of the Audit Committee, and Tom Schnettler of Piper Sandler Merchant Banking (搜索) representing the new Series C investors.
Beyond the STRIDE trial, the financing will support continued operational scale-up, advancement of regulatory work toward a PMA submission, and preparations for U.S. commercialization. The eShunt System (搜索) remains an investigational device and has not been approved by the FDA or any other regulatory agency for commercial sale.