Dive Brief:
- CereVasc has raised $85 million from investors including Johnson & Johnson’s corporate venture capital arm and Medtronic.
- The Series C financing, which CereVasc disclosed Thursday, will support an ongoing pivotal trial of a minimally invasive treatment for the buildup of fluid in the brain.
- CereVasc began the study in 2024. With primary completion estimated for December, CereVasc is working toward a future premarket approval filing and preparing for U.S. commercialization.
Dive Insight:
CereVasc’s pivotal trial is enrolling people with normal pressure hydrocephalus. The condition is defined by blockages to the flow of cerebrospinal fluid, or CSF, after it exits the ventricles, causing symptoms such as mild dementia and difficulty walking.
Physicians treat the condition by surgically inserting a ventriculoperitoneal shunt to drain CSF from the ventricles into the abdominal cavity.
The shunts are well established and can effectively alleviate symptoms. However, the procedure entails drilling a hole in the skull, and post-surgery problems are common. An analysis of U.S. claims data found 25% of patients had complications or were readmitted within 30 days of the procedure.
CereVasc’s eShunt uses a minimally invasive, endovascular approach with femoral venous access. The company designed the medical device to solve issues associated with ventriculoperitoneal shunts, such as overdrainage of CSF and post-procedure pain and infection.
The pivotal trial is comparing eShunt to the surgical ventriculoperitoneal shunt procedure. The study’s primary efficacy endpoint is assessing change in gait impairment after six months. CereVasc is assessing adverse events after six months for the primary safety endpoint. Patients in the eShunt cohort will stay overnight at the hospital, but CereVasc has said the one-hour procedure could support outpatient use.
Piper Sandler Merchant Banking led the investment in CereVasc, supported by Bain Capital Life Sciences, J&J’s venture capital arm, Medtronic and Perceptive Xontogeny Venture Funds. Medtronic sells devices to treat hydrocephalus. J&J exited the space when it sold its Codman Neurosurgery business to Integra in 2017.
