Hydrocephalus, Normal Pressure

Proceeds to support the clinical development of the eShunt System including the recently approved pivotal trial in Normal Pressure Hydrocephalus Financing co-led by Bain Capital Life Sciences and existing investor Perceptive Xontogeny Venture Fund BOSTON, May 13, 2024 /PRNewswire/ -- CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced today it has successfully completed the initial closing of a $70 Million Series B financing. The financing was jointly led by Bain Capital Life Sciences and existing investor Perceptive Xontogeny Venture Fund (PXV), with additional participation from other existing investors. Proceeds from the financing will be used to support the clinical and regulatory development of CereVasc's eShunt System, including its upcoming STRIDE pivotal study in patients with Normal Pressure Hydrocephalus. STRIDE is a multi-center, randomized controlled trial that will assess the safety and efficacy of the eShunt System compared to the current standard-of-care ventriculo-peritoneal (VP) shunt and serve as the basis for a future Premarket Approval (PMA) submission to the FDA. "We are thrilled to partner with this premier group of investors who support our vision and novel approach to bringing an innovative treatment for hydrocephalus to the market," said Dan Levangie, Chairman & CEO of CereVasc. "Their commitment is a testament to the clinical progress we have made with the eShunt System, and to the potential we have to transform hydrocephalus treatment. We are now well positioned to execute our pivotal clinical trial in advance of regulatory approvals." In conjunction with the financing, Evan Greif, a Vice President at Bain Capital Life Sciences, will join CereVasc's Board of Directors. "CereVasc has a distinct opportunity to dramatically improve the care of patients with hydrocephalus. We look forward to partnering with Dan and his team to bring this potential breakthrough technology to the global market," said Mr. Greif. Piper Sandler served as the Company's financial advisor for the Series B transaction. About CereVasc, Inc. Located in Massachusetts' healthcare hub, CereVasc, Inc., is a clinical stage, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever, groundbreaking percutaneous transvenous-transdural access to the central nervous system intended to allow the first minimally invasive treatment for communicating hydrocephalus (CH), a potential improvement to the current standard of care. The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon-in-Chief and Chair of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Endovascular Neurosurgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at . The eShunt® Device is an investigational device and not available for sale within or outside the United States. Company Contacts: DJ Cass CereVasc, Inc. [email protected] SOURCE CereVasc, Inc.

The STRIDE study will assess the safety and effectiveness of the eShunt System in treating patients with NPH, in comparison to ventriculo-peritoneal shunt, which is the current standard of care CereVasc receives FDA IDE approval for the STRIDE study of eShunt System. (Credit: KOMMERS on Unsplash) CereVasc has secured the US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to start the STRIDE study of the CereVasc eShunt System for the treatment of normal pressure hydrocephalus (NPH). eShunt System, which is CereVasc’s initial product, adopts a percutaneous transvenous-transdural approach to the central nervous system. The investigational system aims to offer the first minimally invasive treatment for communicating hydrocephalus (CH), potentially improving the existing standard of care. It has an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components for CH treatment. The STRIDE study will assess the safety and effectiveness of the eShunt System in treating patients with NPH compared to the current standard of care, which is the ventriculo-peritoneal (VP) shunt. Charles Matouk, neurovascular surgery chief at Yale New Haven Health, will be the principal investigator for the STRIDE study. CereVasc chairman and CEO Dan Levangie said: “FDA approval of the STRIDE study is a significant milestone for CereVasc. The team has worked tirelessly to develop the eShunt System and we believe STRIDE will result in clinical data to support the use of our system in the treatment of patients with NPH. “We believe there is a significant unmet need in the treatment of NPH, and we are grateful for the work of our clinician collaborators, advisers and partners to develop this protocol.” The latest development comes after CereVasc treated the first patient in a pilot study of the eShunt system under the FDA’s IDE approval in August 2022. In September last year, the medical device company secured a separate FDA IDE supplement to expand the clinical trials of its next-generation eShunt System in the same patient population. The Gen2 eShunt System has been engineered to streamline device preparation, elevate the system’s user-friendliness, and maintain the performance of the eShunt Implant.

With this FDA IDE approval, CereVasc will initiate the STRIDE pivotal study. BOSTON, May 7, 2024 /PRNewswire/ -- CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced today that it has received approval from the US Food and Drug Administration (FDA) to initiate its "Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus" (STRIDE trial). The IDE approval allows the Company to commence its groundbreaking STRIDE pivotal study comparing the safety and efficacy of its novel eShunt System for the treatment of patients with Normal Pressure Hydrocephalus to treatment with the current standard of care, the ventriculo-peritoneal (VP) shunt. Charles Matouk, MD, Chief, Neurovascular Surgery, at Yale New Haven Health, will serve as Principal Investigator of the STRIDE study. "I am thrilled to participate in and lead the STRIDE study. Our experience with the eShunt System in pilot clinical studies has been extremely encouraging and I believe the STRIDE study has the potential to provide us the information we need to begin more widespread use of the eShunt System," said Dr. Matouk. "FDA approval of the STRIDE study is a significant milestone for CereVasc. The team has worked tirelessly to develop the eShunt System and we believe STRIDE will result in clinical data to support the use of our system in the treatment of patients with Normal Pressure Hydrocephalus (NPH)," said Dan Levangie, CereVasc Chairman & CEO. "We believe there is a significant unmet need in the treatment of NPH, and we are grateful for the work of our clinician collaborators, advisors and partners to develop this protocol," he continued. About CereVasc, Inc. Located in Massachusetts' healthcare hub, CereVasc, Inc., is a clinical stage, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever, groundbreaking percutaneous transvenous-transdural access to the central nervous system intended to allow the first minimally invasive treatment for communicating hydrocephalus (CH), a potential improvement to the current standard of care. The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon-in-Chief and Chair of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Endovascular Neurosurgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at . The eShunt® Device is an investigational device and not available for sale within or outside the United States. Company Contacts: DJ Cass CereVasc, Inc. [email protected] SOURCE CereVasc, Inc.