Hydrocephalus, Normal Pressure

With approval from ANMAT, CereVasc has initiated enrollment of the STRIDE trial in Argentina BOSTON, Feb. 13, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, announced today that it has received approval from Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT) to initiate the STRIDE trial, a clinical study evaluating CereVasc's eShunt System as a treatment for normal pressure hydrocephalus (NPH). The trial will evaluate the safety and effectiveness of the eShunt System versus the current standard of care, the ventriculo-peritoneal (VP) shunt, in draining accumulated cerebrospinal fluid from the brain in elderly patients. The results of the STRIDE trial will serve as the basis for CereVasc's anticipated submission to regulatory agencies for approval to market the eShunt System. "Treatment is essential for patients with NPH, as this progressive, life-threatening form of communicating hydrocephalus can cause symptoms including cognitive dysfunction, gait disturbance and urinary incontinence," said Pedro Lylyk, M.D., CEO of ENERI and Clinica la Sagrada Familia in Buenos Aires and co-lead investigator of the STRIDE trial. "Positive findings from the STRIDE trial will broaden access to NPH treatment in Argentina, as more patients would likely be eligible for a minimally invasive procedure than for open brain surgery." The eShunt System is the only minimally invasive, endovascular shunt and the first new treatment option developed for NPH since the VP shunt was introduced more than 60 years ago. "We're pleased that ANMAT has approved this study, enabling us to move closer to a new standard in NPH treatment designed to reduce recovery time and complications for patients," said Dan Levangie, Chairman and CEO of CereVasc. "The launch of the STRIDE trial in Argentina represents a key milestone in CereVasc's mission to improve the quality of life for people around the world who are affected by this devastating neurological condition." For more information, please visit . 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). The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and 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 has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established. Company Contacts: DJ Cass CereVasc, Inc. [email protected] Media Contacts: Ethan Metelenis Precision AQ [email protected] Christina Renfroe Precision AQ [email protected] SOURCE CereVasc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

97% of subjects treated (29/30) experienced improvement in clinical symptoms of NPH 0 Serious Adverse Events (SAEs) related to the study device or procedure BOSTON, Feb. 5, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, today reported initial results of its pilot clinical study of the eShunt® System in the treatment of elderly patients with normal pressure hydrocephalus (NPH). This U.S. FDA approved Investigational Device Exemption (IDE) Study (ClinicalTrials.gov ID NCT05232838) is a prospective, non-randomized, open-label, multi-center study being conducted at 11 academic medical centers in the United States, in subjects with NPH for whom a traditional cerebrospinal fluid (CSF) shunt implant is indicated. The objective of the study is to evaluate the safety and efficacy of the eShunt System procedure. CereVasc reported the study results in 30 elderly patients treated with its eShunt System in the U.S., in which the Primary Safety and Primary Efficacy Endpoints were both achieved. Key results include: 97% of subjects treated (29/30) experienced improvement in clinical symptoms of NPH 0 Serious Adverse Events (SAEs) related to the study device or procedure 0 Unanticipated Adverse Device Effects were reported Average Length of Hospital Stay of 1.3 days At the 90-day Primary Endpoint, no (0%) Serious Adverse Events related to the study device or procedure, and no (0%) Unanticipated Adverse Device Effects were reported. Additionally, 97% (29/30) of patients treated demonstrated improvement in the clinical symptoms of NPH; including gait improvement measured by the Timed Up and Go (TUG) test, cognitive improvement measured by the Montreal Cognitive Assessment (MoCA), and improvement in urinary symptoms as measured by the Neurogenic Bladder Symptom Score (NBSS). "The results of this study show that an endovascular approach to treating NPH may improve overall care and clinical outcomes," said Charles Matouk, MD, Chief, Neurovascular Surgery, at Yale New Haven Health. "A minimally invasive approach will allow us to make treatment available to more patients." In this study, no Serious Adverse Events (SAEs) were reported in the first 90 days. Published data on conventional open surgical shunt procedures for NPH have documented a 25.15% rate of complications or hospital readmission within 30 days of ventricular shunting. This review also documented an average hospital stay length of 3.0 days.* "We are tremendously encouraged by these outstanding preliminary safety and efficacy results and to observe the record of rapid recovery and abbreviated length of hospital stay experienced by the subjects treated with the eShunt System," said Dan Levangie, Chairman & CEO of CereVasc, Inc. "We are encouraged by the absence of Serious Adverse Events at 90 days combined with clinical improvement in nearly every patient, which supports our belief that an endovascular, minimally invasive treatment approach could provide significant safety and efficacy benefits, allowing a greater number of patients with this neurodegenerative disorder to receive treatment." About Normal Pressure Hydrocephalus Normal pressure hydrocephalus (NPH) is most commonly seen in adults aged 60 or over. The Hydrocephalus Association estimates that 800,000 older Americans may be living with NPH, and it is estimated that more than 80% of cases remain unrecognized or untreated. Without appropriate diagnostic testing, NPH is often misdiagnosed as Alzheimer's disease or Parkinson's disease, the result of a stroke, or other neurodegenerative conditions. Sometimes the symptoms are mistakenly attributed to "normal aging." NPH is, however, one of the few treatable forms of dementia. 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). The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and 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 has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established. * Nadel, J.L., et. Al, NEUROSURGERY VOLUME 86 | NUMBER 6 | JUNE 2020 | 843 Company Contacts: DJ Cass CereVasc, Inc. [email protected] Media Contacts: Ethan Metelenis Precision AQ [email protected] SOURCE CereVasc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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.