CEREVASC, INC.


Associated tags: CSF, Tufts Medical Center, Patient, Doctor of Philosophy, DSM-IV codes, Hydrocephalus, Pharmaceutical industry, Medical device, CH, MD, Sale, Neurosurgery, NPH, FDA

Locations: MASSACHUSETTS, CH

CereVasc Receives FDA IDE Approval for the STRIDE Pivotal Study of the eShunt System for Treatment of Normal Pressure Hydrocephalus

Retrieved on: 
Tuesday, May 7, 2024
FDA, Safety, Effectiveness, NPH, Food, STRIDE, IDE, MD, Patient, Treatment, Principal, DSM-IV codes, Pharmaceutical industry

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). 

Key Points: 
  • With this FDA IDE approval, CereVasc will initiate the STRIDE pivotal study.
  • 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.
  • "FDA approval of the STRIDE study is a significant milestone for CereVasc.

CereVasc's eShunt® System Study Data Presented at the ABC WIN Seminar

Retrieved on: 
Tuesday, January 23, 2024
Hydrocephalus, Patient, Subarachnoid hemorrhage, ABC, DSM-IV codes, FDA, NPH, Treatment

BOSTON, Jan. 23, 2024 /PRNewswire/ -- CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that data from its clinical studies in the United States and Argentina, examining the use of its eShunt System to treat communicating hydrocephalus, was presented at the ABC WIN Seminar in Val d'Isere.

Key Points: 
  • BOSTON, Jan. 23, 2024 /PRNewswire/ -- CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that data from its clinical studies in the United States and Argentina, examining the use of its eShunt System to treat communicating hydrocephalus, was presented at the ABC WIN Seminar in Val d'Isere.
  • "We are pleased for our team to share the initial results of these thirty-one patients who have been treated with the eShunt System across multiple hydrocephalus etiologies and warrants the study of the device in a pivotal trial setting," said Dr. Pedro Lylyk, Director General of ENERI.
  • Dan Levangie, CereVasc President & CEO stated, "We are grateful to ABC WIN for the opportunity to have Dr. Lylyk present the encouraging data from our investigators in the trials of the eShunt System.
  • We are looking forward to leveraging the experience gained in these studies to support our pivotal study this year."

CereVasc eShunt® System Study Data Presented at the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress in Marseille

Retrieved on: 
Wednesday, September 13, 2023
Hydrocephalus, Sagrada Família, DSM-IV codes, Trial of the century, Congress, Subarachnoid hemorrhage, CH, Patient, Intracranial pressure, Pharmaceutical industry, Medical device

Trial data reporting the investigational use of the eShunt System in patients with hydrocephalus secondary to subarachnoid hemorrhage was presented by Ivan Lylyk, M.D., one of the lead investigators based at Clínica La Sagrada Familia in Buenos Aires, Argentina.

Key Points: 
  • Trial data reporting the investigational use of the eShunt System in patients with hydrocephalus secondary to subarachnoid hemorrhage was presented by Ivan Lylyk, M.D., one of the lead investigators based at Clínica La Sagrada Familia in Buenos Aires, Argentina.
  • The study, conducted under the leadership of Pedro Lylyk, M.D., represents the first-ever treatment with the eShunt System and the world's first endovascular treatment of CH.
  • "We are excited by the initial data demonstrating the potential to provide patients a minimally invasive treatment for communicating hydrocephalus.
  • The data presented at ESMINT bolster our confidence in the potential of the Company's minimally invasive treatment of hydrocephalus as we transition to the pivotal clinical trial in early 2024."

CereVasc & LianMedical Announce Corporate Partnership

Retrieved on: 
Monday, June 26, 2023
Partnership, DSM-IV codes, Patient, Standard of care, Pharmaceutical industry, Nursing, Macaw, Hydrocephalus

BOSTON and SHANGHAI, June 26, 2023 /PRNewswire/ -- CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, and LianMedical, a medical device company focused on accelerating the introduction of breakthrough medical technologies to markets in Asia, announced today a partnership focused on bringing CereVasc's eShunt® System and related products to patients and providers in China, Hong Kong, Taiwan, and Macaw.

Key Points: 
  • BOSTON and SHANGHAI, June 26, 2023 /PRNewswire/ -- CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, and LianMedical, a medical device company focused on accelerating the introduction of breakthrough medical technologies to markets in Asia, announced today a partnership focused on bringing CereVasc's eShunt® System and related products to patients and providers in China, Hong Kong, Taiwan, and Macaw.
  • "We are very excited by the opportunity for our products to improve the standard of care for patients with hydrocephalus in these territories and believe we have identified the ideal partner in LianMedical to support these expansion efforts," said Dan Levangie, President & CEO of CereVasc, Inc.  Luxin Wang, CEO of LianMedical, continued "There is significant unmet clinical need in Hydrocephalus treatment in Asia.
  • The eShunt® System is an innovation that can potentially revolutionize the standard of care and benefit thousands of patients.
  • We are excited to partner with Dan and his team to capitalize on this significant opportunity."

CereVasc's Minimally Invasive Central Nervous System Therapy Delivery System Receives Outstanding Presentation Award at American Society of Gene & Cell Therapy Annual Meeting

Retrieved on: 
Wednesday, June 14, 2023
University of Massachusetts, Therapy, Gene, Stroke, Doctor of Philosophy, CNS, DSM-IV codes, Central nervous system, Poster, New England Center for Children, Annual general meeting, Cell, CPA, American Society of Gene and Cell Therapy, Cisterna magna, Research, DVM, Society, Pharmaceutical industry, Medical device

BOSTON, June 14, 2023 /PRNewswire/ -- CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel treatments for neurological diseases, announced today that a presentation of study results for its minimally invasive Central Nervous System (CNS) Delivery System was awarded an Outstanding Poster Presentation Award by the American Society of Gene and Cell Therapy as part of their 2023 Annual Meeting.

Key Points: 
  • BOSTON, June 14, 2023 /PRNewswire/ -- CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel treatments for neurological diseases, announced today that a presentation of study results for its minimally invasive Central Nervous System (CNS) Delivery System was awarded an Outstanding Poster Presentation Award by the American Society of Gene and Cell Therapy as part of their 2023 Annual Meeting.
  • "We are honored that ASGCT recognized data on our minimally invasive CNS Delivery System with an Outstanding Poster Presentation Award," said Dan Levangie, Chairman and CEO of CereVasc.
  • "We appreciate the challenges faced by CNS therapeutic researchers and industry to identify an effective and minimally invasive route of administration for their therapeutic assets.
  • We believe our data highlighted with this Award demonstrates the potential of our novel alternative to more invasive techniques employed to deliver therapies to the CNS.

CereVasc to Present Data on its Minimally Invasive CNS Delivery System at Upcoming American Society of Gene and Cell Therapy Annual Meeting

Retrieved on: 
Thursday, May 4, 2023
Central nervous system, DSM-IV codes, Patient, Society, Gene, CNS, Cell, Pharmaceutical industry

BOSTON, May 4, 2023 /PRNewswire/ -- CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel treatments for neurological diseases, announced today that data on its minimally invasive Central Nervous System (CNS) Delivery System will be presented for the first time at the American Society of Gene and Cell Therapy Annual Meeting being held on May 16-20, 2023, in Los Angeles.

Key Points: 
  • BOSTON, May 4, 2023 /PRNewswire/ -- CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel treatments for neurological diseases, announced today that data on its minimally invasive Central Nervous System (CNS) Delivery System will be presented for the first time at the American Society of Gene and Cell Therapy Annual Meeting being held on May 16-20, 2023, in Los Angeles.
  • "We are excited to share the results of our in vivo investigation using the eShunt® platform to deliver gene therapy to the CNS," said Dan Levangie, Chairman and CEO of CereVasc.
  • "The gene and cell therapy community has made tremendous progress in bringing life-changing therapies to patients, but the route of administration for CNS focused therapies can be an obstacle to clinical success.
  • We believe our novel approach has the potential to provide the community an attractive solution to common CNS delivery challenges," continued Levangie.

CereVasc Appoints Dr. Adel Malek Chief Medical Officer

Retrieved on: 
Tuesday, March 28, 2023
Hydrocephalus, Tufts University School of Medicine, University, Stroke, Naval Hospital Boston, Research, DSM-IV codes, Chiari malformation, Harvard Medical School, Tufts Medical Center, MD, Hemodynamics, Pleasure, Neurosurgery, Massachusetts Institute of Technology, Neuro, Health, Cerebrovascular disease, Safety, Medical device, Brigham

BOSTON, March 28, 2023 /PRNewswire/ -- CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, names Adel Malek, MD PhD as the company's Chief Medical Officer.

Key Points: 
  • BOSTON, March 28, 2023 /PRNewswire/ -- CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, names Adel Malek, MD PhD as the company's Chief Medical Officer.
  • Dr. Malek is Chief of Neurovascular Surgery and Director of the Cerebrovascular and Endovascular Division in the department of Neurosurgery at Tufts Medical Center and Professor of Neurosurgery at Tufts University School of Medicine.
  • "We are thrilled to welcome Dr. Malek to the leadership team at CereVasc.
  • With his vast experience, innovative thinking and focus on patient care, Dr. Malek is well suited to guide the medical strategy for CereVasc as we expand our clinical and product development programs," said Dan Levangie, Chairman and CEO of CereVasc.

Tufts Medical Center Neurosurgeons and CereVasc Co-founders Honored by the Society of Vascular and Interventional Neurology for Innovation in Hydrocephalus Treatment

Retrieved on: 
Monday, November 21, 2022
Tufts University School of Medicine, Doctor of Philosophy, Chicago Innovation Awards, Trauma, Society, White matter, Abdomen, Hydrocephalus, Infection, Skull, Neuroradiology, VPS, Cerebrospinal fluid, Sale, DRS, Lowell General Hospital, CH, Disability in Canada, Tissue, Tufts Medical Center, Patient, Disease, Failure, Craniotomy, Pain management, FAHA, Brain, Medical device, Medical imaging, MD, Neurosurgery

"SVIN and the neuroendovascular community will benefit greatly from the work they are doing," he continued.

Key Points: 
  • "SVIN and the neuroendovascular community will benefit greatly from the work they are doing," he continued.
  • The health system is dedicated to providing patients with the highest quality of care as close to home as possible.
  • Located inMassachusetts'healthcare hub, CereVasc, Inc., is a clinical-stage, venture-funded, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases.
  • The eShunt device concept originated from Tufts Medical Center physiciansCarl Heilman, MD, Neurosurgeon-in-Chief and Chairman of Neurosurgery, andAdel Malek, MD, PhD, Neurosurgeon and Chief of Neurovascular Surgery.

CereVasc Announces First Patient Treated in U.S. Pilot Trial Evaluating the eShunt System in Patients with Normal Pressure Hydrocephalus

Retrieved on: 
Monday, August 29, 2022
CEO, Safety, Doctor of Philosophy, Associate, US Foods, Sale, CSF, IDE, Food, NPH, CH, FDA, Lists of diseases, Tufts Medical Center, Patient, Pharmaceutical industry, Neurosurgery, MD

The study, 'US Pilot Study of the CereVasc eShunt System in Normal Pressure Hydrocephalus (NPH)', is being conducted under an investigational device exemption (IDE) approved by the US Food and Drug Administration (FDA) earlier this year.

Key Points: 
  • The study, 'US Pilot Study of the CereVasc eShunt System in Normal Pressure Hydrocephalus (NPH)', is being conducted under an investigational device exemption (IDE) approved by the US Food and Drug Administration (FDA) earlier this year.
  • The patient was treated at Yale Medicine by Dr. Charles Matouk, Associate Professor of Neurosurgery; Vice Chair of Clinical Affairs, Neurosurgery; Chief, Neurovascular Surgery; Director, Neurovascular/Endovascular Fellowship.
  • Its flagship product, the eShunt System, is intended to offer the first minimally invasive treatment for communicating hydrocephalus (CH) and an improvement to the current standard of care.
  • The patented eShunt System includes an endovascularly implantable cerebral spinal fluid (CSF) shunt anddelivery components, which are designed to treat CH without invasive surgery.

CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System

Retrieved on: 
Tuesday, August 9, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CSF, Literature, CEO, NPH, Lists of diseases, Sale, Tufts Medical Center, Patient, CH, Safety, Doctor of Philosophy, IDE, Physician, Hydrocephalus, Normal pressure hydrocephalus, Food, Subarachnoid hemorrhage, Pharmaceutical industry, Neurosurgery, MD

BOSTON, Aug. 9, 2022 /PRNewswire/ -- CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). 

Key Points: 
  • "We are excited to receive IDE approval from FDA to conduct a second pilot study in the US of the eShunt System in patients who develop hydrocephalus following subarachnoid hemorrhage.
  • Enrolling in parallel with our first IDE study in patients with Normal Pressure Hydrocephalus (NPH), this study will allow us to further examine the safety and efficacy of the eShunt System in a second etiology of hydrocephalus, both of which present a number of management challenges to physicians," said Dan Levangie, Chairman and CEO of CereVasc.
  • Its flagship product, the eShunt System, is intended to offer the first minimally invasive treatment for communicating hydrocephalus (CH) and an improvement to the current standard of care.
  • 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.