Latest news with #InvestigationalTestingAuthorization
Yahoo
4 days ago
- Health
- Yahoo
CereVasc Receives Health Canada Investigational Testing Authorization for STRIDE Clinical Trial of the eShunt® System
The STRIDE trial is actively enrolling at multiple sites in the United States and Argentina for the treatment of elderly patients with Normal Pressure Hydrocephalus (NPH) BOSTON, June 18, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, announced today that it has received Investigational Testing Authorization (ITA) from Health Canada to conduct 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. "A minimally invasive, endovascular approach to treating NPH has the potential to improve recovery times and reduce the possibility of post-operative complications for patients living with this progressive, neurological condition," said Dr. Vitor Mendes Pereira, Neurosurgeon and Director of Endovascular Research and Innovation at St. Michael's Hospital. "I am encouraged by initial study results of the eShunt System and look forward to participating in the STRIDE trial, with the goal of improving care and clinical outcomes for patients." 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. "This marks another important milestone for patients and caregivers living with NPH, as the eShunt System is designed to make treatment accessible for more patients while potentially improving outcomes," stated Dan Levangie, Chairman and CEO of CereVasc. "Authorization from Health Canada for the STRIDE clinical trial brings us closer to our mission of improving the quality of life globally for people living with this debilitating 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 enable 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 CassCereVasc, Media Contacts: Ethan MetelenisPrecision Christina RenfroePrecision View original content to download multimedia: SOURCE CereVasc Sign in to access your portfolio
Cision Canada
10-06-2025
- Business
- Cision Canada
Spiderwort Biotechnologies Inc. Receives Health Canada Investigational Testing Authorization for Next-Generation Dermal Filler
® represents the next-generation in medical aesthetics leveraging Spiderwort Biotechnologies regenerative cellulose-based technology platform OTTAWA, ON, June 10, 2025 /CNW/ - Spiderwort Biotechnologies Inc., a pioneering biotechnology company focused on cellulose-based regenerative medicine, today announced it has received Investigational Testing Authorization (ITA) from Health Canada for CelluJuve ®, its next-generation cellulose-based dermal filler currently under development. The ITA enables Spiderwort Biotechnologies Inc. to initiate a human clinical trial in Canada to evaluate the safety and performance of CelluJuve ® for tissue augmentation and rejuvenation. The planned clinical trials will evaluate the interaction between CelluJuve® and human tissues. This authorization follows the company's successful completion of ISO 10993 biocompatibility testing and human skin safety testing for CelluJuve ®. "Receiving the Investigational Testing Authorization from Health Canada is a critical inflection point in our mission to transform the landscape of regenerative medicine in multiple categories," said Dr. Charles M. Cuerrier, CEO of Spiderwort Biotechnologies Inc."This achievement validates our rigorous development approach and accelerates our path toward bringing CelluJuve ® to patients and clinicians who are seeking innovative alternatives in dermal fillers. We're excited to begin the clinical evaluation phase and demonstrate the potential benefits of our cellulose-based technology Aerocel™ in medical aesthetics and beyond." "As a board certified dermatologist with extensive experience in facial aesthetics, I am encouraged by CelluJuve®'s innovative approach to tissue augmentation." Dr. Joely Kaufman, MD, FAAD, member of Spiderwort's Clinical Advisory Board, "The preliminary data suggests that this cellulose-based technology could potentially offer an alternative method to address the signs of facial aging. I look forward to seeing the clinical results of this promising biomaterial." CelluJuve ® is under development to provide medical professionals with a cellulose-based alternative to current dermal fillers. The product is designed to work with the body to create a natural look and feel by providing a framework for collagen deposition, with the initial target for Spiderwort Biotechnologies Inc.'s research being nasolabial fold remediation. The company's state-of-the-art ISO 5 cleanroom facility, announced earlier this year, will support the production of medical-grade CelluJuve ® for the upcoming trials, ensuring all materials meet the quality standards required for human use. "CelluJuve® is a testament to where bold science can lead," said Dr. Andrew Pelling, Chief Science Officer at Spiderwort Biotechnologies Inc."We're demonstrating how plant-derived biomaterials can become a powerful foundation to address a variety of medical needs. These recent and critical regulatory advancements in our product portfolio reveal how nature inspired innovation can unlock entirely new frontiers in rejuvenating and regenerating human tissues." CelluJuve ® is a device under development. While it has received Investigational Testing Authorization from Health Canada for clinical trials, it is not yet approved by Health Canada or the U.S. Food and Drug Administration (FDA) for commercial use, and it is not available for sale. The safety and effectiveness of CelluJuve ® in humans has not been fully established and will be evaluated in upcoming clinical trials. For more information about Spiderwort Biotechnologies and CelluJuve ®, please visit About Spiderwort Biotechnologies Inc. Spiderwort is transforming biotechnology with a platform of cellulose-based biomaterials that serve as the scaffolds for the regenerative medicine of the future. Spiderwort's biomaterials have shown promise in the treatment of spinal cord injuries and soft tissue regeneration. Spun out as a startup from the Pelling Lab, Spiderwort is led by CEO Charles M. Cuerrier and inspired by the work of CSO and TED Fellow Andrew E. Pelling. Learn more at
