, Dec. 19, 2011
/PRNewswire/ -- Cerevast Therapeutics Inc., a privately held medical technology company, announced today that it has received CE mark clearance of its SonoLysis Headframe System, the Clotbust ER
providing approval to commercialize the product in Europe
The Clotbust ER is a first-in-class ultrasound device for the treatment of ischemic stroke, representing a novel product in an extremely high area of unmet medical need. Designed for rapid deployment in the emergency room setting, the device has been engineered to non-invasively deliver therapeutic ultrasound energy to the region of the occluded vessel in the brain as a treatment for ischemic stroke when used in combination with standard intravenous thrombolytic therapy (tissue plasminogen activator - tPA/Alteplase).
The device contains multiple transducers incorporated into a unique, operator-independent headframe. The Clotbust ER is designed to self-align the transducers based on common landmarks on the skull. Proprietary software controls the ultrasound parameters, which in turn allows the device to deliver consistent therapeutic levels of ultrasound energy necessary to achieve acoustic streaming and enhanced clot lysis within the occluded vessel of the brain without the need for a trained sonographer or vascular technician.
"Achieving CE mark clearance represents a major accomplishment for Cerevast," said Bradford A. Zakes, Chief Executive Officer. "The Clotbust ER significantly reduces the technical challenges associated with the administration of transcranial ultrasound for the treatment of ischemic stroke. Unlike conventional Doppler instruments that are designed and approved for diagnostic purposes only, the Clotbust ERdelivers therapeutic ultrasound energy to the region of the occlusion without the need to aim the transducer or hold it in place by hand for extended periods of time. This represents a major advancement in the emergency room setting where trained sonographers or vascular technicians are not always available."
"It is critically important that treatment be initiated as quickly as possible once a stroke patient presents to the hospital," said Andrei Alexandrov, MD, Professor of Neurology and Director, UAB Comprehensive Stroke Research Center. "The operator-independent design of the Clotbust ER enables safe, fast and reliable amplification of systemic thrombolytic treatment in the emergency room setting. I look forward to the benefit this product will bring to those patients that suffer the debilitating effects of an ischemic stroke."
About Cerevast Therapeutics, Inc.
Cerevast Therapeutics, Inc. is a medical technology company focused on the development of SonoLysis for the treatment of acute ischemic stroke. Cerevast is a recognized leader in the field of SonoLysis with a dominant intellectual property estate comprising more than 75 issued U.S. patents, 250 foreign issued equivalents and an extensive data package of pre-clinical and clinical studies. The Company is a privately held corporation headquartered in Redmond, WA.
SonoLysis is the term used to describe the application of ultrasound energy to disrupt or "lyse" blood clots in the vasculature. In the setting of acute ischemic stroke, clinical studies have demonstrated that the combination of transcranial ultrasound with conventional thrombolytic therapy results in a significant improvement in both vessel recanalization and rate of complete recovery compared to conventional thrombolytic therapy alone a major advance in treatment.
SOURCE Cerevast Therapeutics Inc.