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).
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Cerevast Therapeutics has recently completed the stroke treatment portion, Phase II, of the Combined Lysis of Thrombus in Brain Ischemia with Transcranial Ultrasound in Brain Ischemia (CLOTBUST-HF), an NIH funded Phase I/II trial. This phase of the study consisted of 20 ischemic stroke patients who were treated with two hours of continuous ultrasound insonation using the Cerevast Clotbust ERTM device while undergoing concomitant thrombolytic therapy.
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Cerevast Therapeutics has recently closed the first part of its Series “C” financing. Read the Notice of Exempt Offering of Securities on file with the U.S. Securities and Exchange commission.
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Cerevast Therapeutics has recently completed the healthy volunteer phase of the Combined Lysis of Thrombus in Brain Ischemia with Transcranial Ultrasound in Brain Ischemia (CLOTBUST-HF), an NIH funded Phase I/II trial. In this initial phase of the study, 15 healthy volunteers were safely treated with two hours of continuous ultrasound insonation using the Cerevast ClotBust™-ER device.
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