Biosan Medical, an emerging medical device company, announced today that it has been issued U.S. Provisional Patent No. 61,957,293 for its revolutionary Ventritek105® Stroke Treatment Device and Method (“Device & method for CSF auto-transfusion therapy for the treatment of SAH (subarachnoid hemorrhage), Alzheimer’s Disease & other Neuro-Degenerative CNS diseases”).
Approximately 50 percent of those affected by hemorrhagic strokes die within 30 days of the initial event (median age of death due to SAH is 59 years). The Ventritek device and method has been used successfully by neurosurgeon and prominent researcher David Michaeli, M.D., Ph.D., in Russia to treat 40 patients who had a severe, stroke-caused Intra Ventricular Hemorrage (“IVH”), which is a bleeding into the brain's ventricles where cerebral spinal fluid (CSF) is produced and circulates into the subarachnoid space. Dr. Michaeli, recognized as the “Father of MRI in Russia” and inventor of the Ventritek105 device, treated his study patients at the Polenov Neurosurgery Research Institute, St. Petersburg, Russia. More than 90% of the study patients treated with the Ventritek105 system and method to purify their blood-tainted CSF were alive and well at 30-day follow-up. These patients were not part of a clinical study, but were treated on a compassionate-use basis by Dr. Michaeli.
There is a dire unmet clinical need for a superior means by which to drain blood-tainted cerebral spinal fluid from a stroke patient’s brain,” said Ofer Taran, CEO of Biosan Medical. “Up to 15% of all stroke cases are defined as SAH and IntraCerebral Hemorrhage with or without IntraVentricular Hemorrhage (IVH). Total worldwide costs for 2009 of treating SAH and other hemorrhagic strokes are staggering and amount to over $30 billion annually. These patients are potentially treatable with our Ventritek device and method.” The revolutionary Ventritek105® Stroke Treatment Device & Method is designed to replace the currently long, arduous and risky CSF drainage-and-purification procedure used with Stroke patients. The patented Ventritek105® device and method is designed to offer neurosurgeons a revolutionary way of safe, quick, and monitored purification of a patient’s blood-tainted CSF by reinfusion back into the sick patient's brain.
The system, in contrast to the current standard External Ventricular Drainage (EVD) procedure, is designed to decrease patient recovery time during the CSF drainage/purification process by more than 80%, as well as dramatically minimize patient suffering and risk of developing post-Stroke Hydrocephalus and Cerebral Vascular Spasm (CVS), while offering huge savings in medical costs.