TEL AVIV, Israel--(BUSINESS WIRE)--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.
About the Ventritek105® Stroke Treat Device & Method from Biosan
A stroke refers to rapid loss of brain function due to a disturbance in the blood supply to the brain, which can be caused by a hemorrhage (bleeding) from a burst blood vessel. The brain is surrounded by CSF—Cerebral Spinal Fluid. When the circulatory path of the CSF is blocked as a result of a hemorrhage, fluid begins to accumulate, causing the Brain Ventricles (BV) to enlarge (Hydrocephalus), and also causing a sharp increase in Intracranial Pressure (ICP) elevation that can cause great physical and mental impairment, and death. The term Subarachnoid Hemorrhage (SAH) refers to bleeding into the Subarachnoid Space or CSF that surrounds the brain as the result of a ruptured artery in the brain. The current standard External Ventricular Drainage (EVD) method of CSF drainage has great disadvantages as it requires a long-time cure (1–6 weeks) to clean the CSF from blood, continuously exposing the patient to extreme suffering. Additionally, the products of red blood cells’ fragmentation act as poison to the body and, as a result, often cause Acute Ventricular Dilatation (AVD) or Acute Ventriculomegaly (AV), deep coma, severe Aseptic Meningitis, Hyperthermia, severe Cerebral Vascular Spasm, and can lead to a secondary brain Infarct.
Purified CSF (from Beta Amyloidal Proteins ) that are reinfused into the brain’s ventricular system opens plugs of the Brain Lymphatic System (s.c. Glimphatic System), which is believed to facilitate substantial improvements of the patient's behavior and memory.
NOTE: The Ventritek105® treatment device & method are not approved for use in the United States.