PLEASANTON, Calif., July 26, 2017 /PRNewswire/ -- Cerebrotech Medical Systems, an innovative medical device company
"This multi-center clinical trial shows the viability of a non-invasive technology that can quickly identify treatable devastating strokes in ambulances or emergency rooms to enable rapid triage those patients to specialized, capable treatment centers, thereby saving lives," said Christopher P. Kellner, M.D., Director of the Intracerebral Hemorrhage Program at Mount Sinai and Assistant Professor of Neurosurgery at the Icahn School of Medicine at Mount Sinai. "This trial demonstrates that Cerebrotech's device has the potential to do for stroke what EKG has done for heart attack."
Dr. Kellner presented data demonstrating that Cerebrotech's device is capable of differentiating large strokes from small strokes with sensitivity of 93% (95% CI 83-98) and specificity of 92% (95% CI 75-99). Comparison of large strokes to healthy adults yielded 100% specificity. Importantly, Kellner's presentation also demonstrated the underlying reasons why the device offers this level of accuracy. The data show that subjects with large strokes (55 ischemic and 2 hemorrhagic) have significantly higher bioimpedance asymmetry, a measure of the electrical characteristics of the brain, compared to those with small strokes (16 ischemic and 10 hemorrhagic) that do not require emergent triage to special centers. Large stroke subjects had an average asymmetry score of 16.5% (95% CI 14.6-18.4), versus those with small strokes, which had an average asymmetry score of 8.0% (95% CI 6.9-9.0, p<0.0001). Average bioimpedance asymmetry in a cohort of 79 healthy adults was 5.0% (95% CI 4.5-5.5). By measuring bioimpedance asymmetry, the device is able to identify stroke and differentiate large strokes from small strokes.
The presented data consisted of: the VITAL study (N=128), which evaluated patients presenting with a range of brain injuries including strokes and was conducted by a group that included distinguished researchers from Icahn School of Medicine at Mount Sinai (New York City), The Medical University of South Carolina, Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, and Baptist Medical Center Jacksonville; an initial pilot study (N=41) conducted at The Medical University of South Carolina; and a study of healthy volunteers for baseline comparators. The data were managed by Vastrax, a first-of-its kind neurovascular clinical research and development partner.
"There is a critical, highly-visible unmet need for effective, early stroke assessment in ambulances and emergency rooms to identify which patients need triage directly to specialty stroke hospitals for immediate surgical intervention," said Mitch Levinson, President and CEO, Cerebrotech Medical Systems. "By helping to minimize treatment delays, this technology has the potential to substantially improve healthcare outcomes for hundreds of thousands of people each year across the globe."
Cerebrotech's technology, Volumetric Integral Phase-shift Spectroscopy (VIPS), passes low-energy electromagnetic waves through the brain, detecting small changes to the brain's electrical properties. These electrical characteristics, called bioimpedance, are related to brain tissue and fluid status, and asymmetries can be indicative of clinical problems. Quantitative results provided by the device can be obtained in seconds by medical professionals after minimal training, and the simple device design allows results to be obtained without interfering with any aspect of patient care. The device holds a CE mark, but is not yet cleared for sale in the U.S.
Early detection of brain injury means early intervention, which can greatly improve patient outcomes and transform the management paradigm of these life-threatening neurological events. Every 45-minute reduction in time to thrombectomy, the new standard of care for large vessel occlusion strokes, yields a 10% increase in the number of patients achieving functional independence at 3 months.1
The Society of NeuroInterventional Surgery (SNIS), a worldwide scientific and educational association, is dedicated to excellence in comprehensive, minimally-invasive care of patients with stroke, brain aneurysms, and other diseases in the head, neck and spine. SNIS draws its membership from three areas - interventional neuroradiology, endovascular neurosurgery and interventional neurology.
About Cerebrotech Medical SystemsCerebrotech Medical Systems, Inc., is a venture capital-backed company dedicated to designing neurotechnology solutions to improve the care of brain-injured patients worldwide. The company is developing a portable, noninvasive neuro-monitoring device that allows for earlier detection of potentially life-threatening conditions such as large vessel occlusion stroke, cerebral edema, traumatic brain injury, and others. Founded in 2010 and based in Pleasanton, CA, Cerebrotech's core intellectual property is licensed exclusively from the University of California at Berkeley. For more information, visit www.cerebrotechmedical.com.
1 Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016;316(12):1279-1288. doi:10.1001/jama.2016.13647
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SOURCE Cerebrotech Medical Systems
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