Vycor Medical, Inc. ("Vycor") (OTCQB: VYCO), a medical device company with a suite of FDA approved products, announced today that the Minimally Invasive Cranial Surgery Program at the Ohio State University (Columbus, OH) has commenced an animal study to evaluate a comparison of tissue damage when using Vycor's patented ViewSite Brain Access System ("VBAS") as compared to an open resection technique (using standard "blade retractors").
The results of the study will be measured by diffusion tensor imaging (DTI), a magnetic resonance imaging (MRI) technique that can quantify damage to the brain's white matter, the axons or bundles of nerve cells that connect the brain's different neuron cells. This will be the first study directly comparing the cerebral trauma caused by VBAS and blade retractors.
VBAS is a suite of clear cylindrical disposable devices which provide neurosurgeons a stable, minimally invasive working channel to access targeted sites within the brain, such as tumors. The "blade retractor" has been the standard of care device for brain access and retraction for more than 50 years. VBAS is now approved in over 100 hospitals in the U.S. and the number continues to grow. To date, more than 4,000 surgeries have been performed utilizing VBAS. Vycor has a clear plan to continue to drive VBAS adoption with a goal of having the VBAS device become the new "Standard of Care" for brain access and retraction.
David Cantor, Vycor's President, commented, "The Ohio State study, if successful, will add to the growing data showing that VBAS is clinically superior to the blade retractor and is a less invasive access device for neurosurgery. It is VBAS' minimally invasive profile that has led neurosurgeons to use the device in procedures that they considered previously to be inoperable."
Mr. Cantor continued, "The annual worldwide addressable market for the current VBAS products is estimated at approximately $400 million -- of which approximately $115 million is in the U.S. In the past two years, our VBAS sales have shown strong growth and we believe that eventually the VBAS device will become the 'Standard of Care' for brain access and retraction."
Advantages of the innovative Vycor VBAS over the long-established standard of care device, the "blade retractor," include:
Provision of a minimally invasive approach into the brain which results in reduced "white matter" damage to the surrounding tissue and is likely to lead to improved surgical outcomes for patients. Improved visibility for the surgeon due to the VBAS transparent tubular form. Reported to result in reduced surgical time which results in lower costs of procedures. The ability to be used with IGS (Image Guided Systems).
The product's minimally invasive profile and clinical superiority has been documented in five studies including peer-reviewed articles by leading institutions including Johns Hopkins University, University of Illinois at Chicago, and the Cleveland Clinic (Pediatrics Department).
About Vycor Medical, Inc.
With corporate headquarters in Boca Raton, FL, Vycor Medical, Inc. ("Vycor") is a publicly traded company (OTCQB: VYCO) dedicated to providing the medical community with innovative and superior surgical and therapeutic solutions and has a growing portfolio of FDA-approved medical solutions that are changing and improving lives every day. The Company operates two business units: Vycor Medical and NovaVision, both of which adopt a minimally or non-invasive approach. Both technologies have exceptional sales growth potential, address large potential markets, have the requisite regulatory approvals and are commercialized and generating revenue. The Company has a strong patent portfolio with 34 granted patents and a further 21 patents pending.
Vycor Medical's flagship, ViewSite Surgical Access Systems (VBAS) is a suite of clear cylindrical minimally invasive disposable devices that hold the potential for speedier, safer and more economical brain surgeries and a quicker patient discharge. VBAS is designed to optimize neurosurgical site access, reduce patient risk, accelerate recovery and add tangible value to the professional medical community. Vycor Medical is ISO 13485:2003 compliant, has FDA 510(k) clearance for VBAS for brain and spine surgeries and regulatory approvals for brain surgeries in Australia, Canada, China, Europe, Japan, Korea and Russia. For an overview of Vycor Medical's VBAS see http://player.vimeo.com/video/39766887
NovaVision develops and provides science-driven neurostimulation therapy and other medical technologies that help improve and partially restore sight in patients with neurological vision impairments. The company's proprietary Visual Restoration Therapy® (VRT) platform is clinically supported to improve lost vision resulting from stroke, traumatic brain injury ("TBI"), or other acquired brain injuries. VRT is the only FDA 510(k) cleared medical device in the U.S. aimed at the restoration of vision for neurologically induced vision loss and can be prescribed by any ophthalmologist, optometrist, neurologist or physiatrist. VRT also has CE Marking for the EU. NovaVision also provides Neuro-Eye Therapy (NeET) in the EU, aimed at increasing visual sensitivity deep within the field defect. NovaVision also provides a fully portable and ADA-compliant Head Mounted Perimeter (HMP) which aids in the detection and measurement of visual field deficits. For an overview of NovaVision see http://player.vimeo.com/video/39765566