BOCA RATON, FL--(Marketwired - May 1, 2013) - Vycor Medical, Inc. ("Vycor") (OTCBB: VYCO) announced today it has finalized the design of two differently-sized prototypes of its existing ViewSite™ Brain Access System ("VBAS") product suite which are specifically targeted at the pediatric neurosurgical market. It is anticipated that the new devices will be commercially available by the end of 2013 and will fall under the Company's existing U.S. FDA 510(k) clearance for VBAS.
The devices were developed in close collaboration with a leading pediatric neurosurgeon from the Children's Hospital Central California. The Pediatric neurosurgeon identified a need to develop a much smaller VBAS than those currently available which would allow for endoscopic intra-ventricular work such as the placement of catheters and shunts and to gain access to ventricular tumors.
VBAS is a suite of clear cylindrical disposable devices that 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.
As part of Vycor's growth strategy, new product development is targeted at driving the use of its existing VBAS product range through ancillaries that will facilitate its use and through new product extensions to broaden VBAS applicability to procedures currently not addressed by its existing product line. Management has estimated, based on AANS statistics by cranial procedure, that there are in the U.S. alone approximately 200,000 annual applicable procedures for its current VBAS device range and an additional 130,000 procedures that could be addressed through product extensions.
It is estimated that there are approximately 300 pediatric neurosurgeons in the US and two new devices will help address an estimated 25,000 procedures in the US which were previously un-addressable by Vycor's existing VBAS product range.
David Cantor, Vycor's President, commented, "We believe that the addition of these two new devices into the market represents an exciting opportunity for the Company to address under-served pediatric neurosurgical needs in the market and is consistent with our stated objective of adding new product variations to our core VBAS product line. Given the devices extremely small dimensions and smooth shape, we believe they represent a significant step forward in minimally invasive retraction."
About Vycor Medical, Inc.
With corporate headquarters in Boca Raton, FL, Vycor Medical, Inc. ("Vycor") is a publicly traded company (OTCBB: 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(R) (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 510K 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
For the latest information on the company, including media and other coverage, and to learn more, please go online at www.vycormedical.com or www.novavision.com.
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