BOCA RATON, FL -- (Marketwired) -- 04/29/14 -- Vycor Medical, Inc. ("Vycor") (OTCQB: VYCO), a provider of innovative and superior neurosurgical and neurotherapeutic solutions, today announced continued momentum and an increase in the number of hospitals that have approved use of Vycor's patented ViewSite Brain Access System ("VBAS") device. During this calendar year, VBAS has been approved by 12 new U.S. hospitals and is now approved in more than 170 hospitals in the U.S. with additional hospitals going through the approval process. To date, more than 5,000 surgeries have been performed utilizing VBAS.
David Cantor, President of Vycor, commented, "Neurosurgeons continue to demand the VBAS system to treat their patients, helping us to expand our global market presence. The patented, innovative VBAS product continues to gain traction in both the U.S. and international markets and we remain convinced that the VBAS device will become the 'Standard of Care' for brain retraction and access."
VBAS is a suite of clear cylindrical disposable devices used to access target sites such as tumors within the brain which provide a working channel during neurosurgery for their removal. The devices are being used in brain surgeries in the U.S. and internationally. The company is ISO 13485:2003 compliant, has U.S. FDA 510(k) clearance for brain and spine surgeries and full regulatory approvals for brain in Australia, Canada, China, Europe (EU - Class III), and Japan and is seeking or has partial regulatory approvals in India, Korea, Russia, Taiwan and Vietnam. Vycor has 8 granted and 8 pending patents worldwide.
The VBAS system provides a minimally invasive approach into the brain, offering clinical advantages that have been validated in various peer-reviewed articles and have enabled previously inoperable procedures to take place, thereby saving and changing lives. The product's minimally invasive profile and clinical superiority has been documented in five studies including peer-reviewed articles by leading institutions including John's Hopkins University, University of Illinois at Chicago, and the Cleveland Clinic (Pediatrics Department). Additional studies are anticipated in the near future further supporting the products clinical benefits.
Traditional tools for brain retraction have not changed much in more than 50 years. Advantages of the innovative Vycor VBAS over the long-established standard of care device, the "blade retractor", include:
A corporate video on the whole of the Vycor Group, which highlights VBAS and includes commentary from several neurosurgeons, can be found at: http://player.vimeo.com/video/39903199
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-cleared 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.
Vycor Medical's 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. The company is ISO 13485:2003 compliant, has U.S. FDA 510(k) clearance for brain and spine surgeries and full regulatory approvals for brain in Australia, Canada, China, Europe (EU - Class III), and Japan and is seeking or has partial regulatory approvals in India, Korea, Russia, Taiwan and Vietnam. 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 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.
In March 2014 the Company soft-launched NeuroEyeCoach in the US, which is the first commercially available saccadic therapy deliverable via the web to patients' computers at their own homes. The program is supported by more than four decades of scientific findings and was developed as collaboration between the Company, and Josef Zihl, a NovaVision Scientific Advisor and world thought leader in saccadic training and the pioneer of this computer based training technique. The program is designed to result in a meaningful improvement in the patients visual search performance resulting in improvements in their navigation and object finding skills. Given that NeuroEyeCoach addresses the patients difficulty with their eye movements and their ability to integrate visual information while VRT focuses on the restoration of lost vision the two therapies are highly complementary. For an overview of NovaVision see http://player.vimeo.com/video/39765566
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Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "forecast", "anticipate", "estimate", "project", "intend", "expect", "should", "believe", and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Vycor Medical's actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Vycor Medical's filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Vycor Medical herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Vycor Medical disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.