SOURCE: Vycor Medical, Inc.

Vycor Medical, Inc.

August 07, 2014 08:00 ET

New Image Guided VBAS Prototype Work Completed

BOCA RATON, FL--(Marketwired - Aug 7, 2014) - Vycor Medical, Inc. ("Vycor") (OTCQB: VYCO), a provider of innovative and superior surgical and therapeutic solutions, announced that it had successfully completed the development of new prototypes of its patented ViewSite™ Brain Access System ("VBAS") device that will be fully compatible with selected image-guided systems. The device has been specifically designed to house the pointer utilized in image-guided systems. The pointer will be firmly held in place in the introducer through a novel approach while the working channel will remain unchanged. The Company will now commence the testing of these devices. Initially the Company plans on manufacturing four new devices targeted at this market, this development being spurred by strong neurosurgeon demand. VBAS is currently approved in over 170 hospitals in the U.S. and more than 6,500 surgeries have been performed worldwide utilizing VBAS.

VBAS is a suite of clear cylindrical disposable devices used to access target sites such as tumors within the brain, which provides a working channel during neurosurgery for their removal. The devices are being used in brain surgeries in the US 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 Brazil, India, Korea, Russia, Taiwan and Vietnam.

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 surgeons at leading institutions including Cleveland Clinic (Pediatrics Department), Johns Hopkins University, Ohio State University and University of Illinois at Chicago. Additional studies are anticipated in the near future further supporting the products clinical benefits.

Traditional tools for brain access and 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:

  • 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
  • Stable working channel and more accurate target access
  • Reported to result in reduced surgical time which results in lower total costs of procedures
  • Has been reported to have been used in procedures that were otherwise considered to have been inoperable using existing standard retractors

A corporate video on the whole of the Vycor Group, which highlights VBAS and includes commentary from several neurosurgeons, can be found at: Vycor Corporate Video

Commenting on the completion of the new prototype work, Peter Zachariou, Chief Executive Officer of Vycor, stated, "Vycor's mission is to develop devices which address a significant need and provide innovative neurosurgical solutions. Working with surgeons and other partners we believe this new fully IGS-compatible suite of VBAS devices will further revolutionize the way in which surgeons perform brain surgery and will assist Vycor in its goal of making the VBAS device the 'Standard of Care' for brain retraction and access."

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 VBAS Video.

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 patient's 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 NovaVision Video.

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