The Ohio State University Commences Key Comparative Study of Vycor's Patented ViewSite(TM) Brain Access System (VBAS)
May 20 2013 - 8:30AM
Marketwired
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
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.
Safe Harbor Statement
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.
Vycor Medical, Inc. Investor Contacts: The Del Mar
Consulting Group, Inc. Robert B. Prag President 858-794-9500 Email
Contact or Alex Partners, LLC Scott Wilfong President 425- 242-0891
Email Contact
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