UPDATE: Vycor Develops New Devices Targeted at the Pediatric Market
May 01 2013 - 11:05AM
Marketwired
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®
(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.
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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