Vycor's Patented VBAS Minimally Invasive Neurosurgical Device
Accepted by 12 New U.S. Hospitals This Year
VBAS Now Approved by 170 U.S. Hospitals and Growing; More Than
5,000 Surgeries Performed to Date
BOCA RATON, FL--(Marketwired - Apr 29, 2014) - 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:
- Provision of a minimally invasive approach into the brain which
results in reduced "white matter" damage to the surrounding tissue
due to the products tubular shape.
- VBAS applies rigid, constant and equally distributed pressure
to the surrounding tissue.
- The tubular retractor provides enhanced visualization and more
stable retraction of the surrounding tissue.
- Reported to result in reduced surgical time which results in
lower costs of procedures and improved surgical outcomes for
patients.
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
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: Hayden IR Brett Maas,
Managing Partner (646) 536-7331 Email Contact Or Cameron Donahue,
Partner (651) 653-1854 Email Contact
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