Vycor Medical and Devon Medical Start SFDA Registration Process to Market ViewSite Brain Access System (VBAS) in China
March 16 2010 - 5:00AM
Marketwired
Vycor Medical, Inc. (OTCBB: VYCO) announced today that it has
started the process for State Food and Drug Administration (SFDA)
registration in the People's Republic of China (PRC) with recently
appointed exclusive distribution partner, Devon Medical, Inc., a
manufacturer and distributor of creative, safe, and cost-effective
medical devices.
Vycor Medical and Devon Medical will jointly distribute Vycor's
VBAS (ViewSite™ Brain Access System), a new approach to brain
retraction, in China and South Korea. The device allows surgeons to
access various regions in the brain for numerous procedures. The
design goals of VBAS were to produce less tissue trauma, allow
surgeons to see the surrounding tissue during the procedure, and
require less retractor repositioning. Achieving these goals could
lead to speedier recovery, more precise surgeries, and lower
costs.
"Devon Medical believes that the Chinese medical device market
is poised to explode, as government entities have embarked on an
aggressive, large-scale healthcare reform plan focused on improving
patient care," says Dr. John A. Bennett, CEO of Devon Medical.
The PRC government plans to spend $125 billion USD in addition
to normal healthcare budget allocations over the next three years
to implement a healthcare reform plan, according to multiple
sources. According to the China Business Review, sources in China
estimated the size of the country's medical device market at $8-$10
billion USD in 2008, and believe the market could grow to $16
billion USD by the end of this year.
"We estimate, from our extensive meetings with healthcare
personnel in China, that the top 70 hospitals in the country
perform over 300,000 craniotomies annually," says Bennett. "It is
for these reasons that we believe the VBAS will be successful in
this part of the world."
"We have received very positive feedback on the utility of VBAS
from surgeons in the United States, and we are excited to expand
the device's use to help physicians and patients in other
countries," says Kenneth T. Coviello, CEO of Vycor. "The need and
potential for VBAS in China was immediately recognized by Dr.
Bennett and Devon Medical. His team has already showed its
expertise in the Chinese regulatory and marketing arenas, and we
look forward to leveraging their industry experience as we enhance
brain and spinal surgery capabilities. We are very excited to join
efforts with Devon Medical to advance medicine, and also to help
create manufacturing jobs in the United States."
Devon Medical's staff of FDA-regulatory experts in China fosters
business and healthcare relationships throughout the country, and
is currently working with medical device distributors in Beijing,
Shanghai, and Shandong.
"We pride ourselves on driving technological innovation that
advances medicine, disease treatment, and patient care, and are
committed to enhancing the domestic economy by manufacturing
products in the U.S. and selling them abroad," says Bennett. "Vycor
Medical shares these passions, and we are ecstatic to leverage our
relationships with the largest hospitals and local distributors in
China to make this groundbreaking innovation accessible
immediately."
Devon Medical has met with top hospitals in China, including
Beijing Tiantan Hospital, Shanghai Huashan Hospital, and the Hunan
Xiangya Hospital System. These hospitals combined perform over
30,000 craniotomies annually, according to hospital officials.
About Vycor Medical Vycor Medical is a
medical device company specializing in products for brain and
spinal surgery. VBAS (ViewSite Brain Access System) is the
company's first product, and is a unique new approach to brain
retraction which the company believes will offer major benefits to
both surgeons and patients. Vycor Medical is an ISO certified
manufacturer. Please visit www.vycormedical.com for more
information.
About Devon Medical Devon Medical
(www.devonmedicalinc.com) is a Devon International Group company
that provides the medical community with creative, safe, and
cost-effective medical products. The company has cultivated an
exclusive line of innovative medical devices designed to advance
healthcare treatments and maximize safety for healthcare workers
and patients worldwide. The company is headquartered in King of
Prussia, Pennsylvania, and has offices in Beijing and Shanghai
staffed with bilingual engineers, product developers, and
FDA-regulatory experts.
With the exception of historical information contained in this
press release, content herein may contain "forward looking
statements" that are made pursuant to the Safe Harbor Provisions of
the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and are
subject to uncertainty and changes in circumstances. Investors are
cautioned that forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially
from the statements made. These factors include general economic
conditions, delays and risks associated with the performance of
contracts, risks associated with international sales and currency
fluctuations, uncertainties as a result of research and
development, acceptable results from clinical studies, including
publication of results and patient/procedure data with varying
levels of statistical relevancy, risks involved in introducing and
marketing new products, potential acquisitions, consumer and
industry acceptance, litigation and/or court proceedings, including
the timing and monetary requirements of such activities, the timing
of finding strategic partners and implementing such relationships,
regulatory risks including approval of pending and/or contemplated
510(k) filings, the ability to achieve and maintain profitability
in the Company's business lines, and other factors discussed in the
Company's Annual Report on Form 10-K, subsequent Quarterly Reports
on Form 10-Q and Current Reports on Form 8-K. The Company disclaims
any obligation to update its forward-looking relationships.
Press Contacts: Vycor Medical, Inc.: Jim Morham 951-833-8425
Email Contact Devon Medical, Inc.: Darren M. Behuniak 610-755-4958
Email Contact 80 Orville Drive Suite 100 Bohemia, NY 11716
631.244.1435 www.vycormedical.com
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