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Vycor Medical and Devon Medical Start SFDA Registration Process to Market ViewSite Brain Access System (VBAS) in ChinaFont size: A | A | A5:00 AM ET 3/16/10 | Marketwire
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(TM) 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.
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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
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
SOURCE: Vycor Medical
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