Medical device maker Vycor Medical Inc. today announced it has started the registration process for State Food and Drug Administration (SFDA) in the People’s Republic of China (PRC) in collaboration with recently appointed exclusive distribution partner Devon Medical Inc., a manufacturer and distributor of creative, safe, and cost-effective medical devices.
The two companies will jointly distribute Vycor’s VBAS (ViewSite™ Brain Access System), a new approach to brain retraction, in China and South Korea, leveraged by the PRC government’s plans to spend USD$125 billion in addition to its usual healthcare budget over the next three years.
According to the China Business Review, China’s medical device market is estimated to be between USD$8 billion – UDS$10 billion in 2008, and forecast that the market could grow to USD$16 billion USD by the end of this year.
Dr. John A. Bennett, CEO of Devon Medical agrees.
“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,” he stated in the press release.
VBAS gives surgeons access to various regions in the brain for numerous procedures. It was designed to produce less tissue trauma, allow surgeons to see the surrounding tissue during the procedure, and require less retractor repositioning. The end result is a faster recovery, more precise surgeries, and lower costs.
Dr. Bennett says that extensive meetings and discussions with Chinese healthcare professionals show that the top 70 hospitals in China perform more than 300,000 craniotomies each year. On this number alone, he said he believes the VBAS will be successful in the PRC.
“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,” Kenneth T. Coviello, CEO of Vycor stated. “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 is supported by a staff of FDA-regulatory experts in China with established and potential business and healthcare relationships throughout the country.
“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,” Dr. Bennett stated. “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.”