NuVasive, a medical device manufacturer based in San Diego, California, received clearance in Japan for two of its titanium alloy implants. With this approval, NuVasive will have access to the second largest spine device market in the world.
According to details from a press release by the company, both the company’s CoRoent large tapered and CoRoent large impacted titanium alloy implants have been approved for sale in Japan. These devices are used during posterior spinal fusion operations. As the first interbody fusion cages to be approved in the country, NuVasive will have access to a very large market.
Alex Lukianov is CEO and chairman at NuVasive. In prepared remarks, he said, "This is an exciting stepping stone for NuVasive! For several years, we have been thoughtfully laying the groundwork and making the investments to support a direct operation in Japan, a market estimated to be close to $400 million in size.” He continued, "We are proud to see all of those efforts coming to fruition so that our revenue ramp can begin in earnest at the start of the 1st quarter."
The company also plans to launch posterior thoracolumbar and cervical devices in the Japanese market over the coming years. In addition, the company hopes to launch its lateral XLIF solution in the Japanese market.
The Japanese regulatory win for CoRoent follows other wins in other countries. The United States Food and Drug Administration approved the device in March. It also won FDA approval for a PCM cervical disc system in October.
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