Robotics Maker Curexo Clears Two Big Regulatory Hurdles

Curexo, Inc. announced the CE marking of its CUVIS-spine surgical robot on May 18, 2020. The company also announced on June 3, 2020 approval of its CUVIS-joint by the Korean Ministry of Food and Drug Safety for total knee arthroplasty (TKA).

The robots were both developed by Curexo, Inc., a Korean medical robot company with a long history of surgical robot development. The CUVIS-spine has been available in South Korea since late last year after receiving approval from Korea’s Ministry of Food and Drug Safety. CE marking, and subsequent launch in Europe will bring the company one step closer to its goal of reaching the global market. The company plans to apply for U.S. FDA clearance for the CUVIS-spine in the near future.

The CUVIS-spine is currently capable of navigating pedicle screws using preoperative imaging and plans and adjusting navigation based on patient movement. The features and limitations are similar to other spine surgery robots such as Medtronic’s Mazor X, and Zimmer Biomet’s ROSA.

The CUVIS-joint uses an optical tracking system, a six-axis arm, and provides an open platform for use of a wide array of implants. Like other TKA robotic-assisted surgery systems, such as Stryker’s MAKO, the CUVIS-joint is intended to provide more accurate bone cuts based on preoperative imaging and planning by the surgeon.

An official from Curexo explained the importance of using a robot for TKA, “Manual artificial joint surgery is performed by relying on the X-ray picture to determine the affected area and depends on the doctor’s experience. [The CUVIS-joint] is equipped with an auto segmentation function, automatic implant size selection, and bone cutting position guide function.”

Curexo also produces a gait rehabilitation robot called InMotion, which was distributed in the U.S. by Bionik Laboratories, Corp until 2019. Curexo, Inc. has strong ties with U.S.-based surgical robot manufacturer, Think Surgical, Inc., which is another branch of a Korean food and beverage company, Korea Yakult. The companies established a partnership in 2007 to help fund trials needed for updates to the Robodoc, a surgical robot for hip and knee replacement, and to distribute the robot. Curexo is currently a distributor for the Think TSolution One. The company plans to continue even after release of the CUVIS-JOINT, as both product have different characteristics, according to a company representative.

Think Surgical, Inc. changed its name from Curexo Technologies, Inc. in 2014. Curexo currently distributes Think Surgical’s Robodoc and Tsolution One in South Korea, but it is not clear how the agreement will develop with the launching of Curexo’s own robot.

Curexo CEO Jae-Jun Lee described the milestone in a press release as meaningful, because “now Curexo is aiming for the global market with a self-developed surgical robot. The following task will be FDA approval and entering the U.S. market, which is number one in surgical robots.”

In the press release announcing the CUVIS-joint approval he added, “We are very happy to be able to compete with the products of world-renowned companies with domestic surgical robots as we have prepared our best to do so. We will showcase all our capabilities and promote successful overseas entry into the Asian market as well as the domestic market.”

A prior affiliation with the surgical robot division of Hyundai Heavy Industries, along with Think Surgical has positioned Curexo to make a splash in the global surgical robot market.