HONG KONG – Seoul, South Korea-based 3D inspection device maker Koh Young Technology Inc. is looking to expand into the global market with its neurosurgical robotics system Kymero after securing its first client in its home country in June.

A company source told BioWorld that Koh Young is “eyeing the Chinese and American markets, which are both much bigger than the Korean market. We are currently in the process of applying for the necessary approvals in both countries.” The company also is targeting the European market, the source added.

Koh Young inked an agreement with Yonsei University’s Severance Hospital in early June to commercially deploy Kymero. The system will be used in Severance’s neurosurgical procedures, such as deep brain stimulation, 3D electroencephalography, biopsies and shunts, as well as in Parkinson’s disease and epilepsy operations once the system is installed and surgeon training is completed. This agreement is “the first step for Koh Young to launch the product in the Korean market,” the source said. The source declined to provide further details of the agreement.

Severance used Intuitive Surgical Inc.’s almost two-decade old surgical system, Da Vinci, to perform Korea’s first robot-assisted surgery in 2005. The hospital since has performed 20,000 robot-assisted surgeries as of June 2018.

Koh Young began the development process for Kymero in 2011 as part of a ₩20.7 billion ($17.23 million) government project launched the same year. The company received Ministry of Food and Drug Safety (MFDS) approval five years later. Severance, one of the biggest hospitals in the country, conducted a two-year clinical trial after the approval was granted, with the system’s margin of error decreased to 0.98 mm by the trial’s completion.

According to the company, Kymero combines a navigation platform guiding the surgeon to the location of the lesion through the brain’s pathways and robotic arms to aid with precise positioning. CT or MRI images uploaded to the system also provide the surgeon with a 3D view of the surgical site and the pathway via a screen. A scanner on the operating table will use a 3D co-ordinate system and obtain the target co-ordinates for the surgical site.

“The robotics system will precisely measure the coordinates, thereby increasing the surgery’s accuracy,” according to Koh Young’s CEO Kwangill Koh. This accuracy will help guide the surgeon to the precise site without impacting the numerous arteries, veins and nerves that make up the brain, minimizing cerebral hemorrhages and cardiac infractions.

Looking at the space

For its part, France’s Medtech’s Rosa system received U.S. FDA approval in 2007 for use in brain and spinal surgery. That company now is part of Zimmer Biomet. However, Mirae Asset Daewoo analyst Choong-hyun Kim said in a June 3 research note that the Korean company potentially faces a bigger competitor in U.S. giant Medtronic plc, “an industry leader in surgical equipment whose biggest advantage is its ability to provide packaged sales of medical devices related to neurosurgery.” Kim said that Kymero’s success depends on its ability to “gain the upper hand in markets outside the U.S.”

Other surgery robotics manufacturers closer to home include Meerecompany Inc., which launched its laparoscopic surgical robot Revo-i in 2008. Revo-i was the first surgical robot to be developed by a Korean company, providing competition for Da Vinci. However, Kim said that Revo-i’s market cap was $200 million, compared with Da Vinci’s $67.6 billion cap. Fellow Korean company Curexo Inc won MFDS approval for CUVIC-spine, its robot-assisted spinal surgery device, in December 2019.

Mirae Asset’s note also said that “advancing overseas is critical, with the Korean market estimated to be only ₩40-50 billion at best, even when including consumables … we think a target of around 100 systems globally (excluding the U.S.), with potential upside from entry into the U.S., would be a reasonable assumption.” It also estimated the Kymero robotics system to be priced at the ₩1 billion level.

The note also said that the clinical data submitted by Koh Young to demonstrate Kymero’s safety and accuracy must be backed up by data demonstrating the costs-benefits for the company to achieve its goal of expanding across global markets. Kim also expects the company to seek partnerships with medical professionals for additional clinical data points and publish them in peer-reviewed journals. He said that Kymero would benefit from a sound and systematic training course to familiarize surgeons with the new system.

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