Koh Young Technology Inc., a South Korean developer of 3D optical inspection devices used in electronics manufacturing, is set to install its brain surgery robot in a US hospital, which would mark the medical device’s first foray into an overseas market in nine years since its development.
The company said on Thursday that it plans to deploy its brain surgery robot, called Geniant Cranial, this summer at an undisclosed US hospital known nationally for its neurosurgery program.
“We are in talks to complete the installation in July or August,” said an official from Koh Young.
This would mark the first export of the medical device since it was developed in 2016.
The milestone also comes six months after the robot was cleared by the US Food & Drug Administration (FDA) for clinical use in January.
The Kosdaq-listed company expects its US launch will pave the way for more orders from the US and other foreign countries.
In January, it filed for a review of its medical use in Japan with the Pharmaceuticals and Medical Devices Agency (PMDA) while planning to apply for its review in China in the fourth quarter.
The number of major hospitals with neurosurgery departments or centers stands at 1,437 in the US, 1,750 in Japan and 2,216 in China.
“We believe it is highly likely to secure approval in Japan before the end of this year, given the progress of the review process so far,” said an official from Koh Young. “Immediately after the nod, we will kick off marketing activity.”
SHARP CUT IN BRAIN SURGERY TIME
Geniant Cranial is a global brand for Kymero, the brain surgery robot marketed in Korea. It is also an upgraded version of the Korean model, the company said.
The company has applied for US approval for its use as a navigated neurosurgical positioning robot.
The device is designed to deliver exceptional accuracy in complex stereotactic and navigated procedures, Koh Young said.
It can be mounted on a surgical bed – the first of its kind – enabling operators to monitor the robot’s position and posture in real time via an optical sensor.
Powered by artificial intelligence, the robot uses a high-precision optical sensor to navigate the patient’s brain without physically touching nerves and arteries. It can also implant electrodes deep in the brain to treat Parkinson’s disease.
Kymero has performed more than 500 surgeries at nine major local medical centers, including Korea’s top Seoul National University Hospital, since 2020. It has helped cut brain surgery time drastically, to 10 minutes from 10 hours, the company said.
Koh Young is the world’s No. 1 maker of 3D solder paste inspection (SPI) systems, which test printed circuit boards used for electronics, semiconductors and others to make sure that they are printed correctly.
It has been developing medical robots since 2011 to diversify its business portfolio.
The firm is also developing a digital X-ray device to be linked with the neurosurgical robot to expand its product portfolio to other devices for brain surgeries, starting from the device’s commercialization.
Koh Young shares rose 3.8% to end at 16,050 won ($11.79) on Thursday.
Allianz Global Investors is one of Koh Young’s major shareholders, with a 7.99% stake.
By Jung-hwan Hwang
jung@hankyung.com
Sookyung Seo edited this article.
