韩国私营医疗机器人公司Endorobotics旧有FDA获批与Olympus分销合作被媒体报道

A minimally invasive surgical robot developed by Korean medical robotics firm Endorobotics has secured approval from the U.S. Food and Drug Administration (FDA) and signed a global exclusive distribution agreement with Olympus, the world's largest endoscopy company. The company is credited with securing differentiated technological competitiveness by combining robotic technology with existing endoscopes to enable precision procedures without requiring separate large-scale surgical equipment.
According to the science and technology industry on the 26th, Endorobotics was recently selected as an outstanding case of public research achievement commercialization by the Korea Innovation Foundation (COMPA). The firm earned high marks for securing FDA 510(k) approval for its endoscopic surgical robot "ROBOPERA" in September last year, subsequently raising 32.5 billion won in Series C funding at the end of the same year, and signing a global exclusive distribution agreement with Olympus in May this year.
ROBOPERA's biggest distinguishing feature is that its approach differs from existing surgical robots. While typical robotic surgery involves incising the abdomen to insert robotic instruments, ROBOPERA applies a structure in which a robotic arm attaches to and detaches from the end of a general diagnostic endoscope that hospitals already possess.
The method involves approaching the lesion with an endoscope inserted through the mouth or anus, then using the robotic arm to grasp and resect tissue. Since there is no need to newly build a separate large-scale robotic system, the approach is cited as reducing hospitals' burden of equipment adoption and allowing the existing endoscopic procedure environment to be used as is.
The core technological competitiveness lies in the device's precision. Endoscopic submucosal dissection (ESD), used to treat early-stage stomach cancer or colorectal cancer, is a highly difficult procedure requiring precise resection of only the lesion in a narrow space. Even a small tremor of the hand can affect the outcome, making the procedure highly dependent on medical staff's skill. Accordingly, ROBOPERA is designed so that the robotic arm, which moves in multiple directions from the end of the endoscope, can stably fix and precisely manipulate tissue, enhancing procedural accuracy and safety.
The U.S. FDA approval is also a result of recognition of this technology. FDA 510(k) is a medical device approval procedure that requires proving that safety and performance are equivalent to existing approved products. Endorobotics also became the first Korean company to obtain the "NAY" product code assigned to robotic control surgical systems. This is the same product classification as the "da Vinci" surgical robot of Intuitive Surgical, the leading company in the global surgical robot market.
The technology was developed based on public research achievements accumulated over more than a decade. Beginning in 2012, CEO Kim Byung-gon and a research team led by Korea University professor Hong Dae-hie developed core technology for flexible endoscopic surgical robots with support from the Ministry of Science and ICT and the National Research Foundation of Korea, later founding Endorobotics through technology transfer. It subsequently proceeded to the commercialization stage after verification of clinical application potential, and follow-up commercialization is being pursued through COMPA's demand discovery program and demonstration projects.
The company assessed that its public research and development track record also had a positive effect on overseas investment and business expansion. Indeed, it succeeded in raising 32.5 billion won in Series C funding last year, including a strategic investment from Olympus, which led to this year's global exclusive distribution agreement.
"The very fact that this is technology accumulated through public research and development became the foundation for gaining the trust of global investors and medical device companies," said Kim Byung-gon, co-CEO of Endorobotics. "The FDA approval was also possible because of the research achievements accumulated over a long period."
"We will continue to support technology commercialization so that excellent public research achievements can be utilized in the actual market," said Kim Byung-kook, president of COMPA. "We will further expand success cases in which laboratory technology secures competitiveness in the global market."