Cyber Surgery, the first Basque surgical robot for the spine to reach hospitals.
● Cyber Surgery successfully completes clinical trials on patients at the Donostia University Hospital in San Sebastian and the Cruces University Hospital in Bilbao.
● The operation is based on the placement of transpedicular screws to treat pathologies such as scoliosis, canal stenosis, degenerative diseases, tumours or vertebral fractures.
● With this robot, the operations are minimally invasive, speeding up the patient’s recovery, increasing the precision in the placement of the screws and reducing the time of the intervention.
Cyber Surgery, a healthcare technology startup specialising in medical robotics, has successfully completed a clinical trial on patients with its surgical robot for spinal operations. It is the first Spanish robot to reach this important milestone, which is the prelude to its market launch. After receiving approval from the Spanish Agency for Medicines and Health Products (AEMPS) to begin the certification of its innovative technology in patients, Cyber Surgery has completed the trials in patients in two reference hospitals of the Basque Health Service (Osakidetza), Hospital Universitario Donostia, in San Sebastian, and Hospital Universitario Cruces, in Bilbao.
The clinical trials have been exclusively aimed at interventions based on the placement of transpedicular screws, which is the most commonly used operation for the treatment of different types of pathologies that affect the spine, such as scoliosis, canal stenosis, degenerative diseases, tumours or vertebral rupture. These interventions have been performed and directed by Dr. Nicolás Samprón, neurosurgeon at the Donostia University Hospital (San Sebastián) and Dr. Iñigo Pomposo, head of the neurosurgery service at the Cruces University Hospital (Bilbao), along with his team. In addition to these doctors, the radiology teams from Hospital Universitario Donostia, Hospital Universitario de Cruces and Hospital Universitario de Araba are participating in order to verify the post-surgery images and confirm that everything is working correctly.
The objective of these trials is to clinically validate the safety and effectiveness of the robot, after the previous tests carried out on cadavers and the technical checks to verify its biocompatibility, electromagnetic compatibility, sterilisation and functionality. Once these preliminary steps had been completed, patient trials began in November. The ultimate goal of these patient trials is to achieve full validation of the robot, so that it can be available to other hospitals from 2024.
High precision for the doctor and minimally invasive for the patient
One of the characteristics that differentiates Cyber Surgery’s robot from others in the sector is that it has its own patient location and tracking technology, which allows for greater precision, reduced exposure to X-rays, both for the patient and the surgeon, improved ergonomics in the operating theatre and shorter surgery times. Therefore, the Cyber Surgery robot stands out for its great benefits both for the doctor, due to its high precision, ease of handling, ergonomics and adaptability, and for the patient, as thanks to its technology it manages to be minimally invasive, speeding up the recovery process, from an estimated 9-10 days to 6-7 days.
In the words of Dr. Iñigo Pomposo, the neurosurgeon who has led the clinical trials at Cruces University Hospital: “Cyber Surgery’s robot is going to mark a before and after in the way in which we surgeons plan and perform spinal surgeries today, thanks to the application of the latest imaging technologies and a unique system on the market that allows us to reach where other robots cannot, improving direct vision in the intervention,” he says.
For Dr. Nicolás Samprón, neurosurgeon who has led the clinical trials at the Hospital Universitario Donostia: “One of the main benefits of Cyber Surgery’s robotic assistant is its great capacity to adapt to the surgeons’ needs, its ease of use and its high precision. This allows us to perform spinal operations with a greater degree of safety for the patient and often reduces the likelihood of having to perform new operations in the future,” he says.
This robot is designed to assist the doctor in spinal operations by achieving the highest levels of precision in the placement of the screws, which is achieved thanks to its innovative technology. As Jorge Presa, CEO of Cyber Surgery, explains: “The robots that guide the surgeon do so on the basis of information from the medical image, the planning that the doctor has done in the software and the system that reads the position of the robot in relation to the patient. Currently, this is done using optical technology, but we have developed our own technology, which is haptic – instead of optical – tracking, where the system “touches” the patient at all times and is much more precise than optical tracking. Therefore, among other benefits, we also manage to improve patient safety.
Cyber Surgery’s robot also achieves more precise and safer surgery, thanks to artificial intelligence, which helps the surgeon to plan the operation and perform the intervention. As well as improving ergonomics, it has a faster start-up, can be adapted to different screw manufacturers and improves the surgeon’s experience with the use of augmented reality.
From R&D project to patient-tested robot
This is a major step forward in technology applied to medicine that was born of an R&D project between Egile Corporation XXI, the Ceit research centre and the University Clinic of Navarra in 2013. It was joined by collaborators such as the Vicomtech research centre, the Biodonostia Health Research Institute (IIS Biodonostia) and the Biocruces Health Research Institute (IIS Biocruces), coordinated by BIOEF, the Basque Foundation for Health Innovation and Research, which have always supported Cyber Surgery and have become a fundamental part of bringing this robot to the market. These clinical trials are part of the European TBMED project, which has provided the funding and guidance to carry out this type of trial.
From then until today, Cyber Surgery has evolved a lot since it was formed as a company in 2017, launching five international patents and performing the first cadaver tests, until Cyber Surgery was formed in November 2017. They now have a team of more than 25 people and a great deal of support from doctors and healthcare institutions. The team includes PhDs and senior engineers in various disciplines. From mechanics, software, robotics, telecommunications and bioengineering, among others.