Cyber Surgery has successfully completed a clinical trial on patients with its surgical robot for spinal operations. Our robot is the first of its kind, developed in Spain to reach this important milestone, which is the prelude to its market launch. After receiving certification from the Spanish Agency of Medicine and Health Products (AEMPS) to test its innovative technology on patients, Cyber Surgery carried out the clinical trial on patients in two prominent hospitals of the Basque Health Service (Osakidetza), Hospital Universitario Donostia, in San Sebastian, and Hospital Universitario de Cruces, in Bilbao.
The clinical trial was 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 affecting the spine, such as scoliosis, canal stenosis, degenerative diseases, tumors, or vertebral fractures. Additionally, the robot can also be used for other spinal procedures, such as surgical planning or bone cutting; the first step in Cyber Surgery’s strategy to create a fully robotic operating room.
These interventions have been performed and directed by the leading investigators of the trial, Dr. Nicolás Samprón, neurosurgeon at Hospital Universitario Donostia (San Sebastian) and researcher of the IIS Biodonostia group, and Dr. Iñigo Pomposo, head of the neurosurgery service at Hospital Universitario de Cruces (Bilbao) and researcher of IIS Biocruces Bizkaia, alongside their teams. In addition to these physicians, radiology teams from Hospital Universitario Donostia, Hospital Universitario de Cruces and Hospital Universitario Araba participated to accordingly verify the post-surgery images and confirm the results and accuracy of the system.
This trial clinically validates the robot’s accuracy, safety, and effectiveness in guiding the surgeon during screw placement. After extensive validation and human cadaver testing, the human patient trial began in November of 2022. The ultimate objective of this patient trial is to certify the robot and make it commercially available in 2024.
Minimally invasive for the patient and highly precise for the physician
One of the features that differentiates Cyber Surgery’s robot from others in the field is that it has a patented technology for locating and tracking the patient, which makes it possible to obtain greater precision, reduce exposure to X-rays, both for the patient and the surgeon, improve the workflow in the operating room and reduce the time needed for the intervention. For those very reasons, the Cyber Surgery robot stands out for its great benefits for both the patient, as it is minimally invasive and speeds up the recovery process in the hospital, from 9-10 to 6-7 days, as well as the physician, due to its high precision, ease of handling, ergonomics, and adaptability.
In the words of Dr. Iñigo Pomposo, head of the neurosurgery service who has led the clinical trials at Cruces University Hospital: “Cyber Surgery’s robot has a system for determining trajectory that is much more precise than others on the market, which results in greater safety for our patients. These trials are the culmination of a long joint collaboration and the beginning of implementation in other areas such as brain surgery.”
For Dr. Nicolás Samprón, neurosurgeon who led the clinical trials at 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 in a minimally invasive way, with a greater degree of safety and reducing our patients’ recovery times.”
Our robot is designed to assist the physician in spinal operations, achieving the highest levels of precision, 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 doctor’s planning in the software and the system that can read the position of the robot in relation to the patient. Currently, this is done by means of optical technology, but we have developed our own haptic technology, where the system knows the patient’s position at all times in a more precise and user-friendly way than optical systems. Therefore, we manage to improve patient safety, among other benefits.” In addition, Cyber Surgery’s robot, thanks to its built-in artificial intelligence, supports the surgeon during the planning and intervention process, making the surgery even safer and optimizing the process.
From R&D project to patient-tested robot
This is a major step in medical technology that was born from an R&D project led by Egile Corporation XXI, together with the Ceit research center and Clínica Universitaria de Navarra, in 2013. It was later joined by collaborators such as the Vicomtech research center, the Biodonostia Health Research Institute (IIS Biodonostia) and the Biocruces Bizkaia Health Research Institute (IIS Biocruces), coordinated by BIOEF, Basque Foundation for Health Innovation and Research, which have always supported Cyber Surgery and are a fundamental part of bringing this robot to the market. These clinical trials have been funded through the open call within the European project TBMED (“An open innovation testing bed for the development of high-risk medical devices”) coordinated by the applied research centre “Fundación CIDETEC”. TBMED project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 814439”.
Cyber Surgery has evolved a lot since its establishment as a company in 2017 when the first tests on cadavers were being performed. In 2018, it incorporated Basque FCR (Gestión de Capital Riesgo del País Vasco – Spri Group), Geroa EPSV and IMQ (a leading healthcare group in the Basque Country) in its shareholding. In light of the good results, it is currently in the process of increasing capital for the international commercial launch.
The team is made up of 26 people, including doctors and engineers from different disciplines such as mechanics, software, robotics, telecommunications and bioengineering. Since its creation, five international patents have been applied for and it has outstanding support from doctors and international healthcare institutions.
