CMCiB participates in the preclinical studies of Rob Surgical's surgical robot, the first one designed and manufactured in Catalonia
The centre reaches a milestone in its track-record by adding the first Good Laboratory Practice (GLP) study in its portfolio where the tested product at the centre will reach clinical trials in humans in accordance with international Good Clinical Practice (GCP).
The Centre for Comparative Medicine and Bioimage (CMCiB) of the Germans Trias i Pujol Research Institute (IGTP) participates in the preclinical studies and successful Good Laboratory Practice (GLP) testing of Rob Surgical Bitrack robotic system, which has recently received authorisation to conduct FIH clinical trials. This authorisation is issued by the Spanish Agency of Medicines and Medical Devices (AEMPS) and the Ethics Committee of the Hospital Clínic de Barcelona. According to Rob Surgical, the first human series will be conducted in accordance with internationally recognised clinical trial protocols established by Good Clinical Practice (GCP).
Bitrack System of Rob Surgical was tested under GLP conditions at CMCiB facilities. Bitrack, the first surgical robot designed and manufactured in Catalonia, is the result of more than ten years of cutting-edge research in surgical robotics. Their value proposition is to improve the efficiency of today's robots through unique technology, improved usability, and lower acquisition costs for hospitals. The preclinical studies of medical devices such as surgical robots help improve people's health by ensuring the safety and efficacy of these devices before they are used in humans. Preclinical testing involves evaluating the device in animal models, human cadavers or simulations to assess its performance, potential risks, and benefits.
"Bitrack is the first medical device tested in the CMCiB that is going to start a clinical trial, after COVID ventilators. The CMCiB was born in 2019 to be a tool for accelerating technology and medical knowledge and for the improvement of people's health. This achievement positions us where we want to be, in the service of medical innovation" explains Sara Capdevila, Technical Director at CMCiB.
By conducting preclinical testing, researchers can identify and address potential issues with the device, refine its design and functionality, and optimize its performance. This helps to ensure that the device is safe and effective when it is used in human patients.
"The success of preclinical animal and cadaver trials, the latter thanks to CMCiB's collaboration, has enabled Rob Surgical to be ready to conduct FIH trials and take a major step towards its founding purpose of universalising precision surgery and bringing its benefits to hospitals, surgeons and patients worldwide" remarks Jaume Amat, CEO of Rob Surgical.
For example, in the case of surgical robots, "preclinical testing can help to refine the robot's movements, accuracy, and control mechanisms to improve surgical outcomes and reduce the risk of complications such as tissue damage, bleeding, or infection. By ensuring the safety and efficacy of surgical robots through preclinical validation, patients can benefit from more precise and less invasive surgical procedures, reduced recovery times, and improved outcomes" adds Sara Capdevila.
Overall, preclinical studies of medical devices is an important step in the development and deployment of new technologies that can improve people's health. By ensuring the safety and effectiveness of these devices, preclinical testing can help to minimize risks, maximize benefits, and improve patient outcomes.
CMCiB is accredited to perform GLP validation studies of medical devices in its surgical area since 2021. The centre was awarded the certificate for complying with good laboratory practices (GLP) in line with the European Directive 2004/9/CE.