Cyber Surgery has just taken a major step toward entering the U.S. market, supported by the backing of SPRI’s Fast Track Innobideak program. The med-tech company behind ALAYA, the first surgical robotic assistant for spine procedures with a CE mark under the MDR and patented Kinematic Navigation Technology, targets complex procedures such as vertebral screw placement in the lumbar and thoracic regions. This technology is used in cases of scoliosis, fractures, and degenerative spinal conditions.
Strategic backing accelerates global expansion.
In 2024, Cyber Surgery launched the TRIALAY project, Preclinical Trials and Validations of the ALAYA Robotic System for Market Certification, thanks to the support of SPRI via the Fast Track Innobideak program. This funding injection allowed the company to advance significantly in validation and compliance processes aligned with FDA regulatory standards.
These developments mark a turning point: Cyber Surgery is now solidifying its roadmap toward FDA clearance and entering the U.S. market. “The support from SPRI has been crucial in accelerating our validation process and achieving the regulatory maturity necessary for international expansion” says Jorge Presa, CEO of Cyber Surgery.
Toward a new era in spinal surgical procedures.
Cyber Surgery’s goal is not just to enter a new market, but to bring a paradigm shift to spinal surgery with less-invasive procedures, greater precision, and a safer environment for surgeons and patients. Once cleared by the FDA, ALAYA will be the first surgical, robotic assistant for spinal procedures available in the U.S. with patented Kinematic Navigation Technology.
With a dedicated team of over 30 professionals and a robust R&D foundation, Cyber Surgery is ready for this next leap. Their ambitions don’t stop there. The company’s roadmap envisions not only expansion to the U.S., but also broader international coverage and the further evolution of modular robotic platforms for multiple surgical procedures.
What this means for stakeholders:
- For hospitals and surgeons in the U.S., access to a surgical robotic assistant for spine procedures with CE and pending FDA clearance will soon be available. It has been tested in European health systems and is designed for precision, safety, and minimally invasive procedures.
- For patients, it means shorter surgeries, reduced radiation exposure, less invasive interventions, and potentially faster recovery — a leap forward in spinal care.
- For investors and partners, it is a mature, regulated medical device backed by public funding and ready for global markets, offering clear opportunities for collaboration and deployment.
Cyber Surgery’s journey from Gipuzkoa to New York marks a milestone in the global expansion of European medtech innovation and a new step in delivering safer, more efficient spinal surgery worldwide.
