SURF-UP
Such a disruptive way to perform surgery arises from the combination of focused ultrasound with robotics: the former guarantees non-invasiveness, while the latter ensures precision and flexibility.
SURF-UP (Surgery by Using a Robotic Focused Ultrasound Platform) stems from the results collected in 2 major European projects (i.e., FUTURA and FUTURA2020) and - from TRL 4 - it aims to reach TRL 6. In parallel to the jump of TRL and to support this jump, efforts will be dedicated to address market readiness towards commercialisation and deployment, to define a proper business model, to deal with the intellectual property protection, and to establish key commercial partnerships, while acting as the legal manufacturer of the device. To move from the current platform implementation towards its clinical version, while fulfilling the final user's expectations, SURF-UP will set up an iterative process based on a constant interaction with early customers and end-users. This will be needful during the on bench technology assessment and its pre-clinical validation (on porcine and ovine model). The pre-clinical validation aims at proving the SURF-UP platform safety, usability and efficacy in a relevant environment, in its intended application. Towards further market and investment readiness, regulation, certification and standardisation will be addressed by designing and developing the medical device under the guidance of the applicable regulation, i.e., (EU) 2017/745 - Medical Device Regulation.
The documentation produced to demonstrate the platform compliance to the ISO standards, as well as the results from the pre-clinical validation, will be used to finally submit a protocol for later clinical trials on human subjects.
FUNDER: MUR - Fondo Italiano per le Scienze Applicate (FISA)
TOPICS: focused ultrasound surgery, robotics
PERIOD: 2024-2027
FUNDING: ~ 1.8 M€
COORDINATOR: Arianna Menciassi