Periodic Reporting for period 1 - X-BONECUT (Next generation robotic surgery: robotic vision based safe endoscopic spine surgery)
Reporting period: 2019-11-01 to 2020-10-31
For surgical robotics to make the next paradigm shift, the ability for robots to take their own decisions must be developed. As a first step, they need to be aware of the environment where they are working in. In other words: they need to have “robotic eyes”. This is exactly what Deneb Medical (DM) is developing with its Platform.
This surgical robotic platform approach enables multiple market applications, for which Deneb Medical has defined a product pipeline. The first product in this pipeline is DM’s X-BONECUT.
1,4M spine surgeries are performed in the US and EU today and 75% of them are lumbar spine surgeries (1,1M). Less than 10% of all lumbar spine surgeries are performed in a minimally invasive (MIS) way. However, the MIS approach has important benefits for the patient, as it is minimally invasive, requires minimal hospital stay, reduces damage to muscles and other soft tissues, there’s less blood loss and sometimes requires only local anaesthesia. However, it does imply a higher risk of incidental durotomy (unintended tearing or puncturing of the duramater, a thin membrane that covers the brain and central nervous system) or nerve root damage and it is more complex to execute.
In this context DM’s X-BONECUT will be a surgical robot tailored to perform MIS lumbar surgeries in a safe and fast way, eliminating the risk of surgical unintended damage (SUD) to duramater (incidental durotomy - ID) and nerves, reducing overall surgery time and with an easy learning curve. X-BONECUT will add to private and public health institutions up to 7B$ in value in EU and US, as it will help reduce total average direct costs to hospitals in 7B$.
The overall objectives of the project are to convert the current prototype into a product fulfilling the medical device standards, to execute the trials before the first human cases (pre-clinical trials) and to define a solid market access strategy.
a) Product industrialisation: the specifications of all the subsystems of the robot have been completed and the prototype has been evolved to a version closer to the final product. Additionally, the disposable element of the solution, key for the system’s performance and safety, has also been further developed.
All the industrialisation process is being done according to the standards ISO 13485 of the EU.
b) Pre-Clinical trials: in order to execute surgeries in animals a strict regulation has to be followed. Deneb has prepared the preclinical test protocol that ensures the fulfilment of these regulations and all ethic aspects of the preclinical trials. The future clinical trials will be executed in in vivo minipigs and human cadavers and will follow the aforementioned preclinical test protocol.
c) Business development/Market access: during this period Deneb has continued in contact with important KOL surgeons as well as industrial market players. The company is also working to define a market access strategy in Europe.
During the next decades the increasing aging population will put stress in healthcare systems since the incidence of spinal diseases is directly linked to patient age. There is an urgent clinical need and a strong economical ground to develop less invasive, fast and easy to use surgical systems to bring our patients the best treatment possible at affordable costs.