Today, the most important surgical problem, common to all surgical disciplines, is the elimination of surgical unintended damage (unintended or unnecessary damage to critical tissues). The value proposition of surgical robotics so far is based on movement precision and precise guidance. Not only the DaVinci but also other surgical robots as for example Mazor’s Rennaissance, Zimmer’s Rosa or Globus Medical’s Excelsius GPS are based on this value proposition.
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.
The conclusions of this project are that with the successful completion of the set tasks, deliverables and milestones, Deneb has been able to obtain technological and preclinical validation of the complete system, including the newly integrated functionalities. This validation has prepared Deneb for the next steps of clinical validation. In parallel, Deneb has made great advances regarding dissemination and explotation activities, for instance, by signing an agreement with Medtronic, which have had a great impact in consolidating the business and commercialization plans.
