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Next generation robotic surgery: robotic vision based safe endoscopic spine surgery

Periodic Reporting for period 2 - X-BONECUT (Next generation robotic surgery: robotic vision based safe endoscopic spine surgery)

Reporting period: 2020-11-01 to 2022-04-30

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.
Next the work performed from the beginning of the project is briefly explained:

Product industrialization:

For the industrialization of X-BONECUT, the specifications of all the subsystems of the robot have been completed, and the final prototype has been developed. Additionally, the disposable element, key for the system’s performance and safety has also evolved to its final version. The entire industrialization process has been done according to the European standard ISO13485.

Preclinical trials:

In order to execute surgeries in animals, strict regulations must be followed. Deneb prepared the preclinical test protocol to ensure the fulfillment of these regulations and to comply with all ethic aspect of the preclinical trials. Once the test protocol was approved, Deneb executed the trials in in vivo minipigs and human cadavers, according to the aforementioned protocol. The trials were performed by Dr. Alberto Hernandez, Dr. Susana Nuñez and Dr. Santiago Candela. The facilities chosen for the preclinical trials were Biodonostia Health Research Institute from the Basque Country’s Public Healthcare system, and Specipig, a Preclinical CRO specialized in the pig model.

Clinical trials:

In order to execute clinical trials in human patients, strict regulations must be followed. Deneb prepared the clinical test protocol to ensure the fulfillment of these regulations and to comply with all ethic aspect of the clinical trials. Deneb has also been in contact with different research facilities, hospitals and spine centres, and surgeons to execute the clinical trials.

Business development:

Deneb defined and implemented a Quality Management System according to the ISO 13485, and the degree of implementation of this QMS was verified through an internal audit. Deneb intensified the efforts on dissemination and exploitation activities by making contact with new KOL surgeons and market players, actually signing an agreement with Medtronic. Additionally, Deneb participated in different trade fairs and conferences and updated its website to gain more visibility.
So far, Deneb has developed a system capable of increasing the level of automatization of spine surgeries in a safe way. The company has developed a prototype that is now being converted into a product for minimally invasive approaches, that will bring improved clinical outcomes and shorter recovery times to European and global patients.

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.