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Smart surgery system to selectively ablate bony tissue

Periodic Reporting for period 1 - BoneCut (Smart surgery system to selectively ablate bony tissue)

Reporting period: 2018-06-01 to 2018-11-30

Currently up to 10% of craniotomies and laminectomies end up with incidental durotomies (ID) (damage produced unintendedly to anatomical structures that are not to be damaged during a certain surgical procedure) to the duramater (fibrous membrane that surrounds the brain and the spinal cord and retains the cerebrospinal fluid) or nerves. This means that 190K patients get out of the Operating Room (OR) today with some damage they should not have. Despite the high iatrogenic damage risk however, surgery might be the only solution for patients who develop brain aneurysms or tumours, or who experience significant brain trauma or severe spinal stenosis. Yet, in addition to the clinical risk, the average total extra cost that a hospital incurs in, due to an Incidental Durotomy (ID), is approximately 9,969$ in the US (ID in spine), which makes a total of approximately 1.9 B€ of extra costs for healthcare systems in the USA and EU due to IDs.
BONECUT project aims to reduce x100 times IDs with huge associated savings for healthcare entities. Thus the main challenge of the Project is to avoid surgical iatrogenic damage and specifically, Incidental Durotomies (ID) in craniotomies and spine surgeries.
Deneb Medical’s main achievement so far has been the development of the first version of the BONECUT prototype. This prototype has been tested in InVivo pigs with positive results. Further DENEB has achieved promising results using spectroscopic techniques for tissue identification. These data have been post-processed using DENEB’s proprietary algorithms for tissue identification and the results have been very good. These results are applicable both for BONECUT as well as for the MultiTissue CoBot. Next steps on this technique are its integration on BONECUT from an optical and control point of view and its testing on InVivo pig models. The MultiTissue CoBot will allow the surgeon to distinguish between nerves, blood vessels and other soft tissues, so that selective ablation in soft-tissue surgeries can be done. BONECUT will open up new surgical applications for DENEB’s CoBot: I.e. it will allow renal tumours to be removed by partial nephrectomy without ischemia or will reduce duration and bleeding in liver surgery. Amongst its numerous applications are major surgical disciplines such as urology, neurosurgery, liver surgery, cardiovascular etc. In the future BONECUT will be implemented both in open and endoscopic surgeries allowing new surgical approaches and techniques that cannot be performed today.

During 2018 DENEB has had an important impact and visibility on some relevant events in the medtech sector. DENEB was selected to participate in the Medtech Innovator Accelerator program set up by an organisation called “Medtech Innovator” (https://medtechinnovator.org/) located in Los Angeles and funded by the medtech industry’s big industrial players, such as Johnson&Johnson, Baxter, Olympus, etc. The Medtech Innovator organises a yearly competition where more than 700 medtech start-ups worldwide compete to be selected to participate in the Medtech Innovator Accelerator program. Among the more than 700 participating companies DENEB was selected to pitch in front of a specialised jury formed by people working for the above mentioned big industrial corporations. DENEB pitched in April 2018 in an event held in Dublin and was among the four finalist companies of that event. A last selection of companies was done from the finalists of the different selection events held worldwide and DENEB was finally selected to be one of the 25 participants in the 2018 Medtech Innovator Accelerator program. DENEB’s participation in this exclusive program was an acknowledgement of the impact that BONECUT and the tissue differentiation technology will have once it is in the market.
The accelerator program consisted in an intensive 3-month work period where the participants were assigned mentors from the funding companies and had access to specialists in regulatory, market access, IP, healthcare economics, etc. The aim of the program is to do a 360º analysis of the project and correct, modify and focus each aspect of the project in order to move forward in the correct direction from the technology, product and market perspective. During the accelerator program DENEB was mentored by Johnson&Johnson and Olympus and established a very valuable relationship with those corporations.
Thanks to the Medtech Accelerator Program DENEB had the opportunity to meet relevant KOL surgeons, managers at the FDA’s medtech division and other relevant players in the industry. Additionally, the Medtech Innovator promoted DENEB’s project in social networks with information and interviews such as this one: Deneb Medical.

During 2018 DENEB was also selected to participate in a program called Bind 4.0 (https://bind40.com/) held in the Basque Country (Spain) with the aim of promoting the sale to established companies of innovative products developed by start-ups. In Bind 4.0 an established company “binds” to a start-up he is interested to collaborate with because of its technology or its products. Keralty (https://www.keralty.com/en/web/guest/home)
The technology’s (products and process) stage of development corresponds to TRL 6. Laboratory prototypes of BONECUT solution have already been pre-clinically tested. From a technological point of view the BONECUT is currently positioned at TRL6 as DENEB has already developed a first prototype of BONECUT that was first tested in June 2017: BONECUT executed an autonomous, precise and fast craniotomy on an InVivo pig. Moreover during 2018 it executed successful laminectomies as well. Yet, the system needs to be further developed to overcome some conditions in the surgical theatre. As of today, the BONECUT that has been tested on InVivo animals has filed a European patent application (Ref. EP18382130.5) as well as an American patent application for the solution developed to reliably and safely perform real-time, LIBS tissue analysis in a surgical setup. This is one of the key developments of BONECUT. DENEB has already received the first analysis and evaluation of the European examiner and his feedback has been positive.
DENEB has already completed some pre-clinical trials on InVivo animals with its prototype that demonstrate the technical feasibility of the solution, but there are still more trials to be done. The business-related challenge is to overcome the “preclinical valley” and enable a fast market introduction. BONECUT is expected to obtain around 1.3% of the spinal and cranial surgery market share by 2026, with a turnover of 31,5M€ just after five years in the market. The accumulated EBITDA (2021-2026) will be 30.5M€ and the production capability by 2026 will be 100 systems/year with the consequent disposable supply and maintenance services.

BONECUT project aims to reduce x100 times the risk of IDs with huge associated savings for healthcare entities. The improvement of Risk vs. Benefit ratio increases the number of total eligible patients for surgery, thus increasing the number of patients that can be healed. This has an impact on the reduction of the number of patients that live with chronic pain and their quality of life. Further, it has a huge cost impact for public cost over the years (social security administrations, health services etc). BONECUT helps eradicate IDs both in craniotomies as well as in spine surgeries. IDs in spine surgery have an average total direct cost for the hospital of 9,969$, which BONECUT would save (per surgery). Total average hospital cost for craniotomies is approximately the same.
BoneCut Prototype