Surgify Safety Burrs for safer bone surgery

Project Information

SSB2

Grant agreement ID: 190102751

DOI

10.3030/190102751

Project closed

EC signature date 11 January 2023

Start date 1 September 2022

End date 31 August 2024

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 484 825,00

EU contribution

€ 2 439 377,50

Coordinated by

SURGIFY MEDICAL OY
Finland

Periodic Reporting for period 2 - SSB2 (Surgify Safety Burrs for safer bone surgery)

Reporting period: 2023-09-01 to 2024-08-31

Summary of the context and overall objectives of the project

6 out of 15 top surgical procedures include bone cutting, which are performed using surgical power tools such as high-speed drills. These drills are widely used in neurosurgery, otology (ear), and spinal procedures, which include some of the most demanding surgical bone operations. However, 30% of bone drilling surgeries can lead to severe soft tissue injury. Missing a target by only millimetres or applying slightly too much force can lead to severe complications threatening patients’ life.

The revolutionary Surgify Safety Burr enables surgeons to cut bone accurately and efficiently without compromising the safety of important soft structures. Thanks to the scalable technology, the safety feature can be customized for a wide range of applications e.g. orthopaedics, pediatrics or even robotics-assisted surgery. During the EIC project, Surgify Safety Burr product platform was designed, developed and commercialized to allow safer surgeries for everyone.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The main goal of the project was to design and develop Surgify Safety Burr product platform to reduce the existing huge medical error in bone-drilling surgeries and make them safe.

By the end of the project, we had managed to develop two different product variations of our safety burr (5,4 mm and 4 mm). The reasoning to have two different products came directly from the surgeons to meet their needs in different drilling scenarios covering spinal surgeries, bone surgeries and extremely small bone structures in paediatrics. To make the surgeries even more safe we also developed a sensor solution to predict and detect breakthrough moments during bone surgeries to avoid damaging the soft tissue in the drilling process. We established a partnership with an established console manufacturer (Nouvag) to get the maximum effect of our Safety Burr with data analytics.

In parallel we modified our product design and increased the durability of the burr from 5 minutes to 10 minutes and optimized our production process reducing thus the cost per piece by 40 %. In our burr production we managed to establish partnerships with GMI Corporation and Montemurro Utensili. We developed our in-house assembly capacity, doubling our production capacity.

During the project we conducted clinical trials together with Kuopio University Hospital and Helsinki University Hospital. As a result of these studies the product received a CE mark and very positive feedback from European surgeons. During the project course we also received the FDA clearance and now we have the permission to sell our safety burr around Europe and US.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

To ensure the success of our project, we are continuously developing our product design. By dedicating ourselves to ongoing design improvements and thorough research into alternative features, we enhance our ability to meet our customers’ evolving demands. This proactive approach not only positions us as more appealing in the market but also ensures our competitiveness in the field.

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