Surgify Safety Burrs for safer bone surgery

Información del proyecto

SSB2

Identificador del acuerdo de subvención: 190102751

DOI

10.3030/190102751

Proyecto cerrado

Fecha de la firma de la CE 11 Enero 2023

Fecha de inicio 1 Septiembre 2022

Fecha de finalización 31 Agosto 2024

Financiado con arreglo a

• The European Innovation Council (EIC)

Coste total

€ 3 484 825,00

Aportación de la UE

€ 2 439 377,50

Coordinado por

SURGIFY MEDICAL OY
Finland

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

Período documentado: 2023-09-01 hasta 2024-08-31

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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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