CASE STUDIES

Hailed as a game changer in orthopaedic surgery, the TOKA® HTO surgical solution is about to transform the lives of young, active sufferers of knee osteoarthritis. Using digital imaging modelling, additive manufacturing technologies and supported by a comprehensive training package, surgeons will be able to train, plan and perform patient-specific High Tibial Osteotomy surgery (HTO) to achieve precise intervention and optimum knee alignment with a patient-specific prosthesis to deliver superior comfort, strength and fast recovery.

TOKA® is a collaborative project led by Alberto Casonato of 3D Metal Printing, Professor Richie Gill and researcher Alisdair McLeod from the Centre of Orthopaedic Biomechanics (University of Bath), and consultant orthopaedic surgeons Andrew Toms and Vipul Mandalia from Exeter’s Princess Elizabeth Orthopaedic Centre.

With the help of the SETsquared Business Acceleration Programme, through SETsquared Bath the project has so far secured nearly £1 million from investment partners and a public grant to run the UK first insilico trial to evaluate the ground-breaking technique without a single patient intervention. Results will be published soon and  the first TOKA personalised HTO in-man clinical trials will start in the NHS and Europe by the end of the year

SETsquared’s support throughout was fundamental for the project to secure funding and reach an international audience

FACT FILE

Start Date: 2014

Website: https://www.toka.org.uk/

Location: Bath

Investment Raised: £1m

SETsquared Programme: Health Innovation Programme, Business Acceleration Programme

KEY MILESTONES

November 2014

Alberto Casonato and Prof. Richie Gill meet at a SETsquared Bath event aimed to spark collaboration between academia and industry. They discuss the idea of developing a disruptive personalised solution to knee arthritis.

June 2015

SETsquared Bath sponsors the TOKA project for entry into the Health Innovation Programme organised by West of England Academic Health Science Network - a dedicated programme for MedTech start-ups to develop new business models in the healthcare industry.

December 2015

The University of Bath secures around £20,000 research funding from the Medical Research Council for TOKA concept development. June 2016: TOKA's patent is filed.

December 2016

3D Metal Printing signs an agreement with the RD&E NHS Trust to support TOKA clinical trials.

January 2017

TOKA receives Arthritis Research UK support worth £98,000 to develop the first HRA-approved Insilico Clinical Trial to investigate TOKA's safety equivalent by creating virtual patients using CT scans from real patients.

July 2017

3D Metal Printing receives £100,000 in R&D funds from Innovate UK to develop the TOKA patient-specific high tibial osteotomy.

January 2018

3D Metal Printing signs a manufacturing partnership with Renishaw Medical AM division to validate the TOKA manufacturing process.

April 2018

TOKA secures £100,000 funding from SBRI Healthcare to enter its Technology in Surgery Phase 1 competition to develop digital applications to support surgeons in surgical planning.

June 2018

University of Bath receives £9,000 in research funds from the Higher Education Innovation Fund (HEIF).

July 2018

The TOKA project is showcased at the 8th World Congress of Biomechanics in Dublin.

December 2018

TOKA's patent is filed in Europe and the US.

January 2019

The TOKA Team's research findings are published in the Bone & Joint Journal: "The effect of plate design, bridging span, and fracture healing on the performance of high tibial osteotomy plates".

May 2019

The TOKA project joins SETsquared's Scale-Up Programme.

Q4 2019

First in-man clinical trials to begin at the RD&E NHS Trust and at the Orthopaedic Institute Rizzoli, Bologna (Italy).

“High tibial osteotomy is a complex, three-dimensional alignment puzzle which we have so far only able to try and solve in two dimensions. Current implants and techniques are a one-size-fits-all solution and rely entirely on the surgeon’s intra-operative technical ability. Results can therefore be variable, with a significantly longer rehab period, are associated with high incidents of complications and often require metalwork removal at a later date. Combining visual imaging and 3D printing technology offers amazing potential”.

Professor Andrew Toms, Consultant Orthopaedic Surgeon, Princess Elizabeth Orthopaedic Centre

 “The support of SETsquared has been vital to help bring this breakthrough technology to the attention of investors and healthcare professionals and to raise more than £350,000 to fund development and run the UK’s first virtual clinical trials. A further £600,000 in investor funding and grants will enable us to complete a multi-centre live trial and gear up our manufacturing operation to go to market by the end of 2019”.

Alberto Casonato, Founder
3D Metal Printing