Firm’s implant gets thumbs up at awards

It plans to do so with a revolutionary 21st-century solution.

“We have used cutting-edge 3D CT technology to design an implant which is the first that can fully mimic the natural but complex movements of the thumb,” said company co-founder Dr Brendan Boland, who plans to make this implant, called the ‘InDx’, as widely used globally as hips, knees, and shoulder joint replacements.

Dr Boland says that at present the treatment options for the 40 million sufferers of basal thumb joint arthritis in the EU and the US include an implant with a 40% failure rate, or a surgical procedure which was developed in the 1950s and which results in a significant loss of hand function.

Loci orthopaedics win intertradeirelands Seedcorn 2019. Congrats from HBAN and enjoy the journey. pic.twitter.com/tBJakl60m1

— John Phelan (@johnphelan99) November 22, 2018

Basal thumb base arthritis, he explains, is a cripplingly debilitating condition which prevents sufferers from being able to perform simple tasks such as turning a key or using a phone.

Given that the percentage of the population over 65 is now set to increase significantly in the Western world, Dr Boland says the potential market for thumb implants can be expected to grow to over €1bn in the next five years.

The need for a solution to the problem of thumb joint arthritis was identified by Dr Boland and his co-founder Gerry Clarke, five years ago when they took part in a BioInnovate programme.

“We were part of a team sent to Cork University Hospitals to observe orthopaedic procedures and identify unmet needs. We observed for weeks and found that thumb joint arthritis stood out as a particularly significant unmet need,” Dr Boland said.

They began working on developing solutions at the National University of Ireland Galway (NUIG) in 2015, securing €505,000 in commercialisation funding from Enterprise Ireland.

In 2017, Dr Boland and Mr Clarke set up Loci Orthopaedics as a spin-out company at the Business Innovation Centre at NUIG. Since then they have worked on carrying out preclinical trials and fundraising to take the product to the next level.

This summer, the company raised the €2.75m in seed investment it needed to proceed with plans to carry out clinical trials and seek regulatory approval in both the US and the EU.

“We expect to carry out our first clinical trial about a year from now and to have full commercialisation in two years across the EU and the US,” said Dr Boland, explaining that the funding will keep the company financed for the next two years.

While making plans to develop sales internationally, the company has gone to great lengths to ensure that manufacturing of the InDx implant is kept on the island of Ireland.

The device and associated implant set are fabricated between Galway and Waterford, the packaging is also here in Galway and the final sterilisation in Mayo. We are keen to support local jobs and companies as much as possible

-said Dr Boland, adding that only the testing is done outside Ireland.

Currently employing a staff of three, the company expects to take on an additional eight people over the next three years, including engineers, regulatory affairs staff as well as sales and marketing people.

Dr Boland says that the plan, once they have completed clinical trials and secured FDA approval, is to have a limited release in the US in 2021 and to launch in the EU soon afterwards.

Winning the overall award in this year’s Intertrade Ireland Seedcorn competition has provided Loci Orthopaedics with an additional €100,000 and boosted its ability to raise further funding in the future.

“The prize money will prove invaluable in supporting our orthopaedic joint implant ‘InDx’ at such a crucial stage in its development and will allow us to invest in securing additional personnel and provide further support for expansion,” said Dr Boland.

Future plans for Loci Orthopaedics include ongoing R&D, focusing on other joint implants to increase the product portfolio.