Innovative Dublin-based hip fracture fixation company X-Bolt Orthopaedics has raised €1.8m in a seed-funding round led by AIB Seed Capital Fund.
As well as AIB Seed Capital, which is co-managed by Enterprise Equity, the investment syndicate also included knowledgeable private investors with backgrounds in med tech and medical practice.
The seed investment is set to advance FDA approval of the X-Bolt product in the US and fast track commercialisation of the product to the global export market.
Former orthopaedic surgeon Dr Brian Thornes established X-Bolt Orthopaedics in 2007 to develop a unique expanding bolt medical device used for hip fracture fixation.
Addressing a gap in the global market, the X-Bolt, which is already in use in more than 100 patients in Irish and UK hospitals, improves the efficiency of current hip-fracture treatment and reduces the requirement for costly and often devastating repeat surgery.
Hip fractures typically account for 20-30pc of all trauma orthopaedic bed occupancy, with some 2,500 hip fractures fixed annually in Ireland. About 5pc of these will require a second operation owing to inadequate fixation in the hip bone. This arises because the fixation device fails to anchor securely in bone that is fragile and soft through osteoporosis. X-Bolt overcomes this by using an expanding bolt which achieves a secure anchorage in the femoral head.
Repeat surgery and associated prolonged hospital stay due to inadequate fixation is estimated at €4m per annum in Ireland alone. Use of X-Bolt is set to eliminate these additional costs, reduce complication rates and reduce the average acute hospital bed stay.
The company outsources manufacture, packaging and sterilisation to med-tech companies based in the West of Ireland, accounting for indirect employment of about 30 people, in addition to currently directly employing five people in its Santry, Dublin, office.
The company plans to increase direct employment through export sales to UK, Europe and US over the next two years. This in turn will lead to a greater increase in business and employment to its Irish med-tech supply base.
TightRope ankle treatment
Thornes previously developed and licensed the ankle treatment ‘TightRope’ to a US multinational in 2003.
To date, more than 120,000 Tightropes have been used worldwide, with many football and rugby professionals amongst its recipients. Recent multicentre clinical trials in Canada and Scandinavia have scientifically concluded that the Tightrope has set the new gold standard for ankle syndesmosis injuries.
The concept for the X-Bolt is a simple one, versus traditional screw fixation. It came to Thornes while fitting a plasma-screen television in his apartment.
“I was using an expanding bolt to put the bracket onto the wall,” said Thornes. “I thought that an expanding bolt mechanism would be handy for bone fixation, particularly in osteoporotic bone that is otherwise difficult to get good screw purchase. Having seen the success of the Tightrope for ankle fractures and other anatomical areas, I have always been keen to solve other clinical problems as a medical device designer and entrepreneur.”
This latest investment brings to €3.3m the total investment in the company in the past three years. The X-Bolt device is patented in Europe, with additional patent pending instrumentation, and expects to obtain FDA approval in the US later this year. The X-Bolt has already received CE Mark regulatory approval by British Standards Institute (BSI).