Wednesday, 15 January 2014
Bumper seed investment set to fast track commercialisation of innovative X-Bolt hip fracture fixation product to the global export market
X-Bolt Orthopaedics, an innovative hip fracture fixation company based in Dublin, has completed an equity investment round of €1.8million. The funding round was led by the AIB Seed Capital Fund, co-managed by Enterprise Equity Venture Capital. The investment syndicate also included knowledgeable private investors with backgrounds in MedTech 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.
X-Bolt Orthopaedics was established in 2007, by former orthopaedic surgeon Dr. Brian Thornes, to develop a unique expanding bolt medical device used for hip fracture fixation. Addressing a real problematic gap in the global market, the X-Bolt, which is already in use in over 100 patients in Irish and UK hospitals, greatly improves the efficiency of current hip fracture treatment and reduces the requirement for very costly and often devastating repeat surgery.
Hip fractures typically account for 20-30% of all trauma orthopaedic bed occupancy with some 2,500 hip fractures fixed annually in Ireland. Approximately 5% 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 very 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. In addition and most importantly, it is hoped that X-Bolt will help elderly patients mobilise faster and more fully, whilst being saved from the pain, distress and risk associated with repeat surgery which presently arises in a significant percentage of cases.
The company outsources manufacture, packaging and sterilisation to MedTech companies based in the West of Ireland accounting for indirect employment of approximately 30 people, in addition to currently directly employing five people in its Santry 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 MedTech supply base.
X-Bolt Orthopaedics’ founder, Dr. Brian Thornes, previously developed and licensed the ankle treatment "TightRope" to a US multinational in 2003. To date over 120,000 Tightropes have been used worldwide, with many top 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 very simple one, versus traditional screw fixation. It came to Dr. 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).
Rory Hynes, a Partner in Enterprise Equity (who co-manage the AIB Seed Capital Fund), said: “We were attracted to this investment opportunity by a variety of factors, not least the fact that X-Bolt has already been used successfully in a substantial number of hip-fracture surgical procedures and therefore a proven product. Dr Thornes has combined his knowledge and experience as an orthopaedic surgeon with his proven product development ability with TightRope to develop an innovative and well-thought-out family of X-Bolt hip fracture fixation devices.”