Irish X-Bolt Orthopaedics Hopes Equity Round will see it through FDA

Hip fracture fixation company, X-Bolt Orthopaedics, based in Dublin, has completed an equity investment round of €1.8million which it says will advance FDA clearance of the X-Bolt product in the US and fast track commercialisation of the product to the global export market.

Background

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.

Former orthopaedic surgeon Dr Brian Thornes, formed X-Bolt Orthopaedics in 2007 with the goal of developing a unique expanding bolt medical device to be used for hip fracture fixation. The ensuing X-Bolt has already been used in over 100 patients in Irish and UK hospitals since gaining its CE mark. The company claims it greatly improves the efficiency of current hip fracture treatment and reduces the requirement for very costly and often devastating repeat surgery, estimated to amount to some €4million per annum in Ireland alone.

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.

This latest investment brings to €3.3 million 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.

Company comments

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.”

Source: X-Bolt Orthopaedics

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