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Surgeon Leaves Clinical Practice to Focus on Hip Fracture Fixation System

Posted in Surgeon as Entrepreneur | Jun 2016 | Comments (0)

Tags: medical device developmententrepreneursurgeon entrepreneursinnovationcommercialization

Brian Thornes, Founder and CEO of X-Bolt Orthopaedics, left his surgeon residency in 2005—his last year in the program—to obtain his MBA and fully invest his time and skills into entrepreneurism.

During his residency, he invented the Ankle Syndesmosis TightRope (now licensed to Arthrex) to treat ankle fractures. Yearly TightRope sales top more than 30,000 units, and over 200,000 have been implanted worldwide, according to Thornes.

Following the success of TightRope, he left his residency to create X-Bolt, an expanding bolt device for the treatment of hip fractures.

The X-Bolt received its CE Mark in October 2011, and the company is working with Musculoskeletal Clinical Regulatory Advisers for the device’s FDA 510(k). Thornes expects FDA clearance later this quarter, and plans to commercialize and conduct clinical trials in the U.S. later this year.

ORTHOPRENEUR spoke to Thornes to learn more about the X-Bolt and his move from clinical work into entrepreneurism.

ORTHOPRENEUR: Why did you decide to leave the clinical world and embark on this business venture?

Brian Thornes_1_cropThornes:
I got the bug when I invented the TightRope. After seeing it take off clinically, I thought it was fun and easy. The X-Bolt is also fun, but it’s not so easy. It’s interesting because as a surgeon in Ireland, you’re generally a public employee, so you kind of know what your day–to-day is going to be. You’re juggling a lot of things when running a business, so it’s more interesting and more dynamic.

The light bulb moment for the X-Bolt came in 2007 when I was putting up a plasma screen on my wall at home, using an expanding bolt. I was mostly trauma-trained, and I’m very aware of osteoporotic bone and the difficulties that surgeons have in getting good fixation particularly osteoporotic cancellous bone in the femoral head. I thought that this would be the type of device that is needed for fixation in hips. In 2008, I embarked on my first funding round. We raised €750,000 (~US $1 million) to fund initial prototyping and bring us up to getting the CE Mark, which we received in 2011.

ORTHOPRENEUR: What is the greatest challenge you faced with the commercialization of the X-Bolt, and how did you overcome it?

Thornes: Getting clinical evidence, because surgeons will not change their habits unless they have overwhelming clinical evidence to assume that [a new device] was better. In 2012, we started a clinical trial in the U.K. called WHiTE One, which stands for The Warwick Hip Trauma Evaluation. It was a 100-patient randomized control trial, which compared the X-Bolt against a standard sliding hip screw. It was just reported in The Bone & Joint Journal that there were 0% reoperations for the X-Bolt, and 6% for the screw group. We have proven that we are a safe and effective device.

To get physical superiority, we have just embarked on a 1,000-patient hip fracture trial. The company is investing €1 million (~$1.2 million) into that trial. It’s going to be in ten centers in the U.K. and we’ll report results in 2018. What we’re looking for is the reoperation rate. Classically, there’s about a 5% or 6% reoperation rate with hip fracture fixations. The problem is there’s a huge socioeconomic burden to have elderly patients readmitted and their hip fixation redone or converted to a total hip replacement. Per case, that probably adds an extra $80,000 to the hospital or the system. For the patient, it’s terrible because they become more dependent and may get infections and pressure sores, and it’s not good for an elderly patient to be debilitated for that length of time. The average age of hip fracture patients is 84, so they usually come in with a lot of other intercurrent illnesses. Every day they’re in the hospital incumbent, they run the risk of getting other complications—it’s like a spiral of doom when they’re not mobilizing.

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