
X-Bolt Orthopaedics, developer of the Sliding Hip Screw and Pro-X1 Trochanteric Nail, raised $3.5 million and aims to raise up to $1 million more before the end of the year as it seeks to scale in the U.S.
Company founder Brian Thornes, M.D., inventor of the Tightrope ankle device for sports medicine applications, seeks support for the Pro-X1 nailing system for hip fracture repair, which gained FDA 510(k) clearance earlier this year.
Pro-X1, like Tightrope, is a replacement for screws that are traditionally used in treating fractures. The device has been shown to reduce the need for repeat surgery.
Dr. Thornes has indicated that the company has a pipeline of products to come. “The investment is to commercialise the Pro-X1 product and then we’ll need to raise again based on future prospects,” he said. “With rules surrounding the Employee Investment Incentive Scheme set to change shortly, we’re also looking at topping up this year with plans to talk to up to ten individuals to raise between $500,000 and $1 million.”
X-Bolt will seek marketing approval for the product in the EU, though it is not a priority at this time.
“Unfortunately, medical device regulation has become tougher in the EU and that is coupled with lower margins, meaning that our focus right now is on the U.S. We’ll then use the clinical cases we have in the U.S. to look to get approval in the EU,” he said.
Source: Business Post
X-Bolt Orthopaedics, developer of the Sliding Hip Screw and Pro-X1 Trochanteric Nail, raised $3.5 million and aims to raise up to $1 million more before the end of the year as it seeks to scale in the U.S.
Company founder Brian Thornes, M.D., inventor of the Tightrope ankle device for sports medicine applications, seeks support for the Pro-X1...
X-Bolt Orthopaedics, developer of the Sliding Hip Screw and Pro-X1 Trochanteric Nail, raised $3.5 million and aims to raise up to $1 million more before the end of the year as it seeks to scale in the U.S.
Company founder Brian Thornes, M.D., inventor of the Tightrope ankle device for sports medicine applications, seeks support for the Pro-X1 nailing system for hip fracture repair, which gained FDA 510(k) clearance earlier this year.
Pro-X1, like Tightrope, is a replacement for screws that are traditionally used in treating fractures. The device has been shown to reduce the need for repeat surgery.
Dr. Thornes has indicated that the company has a pipeline of products to come. “The investment is to commercialise the Pro-X1 product and then we’ll need to raise again based on future prospects,” he said. “With rules surrounding the Employee Investment Incentive Scheme set to change shortly, we’re also looking at topping up this year with plans to talk to up to ten individuals to raise between $500,000 and $1 million.”
X-Bolt will seek marketing approval for the product in the EU, though it is not a priority at this time.
“Unfortunately, medical device regulation has become tougher in the EU and that is coupled with lower margins, meaning that our focus right now is on the U.S. We’ll then use the clinical cases we have in the U.S. to look to get approval in the EU,” he said.
Source: Business Post
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.