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Orthofix Medical Inc.

Orthofix FIREBIRD SI Fusion System Receives Additional FDA Clearance for Nanotechnology

“The FIREBIRD SI Fusion System with NANOVATE™ technology is one of the many new differentiated solutions that Orthofix is proud to highlight during the upcoming North American Spine Society (NASS) 2020 virtual annual meeting,” said Kevin Kenny, Global President of Orthofix Spine.

Orthofix Announces FDA Clearance and First Patient Implants of FIREBIRD SI Fusion System for Low Back Pain

The FIREBIRD SI Fusion System is implanted through a minimally invasive surgery that typically can be performed in about an hour and may lead to less time at the hospital and a faster recovery than a traditional sacroiliac joint fusion surgery. The procedure with the FIREBIRD SI Fusion System involves inserting two to four bone screws across the SI Joint to stabilize during the fusion process.

Orthofix Completes Acquisition of FITBONE Limb Lengthening System

The transaction also includes other potential applications of the technology which are in development, including the FITSPINE® system for fusionless surgery to treat early-onset scoliosis.

Orthofix Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators

The STIM onTrack technology works with the Orthofix Bone Growth Therapy devices. The mobile device app is an accessory designed to help patients adhere to their prescriptions and improve their clinical outcomes.

Orthofix Announces Agreement to Acquire FITBONE Limb Lengthening System

Terms of the agreement include $18 million in cash closing consideration and a manufacturing supply contract with Wittenstein SE.

4/23/19: Orthofix M6-C Artificial Cervical Disc – First US Patient Implants Following FDA Approval

Designed with an artificial viscoelastic nucleus and fiber annulus that mimics the anatomic structure of a natural disc, the M6-C artificial cervical disc device is the only artificial cervical disc available in the U.S. that enables compression or “shock absorption” at the implanted level. The disc also provides a controlled range of motion when the spine transitions in its combined complex movements.

Orthofix Medical Report: Full Two-Year Authoritative Data on the M6-C Artificial Cervical Disc Study Shows Significant Improvement in Neck and Arm Pain

4/4/19: The data demonstrates that patients treated with the M6-C artificial cervical disc had significant improvements in neck and arm pain, function and quality of life scores.

M6-C Artificial Cervical Disc Receives FDA Approval

2/7/19: M6-C artificial cervical disc is the only artificial cervical disc that mimics the anatomic structure of a natural disc. Designed to restore physiologic motion to the spine, the M6-C disc is indicated as an alternative to cervical fusion. The disc preserves motion by restoring biomechanical function at the treated level after native disc removal and potentially reduces subsequent degeneration of adjacent vertebral segments.