Becker's Spine Review

31 Executive Briefing: Sponsored by: O rthofix is a global medical device company focused on musculoskeletal healing products and therapies. Headquartered in Lewisville, Texas, the company has more than 900 employees worldwide with locations in Italy, Germany, France, Brazil and the UK. Orthofix is made up of two core strategic business units: Orthofix Spine and Orthofix Extremities. Here are 10 things to know about Orthofix Spine: 1. The Orthofix Spine portfolio consists of Spinal Implants, Biologics and Bone Growth Therapies. The portfolio is dynamic in responding to the needs of surgeons and patients through its continuous development and acquisition of new technologies; differentiated through its incorporation of multiple treatment modalities (mechanical, biological and electromagnetic) across its market leading solutions; and restorative through its goal of helping patients with various spinal and bone related conditions regain quality of life. 2. The Spinal Implants portfolio includes motion preservation and spine fixation products used in various surgical procedures of the spine. The organization focuses on providing exceptional training and education programs for surgeons on these product offerings. 3. In February 2019, Orthofix Spine announced U.S. Food and Drug Administration (FDA) approval of the M6-C™ artificial cervical disc for patients suffering from cervical disc degeneration. As part of the business unit's motion preservation offerings, the M6-C disc is designed to restore physiologic motion to the spine, and is indicated as an alternative to cervical fusion. The M6-C device is the only artificial cervical disc that mimics the anatomic structure of a natural disc by incorporating an artificial viscoelastic nucleus and fiber annulus into its design. Like a natural disc, this unique construct allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements. 4. The organization's spine fixation offerings include a wide array of implants designed for use primarily in cervical, thoracic and lumbar fusion surgeries, including advanced interbody and fixation solutions that aid surgeons in repairing spinal alignment, improving disc height, providing nerve decompression and correcting instabilities. The spine fixation products are used globally in a variety of spine procedures involving deformity correction, minimally invasive approaches, sacroiliac joints, degenerative disc disease, trauma and tumors. 5. In recent years, the fastest-growing product line among the spine fixation offerings has been its PTC (PEEK-Titanium Composite) interbody portfolio. PTC products are a unique technology proprietary to Orthofix Spine, where 3D-printed endplates are molded into PEEK. A peer reviewed study specific to the Forza™ PTC spacer, was recently released in The Spine Journal titled, "Evaluation of a Polyetheretherketone (PEEK) Titanium Composite Interbody Spacer in an Ovine Lumbar Interbody Fusion Model: Biomechanical, Microcomputed Tomographic and Histologic Analyses." 6. The Biologics portfolio includes regenerative products and tissue forms, which are regulated by the FDA as human cells, tissues, and cellular and tissue-based products (HCT/P), that enable physicians to successfully treat a variety of spinal and orthopedic conditions. 2019 marks 10 years of partnership between Orthofix and its tissue partner MTF Biologics. The two have been at the forefront of cellular allograft technology since 2009, with the launch of the Trinity Evolution™ allograft. They collaborated to provide the Trinity ELITE™ allograft with FiberLock™ technology in 2013, introducing the first moldable cellular allograft to the market. There have been more than 200,000 procedures recorded to date between the two grafts. 7. The Bone Growth Therapies portfolio includes the No. 1-prescribed bone growth stimulators in the U.S. The spinal offerings include devices indicated as an adjunctive, noninvasive treatment to improve fusion success rates in the cervical and lumbar spine. The devices utilize Orthofix's patented pulsed electromagnetic field ("PEMF") technology. The CervicalStim™ device remains the only FDA-approved bone growth stimulator on the market indicated for use as an adjunct to cervical spine fusion surgery in patients at high-risk for non-fusion. In March 2018, Orthofix announced publication of new data that further confirms the effectiveness of the CervicalStim device in improving fusion rates in patients at high risk for ACDF surgery failure. 8. Orthofix Spine's Bone Growth Therapies devices are accompanied by the STIM onTrack™ mobile app. The app is a first to market mobile application that enables physicians to remotely view patient adherence to their prescription and engages patients in their recovery process through treatment calendars, therapy reminders and educational resources. 9. Orthofix reported $453 million in net sales for the full year of 2018. This is up 4.4 percent compared to 2017. The Orthofix Spine portfolio contributed to 77 percent of the company's net sales in 2018. 10. Brad Niemann serves as the president of Global Orthofix Spine. He became president in June 2018, at the formation of Orthofix Spine, after serving as president of the company's former BioStim (now Bone Growth Therapies) business unit.n 10 things to know about Orthofix Spine Orthofix Medical Inc. is a global medical device company focused on musculoskeletal products and thera- pies. The Company's mission is to improve patients' lives by providing superior reconstruction and regen- erative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, Orthofix's spine and orthopedic extremities products are distributed in more than 70 countries via the Company's sales representatives and distributors.

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