Profile: Orthofix International NV (OFIX.O)
26 Jul 2016
Orthofix International N.V. (Orthofix), incorporated on October 19, 1987, is a global medical device company. The Company is focused on providing reconstructive and regenerative orthopedic and spine solutions to physicians. The company operates in four segments: BioStim, Biologics, Extremity Fixation and Spine Fixation. Its BioStim solutions products include Cervical-Stim, Spinal-Stim and Physio-Stim. Its Biologic solutions products include AlloQuent Structural Allografts, Trinity ELITE, Trinity Evolution, VersaShield and Collage Synthetic Osteoconductive Scaffold. Its Extremity Fixation solutions include Fixator, TrueLok, TL-HEX TrueLok Hexapod System, PREFIX and PREFIX 2, Centronail Titanium Nailing System and Galaxy Fixation System. Its Spine Fixation solutions products include Ascent LE Posterior Occipital Cervico-Thoracic (POCT) System, ATHLET Vertebral Body Replacement (VBR) System, NGage Surgical Mesh System and PILLAR AL PEEK Partial VBR System.
The BioStim segment manufactures, distributes and provides support services of devices that improve bone fusion. These Class III medical devices are indicated as an adjunctive, noninvasive treatment to improve fusion in cervical and lumbar spine, as well as a therapeutic treatment for non-spine fractures that have not healed (non-unions). These devices utilize the Company's pulsed electromagnetic field (PEMF) technology. The Company offers two spinal regenerative stimulation devices, Spinal-Stim and Cervical-Stim, through its subsidiary, Orthofix Inc. Its stimulation products use a PEMF technology designed to enhance the growth of bone tissue following surgery and are placed externally over the site to be healed. Spinal-Stim is a non-invasive spinal fusion stimulator system. Spinal-Stim is designed for the treatment of the lower thoracic and lumbar regions of the spine. The Company's Cervical-Stim stimulator product is a bone growth stimulator indicated for use as an adjunct to cervical (upper) spine fusion surgery in patients at high-risk for non-fusion. Its Physio-Stim regenerative stimulator products use PEMF technology.
The regenerative solutions offered as part of its biologics' portfolio include solutions for various musculoskeletal defects used in spinal and extremity orthopedic procedures. The Company's biologics tissues include Trinity ELITE and Trinity Evolution, which are cortical cancellous allografts that contain viable cells and are used during surgery in the treatment of musculoskeletal defects for bone reconstruction and repair. These allografts are intended to offer a viable alternative to an autograft procedure, harvesting autograft adds risk of an additional surgical procedure and related patient discomfort in conjunction with a repair surgery. It offers a line of Alloquent allograft structural spacers derived from human cadaveric bone. These spacers are used to restore the height lost between vertebral bodies when discs are removed in fusion procedures and to facilitate spine fusion. The Company markets Collage, as an osteoconductive scaffold and a bone graft substitute product. The product is a combination synthetic bone graft substitute consisting of beta tri-calcium phosphate and type 1 bovine collagen. It markets VersaShield, which is a thin hydrophilic amniotic membrane designed to serve as a wound or tissue covering for a range of surgical demands.
The medical devices offered in its Extremity Fixation include both internal and external fixation solutions for extremity repair and deformity correction, both for adults and children. This segment specializes in the design, development, and marketing of the Company's orthopedic products used in fracture repair, deformity correction and bone reconstruction procedures. The Company's fracture repair products consist of fixation devices designed to stabilize a broken bone until it can heal. Its fracture repair products come in two types: external devices and internal devices. External fixation devices are used to stabilize fractures from outside the skin with minimal invasion into the body. These external fixation devices use screws that are inserted into the bone on either side of the fracture site, to which the fixator body is attached externally. The Company's LRS Advanced Limb Reconstruction System uses callus distraction to lengthen bone in various procedures. Its Galaxy Fixation incorporates a streamlined combination of clamps with both pin-to-bar and bar-to-bar coupling capabilities that provide a range of applications and reduces inventory. Its TrueLok Ring Fixation System is a surgeon-designed, lightweight external fixation system for limb lengthening and deformity correction. Its TL-HEX is a hexapod-based system designed as a three-dimensional bone segment reposition module to augment the previously developed TrueLok frame.
The Company's internal fixation devices come in various sizes, depending on the bone that requires treatment, and consist of either long rods, commonly referred to as nails, or plates that are attached with the use of screws. Its external fixation devices include LRS Advanced Limb Reconstruction System, Galaxy Fixation, TrueLok Ring Fixation System and XCaliber. Its internal fixation devices include the Centronail Titanium Nailing System, the Centronail Ankle Compression Nail, the VeroNail and the Contours Lapidus Plating System (LPS).
The Spine Fixation segment specializes in the design, development and marketing of a portfolio of implant products used in surgical procedures of the spine. Spine Fixation distributes its products through a network of distributors and affiliates. This segment uses distributors and independent sales representatives to sell spine products to hospitals, doctors and other healthcare providers, across the globe. The Company offers an array of spinal repair products used during surgical procedures intended to treat a range of spine conditions. Many of these surgeries are fusion procedures in the cervical, thoracic and lumbar spine that utilize metal plates, rods and screws, interbody spacers, Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P), as well as vertebral body replacement devices to promote bone growth.
The Company provides an array of implants designed for use primarily in cervical, thoracic and lumbar fusion surgeries. This includes 3, Reliant and Hallmark cervical plates. Additionally, the Spinal Fixation System (SFS), the Firebird Spinal Fixation System, the Phoenix Minimally Invasive Spinal Fixation System, the Ascent, Ascent LE, and the Centurion POCT Systems are sets of rods, cross connectors and screws, which are implanted during posterior fusion procedures.
The Company competes with Zimmer Biomet, Inc., DJO Incorporated, Smith & Nephew plc, Essex Woodland, Medtronic, Inc., Johnson and Johnson, Stryker Corp., NuVasive, Inc., Globus Medical Inc. and DePuy Synthes.
Orthofix International NV
3451 Plano Pkwy
LEWISVILLE TX 75056-9453