Profile: Orthofix International NV (OFIX.O)
Orthofix International N.V. (Orthofix), incorporated on October 19, 1987, is a diversified, global medical device company focused on providing reconstructive and regenerative orthopedic and spine solutions to physicians across the world. The company operates in four segments: BioStim, Biologics, Extremity Fixation and Spine Fixation. It uses independent distributors, as well as directly distributes its products in the United States, Italy, the United Kingdom, Germany, Switzerland, Austria, France, Brazil, Australia, and Puerto Rico. In several other markets the Company distributes its products through independent distributors. Its BioStim solutions products include Cervical-Stim, Spinal-Stim and Physio-Stim. Its Biologic solutions products include AlloQuent Structural Allografts, Trinity ELITE and Trinity Evolution, among others. Its Extremity Fixation solutions include Fixator, TrueLok and Galaxy Fixation System, among others. Its Spine Fixation solutions products include NewBridge Laminoplasty Fixation System and PILLAR PL & TL PEEK VBR System, among others.
The BioStim segment manufactures, distributes and provides support services of devices that enhance bone fusion. These Class III medical devices are indicated as an adjunctive, noninvasive treatment to improve fusion success rates in cervical and lumbar spine, as well as a therapeutic treatment for non-spine fractures that have not healed (non-unions). This segment uses both distributors and independent sales representatives to sell its devices to hospitals, doctors and other healthcare providers, primarily in the United States. The Company offers two spinal regenerative stimulation devices, Spinal-Stim and Cervical-Stim, through its subsidiary, Orthofix Inc. Its stimulation products use a Pulsed electromagnetic field (PEMF) technology designed to enhance the growth of bone tissue surgery and are placed externally over the site to be healed.
Spinal-Stim is a non-invasive spinal fusion stimulator system commercially available in the United States and approved in Europe. 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 Biologics segment provides a portfolio of regenerative products and tissue forms that allow physicians to treat a range of spinal and orthopedic conditions. This segment specializes in the marketing of the Company's regeneration tissue forms. Biologics markets its tissues through a network of distributors, independent sales representatives and affiliates to supply to hospitals, doctors, and other healthcare providers, primarily in the United States. Its partnership with the Musculoskeletal Transplant Foundation (MTF) allows it to market its Trinity Evolution and Trinity ELITE tissue forms for musculoskeletal defects to enhance bony fusion.
The Company's biologics tissues include Trinity ELITE and Trinity Evolution, which are 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, a thin hydrophilic amniotic membrane designed to serve as a wound or tissue covering for a range of surgical demands. It has across the world rights to market its Trinity Evolution and Trinity ELITE technologies, and market its VersaShield under a private label brand via a non-exclusive marketing agreement for the tissue form.
The Extremity Fixation segment offers products and solutions that allow physicians to treat a range of orthopedic conditions unrelated to the spine. 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. Extremity Fixation distributes its products through a network of distributors, independent sales representatives and affiliates. This segment uses both independent distributors and direct sales representatives to sell orthopedic products to hospitals, doctors, and other health providers, across the globe. The medical devices offered in its Extremity Fixation segment include both internal and external fixation solutions for extremity repair and deformity correction, both for adults and pediatrics.
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. 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, among others. 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, or HCT/P, as well as vertebral body replacement devices to promote bone growth.
The implants offered by Company's products are made of titanium metal, which includes the 3, Reliant and Hallmark cervical plates. Additionally, the Spinal Fixation System (SFS), the Firebird Spinal Fixation Systems, the Phoenix Minimally Invasive Spinal Fixation System, the Ascent and Ascent LE POCT Systems are sets of rods, crossbars and screws that are implanted during posterior fusion procedures. It also offers a range of devices made of Polyetheretherketones (PEEK), including vertebral body replacements and interbody devices.
The Company competes with Biomet, Inc.; DJO Incorporated, Smith & Nephew plc, Essex Woodland, Medtronic, Inc., Johnson and Johnson, Stryker Corp., Zimmer, Inc., NuVasive, Inc. and DePuy Synthes.
Orthofix International NV
7 Abraham de Veerstraat,
P.O. Box 840