Profile: Orthofix International NV (OFIX.O)

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Orthofix International N.V. (Orthofix), incorporated on October 19, 1987, is a diversified, global medical device company focused on developing and delivering repair and regenerative solutions to the spine and orthopedic markets. The Company operates in two global business units, which include Spine and Orthopedics. It designs, develops, manufactures, markets and distributes medical equipment used principally by musculoskeletal medical specialists for spine and orthopedic applications. Its main products are spinal implant products and related human cellular and tissue based products (HCT/P products) used in surgical procedures, non-invasive regenerative stimulation products used to enhance bone growth and the success rate of spinal fusions and to treat non-union fractures, external and internal fixation devices used in fracture repair, limb lengthening and bone reconstruction.

Its products are designed to address the lifelong bone-and-joint health needs of patients of all ages, helping them achieve a more active and mobile lifestyle. Its products also include bone cement and devices for removal of bone cement used to fix artificial implants. It directly distribute its products in the U.S., the United Kingdom, Italy, Germany, Switzerland, Austria, France, Belgium, Brazil and Puerto Rico. In several other markets it distributes its products through independent distributors.

Spine

Spine provides a portfolio of repair and regenerative products that allow physicians to successfully treat a variety of spinal conditions. This global business unit specializes in the design, development and marketing of the Company’s spinal repair products along with regenerative stimulation and biologics products used in spine applications. Spine distributes its products through a network of distributors, sales representatives and affiliates. This global business unit uses both direct and distributor sales representatives to sell spine products to hospitals, doctors and other healthcare providers, globally. Neck and back pain is a common health problem for many people throughout the world and often requires surgical or non-surgical intervention for improvement. Neck and back problems are usually of a degenerative or neurological nature and are generally more prevalent among the older population.

It believes that its Spine products are positioned to address the needs of spine patients both operatively and post-operatively. Its products address the cervical fusion segment as well as the lumbar fusion segment which is the sub-segment of the spine market. It offers a wide array of spinal repair products used during surgical procedures intended to treat a variety 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, or vertebral body replacement devices, and HCT/P, as well as interbody spacers to promote bone growth. Additionally, regenerative stimulators used in spinal applications are designed to enhance bone growth and the success rate of certain spinal fusions by stimulating the body’s own natural healing mechanism post-surgically. These non-invasive portable devices are intended to be used as part of a home treatment program prescribed by a physician.

The human spine is made up of 33 interlocking vertebrae that protect the spinal cord and provide structural support for the body. The top seven vertebrae make up the cervical spine, which bears the weight of the skull and provides the highest range of motion. The next 17 mobile vertebrae encompass the thoracic and lumbar, or thoracolumbar, sections of the spine. The thoracic spine (12 vertebrae) helps to protect the organs of the chest cavity by attaching to the rib cage, and is the least mobile segment of the spine. The lumbar spine (five vertebrae) carries the greatest portion of the body’s weight, allowing a degree of flexion, extension and rotation thus handling the majority of the bending movement. Additionally five fused vertebrae make up the sacrum (part of the pelvis) and four vertebrae make up the final part of the spine, the coccyx.

Spinal bending and rotation are accomplished through the vertebral discs located between each vertebra. Each disc is made up of a tough fibrous exterior, called the annulus, which surrounds a soft core called the nucleus. Excess pressure, deformities, injury or disease can lead to a variety of conditions affecting the vertebrae and discs that may ultimately require medical intervention in order to relieve patient pain and restore stability in the spine.

Spinal fusion is the permanent union of two or more vertebrae to immobilize and stabilize the affected portion of the spine. Its fusion surgeries involve the placement of a bone graft between the affected vertebrae, which is typically held in place by metal implants that also provide stability to the spine until the desired growth of new bone can complete the fusion process. These implants typically consist of some combination of rods, screws and plates that are designed to remain in the patient even after the fusion has occurred. Its products provide a wide array of implants designed for use primarily in cervical, thoracic and lumbar fusion surgeries. These implants are made of metal, bone, or PEEK. Additionally, Spinal Implants and Biologics’ product portfolio includes a allograft with viable cells HCT/P bone grafting product called Trinity Evolution .

The majority of implants offered by its products are made of titanium metal. This includes the 3 Degree, 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 which are implanted during posterior fusion procedures. The Firebird Modular and pre-assembled Spinal Fixation System are designed to be used in either open or minimally-invasive posterior lumbar fusion procedures with its product ProView MAP System. It also offers specialty plates that are used in less common procedures, and as such, are not manufactured by many device makers. These specialty plates include the Newbridge Laminoplasty Fixation System that is designed to expand the cervical vertebrae and relieve pressure on the spinal canal, as well as the Unity plate which is used in anterior lumbar fusion procedures.

It also offers a variety of devices made of PEEK, including vertebral body replacements and interbody devices. Vertebral body replacements are designed to replace a patient’s degenerated or deformed vertebrae. On the other hand, interbody devices, or cages, are designed to replace a damaged disc, restoring the space that had been lost between two vertebrae. Spinal Implants and Biologics also offers the NGage Surgical Mesh System made of titanium metal.

In addition to its Spinal Repair Solutions it 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. Research data shows that its PEMF signal induces mineralization and results in a process that stimulates new regenerative at the spinal fusion site.

Orthopedics

The medical devices offered in its Orthopedics global business unit include both repair and regenerative solutions. Its fracture repair products consist of fixation devices designed to stabilize a broken bone until it can heal. Its fracture repair products come in two main types: external devices and internal devices. With these devices, it can treat simple and complex fracture patterns along with achieving deformity corrections. External fixation devices are used to stabilize fractures from outside the skin with minimal invasion into the body. These 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 bone segments are aligned by manipulating the external device using patented ball joints and, when aligned, are locked in place for stabilization. It believes that external fixation allows micromovement at the fracture site, which is beneficial to the formation of new bone. External fixation may also be used as temporary devices in complex trauma cases to stabilize the fracture prior to treating it definitively. It believe that external fixation is among the minimally invasive surgical options for fracture management. Also, it believes external fixation is the ideal treatment option for complex fractures, or patients which include fractures close to the joints, or patients with known risk factors or co-morbidities.

External devices are designed in part to be used for the same types of conditions that can be treated by internal fixation devices. The difference is that the external fixator is a monolateral or circular device attached with screws to the fractured bone from outside the skin of the arm or leg. The choice of whether to use an internal or external fixation device is driven in part by physician preference although it may also be related to the fracture complexity and anatomical location. Some patients, however, favor internal fixation devices for aesthetic reasons.

The Limb Reconstruction System (LRS) uses callus distraction to lengthen bone in a variety of procedures. It can be used in monofocal lengthening and corrections of deformity. Its multifocal procedures include bone transport, simultaneous compression and distraction at different sites, bifocal lengthening and correction of deformities with shortening. The TrueLok Ring Fixation System is a surgeon-designed, lightweight external fixation system for limb lengthening and deformity correction. In essence, a ring fixation construct consists of circular rings and semi-circular external supports centered on the patient’s limb and secured to the bone by crossed, tensioned wires and half pins. The rings are connected externally to provide stable bone fixation. The main external connecting elements are threaded rods, linear distractors, or hinges and angular distractors which allow the surgeon to adjust the relative position of rings to each other. The ring positions are manipulated either acutely or gradually in minute increments to perform the correction of the deformity, limb lengthening, or bone segment transportation as required by the surgeon. Created with pre-assembled function blocks, it believes TrueLok is a simple, stable, versatile ring fixation system superior to the traditional Ilizarov ring system.

It regenerative biologics products principally include Trinity Evolution , an allograft with viable cells used during surgery that is designed to enhance the success of a bone fusion procedure to facilitate bone fusion. Surgeons will use bone grafts when their patients have a defect in the bone and it needs to be filled. Bone grafts can come directly from the patient’s own bone (autograft) or from donor bone tissue that has been processed in specialized facilities or derived from a synthetic composition that resembles the components of human bone. Its Biologics are being offered only in the U.S. market due to restrictions in providing U.S. human donor tissue in other countries. Its Physio-Stim regenerative stimulator products use PEMF technology similar to that described previously in the discussion of its spine stimulators. The primary difference is that the Physio-Stim physical configuration is designed for use on long bones.

A bone’s regenerative power results in fractures healing naturally within a few months. In certain situations, however, fractures do not heal or heal slowly, resulting in non-unions. Traditionally, orthopedists have treated such fracture conditions surgically, often by means of a bone graft with fracture fixation devices, such as bone plates, screws or intramedullary rods. These are examples of invasive treatments. Its patented regenerative stimulators are designed to use a low level of PEMF signals to activate the body’s natural healing process. It systems offer portability, rechargeable battery operation, integrated component design, patient monitoring capabilities and the ability to cover a treatment area without factory calibration for specific patient application.

The Company competes with Medtronic, Inc.; De Puy Synthes, a division of Johnson and Johnson; Stryker Corp.; Zimmer, Inc.; NuVasive; Biomet Spine Smith & Nephew plc, and Biomet Orthopedics.

Company Address

Orthofix International NV

7 Abraham de Veerstraat
CURACAO    
P: +5999.4658525
F: +5999.4616978

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