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OrthoPediatrics will design, develop and distribute anatomically appropriate orthopedic implants for children and small stature patients with the aid of collaborative input from orthopedic surgeon designers. The company will focus on the following eight core areas:
This product line will consist of flexible nails (Nancy nail), rush rods, cannulated screws, plates, locking plates, pins, and rigid IM rods that are designed to be anatomically appropriate for different segments of the anatomy within the infant, child and adolescent subgroups. OrthoPediatrics is currently collaborating with Dr. J. Eric Gordon (Washington University) to develop the most anatomically appropriate, comprehensive and user-friendly Pediatric IM (Intramedullary) Nailing system. In addition to rigid IM Nails, OrthoPediatrics has secured a license to the most comprehensive Flexible Nailing system in the world, which was designed, in part, by Dr. Pierre Lascomb of Nancy University (France).
The pediatric patient population experiences orthopedic conditions and fractures that are not found in the adult patient population. OrthoPediatrics is in the process of bringing to market a number of technologies to address these specific indications. These products aim to address pediatric indications such as varus/valgus deformity correction, rotational deformity correction, SCFE (slipped capital femoral epiphysis), limb lengthening and others. OrthoPediatrics is currently working in conjunction with some of the top pediatric orthopedic surgeons in the world to ensure the release of a Specialty Plating System used for deformity correction, a SCFE Screw System, and many other proprietary technologies that will address a multitude of orthopedic conditions in a minimally invasive fashion. OrthoPediatrics' patient-specific implant capabilities are unique to the medical device industry. While most orthopedic companies have custom manufacturing departments that can take a standard line product and adapt it to fit certain defects, deformities or patient size, it has been the experience of OrthoPediatrics' management and advisors that these departments are not properly trained to read and truly interpret pediatric x-rays. OrthoPediatrics has and will continue to grow its specialized in house engineering expertise to quickly design and develop patient-specific implants for children. Senior management at OrthoPediatrics has extensive patient-specific and custom orthopedic product experience. The support OrthoPediatrics' will provide to the pediatric orthopedic surgeons for their immediate and unique needs is a distinctive competency of the company. In addition to patient-specific implant capabilities, OrthoPediatrics has the capacity to quickly design and develop custom instrumentation for pediatric orthopedic surgeons. Most instruments used by pediatric orthopedic surgeons today are designed for the adult market. Consequently, many pediatric orthopedic surgeons have altered instrumentation themselves to adjust such instrumentation for their own use. Not only does this put the patient, surgeon and associated hospital at risk, it is also very expensive and time consuming. A pediatric orthopedic surgeon recently described his frustrations with the unmet need in instrumentation in saying, "They changed the size of the screwdriver because the screw was smaller. So the screwdriver was smaller, but our hands are the same size. They micro-sized everything. They hadn't thought about anybody actually using them! " OrthoPediatrics is committed to offering instrumentation that is suited for use in pediatric orthopedic surgery and is ergonomically appropriate for the surgeons. OrthoPediatrics will design this proprietary surgical instrumentation in collaboration with its experienced surgeon designers.
Joint Reconstruction & Limb Preservation The Joint Reconstruction and Limb Preservation category offers the greatest growth opportunity in pediatric implants, with only .15% of all joint-related implants being used in children today. OrthoPediatrics believes that this is the most underserved market segment. OrthoPediatrics' initial product offering will revolve around the highly neglected Juvenile Rheumatoid Arthritis (JRA) market. OrthoPediatrics is currently working directly with a major orthopedic hospital in the United States to commercialize a Pediatric Total Knee and a Small Stature Hip product that has very promising clinical data. OrthoPediatrics intends to design a segmental limb preservation system to be used in lower and upper extremity applications that will be compatible with total knee, hip and shoulder joint replacement devices that are also produced by OrthoPediatrics. In addition, OrthoPediatrics intends to launch the first metastatic oncology system in the marketplace. This portfolio of products will provide surgeons with additional options for limb salvage applications, complicated revision cases and disasterplasties. The pediatric spine market is the largest and most advanced of all the pediatric orthopedic segments. OrthoPediatrics’ initial focus will be in correcting spinal deformities, such as scoliosis. OrthoPediatrics is currently evaluating a number of systems and plans to launch its first product in 2009. Our efforts will focus on providing size and growth appropriate implants and innovative instrumentation systems that incorporate minimally invasive approaches to straighten curved and twisted spines. This approach will also help convert patients and surgeons away from external bracing, which have the complications associated with long term wear and the social stigma that adolescents typically suffer when forced to endure external bracing during adolescent years. Fundamental to the company’s research is its detailed understanding of the healing process in children. To reduce the number of surgeries and improve outcomes for children, the company is actively exploring various biodegradable biomaterials that have great potential in medical implants. These biomaterials enhance the healing of bone or soft tissue injuries to the skeleton, such as those caused by trauma or surgery, and can be designed to dissolve in 2-4 months, and completely in 2-4 years. Implants made from biomaterials offer a number of significant advantages over existing metal implants for patients and surgeons, including a significantly reduced need for implant removal surgery in growing children thereby avoiding unnecessary risk and expense and a more natural clinical result as implant degradation promotes a progressive shift of load to the new bone. The science of biologics is a very promising field for the treatment of various diseases and conditions in children, and is a long-term focus of OrthoPediatrics. Children have unique natural healing properties that, when harnessed, can do amazing things for those suffering from many conditions, such as rare diseases and growth plate issues. OrthoPediatrics is licensing technology and working with Cleveland Clinic Foundation’s Section Head of Pediatric Orthopedics, Dr. Tracy Ballock, who is considered to be a pioneer and leading expert in growth plate biology. The goal of present research is to prevent growth abnormalities after growth plate fractures by regenerating normal growth plate tissue at the site of injury. This promising science could potentially change the way children’s orthopedic conditions are treated today. The company is also exploring several other promising areas in biologics that will complement existing portfolio technologies.
The Device and Medical Equipment segments will further enhance OrthoPediatrics' ability to capitalize on additional opportunities that exist. The company and its advisors have identified several areas where innovation has been stagnant for decades which can now provide significant opportunities for OrthoPediatrics and its customers. For example, cast removal systems (or cast saws) have not been improved in years. Cast saws are often perceived by children as a big robot with hoses, wires, and loud spinning blade. That's intimidating stuff, at best, in the eyes and ears of a child. OrthoPediatrics' goal is to identify and develop commercial opportunities that reduce trauma for pediatric patients, both physically and emotionally. Research and development involving OrthoPediatrics' internal and external resources on specialized products such as heated casting tables specifically designed for children, walkers, wheelchairs, and a revolutionary new cast removal system are presently underway. As OrthoPediatrics works with pediatric surgeons throughout the U.S., we will continue to identify unmet needs and underserved areas that can be addressed through joint ventures and partnerships with other providers who may want to take advantage of OrthoPediatrics' unique branding and distribution. Soft goods for casting are currently being evaluated, such as colorful branded slings and toe socks. The company recognizes that this segment generally produces lower margin products. However, in order to be a broad-based provider to pediatric orthopedic surgeons, OrthoPediatrics will continue to evaluate these products for its portfolio.
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