OrthoPediatrics Corp., a medical device company committed to designing, developing and marketing anatomically appropriate implants, instruments and specialized braces for children with orthopedic conditions, giving pediatric orthopedic surgeons and caregivers the ability to treat children with technologies specifically designed to meet their needs.
The company sells its specialized products, including PediLoc, PediPlates, Cannulated Screws, PediFlex nail, PediNail, PediLoc Tibia, ACL Reconstruc...
OrthoPediatrics Corp., a medical device company committed to designing, developing and marketing anatomically appropriate implants, instruments and specialized braces for children with orthopedic conditions, giving pediatric orthopedic surgeons and caregivers the ability to treat children with technologies specifically designed to meet their needs.
The company sells its specialized products, including PediLoc, PediPlates, Cannulated Screws, PediFlex nail, PediNail, PediLoc Tibia, ACL Reconstruction System, Locking Cannulated Blade, Locking Proximal Femur, Spica Tables, RESPONSE Spine, BandLoc, Pediatric Nailing Platform | Femur, Devise Rail, Orthex, The Fassier-Duval Telescopic Intramedullary System, SLIM Nail, The GAP Nail, The Free Gliding SCFE Screw System, GIRO Growth Modulation System, PNP Tibia System, ApiFix Mid-C System and Mitchell Ponseti and Boston Brace 3D specialized bracing products to various hospitals and medical facilities throughout the United States and various international markets. The company uses a contract manufacturing model for the manufacturing of implants and related surgical instrumentation while the company’s orthopedic bracing products are manufactured in house. The company also operates multiple orthotic and prosthetic (O&P) clinics delivering leading pediatric non-surgical O&P treatment.
The company routinely explores opportunities to acquire or invest in complementary products, technologies or businesses. For example, in 2020, the company acquired ApiFix, Ltd., the developer of a minimally invasive deformity correction system for patients with adolescent idiopathic scoliosis (‘ApiFix System’). The company owns MD Ortho, a manufacturer of orthopedic clubfoot products, and Pega Medical, a medical device company which sells a portfolio of trauma and deformity correction devices for children, including the Fassier-Duval Telescopic Intramedullary System designed to treat osteogenesis imperfecta.
The company owns MedTech Concepts LLC and their digital healthcare hardware and software designed to improve operating room efficiencies, as well as assets from Rhino Pediatric Orthopedic Designs, Inc. which offers specialty braces.
In 2024, the company purchased Boston Brace International, Inc., a Massachusetts corporation (Boston O&P). Boston O&P has developed and manufactures pediatric orthotic and prosthetic devices, including non-surgical scoliosis treatment options, and provides related clinical services.
In 2024, Boston O&P completed an acquisition of substantially all of the assets, including inventory, related to orthotic and prosthetic device clinics located in Virginia and Maryland. Boston O&P also purchased all issued and outstanding share capital of clinics in Florida as well as multiple clinics in Colorado.
In addition to acquisitions, the company looks for partnerships, which can provide the company with complementary enabling technologies. For example, in 2021 the company extended its license agreement for its exclusive distribution rights of the FIREFLY Technology. Also in 2021, the company entered into a license agreement resulting in exclusive distribution rights of the 7D Surgical FLASH Navigation platform for pediatric applications. In 2023, the company entered into a license agreement with Ora Medical resulting in exclusive distribution rights of the Levity gait assist device. In 2024, the company entered into a license and supply agreement with Innovation Lab to bring the Move-DTM brace to market. These partnerships allow for exclusive distribution in children's hospitals across the United States and serve as supporting avenues for the company to focus on high-volume children's hospitals.
The company’s largest investor is Squadron, a private investment firm based in Granby, Connecticut.
The company is the only global medical device company focused exclusively on providing a comprehensive trauma and deformity correction, scoliosis and sports medicine product offering to the pediatric orthopedic market in order to improve the lives of children with orthopedic conditions. The company designs, develops and commercializes orthopedic implants, instruments and specialty bracing products as well as provide O&P clinic services to meet specific needs of pediatric surgeons and their patients. The company currently serves three of the largest categories in this market.
The company markets 75 surgical and bracing systems that serve three of the largest categories within the pediatric orthopedic market: (i) trauma and deformity correction, (ii) scoliosis and (iii) sports medicine procedures.
The company’s global sales organization focuses exclusively on pediatric orthopedics. The company’s organization has a deep understanding of the unique nature of children’s clinical conditions and surgical procedures, as well as an appreciation of the tremendous sense of responsibility pediatric orthopedic surgeons feel for the children whom parents have entrusted to their care. The company provides these surgeons with dedicated support, both in and out of the operating room. The company’s global sales management organization leads a network of sales agencies, stocking distributors, as well as direct sales representatives. As of December 31, 2024, the company’s U.S. sales organization consisted of multiple direct sales representatives, as well as nearly 40 independent sales agencies employing approximately 230 focused sales representatives. Outside of the United States, the company’s sales organization consisted of a network of more than 70 independent stocking distributors, 14 independent sales agencies and multiple direct sales representatives. The company sells its products in over 75 countries outside of the United States.
The company collaborate with pediatric orthopedic surgeons in developing new surgical and bracing systems that improve the quality of care. The company has an efficient product development process that relies upon teams of engineers, commercial personnel and surgeon advisors.
Strategy
The company’s strategies are to continue its laser focus on high-volume children’s hospitals that treat the majority of pediatric patients; Provide a broad product portfolio of implant systems, specialty bracing products, and enabling technologies uniquely designed to treat children by surrounding pediatric orthopedic surgeons with all the products they need; deploy instrument sets and provide unparalleled sales support; expand addressable market through aggressive investment in research and development and select acquisition opportunities; and train the next generation of pediatric orthopedic surgeons.
Product Portfolio
The company has developed a comprehensive portfolio of implants, instruments and specialty bracing solutions specifically designed to treat children with orthopedic conditions within the three categories of the pediatric orthopedic market that the company serves. The company markets 75 surgical and specialized bracing systems that address pediatric trauma and deformity correction, scoliosis and sports medicine/other procedures. Many of the company’s products are available in a variety of sizes and configurations to address a wide range of patient conditions and surgical requirements. These surgical systems are summarized below.
Trauma and Deformity Correction
The company’s trauma and deformity correction product line include more than 7,000 implants, instruments, external fixation components, specialized braces and bone graft substitutes for the femur, tibia, pelvis, upper and lower extremities as well as providing clinical O&P services.
Scoliosis
The company’s scoliosis product category includes the company’s RESPONSE systems for treating spinal deformity in children, the BandLoc 5.5mm/6.0mm sub-laminar banding system, FIREFLY Pedicle Screw Navigation Guides, 7D Flash Naviation image guidance system and ApiFix Mid-C System as well as providing clinical O&P services.
In addition to the company’s direct product offering, the company invests in complementary enabling technologies that allow the company to better serve the children's hospitals in which the company sells. Enabling technologies in the company’s scoliosis space include the FIREFLY Technology, a 3D printed and patient-specific Pedicle Screw Navigation Guide, as well as the 7D FLASH Navigation image guidance system. The company has exclusive distribution rights to both of these complementary technologies, allowing for exclusive distribution in children's hospitals across the United States.
Sports Medicine/Other
The company’s sports medicine/other product category primarily includes the company’s ACL, MPFL Reconstruction system and Telos as well as providing clinical O&P services.
The company’s revenue is typically higher in the summer months and holiday periods, driven by higher sales of the company’s trauma and deformity and scoliosis products, which is influenced by the higher incidence of pediatric surgeries during these periods due to recovery time provided by breaks in the school year.
Product Pipeline
Generally speaking, the company has three product development objectives across the organization: (i) develop innovative new implant and bracing systems that enable surgeons to advance the field of pediatric orthopedics and allow the company to focus on categories of the pediatric orthopedic market the company is not currently addressing; (ii) build-out its current portfolio of products with line extensions that allow these implant and bracing systems to be used in more types of surgeries or non-surgical applications; and (iii) make improvements to the company’s current implants, instruments, and specialty bracing products that improve quality and reduce their cost. The company has a large number of new product ideas under development within the areas of spinal implants, active growing smart implants, trauma implant systems, limb deformity implant systems, and non-surgical devices. The company aspires to launch at least one new implant system and/or line extension/product improvement every quarter across the sompany as well as 4-5 new specialty bracing products each year.
The company has a deep pipeline of new systems that are under development, including the following projects.
3P | Pediatric Plating Platform
In 2022, the company began development of a new plate and screw platform, called 3P, to modernize and revolutionize trauma and deformity treatment in both the upper and lower extremity. The company anticipates a limited launch of the first system, 3P Hip, in the second quarter of 2025, and of the next system, 3P Small/Mini, toward the end of 2025, followed by launches of additional systems throughout 2026-2028. These systems will provide surgeons unparalleled coverage for all plating indications, standardized implants and instruments to improve surgical workflow and inventory efficiency, and novel implants to address currently unmet needs.
Pediatric Nailing Platform | Tibia
The company anticipate a full-scale launch in 2025 for the company’s recently introduced innovative Pediatric Nailing Platform | Tibia, that will use a similar instrument platform to the Pediatric Nailing Platform | Femur system, which was introduced in 2018. This new to the market system will treat deformities and traumatic injuries of the tibia.
Pediatric Nailing Platform | Retrograde Femur
Building upon the tremendous success of the company's PNP | Femur and PNP | Tibia systems, the company is developing a retrograde femoral nailing system designed to support pediatric indications where entry through the knee is preferred. This system will leverage existing instrumentation where possible, and the company anticipates having the most comprehensive small canal offering available on the market at launch.
GIRO Growth Modulation System
The GIRO is a tether device that will be fully launched in 2025, intended for guided growth and deformity correction. Supplementing the company’s flagship PediPlate system, this device offers multi-directional flexibility utilizing a cable assembly designed to improve bone contouring and aiding in minimally invasive treatment, with consideration of a future indication for guided rotational correction.
Active Growing Implants
The company is nearing final developing a new generation of smart implants, which the company refers to as its Active Growing Implants electromechanical lengthening implant or eLLiTM. The company’s Active Growing Implants will utilize a power source of significantly greater strength and control than current magnetic technology and will be adjustable at the time of implantation and non-invasively over the course of treatment to accommodate the changing clinical needs of patients as they heal, grow and age. The company made significant development progress on this in 2024 including receiving Breakthrough Device designation from the FDA. This new technology will be available to address severe pathology associated with early onset scoliosis in the near future.
Growth Guidance for Scoliosis – VerteGlide
The company is developing VerteGlide, a next-generation growth guidance technology for treating certain forms of early onset scoliosis. This procedure uses rods and pedicle screws attached to specific points in the spine and configured similar to a ‘track and trolley’ system which allows the spine to grow naturally while correcting a spinal curve. The company completed development and it is now working with the FDA on regulatory clearance. The company expects a beta launch of this system in 2025 and a full-scale launch in 2026.
Next Generation Scoliosis Fusion System
The company is in final development of its next generation scoliosis fusion system, which will include the ultimate surgical experience for pediatric spinal fusion. The system is designed exclusively for pediatric patients and their surgeons, including innovative implant and instrument designs, with an advanced digital platform to optimize the procedure. The company expects to launch this system in the first half of 2026.
Development of Surgical Workflow Optimization Software
The company has a number of initiatives underway involving the development of pre-operative planning and intraoperative workflow software to assist surgeons in the treatment of spinal, trauma, and deformity correction conditions, as well as the utilization of the company's product solutions for these conditions. These projects encompass both educational and software as a medical device type offerings, leveraging the company's new Playbook product offering.
External Fixation Systems
The company continues to invest in strengthening its external fixation portfolio, with software improvements launched in 2023 and hardware line extensions in 2024. In 2025, the company will launch a new Titanium HA Pin offering to support both Orthex and Drive systems, designed to improve fatigue life and increase flexibility to promote rapid bone healing. Further development will continue to focus on hardware and software upgrades, as well as a completely new system for emergency fracture management and to aid in deformity osteotomy stabilization.
Research and Product Development
The company’s research and development expenses were $11.0 million for the year ended December 31, 2024.
Sales and Marketing
The company’s global sales management organization leads a network of sales agencies, stocking distributors, as well as direct sales representatives. As of December 31, 2024, the company’s U.S. sales organization consisted of multiple direct sales representatives, as well as nearly 40 independent sales agencies employing approximately 230 focused sales representatives. Increasingly, these sales agencies are making the company the anchor line in their businesses or representing the company exclusively. Sales to customers from such agencies represented 59% of the company’s global revenue in 2024.
Outside of the United States, the company’s sales organization consisted of a network of more than 70 independent stocking distributors, 14 independent sales agencies and multiple direct sales representatives. The company sells its products in over 75 countries outside of the United States, including the largest markets in the European Union, Latin America and the Middle East, as well as South Africa, Australia and Japan. To support the company’s international distribution organization, the company has hired a number of regional market managers, whose product and clinical expertise deepens the company’s relationships with both surgeons and its distributors. In the near term, the company expects to selectively expand the number of international markets the company serves, as well as to deepen its penetration of important existing markets, such as Brazil and Germany. In 2024, the company opened warehouses in Germany and Australia and hired a European operations director to continue its growth in the European market.
The company has developed intensive training programs for the company’s global sales organization. The company expects its sales agencies and distributors to continue to deepen their knowledge of pediatric clinical conditions, surgical procedures and the company’s products, thus increasing their effectiveness. The company’s domestic and international sales representatives are usually present in the operating room during surgeries in which the company’s products are used.
Intellectual Property
As of December 31, 2024, the company owned 77 issued U.S. patents and 207 issued foreign patents and the company had 50 pending U.S. patent applications and 66 foreign patent applications. As of December 31, 2024, 13 of the company’s U.S. issued patents have pending continuation or divisional applications in process which may provide additional intellectual property protection if issued as U.S. patents. The company’s issued U.S. patents expire between 2025 and 2043, subject to payment of required maintenance fees, annuities and other charges. As of December 31, 2024, the company owned 42 U.S. trademark registrations and 10 pending U.S. trademark applications, as well as 88 registrations in other jurisdictions worldwide.
Competition
The company has competitors in each of its three product categories, including Johnson & Johnson MedTech (a subsidiary of Johnson & Johnson), Medtronic plc, Smith & Nephew plc, Orthofix, and Hanger clinics.
Government Regulation
The company’s products and its operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States, as well as comparable authorities in foreign jurisdictions. The company’s products are subject to regulation as medical devices under the Federal Food, Drug, and Cosmetic Act (‘FDCA’), as implemented and enforced by the FDA.
The company’s marketed products are Class I and exempted from premarket notification, or Class II devices subject to 510(k) clearance with the exception of the ApiFix Mid-C System which is an unclassified, approved device under the Humanitarian Device Exemption (‘HDE’) regulation.
The company’s Class II products are subject to 510(k) clearance under the FDCA. To obtain 510(k) clearance, the company must submit to the FDA a 510k submission demonstrating that the proposed device is ‘substantially equivalent’ to a predicate device already on the market.
The company’s manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods, facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.
In order to comply with the new regulations and continue selling medical devices in the U.K. following the transition period, the company must appoint a U.K. Responsible Person and register the medical devices with the U.K.'s Medicines and Healthcare product Regulatory Agency, or MHRA.
The advertising and promotion of the company’s products is subject to EU Directives concerning misleading and comparative advertising and unfair commercial practices, as well as other EEA Member State legislation governing the advertising and promotion of medical devices.
Going forward the company is subject to newly enacted SEC requirements to report any material breach of the company’s IT systems and to disclose its processes for assessing, identifying, and managing material risks from cybersecurity threats.
The company’s U.S. operations are subject to the U.S. Foreign Corrupt Practices Act of 1977 or FCPA. The company is also subject to similar anticorruption legislation implemented in Europe under the Organization for Economic Co-operation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions.
History
OrthoPediatrics Corp. was founded in 2006. The company was incorporated in 2007.
