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Orthofix (OFIX) Fitbone Used in 1st US Pediatric Patient Implant
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Orthofix Medical Inc. (OFIX - Free Report) recently announced the first U.S. pediatric patient implant with the Fitbone intramedullary lengthening system for limb lengthening of the femur and tibia bones. The Fitbone system is currently the only intramedullary limb lengthening solution to get the FDA clearance for pediatric and adult use.
The Fitbone intramedullary lengthening system is available through the FDA 510(k) clearance and under the CE Mark approval in European countries.
Last March, Orthofix acquired the FITBONE assets associated with the FITBONE intramedullary lengthening system. With this addition, Orthofix became the only orthopedic company with a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction.
With the latest development, Orthofix’s Global Extremities business is expected to receive a major boost.
More on Fitbone System
The Fitbone system is developed to offer precise and controlled limb lengthening and comprise of the implanted intramedullary nail, a subcutaneously implanted receiver, and an external control set that allows the patient or their caregiver to handle the distraction phase at home. The Fitbone system is available in a 9mm, 11mm and 13mm sizes to tackle the specific needs of patients.
The system has more than 3,500 cases performed in 15 countries since its development. It enables achievement of axial and torsional bone alignment intraoperatively, as part of the limb-lengthening procedure.
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The system is compatible with the OrthoNext digital platform -- the only software tool in the market for deformity analysis and preoperative planning for pediatric and adult orthopedic procedures.
Significance of Fitbone System
Per personnel associated with the implant procedure, deformity correction and limb lengthening can be difficult to plan. The OrthoNext digital planning module helps to streamline the preoperative planning, particularly while using the Fitbone system in adolescent patients where the exact limb alignment is critical.
Recent Developments
In August 2021, Orthofix announced the first patient implant in M6-C artificial cervical disc two-level IDE Study. The clinical study will assess the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy.
In July 2021, Orthofix announced the launch and first patient implant with the fiberFUSE Strip -- an advanced demineralized fiber bone-graft solution containing cancellous bone. The fiberFUSE Strip is created as a convenient preformed bone-graft strip to facilitate optimized application for posterior cervical, posterior lumbar and degenerative spinal procedures.
Industry Prospects
Per a report by Markets And Markets, the global trauma products market is expected to reach $7.6 billion by 2025 from $5 billion in 2020, at a CAGR of 8.3%. Factors like increasing prevalence of degenerative bone diseases, growing incidence of sports injuries, and the rising number of road accidents and falls are expected to drive the market.
Price Performance
Shares of the company have gained 46% in a year’s time compared with the industry’s rise of 14%.
Zacks Rank and Other Key Picks
Currently, Orthofix carries a Zacks Rank #2 (Buy).
Image: Shutterstock
Orthofix (OFIX) Fitbone Used in 1st US Pediatric Patient Implant
Orthofix Medical Inc. (OFIX - Free Report) recently announced the first U.S. pediatric patient implant with the Fitbone intramedullary lengthening system for limb lengthening of the femur and tibia bones. The Fitbone system is currently the only intramedullary limb lengthening solution to get the FDA clearance for pediatric and adult use.
The Fitbone intramedullary lengthening system is available through the FDA 510(k) clearance and under the CE Mark approval in European countries.
Last March, Orthofix acquired the FITBONE assets associated with the FITBONE intramedullary lengthening system. With this addition, Orthofix became the only orthopedic company with a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction.
With the latest development, Orthofix’s Global Extremities business is expected to receive a major boost.
More on Fitbone System
The Fitbone system is developed to offer precise and controlled limb lengthening and comprise of the implanted intramedullary nail, a subcutaneously implanted receiver, and an external control set that allows the patient or their caregiver to handle the distraction phase at home. The Fitbone system is available in a 9mm, 11mm and 13mm sizes to tackle the specific needs of patients.
The system has more than 3,500 cases performed in 15 countries since its development. It enables achievement of axial and torsional bone alignment intraoperatively, as part of the limb-lengthening procedure.
The system is compatible with the OrthoNext digital platform -- the only software tool in the market for deformity analysis and preoperative planning for pediatric and adult orthopedic procedures.
Significance of Fitbone System
Per personnel associated with the implant procedure, deformity correction and limb lengthening can be difficult to plan. The OrthoNext digital planning module helps to streamline the preoperative planning, particularly while using the Fitbone system in adolescent patients where the exact limb alignment is critical.
Recent Developments
In August 2021, Orthofix announced the first patient implant in M6-C artificial cervical disc two-level IDE Study. The clinical study will assess the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy.
In July 2021, Orthofix announced the launch and first patient implant with the fiberFUSE Strip -- an advanced demineralized fiber bone-graft solution containing cancellous bone. The fiberFUSE Strip is created as a convenient preformed bone-graft strip to facilitate optimized application for posterior cervical, posterior lumbar and degenerative spinal procedures.
Industry Prospects
Per a report by Markets And Markets, the global trauma products market is expected to reach $7.6 billion by 2025 from $5 billion in 2020, at a CAGR of 8.3%. Factors like increasing prevalence of degenerative bone diseases, growing incidence of sports injuries, and the rising number of road accidents and falls are expected to drive the market.
Price Performance
Shares of the company have gained 46% in a year’s time compared with the industry’s rise of 14%.
Zacks Rank and Other Key Picks
Currently, Orthofix carries a Zacks Rank #2 (Buy).
A few other similar-ranked stocks from the broader medical space are Envista Holdings Corporation (NVST - Free Report) , BellRing Brands, Inc. (BRBR - Free Report) and Henry Schein, Inc. (HSIC - Free Report) , each carrying a Zacks Rank #2. You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.
Envista Holdings has an estimated long-term earnings growth rate of 27%.
BellRing Brands has an estimated long-term earnings growth rate of 29%.
Henry Schein has a projected long-term earnings growth rate of 14%.