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Orthofix JuniOrtho Plating System Gets Regulatory Clearances

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Orthofix Medical Inc. (OFIX - Free Report) recently announced the receipt of the FDA’s 510(k) clearance as well as the CE Mark approval for its JuniOrtho Plating System. Notably, the fixation system, which has been specifically created for pediatric patients, has been engineered to address the issues of advanced deformity and trauma reconstruction of the lower extremities.

Per the medical fraternity, the rapid and extensive technological advancements in deformity corrections will help benefit children with deformities across the globe through corrective surgeries.

For investors’ note, the JuniOrtho Plating System is part of the JuniOrtho line of pediatric solutions, which includes the TL-HEX system, TrueLok Ring Fixation System and eight-Plate Guided Growth System+.

With the recent clearances, Orthofix’s Global Extremities business is expected to receive a major boost.

Significance of the Approvals

Per management, the JuniOrtho Plating System will now offer both an internal and external fixation systems to surgeons, thus expanding its portfolio of pediatric deformity care solutions. Orthofix believes the system will be able to address the surgical requirements of pediatric patients of all ages, advancing the company’s pediatric orthopedics portfolio.

The JuniOrtho Plating System has been designed to reduce the contamination risk and optimize efficiency during procedures.

Notably, a pre-operative planning software option that streamlines the implant selection before the surgical procedure complements the JuniOrtho Plating System. The platform enables the surgeon to accurately plan the corrective surgery. The software has been specifically developed to be used in combination with the JuniOrtho Plating System and is currently available in Europe. The U.S. release has been planned later this year.

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.

Given the market potential, the dual regulatory approvals are expected to boost the company’s business.

Recent Developments

Of late, Orthofix has been witnessing a few developments across its business arms.

The company, in June, announced the receipt of the FDA’s 510(k) clearance as well as the first patient implants of the FIREBIRD Sacroiliac (“SI”) Fusion System. Notably, the FIREBIRD SI Fusion System is the first 3D printed titanium bone screw to be launched in the United States for treating SI joint dysfunction.

During its first-quarter 2020 earnings call in May, the company confirmed that its Motion Preservation Solutions recorded impressive sales growth driven by M6 artificial discs. Notably, the adverse revenue impacts of M6 resulting from the pandemic was less than other product lines.

In March, Orthofix announced the completion of asset acquisition associated with the FITBONE intramedullary lengthening system for the femur and tibia bones.

Price Performance

Shares of the company have lost 2.4% in the past three months against the industry’s 20.8% growth and the S&P 500's 15.5% rise.



 

Zacks Rank & Stocks to Consider

Currently, Orthofix carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Quest Diagnostics Incorporated (DGX - Free Report) , Laboratory Corporation of America Holdings (LH - Free Report) or LabCorp and QIAGEN N.V. (QGEN - Free Report) .

Quest Diagnostics’ long-term earnings growth rate is projected at 13.2%. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

LabCorp’s long-term earnings growth rate is estimated at 7.5%. The company presently sports a Zacks Rank #1.

QIAGEN’s long-term earnings growth rate is estimated at 22.3%. It currently flaunts a Zacks Rank #1.

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