Orthofix Announces FDA 510(k) Clearance for the Rodeo Telescopic Nail

Rhea-AI Summary

Orthofix Medical Inc. (NASDAQ:OFIX) has received FDA 510(k) clearance to market its innovative Rodeo Telescopic Nail designed to treat deformities or fractures in patients with osteogenesis imperfecta. The device stabilizes limbs and accommodates natural growth in pediatric patients, addressing biomechanical challenges in a streamlined procedure. The system enhances bone fixation in fragile OI patients, optimizes operational efficiency, reduces costs, and lessens contamination risks. This marks Orthofix's dedication to serving the pediatric market with tailored solutions for conditions like OI.

Positive

• Orthofix received FDA clearance for its Rodeo Telescopic Nail, expanding its product portfolio and market reach.

• The device addresses biomechanical and procedural challenges in treating deformities or fractures in patients with osteogenesis imperfecta.

• The innovative design enhances bone fixation and streamlines the surgical procedure, improving patient outcomes.

• The system's instrumentation and sterile pack configurations optimize operational efficiency in the operating room, reducing costs and contamination risks.

Negative

• The U.S. market release of the Rodeo Telescopic Nail may impact revenue potential until broader adoption is achieved.

• The prevalence of osteogenesis imperfecta is relatively low, potentially limiting the immediate market demand for the device.

Medical Device Analyst

The FDA's 510(k) clearance is a pertinent step for Orthofix Medical Inc.'s expansion of the Rodeo Telescopic Nail, as it opens up the lucrative U.S. market for this unique medical device. The Rodeo nail is designed to address both biomechanical and procedural challenges faced by children with osteogenesis imperfecta. This kind of tailored innovation could see a favorable uptake due to the underserved nature of pediatric orthopedics, particularly for a condition like OI that has limited treatment options. Given the fact that the device is already in use in Europe with over 170 surgeries, this suggests a tested and potentially reliable product entering the U.S. The company's ability to streamline surgery procedures and reduce costs through the design of the Rodeo nail system can be appealing to healthcare providers. Additionally, the company's strategy of launching during National OI Awareness Week might boost visibility and adoption rates. A critical factor for investors to watch would be the rate of adoption in U.S. hospitals and the feedback from clinical use in the domestic setting.

Healthcare Market Analyst

Orthofix's strategic focus on products that serve niche markets, such as pediatric orthopedics for rare conditions like osteogenesis imperfecta, demonstrates a targeted approach that could potentially yield high margins. However, the addressable market size might be relatively small given the rare nature of OI. Moreover, successful market penetration will likely depend on the company's ability to effectively work with pediatric orthopedic surgeons and gain their endorsement. From an investment standpoint, the launch can be seen as a positive development, but the long-term impact on the company's revenue will be contingent upon broader adoption and possible expansion into other indications that the Rodeo nail may serve. Investors should also consider the competitive landscape and how Orthofix's offering compares in terms of cost and clinical outcomes.

Financial Analyst

The financial implications for Orthofix following the FDA clearance of the Rodeo Telescopic Nail could be significant. While initial costs associated with market entry and education may dampen short-term profitability, long-term gains could be achieved if the device gains traction within the U.S. Given Orthofix's established presence in the global spine and orthopedics market, distribution and manufacturing capabilities are likely already robust. Key factors that could influence the stock price include sales growth trajectory, any potential reimbursement challenges and operational efficiencies gained from the product's streamlined surgical process and reduction in contamination risk. As a retail investor, it is prudent to monitor the company's quarterly financials for indications of the Rodeo nail's revenue contribution, as well as listen to management commentary on market adoption and sales performance.

LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo^™ Telescopic Nail.

The Rodeo Telescopic Nail by Orthofix is an innovative device to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta. (Photo: Business Wire)

The Rodeo Telescopic Nail is an innovative device indicated to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta (OI). The nail implant serves to stabilize the patient’s limb while also elongating (or telescoping) to accommodate the natural growth of pediatric patients.

The Rodeo system is designed to address many of the biomechanical and procedural challenges associated with current OI telescopic rod systems. Specifically, its patented design provides the strength and reliable bone fixation required when implanting in the inherently fragile bone associated with OI patients. The implant procedure is streamlined and the system’s instrumentation and sterile pack configurations aid in optimizing efficiency in the operating room and eliminate the need to sterilize trays leading up to the surgery, thereby reducing procedural costs, O.R. time, and risks of contamination.

“The launch of the Rodeo Telescopic Nail represents Orthofix’s continued commitment to address the underserved pediatric market with specialized solutions tailored to the specific needs and unique conditions, such as OI, of this patient population,” said Kim Elting, President of Global Orthopedics. “The Rodeo system has been very well received in Europe, and we are pleased to be able to announce this limited U.S. market release during National OI Awareness Week and join in educating others about this genetic bone disorder that is present at birth.”

Often referred to as brittle bone disease, OI affects both males and females equally throughout the world with a prevalence estimated to be one in 10,000 births. A child born with OI may have bones that break easily or form abnormally. In more severe cases, it can involve hundreds of fractures that occur without apparent cause.

Orthofix will be exhibiting at the EPOSNA Annual Meeting (Booth #24) May 8-11 in National Harbor, Maryland, and featuring the Rodeo Telescopic Nail in an educational symposium entitled “Osteogenesis Imperfecta Disease: Shared Experiences on Different Techniques and the Latest Solutions.”

The Rodeo Telescopic Nail will be available soon at select institutions in the U.S.; it has been in clinical use in a limited number of European countries since 2022 with more than 170 surgeries performed to date.

For more information about Orthofix’s full portfolio of pediatric solutions, please visit OrthofixKids.com.

About Orthofix

Orthofix is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Its products are distributed in more than 60 countries worldwide.

The Company is headquartered in Lewisville, Texas, where it conducts general business, product development, medical education and manufacturing, and has primary offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined Company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Maidenhead, UK, Munich, Germany, Paris, France and São Paulo, Brazil.

Forward-Looking Statements

This news release may include forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” “continue” or other comparable terminology. Orthofix cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Each forward-looking statement contained in this news release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of robust clinical validation; and the risks identified under the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on March 5, 2024. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Orthofix does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240509384510/en/

Media Relations

Denise Landry

DeniseLandry@orthofix.com

214.937.2529



Investor Relations

Louisa Smith, Gilmartin Group

IR@orthofix.com

Source: Orthofix Medical Inc.

FAQ

What is the purpose of the Rodeo Telescopic Nail by Orthofix?

The Rodeo Telescopic Nail is designed to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta.

What are the benefits of the Rodeo Telescopic Nail system?

The system stabilizes limbs, accommodates natural growth in pediatric patients, enhances bone fixation, and streamlines the surgical procedure, reducing costs and contamination risks.

Where will the Rodeo Telescopic Nail be available?

The device will be available soon at select institutions in the U.S. after being in clinical use in a number of European countries.