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13 May
Orthofix Medical's (OFIX) Telescopic Nail Gets FDA Clearance

Orthofix Medical Inc. OFIX recently announced the receipt of FDA 510(k) clearance to market its Rodeo Telescopic Nail.

The nail implant is likely to stabilize the patient’s limb while also elongating (or telescoping) to accommodate the natural growth of pediatric patients.

In the past six months, OFIX’s shares have gained 41.2% compared with the industry’s rise of 23.9%. The S&P 500 increased 16.2% in the same time frame.

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The Rodeo Telescopic Nail is a novel surgical tool designed to cure fractures or abnormalities in individuals with osteogenesis imperfecta (OI). In addition to telescoping to suit pediatric patients' natural growth, the nail implant stabilizes the patient's limb.

The frequency of OI is believed to be one in 10,000 births, and it affects both genders equally worldwide. A newborn with OI can have easily broken or malformed bones.

The Rodeo system is intended to address numerous biomechanical and procedural obstacles linked to existing OI telescopic rod systems. As the bone in OI patients is naturally brittle, the system’s innovative design offers the strength and stable bone fixation needed for successful implanting.

The implant procedure is streamlined, and the system’s instrumentation and sterile pack configurations aid in optimizing efficiency in the operating room (OR) and eliminate the need to sterilize trays for surgery, thereby reducing procedural costs, OR time, and risks of contamination.

The Rodeo Telescopic Nail is likely to be available soon at select institutions in the United States. It has been in clinical use in a limited number of European countries since 2022 with more than 170 surgeries performed to date.

Industry Prospects

Per a report by Coherent Market Insights, the global OI treatment market was valued at $722.8 million in 2023 and is expected to witness a growth rate of 2.4% from 2023 to 2030.

Given the market potential, Orthofix is likely to generate additional revenues from the sale of its Rodeo Telescopic Nail post FDA clearance.

Zacks Rank & Stocks to Consider

OFIX carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks in the broader medical space that have announced quarterly results are Align Technology, Inc. ALGN, Ecolab ECL and Boston Scientific Corporation BSX.

Align Technology, carrying a Zacks Rank of 2 (Buy), reported first-quarter 2024 adjusted EPS of $2.14, beating the Zacks Consensus Estimate by 8.1%. Revenues of $997.4 million outpaced the consensus mark by 2.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Align Technology has a long-term estimated growth rate of 6.9%. ALGN’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 5.9%.

Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 1.7%.

Ecolab’s shares have rallied 33.8% against the industry’s 9.3% decline in the past year.

Boston Scientific reported first-quarter 2024 adjusted EPS of 56 cents, beating the Zacks Consensus Estimate by 9.8%. Revenues of $3.86 billion surpassed the Zacks Consensus Estimate by 4.9%. It currently carries a Zacks Rank #2.

Boston Scientific has a long-term estimated growth rate of 12.5%. BSX’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 7.5%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.