Orthofix gets FDA clearance for bone transport system

LEWISVILLE, Texas - Orthofix Medical Inc. (NASDAQ:OFIX), a global medical technology company with a market capitalization of $648 million and healthy gross profit margins of nearly 70%, has announced the receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its TrueLok™ Elevate Transverse Bone Transport (TBT) System, along with the European CE Mark. According to InvestingPro analysis, the company’s stock is currently undervalued, suggesting potential upside for investors. This system offers a limb preservation option for patients with conditions like diabetic foot ulcers and nonhealing wounds.

The TrueLok Elevate system is the first dedicated system for TBT to be cleared by the FDA and is now available in a limited market release in the U.S. and select international markets. The device enables surgeons to create and gradually distract a bone segment in the tibia over several days to improve blood circulation and promote wound healing, potentially reducing the need for amputation.

Dr. Emmy Oji, a podiatric foot and ankle surgeon, noted clinical publications have demonstrated the effectiveness of this approach in diabetic foot cases. The system has already been applied to patients in Europe, with initial cases performed in the UK and Germany.

Diabetic-related complications result in over 160,000 amputations annually in the U.S., presenting a significant market opportunity. TrueLok Elevate could be a critical solution for this patient population, offering potential cost savings and life-preserving benefits. With revenue growth of 7.08% in the last twelve months and a strong current ratio of 2.57, InvestingPro data shows Orthofix is well-positioned to capitalize on this opportunity. For deeper insights into Orthofix’s market position and growth potential, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.

Patrick Fisher, President of Global Orthopedics at Orthofix, emphasized the company’s commitment to innovation in the limb reconstruction market. The TrueLok Elevate system aligns with Orthofix’s focus on limb preservation, deformity correction, lengthening, and complex fracture management.

The TrueLok Elevate system is part of the TrueLok family of external fixators, which includes the TrueLok EVO and TL-HEX™ ring fixation systems. For more information on these products, including indications and contraindications, Orthofix directs interested parties to the Instructions for Use or to contact a local representative.

Orthofix will showcase the TrueLok Elevate System at the upcoming American College of Foot & Ankle Surgeons (ACFAS) Annual Scientific Conference in Phoenix, AZ, from March 27-30.

This news article is based on a press release statement from Orthofix Medical Inc. and does not include any promotional content.

In other recent news, Orthofix Medical Inc. reported its fourth-quarter earnings, revealing a revenue of $215.7 million, which marks a 7.6% increase year-over-year and surpasses the consensus estimate of $212.7 million. The company’s adjusted EBITDA for the quarter also exceeded expectations at $23.9 million, driven by strong performance in the Global Orthopedics segment and BioStim. Orthofix has provided revenue guidance for fiscal year 2025, estimating between $818 million and $826 million, slightly below the Street’s projection of $847 million. This forecast reflects the discontinuation of certain product lines, which impacted revenue expectations.

In a separate development, Orthofix has expanded its Board of Directors by appointing finance expert Vickie Capps, enhancing its strategic capabilities. Additionally, Canaccord Genuity initiated coverage on Orthofix with a Buy rating and a price target of $24.00, citing the successful integration of SeaSpine and a promising product portfolio. The firm expressed optimism about Orthofix’s potential for above-market growth and margin expansion.

Meanwhile, BTIG maintained a Neutral rating on Orthofix, acknowledging the company’s progress but expressing caution about potential weak first-quarter sales for FY25. Despite challenges, Orthofix’s strategic initiatives and recent developments continue to draw attention from analysts and investors alike.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.