OrthoPediatrics announces Femur pediatric nailing platform FDA nod, Q1 earnings

OrthoPediatrics this week announced it won FDA 510(k) clearance for its Femur pediatric nailing platform and released its first quarter earnings, beating sales consensus but missing on loss-per-share expectations on Wall Street.

The Warsaw, Ind.-based company’s Femur system is designed to accompany two pediatric-specific nail offerings, and is an upgrade to an earlier version of the device. OrthoPediatrics said the clearance of the device is the “next step” in the evolution of its intramedullary nailing franchise.

“Our team is excited about the pediatric nailing platform. We worked alongside pediatric orthopedic surgeons to create a system which features dedicated child and adolescent offerings, enhanced fixation options, and state-of-the-art instrumentation. The new platform will allow surgeons to treat a wider range of children and pathologies and serve as the foundation for future intramedullary nailing endeavors,” trauma and deformity correction engineering director Dr. Luis Vega said in a press release.

OrthoPediatrics posted losses of $5 million, or 41¢ per share, on sales of $12.1 million for the three months ended March 31, seeing losses grow 289.1% while sales grew 23.9% compared with the same period during the previous year.

Losses-per-share were just behind the 30¢ consensus on Wall Street, where analysts expected to see sales of $11.5 million, which the company topped.

“We are very pleased by our solid start to the year with greater than anticipated first quarter revenue growth of 24%. Since becoming a public company last October, we have exceeded anticipated growth in every quarter. While all of our product lines contributed, strong domestic scoliosis sales continued to outpace the industry, further establishing our leading market position in pediatric orthopedics. In addition, we significantly increased our investment in consignment sets to $5.5 million and R&D by 77%, which helped support the FDA 510(k) clearance of our pediatric nailing platform | Femur. These investments will further enable our expanding sales force to drive future growth. Once again, we are honored to be recognized as one of the 100 best places to work in Indiana, which validates our culture and its commitment to transforming the lives of children around the world with orthopedic conditions,” CEO Mark Throdahl said in a press release.

Shares in OrthoPediatrics have fallen 1.3% today, at $19.08 as of 2:13 p.m. EDT.

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