OrthoPediatrics Broadens Its Reach with Robotic ENT Approval

OrthoPediatrics US68752L1008

OrthoPediatrics is strategically expanding its technological portfolio beyond its core orthopedic focus. A recent regulatory clearance from the U.S. Food and Drug Administration (FDA) for a robotic system in cochlear implant surgery marks a significant step into adjacent medical specialties. This move aims to leverage the company's existing commercial infrastructure to drive long-term growth diversification.

The company's expansion coincides with strong preliminary financial results for the 2025 fiscal year. Management reported unaudited net revenue of approximately $236.1 million, representing a 15% year-over-year increase. The fourth quarter was particularly robust, with sales reaching $61.3 million, a 16% gain. During that same quarter, OrthoPediatrics generated free cash flow in the range of $6.0 to $7.0 million.

Looking ahead, leadership has provided an outlook for 2026. They are targeting total revenue between $262 million and $266 million, which would equate to growth of 11% to 13%. The company also forecasts an adjusted EBITDA of around $25 million for the coming year.

A Strategic Entry into Otolaryngology

The key development enabling this expansion is the FDA's mid-January clearance of the iotaSOFT system for use in school-aged children. This technology, distributed in collaboration with iotaMotion, facilitates standardized, robot-assisted procedures for inner ear cochlear implantation. By addressing patients as young as four years old, OrthoPediatrics is entering a new, specialized surgical niche.

This foray into ENT (ear, nose, and throat) medicine is not an isolated event but part of a deliberate long-term strategy. The objective is to build a capital-light business model where digital solutions and robotic assistance platforms diversify revenue streams. This approach is designed to reduce reliance on traditional orthopedic implant sales over time.

Regulatory Progress in the European Market

Alongside its U.S. advancements, OrthoPediatrics has also achieved important regulatory milestones in Europe. The company has secured necessary EUMDR certifications for several products within its spine and trauma categories. These clearances are critical for securing and expanding the commercial footprint across European markets.

The publication of the final, audited financial results for fiscal year 2025 is scheduled for late February or early March of 2026. These figures will offer clearer insight into the initial financial contribution of the company's newer technological initiatives.

The core data points:
* Received FDA clearance for its robotic cochlear insertion system.
* Preliminary 2025 revenue rose to $236.1 million, a 15% increase.
* The 2026 forecast anticipates revenue growth of up to 13%.