Company: OFIX
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0000950170-25-026066
Chunk: 90

Company: Orthofix Medical Inc.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1
Chunk 90
---
 be used for surgical planning and spinal navigation with the 7D FLASH Navigation System Spine Module. Traditional spine navigation requires a preoperative CT or intraoperative radiation for image acquisition and registration. 7D MRVision is the 

13

first and only solution that eliminates radiation from the entire navigation workflow. Further enhancements and new features to the Spine Module and Percutaneous Module are in development and are expected to launch in 2025.

In addition to these new products focused on spine, the FLASH Navigation Portfolio also includes our Cranial Module for use in cranial surgeries. The technology uses a completely contactless workflow, acquiring hundreds of thousands of virtual fiducials using the patient’s own anatomy, and results in nearly instantaneous cranial registrations to the skin or skull in almost any surgical position. In 2025, we anticipate the commercial launch of FLASH EVD, a new mobile bed-side navigational system leveraging 7D FLASH Technology designed for fast and reliable EVD placement. Cadaveric testing has been completed and FLASH EVD achieved FDA 510K clearance in December 2024.

Biologics — Regenerative Solutions 

Our biologics portfolio is focused on best-in-class bone grafting solutions from each of the major bone grafting categories - demineralized bone, cellular allografts, and synthetics. The breadth of the portfolio within each segment allows for a consultative approach with both physicians and hospitals to determine the best product based on clinical performance and price. 

Our largest portfolio of products is within DBMs, which includes both putty and fiber-based forms that provide different handling and performance based on clinical applications. Leading this portfolio are Strand Plus, 100% DBM Fiber with Accell, Evo3/Evo3c, and DBM putty with Accell. ABM is a key differentiator within the DBM market. This internally processed, proprietary technology is an open structured, dispersed form of DBM, which increases the bioavailability of bone proteins at an earlier time in the healing cascade. When combined with traditional DBM, it provides a biphasic release of growth factors to promote healing.

Our cellular allografts portfolio features a market-leading graft with Trinity Elite and recently released Virtuous Lyograft, both co-branded with MTF Biologics. Trinity Elite, an allograft with viable cells, has maintained position as a market leader with over a decade of clinical evidence and a series of peer-reviewed publications. Virtuous Lyograft is particularly unique in that it