Company: OFIX
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0000950170-25-026066
Chunk: 91

Company: Orthofix Medical Inc.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1
Chunk 91
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 is a first-of-its-kind, shelf-stable cellular allograft for spine and orthopedic procedures provided in a room-temperature, ready-to-use, moldable form.

Regarding synthetic solutions, our focus products are Cove and Mozaik. Cove, an advanced bioactive synthetic, is the newest introduction into this segment. Cove has a unique surface topography of the β-TCP and HA granule and has demonstrated the ability to grow bone in a muscle pouch. Additionally, Cove has handling characteristics ideal for ensuring graft placement remains where it is needed. The combination of Cove and Mozaik provides different value options within this portfolio to meet varying customer needs.

In addition to each of the major categories, we have continued to invest in products that address specific procedural and clinical needs. Our solutions address many of the issues that physicians see with graft delivery and containment within the surgical site. Several of our solutions address this through handling characteristics of product, shape and design, instrumentation to aid delivery, or even added materials to aid in graft containment. All of these solutions are to improve the ease of use and consistency of our products while driving better clinical outcomes. 

We receive marketing fees through our collaboration with MTF Biologics for Virtuous, Trinity Elite, FiberFuse, and certain other tissues. MTF Biologics processes the tissues, maintains inventory, and invoices hospitals, surgery centers, and other points of care for service fees, which are submitted by customers via purchase orders. We have exclusive worldwide rights to market the Virtuous and Trinity Elite, and exclusive rights to market the FiberFuse tissues in the U.S. 

Our other leading tissue forms and synthetics such as, Strand Plus, Strand, Evo3, Evo3c, Ballast, Cove, and Mozaik are all processed internally through IsoTis Orthobiologics. This completely integrated business unit allows for a continuous feedback cycle with research and development, marketing, manufacturing, and quality to ensure high-quality products delivered with consistent customer fulfillment.

To date, our Biologics products are offered primarily in the U.S. market, due in part to restrictions on providing U.S. human donor tissue and bovine collagen in certain countries. 

Global Spine Future Product Applications

We remain very active with multiple internal developments to support new technology commercialization efforts. These new technologies apply to both the cervical and thoracolumbar spinal anatomy. We expect that the contribution of new, internally developed technologies and any future external acquisitions will be the primary driver of future growth. 

Regarding our Bone