Business Description

Overview We are a leader in developing innovative procedural solutions for compromised bone, grounded in expertise in biomechanical design and anatomy-specific innovation. As pioneers of minimally invasive treatment for sacroiliac joint dysfunction and degeneration, we have developed a deep competency in addressing the challenges of low-density bone in the sacrum. With our additive manufacturing, or 3D-printing, experience developed in sacroiliac fusion, we have established a technology platform that now extends to meet critical unmet needs in thoracolumbar fixation and fusion and pelvic trauma. We market our products primarily with a direct sales force as well as a number of third-party sales agents in the United States, and with a combination of a direct sales force, sales agents and resellers in other countries. As of December 31, 2025, over 140,000 procedures have been performed using our products since we introduced iFuse in 2009. Product and Applications Our products include a series of patented titanium implants and the instruments used to implant them, as well as implantable bone products. Since launching our first generation iFuse in 2009, we have launched multiple implant product lines, including iFuse 3D in 2017, iFuse TORQ in 2021, iFuse Bedrock Granite in 2022, and iFuse INTRA and iFuse TORQ TNT in 2024. In the United States, iFuse, iFuse 3D, iFuse TORQ and iFuse Bedrock Granite have clearances for applications in sacroiliac joint dysfunction, adult spinal deformity and pelvic trauma. iFuse TORQ TNT has clearances for applications in pelvic trauma and sacroiliac joint dysfunction. In the European Economic Areas, iFuse, iFuse 3D and iFuse TORQ have been CE marked for applications in sacroiliac joint dysfunction, adult spinal deformity and pelvic fracture fixation. 5 Product Description Market Regulatory Authorization Regulatory Authorization Date Breakthrough Device Designation ("BDD") iFuse Machined triangular titanium implant with a triangular cross section and porous surface that stabilizes the joint and facilitates biologic fixation of the bone onto the implant to drive fusion. United States (FDA) November 2008 — European Union (CE-Marked) November 2010 — iFuse 3D Second generation, additively-manufactured triangular titanium implant with a porous surface and fenestrated design to self-harvest bone. United States (FDA) March 2017 — European Union (CE-Marked) May 2017 — iFuse Bone (1) Implant manufactured from sterilized recovered cadaveric bone tissue to support and augment the patient's own bone tissue in orthopedic procedures. — — — iFuse TORQ Additively-manufactured threaded implants designed to allow for osteointegration, or incorporation of the bone in the implant's porous surface and structure. United States (FDA) February 2021 — European Union (CE-Marked) March 2025 — iFuse Bedrock Granite (2) Additively-manufactured implant with a machined titanium core and a tulip that attaches to the rod and provides fusion and fixation to the sacroiliac joint as foundational element for segmental spinal fusion. United States (FDA) May 2022 Yes iFuse TORQ TNT (3) A porous threaded design with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum, and through the contralateral ilium. United States (FDA) August 2024 Yes (1) In February 2024 we expanded the platform with the launch of iFuse INTRA / INTRA X, which we believe is the only percutaneous intra-articular implant available for physicians seeking solutions for stabilization and/or fusion. (2) Based on the implant's ability to drive fusion and fixation, iFuse Bedrock Granite is designated by the FDA as a breakthrough device. The BDD was based on the FDA's recognition of iFuse Bedrock Granite as a new technology that can provide substantial clinical improvement over already available therapies. In January 2024, we received FDA clearance for a smaller diameter (9.5mm) iFuse Bedrock Granite implant with both an expanded indication that covers pediatric patients and an expanded application that includes use in the S1 trajectory. This smaller diameter iFuse Bedrock Granite is also designated by the FDA as a breakthrough device.…