Spine devicemaker Orthofix has had a busy 2025. Here are 10 headlines to know:
1. Vickie Capps joined Orthofix’s board of directors. She has extensive experience in finance and executive leadership and is on the board for other companies including Amedisys, Janux Therapeutics and Breg. She previously was on NuVasive’s board of directors.
2. Orthofix’s TrueLok Elevate transverse bone transplant system earned FDA 510(k) clearance and CE Mark from the European Union. TrueLok Elevate is designed for limb preservation and addresses bony or soft tissue deformities.
3. Orthofix CEO Massimo Calafiore saw total compensation of $10.6 million in 2024, according to an April 20 proxy filing.
4. Orthofix’s first quarter sales, including its recently discontinued M6-C and M6-L disc, were $193.6 million. Excluding M6 sales, Orthofix’s quarterly revenue grew 3.9% with $189.2 million.
5. In February, Orthofix announced plans to discontinue the M6 disc replacement line. Orthofix expects a one-time restructuring cost of $8 million mostly linked to the closure of a dedicated manufacturing facility in California, CFO Julie Andrews said in a May 6 earnings call.
6. Orthofix’s TrueLok Elevate was launched commercially. TrueLok Elevate is the first commercially available device in the U.S. with a patented design for transverse bone transport, according to a news release. It is used for limb preservation and addresses bony or soft tissue deformities or defects.
7. So far in 2025, U.S. installments of Orthofix’s 7D Flash navigation system increased 66% year over year, CEO Massimo Calafiore said during an Aug. 5 earnings call.
8. Orthofix earned FDA 510(k) clearance for its new Virata spinal fixation system, and a limited launch was initiated in the U.S. Virata is designed to integrate with 7D Flash, and more than 80% of surgeons participating in the limited launch represent new or incremental business.
9. Orthofix and SMAIO inked a new distribution agreement for the open platform, KEOPS-4ME. The KEOPS-4ME is designed for complex spine surgery and combines data analytics, 3D surgical planning and the use of patient-specific K-rods.
10. Orthofix saw net sales of $205.6 million in the third quarter, a 5% increase year over year.
