The discs posed headwinds for Orthofix’s top-line growth in recent years, CFO Julie Andrews said in a Feb. 26 earning call transcribed by Seeking Alpha. Last year, the disc accounted for $23.4 million in sales, and revenue for M6 discs were highest in the first quarter of 2024.
Details about the discontinuation’s financial impact is expected in Orthofix’s first-quarter earnings call, Ms. Andrews said during the earnings call.
Spine surgeon Scott Blumenthal, MD, said he felt the move was a long time coming.
Researchers in Australia had found the M6-C disc led to complications and osteolysis in some cases, and those same issues were coming up in U.S. patients, Dr. Blumenthal, of Plano-based Texas Back Institute, told Becker’s.
A spokesperson for Orthofix echoed what was said in a Feb. 25 earnings news release, saying the discontinuation is part of Orthofix’s transformation toward its focus on spinal deformity, fixation and enabling technologies.
“We are proud of the rich legacy of the M6 artificial disc and its safety and clinical efficacy record, which has positively benefited patients with over 100,000 devices implanted through the years,” the spokesperson said in a Feb. 26 email to Becker’s. “This product discontinuation is in line with our Company’s strategy and is not being driven by clinical performance.”
