3Spine announced FDA Investigational Device Exemption (IDE) approval for their U.S. pivotal clinical trial. The company previously completed contracting and site initiation at 16 U.S. centers for a prospective real-world evidence (RWE) fusion study, which has been enrolling since May 2021. As sites complete enrollment of their RWE cohort, each center becomes eligible to participate in the IDE. 3Spine plans to complete enrollment of +/- 150 RWE patients to propensity match with +/- 150 IDE patients in an adaptive statistical design.
3Spine's MOTUS device, the implant used in the BalancedBack Total Joint Replacement procedure, is a "first of kind" technology replacing the function of the disc and facet joints through a posterior approach. The procedure broadly addresses leg pain, back pain and spinal instability, while correcting posture and restoring freedom of movement through reconstruction of the functional spinal unit. MOTUS was designated a Breakthrough Device by FDA in 2020.
"Breakthrough Device Designation was critical to our success in the IDE approval process," said Ron Yarbrough, Chief Operating Officer at 3Spine. "This project is the culmination of decades of technical and clinical research in the lumbar spine, and while the courage of pioneering patients and surgeons brought us to this point, today it is all about the tenacity and expertise of the FDA review team. Our interactive review with FDA over the past two years has resulted in comprehensive coverage of an unparalleled number of technical disciplines, reflecting the potentially transformational nature of this spine technology. We are very excited to begin IDE enrollment."
Earlier this year, the company announced $33 million raised in a Series C private offering. To date, 3Spine has raised a total of $52.3 million from private sources.