3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today announced FDA Investigational Device Exemption (IDE) approval for their US pivotal clinical trial. The company previously completed contracting and site initiation at 16 US 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.
MCRA (Washington, DC) supported 3Spine through the study design and IDE approval process. “This is important, breakthrough technology for an underserved patient population,” said Justin Eggleton, Vice President of Spine Regulatory Affairs at MCRA. “The considerations for such a novel treatment required significant resources at FDA, and we appreciate the agency’s dedication to the review. The FDA review team carefully and thoughtfully challenged over 10,000 pages of biomechanical data, clinical history, and an exhaustive battery of non-clinical testing. FDA’s review establishes an important foundation for our project. MCRA is excited to partner with 3Spine as CRO for the IDE to strengthen the safety and effectiveness profile for our future pre-market approval application.”
“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.”
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 the Food and Drug Administration in 2020.
The BalancedBack Total Joint Replacement is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1 for skeletally mature patients due to symptomatic lumbar degeneration with or without foraminal or recess spinal stenosis confirmed by radiographic imaging (CT, MRI, X-rays), with no more than a Grade 1 spondylolisthesis at the involved level. Lumbar degeneration as defined as leg pain or neurologic symptoms with or without back pain due to reoccurring herniated nucleus pulposus, ligamentum flavum hypertrophy, facet degeneration, osteophyte formation, disc degeneration and/or annular degeneration, often causing spinal stenosis (radiculopathy, nerve root compression absent neurologic deficit, radiculitis, or neurogenic claudication). Prior to receiving the BalancedBack Total Joint Replacement, patients must have exhausted conservative (nonoperative) treatment for at least 3 months (opioid use, physical therapy, invasive cortisone anti-inflammatory medications) or be determined to have a neurologic emergency or intractable pain.
MCRA is the leading privately-held independent clinical research organization and advisory firm. The firm supports medical device and biologics clients with regulatory affairs, clinical research, reimbursement, compliance, quality assurance, and logistics. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and has served nearly 1,000 clients globally.
3Spine is a new kind of healthcare company founded to integrate the development, clinical research, and delivery of low back total joint replacement. 3Spine is headquartered in Chattanooga, TN, with research and development facilities in the Greater Boston area and clinical operations in the Cayman Islands. 3Spine has raised a total of $52.3mm to date from private sources.
FOLLOW US ON SOCIAL MEDIA | @ADRSPINE