3Spine has raised US$33 million in an oversubscribed Series C private offering, the proceeds of which will be used to fund a Phase 2 clinical study of its BalancedBack total joint replacement procedure in the USA.
The company’s MOTUS device, the implant used in the BalancedBack total joint replacement procedure, replaces the function of the disc and facet joints through a posterior approach.
According to 3Spine, the procedure broadly addresses leg pain, back pain, and spinal instability, while correcting posture and restoring freedom of movement by reconstructing the functional spinal unit. The company states that its technology is the only 1:1 replacement for lumbar spinal fusion.
MOTUS received breakthrough device designation by the US Food and Drug Administration (FDA) in September 2020 and in January 2022, the American Medical Association assigned a CPT code to track outpatient utilisation of lumbar total joint replacement as a new procedure.
Phase 1 clinical outcomes are published and 3Spine is currently enrolling a 150-patient prospective real-word evidence study at 16 clinical sites across 11 states. The company is additionally enrolling three prospective longitudinal cohorts outside of the United States for single-level disease, two-level disease, and joint replacement adjacent to existing fusion constructs. 3Spine anticipates Investigative Device Exemption (IDE) approval in early Q2.
Healthcare investor Byron DeFoor, who led the offering, said: “I have watched this technology mature over 15 years to this point where it is now one of the most researched biomechanical devices in the history of spinal surgery.
“The capital we have raised through private sources is a testament to the opportunity. Like many people in America, I have personal experience with spinal fusion. We can do better. 3Spine’s motion-based approach has the ability to improve the daily lives of millions of people.”
3Spine was founded by Scott Hodges, Craig Humphreys, and Marc Peterman. Peterman, the company’s CEO, commented: “Hips and knees are some of the most successful procedures in all of medicine. It’s common sense to develop a total joint for the low back, but this is a very hard technical challenge. Scott and Craig have refined this transformational concept to be reproducible and teachable.”
Spine surgeon, Alex Sielatycki (Steamboat Springs, USA), added: “I believe we now have the ‘holy grail’ of surgical spine care. Our published Phase 1 clinical results are truly remarkable, and I am excited to participate in Phase 2 as an IDE site. I fully expect that the next generation of spine surgeons will centre their entire practices around MOTUS and spinal motion preservation. My patients want nothing less.”
To date the company has raised a total of US$50.3 million from private investors.