Proceeds from the financing will be used for a Phase 2 clinical study of the BalancedBack Total Joint Replacement in the United States
The device replaces the function of the disc and facet joints through a posterior approach. (Credit: PRNewswire/3Spine)
3Spine, a U.S. medical device company developing total joint replacement for the lumbar spine, has raised $33 million in an oversubscribed Series C private offering.
Proceeds from the financing will be used for a Phase 2 clinical study of the BalancedBack Total Joint Replacement in the United States. To date, the company has raised a total of $50.3 million from private investors.
3Spine’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.
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 3Spine technology is the only 1:1 replacement for lumbar spinal fusion, with an estimated annual U.S. addressable market size of over $5 billion.
MOTUS was designated a Breakthrough Device by the Food and Drug Administration in September 2020 and in January 2022, the American Medical Association assigned a CPT Code to track outpatient utilization 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-World Evidence (RWE) 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 led the offering. “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 Drs. Scott Hodges, Craig Humphreys, and Marc Peterman. The three share a long track record of innovation in spine care, with a focus on motion preservation. “Hips and knees are some of the most successful procedures in all of medicine,” said 3Spine CEO Marc Peterman.
“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.”
“I believe we now have the ‘holy grail’ of surgical spine care,” said Dr. Alex Sielatycki of Steamboat Springs, CO. “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 center their entire practices around MOTUS and spinal motion preservation. My patients want nothing less.”
Source: Company Press Release