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Spine companies are at the forefront of novel technologies in orthopedics, with more than a handful receiving FDA’s Breakthrough Device Designation just this year.
FDA’s Breakthrough Devices Program is voluntary for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Through the program, FDA seeks to provide timely access to these solutions by speeding their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization.
Presently, there is no public database of products for which FDA has granted the designation; it’s up to companies to choose whether to announce their participation or designation status.
Within 2021, six spine companies did just that. Two designations were granted for vertebral body tethering devices, one for a biologic, one for a tensioning band and one each for a facet joint replacement and a nucleus replacement system.
Auctus Surgical | Auctus Dynamic Vertebral Body Tethering
About the product:
- A flexible alternative to complex fusion in the treatment of scoliosis
- Necessitates only one treatment event, using an external magnet controller for non-surgical adjustment of the spinal curvature over time
- Employs dynamic tension, prevents over-correction
- Compared to fusion, Auctus’ system has little impact on activity and appearance; fusion remains an unimpacted option if this treatment fails
About the company:
- Located in San Francisco, California, U.S.
- Portfolio company of incubator IntuitiveX
- Raising $1 million seed investment to lead to a $5 million series A for prototype iterations, cadaveric and animal testing, and mechanical testing
- Recently received U.S. Patent No. 11,065,037 B2, spinal curvature modulation systems and methods of the Auctus system
- Founding/Co-founding team members bring experience from CoAlign Innovations (sold to Stryker), Oratec Interventions (sold to Smith+Nephew)
Cerapedics Bone Graft in a Spinal Model
Cerapedics | P-15L Bone Graft for the Treatment of Degenerative Disc Disease (DDD)
About the product:
- P-15L Bone Graft is an autologous bone substitute based on a biomimetic small peptide (P-15) technology for the support of bone growth through cell attraction, attachment and activation
- The graft is undergoing study in the U.S. in ASPIRE, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal Investigational Device Exemption study to evaluate the product vs. autologous bone graft in transforaminal lumbar interbody fusion
- The study will include at least 270 patients with DDD at up to 36 clinical trial sites across the U.S.
Cerapedics plans to file a Premarket Approval submission with FDA with the study results
About the company:
- Headquartered in Westminster, Colorado, U.S.
- Leadership has years of experience at Biomet, DePuy AcroMed, Howmedica, LifeCell, Medtronic, Orthovita, Spinal Kinetics, SpineWave, Stryker Orthobiologics, Vertiflex, Zimmer Spine, etc.
Empirical Spine | LimiFlex Paraspinous Tension Band
About the product:
- Investigational device designed as an alternative to fusion for patients receiving surgical decompression for lumbar degenerative spondylolisthesis with spinal stenosis
- Does not involve any screws or bone grafts
- Potential benefits include less invasive and shorter surgery, improved intra- and post-operative outcomes, reduction or elimination of hospitalization length of stay, improved quality of life
- Procedure is suitable for outpatient or ambulatory surgery
- Received approval under the CE Mark in 2009 and has been implanted in over 2,000 European patients
About the company:
- Located in San Carlos, California, U.S.
- Has raised $10 million in funding over two rounds
- Leadership team has experience at Endius, Lanx, Simpirica Spine, Torrey Spine, Zimmer Spine
Premia Spine TOPS Device
Premia Spine | TOPS Facet Arthroplasty System
About the product:
- The first and only facet joint replacement system for the lumbar spine
- Developed to treat spinal stenosis or spondylolisthesis
- Currently the subject of a pivotal clinical trial under an Investigational Device Exemption from FDA
About the company:
- Headquartered in Netanya, Israel, with U.S. operations in Norwalk, Connecticut, U.S.
- Has raised $14.3 million in two rounds
Spinal Stabilization Technologies | PerQdisc Nucleus Replacement
About the product:
- Silicon-based alternative to spinal fusion or total disc replacement
- Reportedly the only commercially available lumbar nucleus replacement system in the world
- Replaces the nucleus pulposus of the intervertebral disc in the L1 – S1 spinal region in patients with single-level discogenic pain
- Redistributes the weight-bearing forces and mechanical properties of the disc in a more natural fashion
- Approved under the CE Mark, but not yet FDA-cleared
About the company:
- Development headquarters in Kilkenny, Ireland, with manufacturing in Westminster, Colorado, U.S.
- Since 2018, has raised $21.5 million in funding
Spino Modulation, a subsidiary of Spinologics | MIScoli Vertebral Body Tethering
About the product:
- An alternative to spinal fusion in the treatment of adolescent scoliosis
- Pivotal clinical trial underway in Canada
About the company:
- Spinologics, founded in 2010 by three spine surgeons, is based in Montreal, Quebec, Canada
