OssDsign AB is sharing TOP FUSION study results showing its nanosynthetic bone graft, OssDsign Catalyst, achieves complete spinal fusion in patients after two years.

The data, soon to be published in the peer-reviewed journal, Biomedical Journal of Scientific & Technical Research, demonstrates that OssDsign Catalyst use leads to consistent and rapid bone healing and remodeling, resulting in improved patient outcomes.

“In spine fusion surgery, the core clinical goal is to stabilize the spine and relieve pain, which requires bridging bone to be formed. The newly published peer-reviewed data, demonstrating 100% fusion rate and improved quality of life outcomes, validates OssDsign Catalyst’s ability to form bridging bone consistently. These results not only strengthen our market position but reinforce OssDsign Catalyst’s status as a true game-changer in spinal surgery,” OssDsign CEO Morten Henneveld said.

OssDsign Catalyst is a nanosynthetic bone graft that shows rapid and robust bone formation, even in poorly vascularized environments. OssDsign Catalyst’s patented nanocrystalline structure and incorporated silicon ions, which mimics the body’s natural bone, enable bone formation in the fusion mass center. The result is a decreased non-union risk, making it highly applicable for both simple and complex patients.  

The TOP FUSION study enrolled 17 patients suffering from degenerative disc disease, degenerative spondylolisthesis, or lumbar spinal stenosis. The trial evaluated the safety and efficacy of OssDsign Catalyst in patients undergoing spinal transforaminal lumbar interbody fusion (TLIF) surgery. 

Post-operative follow-up, including computed tomography (CT) scans, occurred at three, six, 12, and 24 months to assess fusion progress. Medical Metrics Inc. independently reviewed the scans. Three patients recruited withdrew from the study for reasons unrelated to OssDsign Catalyst and the remaining 14 participants completed the follow-up 24 months after surgery.

Post-operative follow-up showed that four patients (29%) were fused at three months, nine patients (64%) fused at six months, 13 participants (93%) fused at 12 months and all TOP FUSION subjects achieved complete fusion at 24 months. All scores used to quantify pain and function, including the Oswestry Disability Index (ODI), visual analog scale (VAS), and overall health in patients (SF-36), showed improvement in quality of life over time at all post-operative follow-up evaluations. No device-related adverse events occurred during the study.

The TOP FUSION trial is a first-in-patient open-label, prospective, single-center clinical study led by Dr. Péter Pál Varga and Dr. Àron Lazary at the National Center for Spinal Disorders at the Buda Health Clinic in Budapest, Hungary. The study’s primary endpoint is assessed by the rate of bone fusion at 12 months by CT as well as the lack of device-related adverse events within the study period. TOP FUSION is a two-year study; a final follow-up was made at 24 months.

OssDsign develops and provides next-generation orthobiologics products. Based on cutting-edge material science, the company develops and markets products that support the body’s own healing capabilities. The company has a strong presence in the U.S. market.

* Reference: Accepted data on file.