Rachel Klemovitch, Assistant Editor06.25.24
Kuros Biosciences has published a peer-reviewed manuscript that details the clinical data of its MAXA Level 1 prospective, multi-center, randomized, intra-patient controlled clinical study in Spine1.
“We are extremely pleased to share the results of the MAXA study with the medical community. The MAXA study demonstrates for the first time that an advanced synthetic bone substitute likely performs better than the current gold standard autograft in a challenging posterolateral fusion location,” said Moyo C. Kruyt, MD, PhD, lead researcher in the MAXA study.
Clinical results include fusion data on 91 patients and 128 segments with 1-year follow-up after surgery from the company’s "Efficacy of Biphasic Calcium Phosphate Ceramic with a Needle-shaped Surface Topography Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Randomized Trial".
Data shows:
2MagnetOs was mixed with venous blood
“We are extremely pleased to share the results of the MAXA study with the medical community. The MAXA study demonstrates for the first time that an advanced synthetic bone substitute likely performs better than the current gold standard autograft in a challenging posterolateral fusion location,” said Moyo C. Kruyt, MD, PhD, lead researcher in the MAXA study.
Clinical results include fusion data on 91 patients and 128 segments with 1-year follow-up after surgery from the company’s "Efficacy of Biphasic Calcium Phosphate Ceramic with a Needle-shaped Surface Topography Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Randomized Trial".
Data shows:
- MagnetOs’s effectiveness as a standalone2 alternative to autograft in challenging posterolateral fusions (PLF);
- Nearly double the fusion rate as compared to autograft in PLF, showing a 79% overall fusion rate with MagnetOs as independently measured with fine-cut CT, compared to 47% for autograft, which included difficult-to-treat patients of current and former smokers (n=19 and 35 respectively); and
- Noninferiority of MagnetOs versus autograft per study design, with primary outcome analysis even indicating MagnetOs superiority.
References:
1Stempels, H. et al., "Efficacy of biphasic calcium phosphate ceramic with a needle-shaped surface topography versus autograft in instrumented posterolateral spinal fusion: A randomized trial." Spine. June 17, 2024. https://doi.org/10.1097/BRS.00000000000050752MagnetOs was mixed with venous blood