Kuros Biosciences Releases MagnetOs MAXA Level 1 Study Outcomes

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:

• 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.

Chris Fair, Chief Executive Officer of Kuros, said, “Kuros is committed to supporting clinical research and providing evidence-based solutions for next generation bone healing technologies.  This study’s acceptance and publication in Spine is proof of that commitment.” Fair continued, “We commend Professor Kruyt and his team for their independent efforts and their desire to provide the spine community and their patients with a robust level 1 study that supports the use of MagnetOs for difficult to treat patients and highlights a viable alternative to autograft.”
 

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.0000000000005075
²MagnetOs was mixed with venous blood