Kuros Biosciences Announces Three Advancements Related to its MagnetOsTM Portfolio Including Impressive Fusion Data from MAXA Prospective Randomized Clinical Trial and Two 510(k) Clearances from FDA - Seite 2

 
In the patients who were smokers, a fusion rate of 80% was observed with MagnetOs compared to just 32% with autograft, further demonstrating that MagnetOs should be the preferred choice for predictable fusions.
 
Professor Moyo Kruijt, Orthopedic Spine Surgeon at the University Medical Centre Utrecht, Netherlands, and Principal Investigator of the study, commented, “The first results from this level 1 study indicate excellent fusion rates for MagnetOs when used standalone. These fusion rates appear to exceed those of other bone graft substitutes we have previously studied in this indication.  We look forward to sharing the definitive numbers after full statistical analysis and peer review.”

Chris Fair, Chief Executive Officer of Kuros, commented, “This additional data from smokers in the MAXA clinical trial, showing more than twice the fusion rate when compared to autograft, provides even further support for MagnetOs as a standalone alternative to autograft in instrumented PLF procedures. This difficult study design was chosen to give surgeons greater confidence in our product and its ability to enable predictable fusions, even in a difficult-to-treat population of patients.”
  
The MAXA study is designed as a multi-center, observer-blinded, randomized, controlled, non-inferiority trial with intrapatient comparisons. This study compared MagnetOs standalone to autograft for posterolateral fusion. A challenging real-world population of patients requiring up to four-level instrumented posterolateral fusion (T10 – S2) were included, and lumbar/thoracolumbar fusion was assessed by CT-scan 12 months after surgery. Patients were randomized to have MagnetOs placed on one side of the spine and the gold standard autograft (at least 50% bone harvested from the iliac crest of the greater pelvis) on the other side of the spine, allowing each patient to act as its own control.
 
510(k) Clearances for MagnetOs Easypack Putty and MagnetOs Putty

MagnetOs Easypack Putty has become the second product in the MagnetOs portfolio to be cleared for use in the interbody space by FDA.  As a result, MagnetOs Easypack Putty can now be used in any interbody space (cervical, thoracolumbar); and packed into any cage approved for use with a bone void filler.