Kuros Biosciences Announces Results from Two Prospective Randomized Clinical Trials: STRUCTURE and MAXA

In This Article:

  • In the MAXA trial, standalone MagnetOs outperformed the gold standard autograft by 73% in posterior spinal fusion in a difficult-to-treat real life patient population (20% smokers). In the STRUCTURE trial, MagnetOs mixed with autograft showed posterolateral fusion rates comparable to autograft fusion rates in the less challenging interbody space

  • In the STRUCTURE trial, according to an interim analysis, Fibrin-PTH did not outperform autograft for interbody fusion, although patients showed excellent clinical outcomes

  • Considering the outstanding clinical results of MagnetOs in the MAXA and STRUCTURE trials, and the recent FDA interbody clearance, Kuros has decided not to proceed to Phase 3 with Fibrin-PTH and focus its resources on MagnetOs

  • Focusing on the MagnetOs program will result in lower development costs and lower expenses in the near-term, extending Kuros' cash runway, while still addressing a $2.4Bn annual bone graft market similar to that originally anticipated for both MagnetOs and Fibrin-PTH together

SCHLIEREN (ZURICH), SWITZERLAND / ACCESSWIRE / December 27, 2023 / Kuros Biosciences, a leader in next generation bone graft technologies, today announced results from two prospective, randomized clinical studies - the STRUCTURE and MAXA trials. In the MAXA trial, MagnetOs showed a 73% higher fusion rate relative to autograft in the challenging posterolateral space.In the STRUCTURE trial, Fibrin-PTH, while demonstrating excellent clinical outcomes, showed fusion rates comparable to autograft in the less challenging interbody space.As a result, Kuros will focus its resources to amplify the continued commercialization of its MagnetOs bone graft family of products.

The MAXA trial is an observer-blinded, randomized, intra-patient controlled, multi-center clinical trial which compared MagnetOs standalone to autograft for posterolateral fusion. The STRUCTURE trial is investigating the safety and efficacy of Fibrin-PTH (KUR-113) in single-level transforaminal lumbar interbody fusion (TLIF) procedures, compared to local autograft in the interbody space. Both treatment groups underwent concomitant posterolateral fusion with MagnetOs mixed with local autograft.

MAXA Study Results

The MAXA study is designed as a 100-patient, multi-center, observer-blinded, randomized, controlled, non-inferiority trial with intrapatient comparisons. This study compared MagnetOs standalone to autograft for posterolateral fusion. 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 either MagnetOs or the gold standard autograft (at least 50% bone harvested from the iliac crest of the greater pelvis) implanted on one side of the spine.