Kuros Biosciences Announces Three Advancements Related to its MagnetOsTM

• New level 1 data from the MAXA Clinical Trial comparing standalone MagnetOs to the gold standard autograft in the challenging posterior spinal fusion approach, demonstrates a fusion rate of 78% versus 45% after one year
• In the difficult-to-treat patient population of smokers, MagnetOs demonstrates impressive 80% fusion rate compared to 32% fusion rate with autograft (intrapatient control)
• MagnetOs Easypack Putty becomes the second product in the MagnetOs portfolio to receive FDA clearance to market for interbody use
• MagnetOs Putty receives FDA clearance for standalone use and can now be used without the need for autograft

ZURICH, SWITZERLAND / ACCESSWIRE / January 4, 2024 / Kuros Biosciences, a leader in next generation bone graft technologies, announced today three advancements related to its MagnetOs portfolio of products: specifically positive results from the MAXA level 1 clinical trial comparing standalone MagnetOs to autograft in a real world patient population in the challenging posterolateral fusion procedure, and two 510(k) clearances from the U.S. Food and Drug Administration (FDA) related to its MagnetOs family of products.

New Data from MAXA Study

Kuros announced additional data from the MAXA level 1 clinical trial evaluating MagnetOs in a challenging posterior spinal fusion model compared to the gold standard autograft (containing at least 50% iliac bone crest), following initial data that was announced on December 27, 2023 . In this trial, MagnetOs was evaluated as a standalone alternative to autograft in an instrumented posterolateral fusion (PLF) model in 91 patients and a total of 130 segments. Notably, 20% of the patients in this study were smokers – an extremely challenging patient population when it comes to achieving fusion. In the 91 subjects that were analyzed after one year, a fusion rate of 78% was observed with MagnetOs compared to a 45% fusion rate with autograft (the intrapatient control), as evaluated by independent reviewers using fine-cut computed tomography (CT) scans.

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.

Additionally, MagnetOs Putty has been cleared for use either standalone or mixed with autograft. This 510(k) clearance expands the device’s indications to also allow use of the device on a standalone basis in the posterolateral spine, pelvis and extremities.

Chris Fair, Chief Executive Officer of Kuros, said: “We are…