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

Kuros Biosciences AG / Key word(s): Study results/Preliminary Results 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 04.01.2024 / 07:00 CET/CEST 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

Schlieren (Zurich), Switzerland, 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.