25.06.2024 07:00:32 - dpa-AFX: EQS-News: Kuros Biosciences Announces Peer-Reviewed Publication of MagnetOs MAXA Level 1 Study Outcomes in Spine, Indicating Superiority Over Autograft (english)

Kuros Biosciences Announces Peer-Reviewed Publication of MagnetOs MAXA Level
1 Study Outcomes in Spine, Indicating Superiority Over Autograft


   Kuros Biosciences AG / Key word(s): Study results/Scientific
   publication
   Kuros Biosciences Announces Peer-Reviewed Publication
   of MagnetOs MAXA Level 1 Study Outcomes in Spine, Indicating
   Superiority Over Autograft
   25.06.2024 / 07:00 CET/CEST
     ____________________________________________________________


   
   Schlieren (Zurich), Switzerland, June 25, 2024 - Kuros
   Biosciences, a leader in next generation bone healing
   technologies, today announced the publication of a peer-reviewed
   manuscript that details the clinical data of its MAXA Level 1
   prospective, multi-center, randomized, intra-patient controlled
   clinical study in Spine^1.


   Published clinical results of "Efficacy of Biphasic Calcium
   Phosphate Ceramic with a Needle-shaped Surface Topography Versus
   Autograft in Instrumented Posterolateral Spinal Fusion: A
   Randomized Trial" include fusion data on 91 patients and 128
   segments with 1-year follow-up after surgery. As previously
   reported and now detailed in the peer-reviewed publication, the
   data demonstrates:
     * MagnetOs^TM effectiveness as a standalone* 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.


   "We are extremely pleased to share the results of the MAXA study
   with the medical community," said Moyo C. Kruyt, MD, PhD, lead
   researcher in the MAXA study. "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."


   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."


   The publication, which includes additional details such as study
   design, patient demographics, inclusion/exclusion criteria, and
   complications reported in the study, can be accessed on the Spine
   website and is also available on the Kuros Biosciences website.


   1.    Stempels, 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
   2.    Van Dijk, et al. eCM. 2021; 41:756-73.
   3.    Duan, et al. eCM. 2019; 37:60-73.
   4.    Van Dijk, et al. Clin Spine Surg. 2020;33(6): E276-E287.
   5.    Van Dijk, et al. JOR Spine. 2018 ; e1039
   6.    Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater.
   *MagnetOs was mixed with venous blood
   Results from in vivo laboratory testing may not be predictive of
   clinical experience in humans. For important safety and intended
   use information please visit kurosbio.com.
   MagnetOs is not cleared by the FDA or TGA as an osteoinductive
   bone graft.
   §MagnetOs has been proven to generate more predictable fusions
   than two commercially available alternatives in an ovine model of
   posterolateral fusion.


   About the MAXA Trial
   The MAXA study is a 100-patient multicenter, observer blinded,
   randomized, intra-patient controlled, non-inferiority trial with
   intra-patient comparisons. Adult patients qualifying for
   instrumented posterolateral spinal fusion of one to six levels in
   the thoracolumbar and lumbosacral region (T10-S2) with the use of
   autograft were included and posterolateral lumbar/thoracolumbar
   fusion was assessed by fine-cut CT-scan 12 months after surgery.
   According to a randomization scheme, MagnetOs was implanted on
   one side of the spine and the gold standard autograft (consisting
   of at least 50% bone harvested from the iliac crest mixed with
   local bone) was implanted on the other side of the spine. The
   investigators were blinded to the side assigned to the grafts
   until just prior to graft application.  Thereby, each patient
   serves as its own control. More details can be found at
   www.clinicaltrials.gov (NCT03625544). Fusion performance of
   MagnetOs was tested with a noninferiority margin of 15%.


   The MAXA clinical trial was funded via an unrestricted research
   grant from Kuros Biosciences.  Unrestricted research grants
   provide funding to clinical investigators with an interest in
   advancing the knowledge and understanding of certain
   technologies. These grants are donations in the form of flexible
   funding that can be directed toward whatever program, project, or
   expense the investigator chooses.
   About 'Spine'
   As the leading international journal in spine surgery, Spine
   publishes high-impact, peer-reviewed original research
   manuscripts. Spine is one of the top referenced journals in the
   field and is recognized for featuring new technology and
   innovative procedures and techniques.
   About MagnetOs
   MagnetOs is a bone graft like no other: thanks to its
   NeedleGrip^TM surface technology, it enables bone formation
   without added cells or growth factors. This surface technology
   provides traction for our body's vitally important 'pro-healing'
   immune cells (M2 macrophages). This in turn, unlocks previously
   untapped potential to stimulate stem cells - and form new bone
   throughout the graft. The growing body of science behind
   NeedleGrip is called osteoimmunology. But for surgeons and their
   patients it means one thing: a more predictable fusion. ^2-6§
   Indications statement
   Please refer to the instructions for use for your local region
   for a full list of indications, contraindications, warnings, and
   precautions.
   About Kuros Biosciences
   Kuros Biosciences is on a mission to discover, develop and
   deliver innovative biologic fusion technologies. With locations
   in the United States, Switzerland and the Netherlands, the
   company is listed on the SIX Swiss Exchange. The company's first
   commercial product, MagnetOs^TM, is a unique advanced bone graft
   that has already been used across three continents in 25,000
   fusion surgeries. For more information on the company and its
   products, visit kurosbio.com.
   Forward Looking Statements
   This media release contains certain forward-looking statements
   that involve risks and uncertainties that could cause actual
   results to be materially different from historical results or
   from any future results expressed or implied by such
   forward-looking statements. You are urged to consider statements
   that include the words "will" or "expect" or the negative of
   those words or other similar words to be uncertain and
   forward-looking. Factors that may cause actual results to differ
   materially from any future results expressed or implied by any
   forward-looking statements include scientific, business, economic
   and financial factors. Against the background of these
   uncertainties, readers should not rely on forward-looking
   statements. The Company assumes no responsibility for updating
   forward-looking statements or adapting them to future events or
   developments.


   For further information, please contact:
   Kuros Biosciences AG
   Daniel Geiger
   Chief Financial Officer
   Tel +41 44 733 47 41
   daniel.geiger@kurosbio.com Investors
   Gilmartin Group
   Vivian Cervantes
   Tel: +1 332.895.3220
   vivian.cervantes@gilmartinir.com


____________________________________________________________

   End of Media Release
     ____________________________________________________________


   Language:    English
   Company:     Kuros Biosciences AG
                Wagistrasse 25
                8952 Schlieren
                Switzerland
   Phone:       +41 44 733 4747
   Fax:         +41 44 733 4740
   E-mail:      info@kurosbio.com
   Internet:    www.kurosbio.com
   ISIN:        CH0325814116
   Valor:       32581411
   Listed:      SIX Swiss Exchange
   EQS News ID: 1930093



   End of News EQS News Service
     ____________________________________________________________


1930093 25.06.2024 CET/CEST

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