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
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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
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1930093 25.06.2024 CET/CEST