KUROS BIOSCIENCES AG Kuros Biosciences treats first patient in clinical trial of MagnetOs Putty
for posterolateral spine fusion
- First in a series of clinical trials comparing MagnetOs head-to-head against other bone grafts
- Reflects commitment to translating benchtop and preclinical data into proof in humans
- Primary endpoint is rate of posterolateral lumbar/thoracolumbar fusion assessed after 1 year
Schlieren (Zurich), Switzerland, April 13, 2021 - Kuros Biosciences (SIX: KURN) today announced it has treated the first patient in a prospectively designed, randomized controlled trial in the U.S. named PROOF, comparing MagnetOs Putty to autograft for posterolateral spine fusion.
This Level 1 quality trial - providing the highest level of clinical evidence - will be the first such U.S. clinical study of MagnetOs for spinal fusion. MagnetOs Putty will be implanted on one side of the spine and the control material, autograft, on the contralateral side, in what will be the first in a series of U.S. studies comparing MagnetOs directly to other bone grafts. A total of 30 patients will undergo a two-level instrumented posterolateral fusion (PLF) procedure.
An interim analysis will be performed once 15 patients have completed their Month 6 visit with available measurements for the endpoints. The primary endpoint is the rate of posterolateral lumbar/thoracolumbar fusion, assessed by CT-scan at Month 12.
Joost de Bruijn, Chief Executive Officer, said: "We are excited with the start of the clinical trial PROOF, as it aims to provide evidence to further differentiate MagnetOs and drive wider adoption in clinical practice across the globe. It is also an important step in our effort to improve spine fusion by bringing together an unprecedented blend of scientific, pre-clinical and clinical studies to make what can be an unpredictable process much more predictable. "
Kuros helps patients live fuller, more active lives by giving surgeons the technology they need to eliminate non-unions. MagnetOs bone graft achieves this with a unique surface design proven to unlock the untapped power of the body's immune system by growing new bone throughout the graft - for more predictable fusions.
Mokbel Chedid, MD, Principal Investigator at Henry Ford Hospital System - West Bloomfield MI, said: "Synthetic bone grafts have previously been sold on the premise of improved clinical outcomes based on data from the benchtop or preclinical setting alone. The PROOF study thus marks an important step in converting our ground-breaking research in the petri dish to Level 1 evidence of efficacy in humans, underlining Kuros's commitment to a translational research approach and to fund research in the field of spine surgery for the benefit of patients, surgeons and our wider society."
Click here for more details on the PROOF study.
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