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.
For further information, please contact:
Kuros Biosciences AG | LifeSci Advisors |
Michael Grau | Mary-Ann Chang |
Chief Financial Officer | Investors |
Tel +41 44 733 47 47 | +44 7483 284 853 |
michael.grau@kurosbio.com | mchang@lifesciadvisors.com |
About MagnetOs
MagnetOs bone graft has an advanced submicron surface topography that leads to the formation of bone in spinal fusion defects rather than scar tissue. In preclinical models, MagnetOs preferentially directs the body's early wound healing response toward the bone-forming pathway, an effect that is so potent that bone can be formed even in soft tissues without the need for added cells or growth factors. This ground-breaking research led to Kuros attaining an osteoinductive claim for MagnetOs in Europe and it is now supported by more than three years of clinical experience since its launch in the United Kingdom in May 2017. Results from in vitro or in vivo laboratory testing may not be predictive of clinical experience in humans. MagnetOs is not cleared by TGA or FDA as an osteoinductive bone graft.
Indications statement
U.S.: MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.
All markets: Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.
About Kuros Biosciences AG
Kuros Biosciences is a leader in next generation bone graft technologies for targeted and controlled bone healing. Kuros's bone graft substitute, MagnetOs, is commercialized in the U.S. and UK for use in posterolateral spinal fusions. Kuros's lead product in development, Fibrin PTH, a drug-biologic combination for spinal interbody fusion, has entered into a phase 2 clinical trial in the U.S. Kuros is located in Schlieren (Zurich), Switzerland, Bilthoven (The Netherlands) and Burlington (MA), U.S. The Company is listed according to the International Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visitwww.kurosbio.comfor additional information on Kuros, its science and product pipeline.
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.
