Biologics

Kuros Biosciences announces start of randomized controlled trial of MagnetOs in spinal fusion Study should further enhance competitive positioning of MagnetOs

Schlieren (Zurich), Switzerland, June 12, 2018

Kuros announced today that the University Medical Center Utrecht (UMCU) in the Netherlands has obtained approval from its ethical committee to start an investigator-led multicenter study comparing MagnetOs with autologous bone in posterolateral spinal fusion.

The study is entitled “A Randomized Controlled Trial of MagnetOs® granules vs. Autograft in Instrumented Posterolateral Spinal Fusion”, with UMCU as principal investigator. UMCU’s Department of Orthopedics is one of the foremost orthopedic clinical research centers in the world. The primary objective is to demonstrate non-inferiority with regard to efficacy and safety of MagnetOs compared to the current gold standard, autograft, harvested from the patient’s own body, in instrumented posterolateral spinal fusion.

The first patients are expected to be enrolled in H2 2018.  

Joost de Bruijn, Chief Executive Officer of Kuros, said: “Spinal fusion is the focus of Kuros’s commercial activity, and this study is expected to generate valuable data to help further differentiate MagnetOs in the bone graft substitute market. It is part of the Kuros philosophy ‘proof what you claim’ and should enhance our competitive positioning.”

Dr. Moyo Kruyt of UMCU, principal investigator of the study said: “We are excited about the prospects of MagnetOs in this study as the solid science underlying MagnetOs has already shown powerful bone generating properties of calcium phosphates with a submicron topography. Replacing patient-own bone with a product like MagnetOs would provide a real clinical benefit.”

Spinal fusion is currently performed by using large amounts of autologous bone graft. A substitute for a patient’s own bone would eliminate the graft harvesting morbidity and associated pain that is one of the main disadvantages of this approach.

About the study

This study is designed as a patient and observer blinded, controlled, randomized, multicenter clinical trial across five centers with intra-patient comparisons. One hundred adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will be recruited and enrolled in this study. Primary endpoint is  posterior spinal fusion rate after one year based on CT-scans.

 MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

For further information, please contact:

Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47

michael.grau@kurosbio.com

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, 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.

 
News release (pdf)

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren
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Drue De Angelis

Drue is Managing Partner for The De Angelis Group, Executive Search firm exclusively for the Ortho & Spine industry.

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