Targeted & controlled bone healing
12 Jun 18
Kuros Biosciences announces start of of randomized controlled trial of MagnetOs in spinal fusion Study should further enhance competitive positioning of MagnetOs

Schlieren (Zurich), Switzerland, June 12, 2018

Kuros Biosciences announces start of of randomized controlled trial of MagnetOs in spinal fusion

Study should further enhance competitive positioning of MagnetOs

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.



Kuros Biosciences AG
Wagistrasse 25, 8952 Schlieren, Switzerland
Tel: +41 44 733 47 47   Fax: +41 44 733 47 40   Email: info@kurosbio.com

About Kuros

  1. Overview
  2. Executive Committee
  3. Board
  4. Careers

Products

  1. MagnetOs

Pipeline

  1. Pipeline
  2. Spinal fusion
    KUR-113
  3. Fracture repair
    KUR-111
    KUR-113
  4. Surgical Sealants
    Neuroseal (KUR-023)

Technologies

  1. Surface Science Technology
  2. Fibrin-Based
  3. Synthetic Cross-Linking Technology
  4. Immune Modulation

Partnerships

  1. Collaborations
  2. Business Development

Investors

  1. Share price
  2. Regulatory filings
  3. Reports & Presentations
  4. Calendar
  5. Corporate governance
  6. Stay informed

News

  1. Press releases
  2. Conferences & Events

Contact

  1. Location
Article
12 Jun 18
Kuros Biosciences announces start of of randomized controlled trial of MagnetOs in spinal fusion Study should further enhance competitive positioning of MagnetOs

Schlieren (Zurich), Switzerland, June 12, 2018

Kuros Biosciences announces start of of randomized controlled trial of MagnetOs in spinal fusion

Study should further enhance competitive positioning of MagnetOs

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.