Targeted & controlled bone healing
29 May 18
Kuros announces start of investigator-led study of MagnetOs Granules for maxillary sinus floor elevation

Schlieren (Zurich), Switzerland, May 29, 2018

Kuros announces start of investigator-led study of MagnetOs Granules for maxillary sinus floor elevation

Kuros Biosciences (SIX: KURN) announced today the start of an investigator-led study at University Medical Center (UMC) Utrecht, using MagnetOs Granules for maxillary sinus floor elevation with two-stage implant placement. Sinus floor elevation is performed to allow placement of dental implants in the maxilla, or upper jaw. It is most commonly performed when the floor of the sinus is too close to an area where dental implants are to be inserted.

The prospective clinical trial will compare MagnetOs Granules to autologous bone (autograft), harvested from the patient's own body, which is the current gold standard treatment. It is being conducted at the Department of Oral and Maxillofacial Surgery & Special Dentistry, UMC Utrecht and is designed as a controlled open-label, randomized non-inferiority trial with 30 patients. The primary outcome is assessment of effectiveness after 4-6 months. The first patients have already been treated.

 

Joost de Bruijn, Chief Executive Officer of Kuros, said: “We are very pleased to be taking part in this investigator-led study with the world-renowned Department of Oral and Maxillofacial Surgery at UMC Utrecht. There is a lot of interest from the clinical research community to study a variety of exciting applications in which our CE marked MagnetOs product can promote bone formation. These investigator-led studies expand the clinical evidence base of MagnetOs, and potentially support its positioning in additional therapeutic areas.”

 

Prof. Toine Rosenberg of the Dept. of Oral and Maxillofacial Surgery at UMC Utrecht, who is leading the study, said: “This is a valuable opportunity to assess promising osteoinductive granules that promote local bone formation, which could help make the delicate task of inserting dental implants easier and more successful. Success in this trial could have implications for multiple other potential applications.”

 

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

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Article
29 May 18
Kuros announces start of investigator-led study of MagnetOs Granules for maxillary sinus floor elevation

Schlieren (Zurich), Switzerland, May 29, 2018

Kuros announces start of investigator-led study of MagnetOs Granules for maxillary sinus floor elevation

Kuros Biosciences (SIX: KURN) announced today the start of an investigator-led study at University Medical Center (UMC) Utrecht, using MagnetOs Granules for maxillary sinus floor elevation with two-stage implant placement. Sinus floor elevation is performed to allow placement of dental implants in the maxilla, or upper jaw. It is most commonly performed when the floor of the sinus is too close to an area where dental implants are to be inserted.

The prospective clinical trial will compare MagnetOs Granules to autologous bone (autograft), harvested from the patient's own body, which is the current gold standard treatment. It is being conducted at the Department of Oral and Maxillofacial Surgery & Special Dentistry, UMC Utrecht and is designed as a controlled open-label, randomized non-inferiority trial with 30 patients. The primary outcome is assessment of effectiveness after 4-6 months. The first patients have already been treated.

 

Joost de Bruijn, Chief Executive Officer of Kuros, said: “We are very pleased to be taking part in this investigator-led study with the world-renowned Department of Oral and Maxillofacial Surgery at UMC Utrecht. There is a lot of interest from the clinical research community to study a variety of exciting applications in which our CE marked MagnetOs product can promote bone formation. These investigator-led studies expand the clinical evidence base of MagnetOs, and potentially support its positioning in additional therapeutic areas.”

 

Prof. Toine Rosenberg of the Dept. of Oral and Maxillofacial Surgery at UMC Utrecht, who is leading the study, said: “This is a valuable opportunity to assess promising osteoinductive granules that promote local bone formation, which could help make the delicate task of inserting dental implants easier and more successful. Success in this trial could have implications for multiple other potential applications.”

 

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.