Scil Technology Announces Positive Results in Preclinical Study of its Lead Dental Bone Augmentation Material

MARTINSRIED, Germany

, June 09, 2005 - 

Scil Technology, a biopharmaceutical company focused on the development of dental and orthopaedic tissue regeneration products, today announced that it has successfully concluded preclinical studies with its lead regenerative dental bone augmentation material, MD05.

This study compared the osteoinductive bone substitute MD05 with conventional bone substitutes in the reconstruction of defects in the cranio-maxillofacial region. The results demonstrated that MD05 was highly superior to the conventional bone substitutes with respect to the formation of new bone and bone marrow and can be favourably positioned in the dental bone augmentation market:

• MD05 has an efficacy superior to autologous bone in a 1:1 mixture with beta-TCP and does not require a second surgical procedure. [1]
• MD05 shows a superior efficacy compared to commercially available competitor products. [2]
• MD05 is safe, the product does not induce excessive bone growth.
• MD05 is an osteoinductive bone substitute, which is comprised of the synthetic carrier, beta-tricalciumphosphate coated with recombinant human growth and differentiation factor-5.

Dr Irina Staatz-Granzer, Managing Director of Scil Technology, commented:
“This biomaterial will be the first synthetic, fully resorbable, compression resistant dental bone augmentation product combining osteoconductive and osteoinductive properties to enter the clinic.”

 

<a name="ref01">[1] Gruber et. al, Int. Journal of Oral Maxillofac. Implants, in preparation

[2] Pöhling et. al, Journal of Periodontology, in preparation

 

About Scil Technology GmbH

Scil Technology is a private biopharmaceutical development company focused on dental and orthopaedic tissue regeneration with a particular emphasis on bone and cartilage repair. The Company’s lead therapeutic candidates are based on recombinant, highly specific human growth factors. These are combined with biodegradable biomaterials to generate local application forms. Scil Technology’s pipeline for dentistry includes products that are targeted at periodontal disease, dental implantology and maxillofacial surgery. Orthopaedic products are developed for spinal fusion, traumatic lesions of  bone and cartilage tissue  and osteoarthritis. Scil Technology has emerged from the Scil Group and is located in the biotechnology cluster in Martinsried, Germany.

For more information please visit: <link www.scil.com>http://www.scil.com

 

Contacts

Media relations:

Sue Charles, MA, MBA, CEO
Northbank Communications
t : +44 (0) 20 7886 8152
e: s.charles@northbankcommunications.com

Douglas Pretsell, Ph.D., Senior Account Manager
Northbank Communications
t : +44 (0) 20 7886 8158
e:  d.pretsell@northbankcommunications.com

At Scil Technology:

Dr Irina Staatz-Granzer, Managing Director
Scil Technology GmbH
t: +49 (0)89 85651824
e: irina.staatz@scil.com

 

Notes for Editors

About MD05

MD05 has two components: a synthetic inorganic carrier, ß-Tricalcium phosphate (ß-TCP), and a recombinant growth factor  - rhGDF-5, a naturally occurring human protein that acts by promoting the growth of bone. ß-TCP is a synthetic calcium-phosphate biomaterial which acts as a scaffold and space-maintainer for new bone ingrowth. It is a well accepted biomaterial for  bone augmentation in dentistry and orthopaedic surgery such as e.g. spinal fusion. Scil uses a proprietary coating technology for the non-covalent association of rhGDF-5 with the surface of the ß-TCP-granules.

About this preclinical study</h3>

This study compared the osteoinductive bone substitute MD05 with conventional bone substitutes in the reconstruction of defects in the cranio-maxillofacial region. Because of its biological inertness, the calvarium (skull) is the principal site for analysing the performance of bone-regeneration materials. 

Analysis of the results revealed that MD05 achieved the best macroscopic performance in terms of skull/implant attachment and solidity of the material. Bone repair assessed histomorphometrically was more than five times greater with MD05 compared to the competitor products and was mostly complete after six weeks. Also, in contrast to the other treatments, bone repair was associated with the formation of normal bone marrow and substantial decrease of fibrous tissue.

In conclusion, MD05 was vastly superior to the conventional bone substitutes with respect to the formation of new bone and bone marrow. Using MD05, complete osseous bridging of the full-thickness critical-size defects in the rat calvarium was achieved after 6 weeks in the absence of excessive bone formation.