Description

MD05 is being developed as a novel regenerative bone substitute material for dental implantology and surgical treatment of periodontal disease. This biomaterial 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-based biomaterial which acts as a scaffold for new bone in-growth. Scil Technology uses a proprietary coating technology for the non-covalent association of rhGDF-5 with the surface of the powder-like beta-TCP-granules (granule size smaller than 1 mm). The resulting formulation has a number of superior technological features:

• Homogeneous coating of the growth factor on the carrier surface
• Stable growth factor / granule association
• Maintenance of structure and activity of the growth factor
• Complete release of the growth factor

Based on the ideal growth factor / carrier combination, MD05 provides a favorable product profile:

• Osteoinductivity
• Osteoconductivity
• Excellent safety profile
• Pressure-resistance
• Biodegradability (complete resorption)
• Fully synthetic
• Favourable handling characteristics (ready-to-use)

Developmental stage

MD05 has commenced Phase IIa clinical trials for dental implantology. A further clinical trial for the treatment of bone defects in severe periodontal disease is also in preparation.

Intellectual property

A patent portfolio on the growth factor rhGDF-5 was licensed from Biopharm GmbH, Heidelberg, Germany, providing Scil with the global, exclusive rights on the growth factor for dentistry and maxillofacial surgery.