European Regulators Approve BonAlive Putty

European regulators have approved BonAlive Biomaterials Ltd.’s putty — a bone graft substitute for the treatment of bony voids and gaps.

The putty builds on the Turku, Finland-based company’s current osteostimulative S53P4 bioactive glass granules, and combines it with a synthetic binder which dissolves soon after implantation. The bioactive granules develop a silica-gel layer, which promotes calcium phosphate deposition and allows for bonding between the native bone and the granules, according to the firm. With the surface transformed into one that is chemically and structurally similar to the mineral phase of natural bone, osteoblast activity is enhanced, which results in increased bone matrix on the surface of the granules. Bone growth is typically observed within six to 12 weeks of implantation.

The putty also increases bone resorption, which results in beneficial bone remodeling. Studies showed similar bone growth at four and eight weeks when comparing the BonAlive putty and BonAlive granules, with highly vascularized and dense bone formation and periosteal growth in both. The putty currently comes in a small applicator size for hand and cranio-maxillofacial surgery, and a larger applicator for orthopedic and trauma surgery.

BonAlive Biomaterials is a developer of bone regeneration technologies. The company providesbiomaterial solutions for the treatment of chronically infected bone. BonAlive products are available in Europe, Middle East, Asia-Pacific, Africa, Brazil and the United States.