Synergy Biomedical announced that it has received Therapeutic Goods Administration clearance in Australia for its bioactive bone graft, BIOSPHERE PUTTY. BIOSPHERE PUTTY is an advanced synthetic bone graft product that has previously received FDA and CE Mark clearances, and has been on the market since 2013.
Regarding the clearance, Dr. Mark Borden, Ph.D., President/CEO of Synergy said, “We are very pleased with our TGA clearance and are excited to launch this innovative, synthetic bone graft in Australia.” Borden added, “This clearance enables more surgeons worldwide access to our next-generation bone graft technology.”
On global expansion: Kevin Booth, Vice President of Sales said, “The launch of BioSphere Putty in Australia represents a significant milestone in expanding our distribution across the globe. The Australian market provides Synergy with a sizable opportunity to grow our BioSphere Putty sales.”
Synergy Biomedical describes BIOSPHERE PUTTY as a synthetic bone graft that utilizes a unique, spherical form of bioactive glass in combination with a resorbable carrier. The product provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques. Based on the Company’s patented BioSphere Technology, BIOSPHERE PUTTY has been shown in vivo to significantly improve the healing potential of bioactive glass. The use of spherical particles allows for precise control over the properties of bioactive glass, and results in an optimal bone healing response. BIOSPHERE PUTTY is the first of several bioactive glass products being developed by Synergy Biomedical.