Exactech, Inc. announced that it has received clearance from the US Food and Drug Administration (FDA) to produce and market a new demineralized bone matrix (DBM) based human allograft bone paste that will enable the company to enter the spinal market. The material is based on a synthetic bioabsorbable polymer carrier technology, previously licensed from Genzyme Corp.
Exactech said it plans to begin marketing the new bone paste material, which it plans to manufacture and distribute, before the end of 2004. Exactech CEO Bill Petty, said, "This is an important addition to our growing line of biologic materials that will substantially broaden our market reach. It is also an important step in Exactech's strategy to increase focus on biologic solutions to orthopaedic problems. The new bone paste represents a substantial growth opportunity for Exactech to add additional biologic products over the medium term. This new material allows us to expand further into the $200 million bone paste market by providing us with the opportunity to enter the spinal market, which we can not do with Opteform and Optefil under our agreement with Regeneration Technologies, Inc.
"We continue to benefit from our strong partnership with RTI. We are fully committed to our Opteform and Optefil bone pastes, which are serving a growing market segment. These are outstanding materials that our surgeon customers value highly in helping to enhance patient outcomes," Petty said.
Exactech launched its first biologic material in 1998 with the introduction of Opteform, a human-derived bone paste produced by the University of Florida Tissue Bank, which subsequently was licensed to and is produced by RTI. Exactech's revenue from tissue services products was up 34 per cent in 2003 to $9.7 million.
Based in Gainesville, Florida, Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians.