The agreement, effective Feb. 4, grants RTI an exclusive license to OPM’s OsteoFab technology platform for spinal applications in all U.S. markets. OsteoFab is a next-generation implant manufacturing process that builds implantable medical devices, layer-by-layer, using only laser light and OPM’s OXPEKK polymer. The OsteoFab process and OXPEKK material combine to create implants that are designed to enable bone ongrowth.
OXPEKK is a proprietary high-performance biocompatible polymer formulation from OPM, designed for medical applications. This strong, pure, radiolucent, hydrophilic, load-bearing material boasts a successful history in orthopedic implant applications.
“We are thrilled to announce this agreement with Oxford Performance Materials,” said Brian K. Hutchison, president/CEO of RTI Surgical. “OsteoFab is an exciting technology that creates new opportunities for innovation in the spinal implant market. We look forward to working with OPM to offer our customers and their patients a new alternative for spinal implants.”
Under the agreement, OPM will manufacture RTI’s spinal implant designs using OsteoFab technology, and RTI will oversee finishing steps, packaging, marketing and distribution of finished products.
“We see RTI Surgical as a growth company in the spinal implant space,” said Scott DeFelice, chairman/CEO of OPM. “RTI is a developer of medical implants with a long history of putting sound science behind their products. From the outset, RTI has worked closely with us and we look forward to a lengthy and productive relationship that leverages the unique benefits of OsteoFab technology to improve patient care.”
RTI Surgical is a global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. The company’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the United States and Europe.
Oxford Performance Materials is a developer/provider of 3D printing and high performance additive manufacturing services. OPM has developed a range of advanced materials technology focused on the high performance polymer polyether-ketone-ketone (PEKK). OPM has developed unique, enterprise-level additive manufacturing solutions utilizing its OXPEKK polymer formulation and proprietary 3D printing processes to deliver fully functional end-use products to the biomedical, aerospace, and industrial markets. In February 2013, OPM Biomedical became the first and only company to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA) to manufacture 3D printed patient-specific polymeric implants, initially for its cranial prostheses line. OPM’s second FDA clearance was for its patient-specific facial implants in July 2014, and its third was in July 2015 for its SpineFab VBR system, which provides the first and only FDA-cleared 3D-printed load-bearing polymeric medical device. All three implant product lines are for permanent implantation.