RTI Surgical® Receives Regulatory Clearances, Expands Distribution of nanOss® Bioactive in Australia, Europe
September 19, 2016
ALACHUA, Fla. (DATE) – RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, announced it has recently received regulatory clearance from the Australian Therapeutic Goods Administration (TGA) for nanOss® Bioactive bone void filler in Australia. The company also announced it has received CE Mark from BSI for nanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler in Europe.
NanOss Bioactive bone void filler is an advanced bone graft substitute composed of nano-structured hydroxyapatite granules and an open structured engineered collagen carrier. It is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. NanOss Bioactive is among few synthetic-based grafts* with peer-reviewed evidence of posterolateral fusion. NanOss Bioactive bone void filler will be distributed for RTI Surgical in Australia by LifeHealthcare Group Limited (ASX: LHC), one of Australia’s leading independent medical device distributors.
NanOss Bioactive Loaded bone void filler is a closed system with a pre-filled mixing syringe for consistency, sterility, compression and easy delivery of NanOss Bioactive bone void filler. NanOss Bioactive 3D bone void filler is an advanced bone graft composed of nano-structured hydroxyapatite granules suspended in a porous gelatin-based foam matrix. NanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler will be distributed by RTI Surgical and its independent distributors in Europe.
“We are pleased to have received regulatory clearance to launch nanOss Bioactive bone void filler in Australia, as well regulatory approval for nanOss Bioactive Loaded bone void filler and nanOss Bioactive 3D bone void filler in Europe,” said Carrie Hartill, executive vice president and chief scientific officer. “These clearances expand our broad portfolio of surgical implants offered across the globe and give surgeons worldwide more options to help their patients improve their quality of life.”
*A product that is manufactured from synthetic material but may also include carrier materials derived from non-human materials.
About RTI Surgical Inc.
RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’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 U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.
Forward Looking Statement
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website atwww.rtix.com or the SEC’s website at www.sec.gov.
