January 24, 2018
ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced the peer-reviewed publication of two-year data of the SImmetry Sacroiliac Joint Fusion System in The Open Orthopaedics Journal. The data show SImmetry provides radiographically evident sacroiliac (SI) joint fusion as early as 12 months with higher fusion rates observed at 24 months, while effectively reducing pain in patients with SI joint disorders. The SImmetry Sacroiliac Joint Fusion System is designed to treat SI joint dysfunction, an underserved condition and, according to the Centers for Disease Control and Prevention (CDC), one of the nation’s leading causes of lower back pain.
“This study demonstrated the SImmetry System effectively promoted SI joint fusion through decortication and also demonstrated a reduction in pain,” said Camille Farhat, President and CEO, RTI Surgical.
This multi-site study evaluated long-term fusion and pain reduction in 18 patients. The study examined computed tomography (CT) evidence of fusion at 12 and 24 months following SI joint fusion performed with decortication and bone grafting. CT scans were independently assessed by three trained musculoskeletal radiologists blinded to one another’s assessments. Fusion was predefined as Solid (presence of solid continuous bridging bone across the treated joint), Possible (presence of possible continuous bridging bone across the treated joint), or No Fusion (no bridging bone). At 24 months post-surgery, 17 of 18 patients (94 percent) had evidence of bridging bone, with 15 of 18 patients (83 percent) categorized as Solid fusion across the SI joint. Of the patients with bridging bone, 15 of 17 (88 percent) were fused within the area of decortication, demonstrating the importance of this step in achieving fusion.
In addition to fusion, the study demonstrated a 73 percent reduction in average pain at 24 months, maintaining the significant pain relief reported at earlier time points. No procedure- or device-related serious adverse events were reported. These data were presented at the International Society for the Advancement of Spine Surgery (ISASS) 2017 Annual Meeting.
RTI Surgical recently acquired the SImmetry Sacroiliac Joint Fusion System, a burgeoning therapy that accentuates RTI’s robust spine portfolio and accelerates the company’s growth.
“This is the first of many publications of clinical data demonstrating the value of SImmetry for patients with SI joint pathology,” Farhat said. “RTI is committed to furthering the body of clinical evidence supporting this technology.”
RTI continues to gather clinical data to support SImmetry, including the EVoluSIon Clinical Study, to include up to 40 sites and 250 patients evaluating SI joint fusion and pain reduction. More than 150 patients have been enrolled to date. An early analysis of the first 50 patients reported in December 2017 showed 72 percent of patients achieved the minimal clinically important difference of ≥ 20-point improvement in SI joint pain through six months. Further, the study showed a 54 percent reduction in mean SI joint pain at six months and, notably, the reduction in opioid use (55 percent) was much greater than previously reported with other SI joint fusion products.
The CDC lists back problems as the second most common cause of disability in U.S. adults1. Approximately 20 percent of all chronic low back pain derives from the sacroiliac joint2.
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 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.
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, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. Additionally, the statement relating to the expected size of the SIJF market in the United States in 2024 is a forward-looking statement. 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 at www.rtix.com or the SEC’s website at www.sec.gov.
1 Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
2 Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116