November 19, 2018
ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, announced HealthPartners, the largest consumer governed nonprofit health care organization in the United States, issued a positive coverage decision for minimally invasive sacroiliac (SI) joint fusion surgery, effective November 1, 2018. This decision expands access to RTI’s SImmetry System for HealthPartners members considering treatment for SI joint pain or dysfunction. The SImmetry System is a minimally invasive surgical solution that uses proprietary decortication technology, bone graft and threaded fixation to facilitate bone fusion, providing an opportunity for long-term pain relief.
It has been reported that up to 30 percent of all chronic low back pain, the second most common cause of disability in American adults, is due to SI joint dysfunction. SI joint fusion surgery using the SImmetry System is designed to stabilize the dysfunctional SI joint by fusing the sacrum and the pelvic bone together.
“As a surgeon in the HealthPartners network who has experience using the SImmetry System, this positive coverage decision is a win for patients suffering from SI joint dysfunction,” said Edward Santos, M.D., a spine surgeon specializing in neck, back, cervical, thoracic and lumbar spinal disorders, and minimally invasive surgery at Summit Orthopedics in Minneapolis. “The SImmetry System is a minimally invasive surgical solution that promotes SI joint fusion through decortication, with a growing body of clinical evidence showing improvements in pain, disability and opioid use for SI joint patients.”
“RTI is encouraged by HealthPartners’ decision, which expands access to the SImmetry System for patients with SI joint pain or dysfunction,” said Camille Farhat, President and CEO, RTI Surgical. “The SImmetry System is supported by a growing body of evidence suggesting long-term pain relief for these patients. We are committed to advancing clinical data for the SImmetry System to aid in further payor decisions.”
Clinical Data Supporting the SImmetry System
The ongoing EVoluSIon Clinical Study is evaluating the impact of SImmetry on SI joint fusion and pain reduction in 250 patients across 23 sites. An early analysis of the first 50 patients published in December 2017 showed a 54 percent reduction in SI joint pain at six months, as well as a 55 percent reduction in opioid use.i A separate CT fusion study on the SImmetry System demonstrated a 73 percent reduction in average pain over 24 months.iiClinical outcomes from 100 patients presented at the International Society for the Advancement of Spine Surgery (ISASS) 2018 Annual Meeting showed the SImmetry System provided a 56 percent reduction in patient-reported pain, and a statistically significant reduction in the use of opioids and other pain medications at six months.iii
For more information on the policy, visit the HealthPartners website.
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 and trauma 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. Connect with us on LinkedIn and Twitter.
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. 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.
i Araghi A et al. Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial. Open Orthop J. 2017;11:1440-1448.
ii Cross W et al. Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System. Open Orthop J. 2018 Jan 17;12:7-16.
iii Araghi A et al. Minimally invasive Sacroiliac Surgery with Decortication and Threaded Implants: Analysis of the EVoluSIon Study. Presented at ISASS 2018.