Orthofix International Announces its Support for the SMISS Prospective Data Registry

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LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ:OFIX) (the Company) announced today its support of the Society for Minimally Invasive Spine Surgery (SMISS) as it initiates the first prospective patient data registry related specifically to minimally invasive spine surgery.

“SMISS is pleased to partner with Orthofix, who has innovative MIS products and the vision to be a founding sponsor of our effort to collect key clinical information on outcomes, complications, adverse events, as well as the cost of treatment for minimally invasive spine surgery.”

On Saturday, October 22nd, during the SMISS Annual Meeting in Las Vegas, NV, the Prospective Data Registry was officially launched, with Orthofix being recognized as one of the key founding sponsors for this program. Bryan McMillan, President Global Spine Business Unit, stated, “We are proud to support SMISS in this important initiative. We believe the SMISS data registry will demonstrate the benefits of minimally invasive spine surgery for the patient, surgeon, and hospital.”

Choll Kim, M.D., PhD, Executive Director of SMISS, commented, “SMISS is pleased to partner with Orthofix, who has innovative MIS products and the vision to be a founding sponsor of our effort to collect key clinical information on outcomes, complications, adverse events, as well as the cost of treatment for minimally invasive spine surgery.”

The multi-center program will enroll up to 250 subjects and outcomes analysis will include a minimum two-year follow up. The primary objectives of the registry will be to determine the rate and incidence of peri-operative and post-operative adverse events in the MIS approach for the treatment of spondylolisthesis, degenerative disc disease, spinal stenosis, disc herniation, and degenerative scoliosis. In addition, Health Related Quality of Life (HRQOL) and Quality Adjusted Life Years (QALY) will be determined.

About Orthofix

Orthofix International N.V. is a global medical device company offering a broad line of minimally invasive surgical, and non-surgical products for the spine, orthopedics, and sports medicine market sectors that address the lifelong bone-and-joint health needs of patients of all ages helping them achieve a more active and mobile lifestyle. Orthofix’s products are widely distributed around the world to orthopedic surgeons and patients via Orthofix’s sales representatives and its subsidiaries, including BREG, Inc., and via collaborations with other leading orthopedic product companies. In addition, Orthofix is collaborating on R&D activities with leading research and clinical organizations such as the Musculoskeletal Transplant Foundation, the Orthopedic Research and Education Foundation, Texas Scottish Rite Hospital for Children, and the Cleveland Clinical Foundation. For more information about Orthofix, please visit www.orthofix.com.

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