SANTA CLARA, Calif., June 15, 2021 (GLOBE NEWSWIRE) – SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the Sacro-pelvic anatomy announced that the Department of Health has granted national reimbursement for the iFuse-3D ™ implant system.
In accordance with the initial reimbursement of the iFuse implant system which entered into force in September 2018, the French health technology assessment body, the Haute Autorité de Santé (HAS), has issued a positive opinion for the implant. Second generation iFuse-3D from SI-BONE, recognizing the therapeutic value of the iFuse-3D implant in relation to the seriousness of the pathology of sacroiliac joint dysfunction (“SI”) and the impact that these dysfunctions can have on quality of life. This reimbursement decision by the French national health system covers SI joint arthrodesis procedures exclusively using the patented and 3D printed iFuse-3D implant from SI-BONE.
“We congratulate HAS and the French Ministry of Health for allowing patients to access our iFuse-3D implant system,” said Laura Francis, CEO of SI-BONE. “Our goal is to provide devices that improve the lives of patients with SI joint dysfunction, and with reimbursement, patients in France can benefit from our unique solution. “
The iFuse-3D Implant is the very first 3D printed titanium implant for use in the SI joint. The implant has a unique fenestrated design and an improved porous surface that resembles the trabecular structure of cancellous bone. These characteristics provide an excellent environment for bone growth, internal growth and growth.1
“This decision of positive coverage by the Ministry of Solidarity and Health for the iFuse-3D implant is good news for the French who suffer from SI joint pain”, declared Prof. JC Le Huec, MD, PhD, Chairman Spine Unit, Polyclinique Bordeaux Nord, University of Bordeaux, France. “In addition to those suffering from SI joint dysfunction due to degeneration or disruption, reimbursement for iFuse-3D will allow surgeons to use this unique technology for pelvic fixation at the base of long spinal fusions as well as in patients with pelvic trauma. involving the SI joint.
1. MacBarb, et al., “Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” Int J Spine Surg, 2017; 11.
About SI-BONE, Inc.
SI-BONE is a medical device company that has been a pioneer in minimally invasive surgery of the SI joint with the iFuse implant system. Studies have shown that the SI joint can be a source of pain in 15-30% of chronic low back pain. The iFuse Implant ™, commercially available since 2009, is the only SI joint fusion device supported by several prospective clinical studies, including two randomized controlled trials, showing improvement in pain, patient function and pain. quality of life resulting from treatment. There are over 90 peer-reviewed publications demonstrating the safety, long-lasting efficacy, and the unique biomechanical and economic benefits of the iFuse implant (www.si-bone.com/results). This body of evidence has enabled many government and private insurers to establish coverage for the SI Joint Fusion procedure exclusively when performed with the iFuse Implant System.
The iFuse Implant System is intended for sacroiliac fusion for conditions such as sacroiliac joint dysfunction that directly results from sacroiliac joint rupture and degenerative sacroiliitis . This includes conditions whose symptoms began during pregnancy or the perinatal period and persisted after childbirth for more than 6 months. The iFuse Implant System is also intended for sacroiliac fusion to increase stabilization and immobilization of the sacroiliac joint in mature skeletal patients undergoing sacro-pelvic fixation as part of a lumbar fusion or thoraco-lumbar. Additionally, the iFuse Implant System is intended for sacroiliac fusion in acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and not all patients may benefit from it.
For more information about the company or the products, including the risks and benefits, please visit www.si-bone.com.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. © 2021 SI-BONE, Inc. All rights reserved.
The statements regarding the adoption and use of the iFuse-3D Implant System and the expanded patient access to the device in markets outside of the United States in this press release are “forward-looking” statements. These forward-looking statements are based on SI-BONE’s current expectations and inherently involve significant risks and uncertainties. These risks include the continued impact that the COVID-19 pandemic may have on the ability and desire of patients and physicians to undergo procedures using the IFuse-3D ™ Implant System, the duration of the COVID-19 pandemic, whether the COVID-19 pandemic will recur in the future, and the ability of SI-BONE to increase demand for iFuse-3D and achieve coverage and determinations of more favorable reimbursements from third-party payers. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements due to these and other risks and uncertainties, many of which are described in the most recent Company documents on Forms 10-K and 10- Q, and other documents filed by the Company with the Securities and Exchange Commission (SEC) available on the SEC website (www.sec.gov), in particular under the heading “Risk factors”. SI-BONE assumes no obligation to update any forward-looking statements and expressly disclaims any obligation or commitment to publicly release any update or revision to any forward-looking statement contained herein, except as required by law.
Matt Bacso, CFA
For SI-BONE, Inc .:
Vice President Marketing
408-207-0700, ext. 3209