French National Healthcare System Adopts Exclusive Reimbursement Policy for SI-BONE, Inc.’s iFuse-3D Implant System™

Rhea-AI Summary

SI-BONE, Inc. (Nasdaq: SIBN) announced national reimbursement for the iFuse-3D Implant System™ by the French Health Ministry, effective June 1, 2021, for five years. This follows a positive opinion from the Haute Autorité de Santé recognizing the implant's therapeutic benefits for sacroiliac joint dysfunction. The implant is the first 3D-printed titanium solution for SI joint fusion, designed for effective bony integration. With reimbursement confirmed, patient access in France improves, allowing surgeons to leverage this technology for various pelvic and spinal conditions.

Positive

• National reimbursement granted for iFuse-3D Implant System in France, enhancing patient access.
• iFuse-3D is recognized for its therapeutic effectiveness in treating SI joint dysfunctions.
• The implant is the first 3D-printed titanium implant for SI joint fusion, promoting bony integration.

Negative

• None.

Exclusive Coverage Takes Effect June 1, 2021, and Extends for 5 Years

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 sacropelvic anatomy announced that the French Health Ministry has granted national reimbursement for the iFuse-3D Implant System™.

As per the original iFuse Implant System reimbursement that became effective in September, 2018, the French Health Technology Assessment body, Haute Autorité de Santé (HAS), issued a positive opinion for SI-BONE’s second generation iFuse-3D Implant, recognizing the therapeutic value of the iFuse-3D Implant in connection with the seriousness of the pathology of sacroiliac (“SI”) joint dysfunctions and the impact these dysfunctions can have to the quality of life. This reimbursement decision by the French National Healthcare System provides coverage for SI joint fusion procedures exclusively using SI-BONE’s patented, 3D-printed, iFuse-3D Implant.

“We commend the HAS and the French Health Ministry to enable patient access to 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 first-ever 3D-printed titanium implant for use in the SI joint. The implant has a unique fenestrated design and an enhanced porous surface that resembles the trabecular structure of cancellous bone. These features provide an excellent environment for bony ongrowth, ingrowth and through growth.¹

“This positive coverage decision by the Ministère des Solidarités et de la Santé for the iFuse-3D Implant is welcome news for the people of France who suffer from SI joint pain,” said, Pr JC Le Huec, MD, PhD, Chairman Spine Unit, Polyclinique Bordeaux Nord, Bordeaux University, France. “In addition to those suffering from dysfunction of the SI joint due to its degeneration or disruption, reimbursement for iFuse-3D will enable 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.”

https://www.has-sante.fr/upload/docs/evamed/CNEDIMTS-6484_IFUSE%203D_16_février_2021_(6484)_avis.pdf

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 pioneered 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% to 30% of chronic low back pain. The iFuse Implant™, commercially available since 2009, is the only SI joint fusion device supported by multiple prospective clinical studies, including two randomized controlled trials, showing improved pain, patient function and quality of life resulting from treatment. There are over 90 peer-reviewed publications demonstrating the safety, durable effectiveness, and biomechanical and economic benefits unique to the iFuse Implant (www.si-bone.com/results). This body of evidence has enabled multiple government and private insurance payors to establish coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The iFuse Implant System is also intended for sacroiliac fusion to augment stabilization and immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. In addition, 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 all patients may not benefit. 

For additional information on the company or the products including 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.

Forward Looking Statements 
The statements regarding adoption and use of the iFuse-3D Implant System and expanded patient access to the device in markets outside of the U.S. 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 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 SI-BONE's ability to increase demand for iFuse-3D and obtain further favorable coverage and reimbursement determinations from third-party payors. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these and other risks and uncertainties, many of which are described in the company's most recent filings on Form 10-K and Form 10-Q, and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov), especially under the caption "Risk Factors". SI-BONE does not undertake any obligation to update forward-looking statements and expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. 

Investor Contact: 
Matt Bacso, CFA 
investors@SI-BONE.com  

Media Contact:
For SI-BONE, Inc.:
Joe Powers
Vice President of Marketing
408-207-0700, ext. 3209
jpowers@si-bone.com

FAQ

What is the significance of the reimbursement for iFuse-3D Implant System?

The national reimbursement allows increased patient access to the iFuse-3D Implant System in France, which is crucial for those suffering from SI joint dysfunction.

When did the reimbursement for iFuse-3D take effect?

The reimbursement for the iFuse-3D Implant System took effect on June 1, 2021.

How long will the iFuse-3D Implant System be reimbursed in France?

The reimbursement for the iFuse-3D Implant System is set to last for five years.

What advantages does the iFuse-3D Implant offer?

The iFuse-3D Implant is designed to integrate well with bone due to its unique fenestrated design and porous surface, which enhances healing.

What is the iFuse-3D Implant System used for?

The iFuse-3D Implant System is used for sacroiliac joint fusion, particularly for conditions like sacroiliac joint dysfunction and pelvic fixation.