French National Healthcare System Adopts Exclusive Reimbursement Policy for SI-BONE, Inc.’s iFuse-3D Implant System™
June 15 2021 - 4:03PM
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 Marketing408-207-0700, ext. 3209
jpowers@si-bone.com
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