SI-BONE, Inc. Announces CIGNA Establishes Positive Coverage for MIS SI Joint Fusion using the iFuse Implant System
December 13 2019 - 8:18AM
SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical
device company dedicated to solving musculoskeletal disorders of
the sacropelvic anatomy, announced today that CIGNA has established
a positive coverage policy for minimally invasive SI joint fusion.
The new policy specifies that coverage will be exclusive for FDA
cleared implants that are placed across the SI joint and intended
to promote bone fusion. This decision follows an extensive amount
of published clinical evidence demonstrating the safety and
effectiveness of the iFuse Implant System, including a recent
publication of 5-year results from a long-term prospective study
called LOIS (Long Term Outcomes from INSITE and SIFI).
Cigna is the fourth largest commercial health plan in the United
States with 14.6 million members. Its new policy, available at this
link:
(https://cignaforhcp.cigna.com/public/content/pdf/coveragePolicies/medical/mm_0303_coveragepositioncriteria_lumbar_fusion_degenerative_conditions.pdf),
became effective December 10, 2019.
“As a result of this positive coverage decision, CIGNA’s members
will have access to the iFuse procedure when deemed medically
necessary by their surgeons,” said Jeffrey Dunn, President, CEO and
Chairman at SI-BONE. “CIGNA’s decision to cover MIS SI joint fusion
is a significant milestone in the continuing adoption of this
important treatment for patients with SI joint dysfunction due to
degenerative sacroiliitis or SI joint disruption.”
About SI-BONESI-BONE is a medical device
company that pioneered the iFuse Implant System, a minimally
invasive surgical system for fusion of the sacroiliac joint to
treat sacroiliac joint dysfunction. The SI joint is believed to be
the last major joint with a clinically proven surgical treatment.
The iFuse Implant, commercially available since 2009, is believed
to be the only SI joint fusion device supported by multiple
prospective clinical studies showing improved pain, patient
function and quality of life resulting from treatment. There are
over 60 peer-reviewed publications supporting the safety,
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.
There are potential risks associated with the iFuse Implant System.
It may not be appropriate for all patients and all patients may not
benefit.
SI-BONE and iFuse Implant System are registered trademarks of
SI-BONE, Inc. ©2019 SI-BONE, Inc. All Rights Reserved.
10593.121319
Media Contact:Joe Powers
jpowers@si-bone.com669-206-2521
Investor Contacts: Lynn Lewis or Carrie
Mendivilinvestors@SI-BONE.com 415-937-5405
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