SI-BONE, Inc. Announces New Technology Add-On Payment for Breakthrough Adult Spinal Deformity Treatment
April 19 2022 - 7:00AM
SI-BONE, Inc., (Nasdaq: SIBN) a Silicon Valley-based medical device
company dedicated to solving musculoskeletal disorders of the
sacropelvic anatomy, today announced that the Centers for Medicare
and Medicaid Services (CMS) has proposed a New Technology Add-on
Payment (NTAP) for the iFuse Bedrock Granite™ implant. The Granite
implant is intended to provide sacroiliac fusion and sacropelvic
fixation as a foundational element for segmental spinal fusion. The
Granite implant was awarded Breakthrough Device Designation by the
FDA and is anticipated to receive regulatory clearance this year.
In designating the Granite implant as a Breakthrough Device, the
FDA determined that it provides for more effective treatment of an
irreversibly debilitating condition than the current standard of
care. The NTAP program, which recognizes new technologies that
provide substantial clinical improvement over already available
therapies, is designed to support timely access to such innovative
technologies for Medicare beneficiaries.
“We are pleased CMS recognizes iFuse Bedrock
Granite, a Breakthrough Device, as being the sacroiliac joint
fixation and fusion technology to treat adult spinal deformity that
potentially will allow hospitals to receive incremental
reimbursement through the NTAP program,” said Laura Francis, CEO of
SI-BONE. “Once finalized, the NTAP will help ensure that Medicare
patients have access to this innovative technology.”
The Fiscal Year 2023 Proposed Hospital Inpatient Prospective
Payment System Rule can be found here (see p. 560 for discussion of
iFuse Bedrock Granite):
https://public-inspection.federalregister.gov/2022-08268.pdf.
The approval for the NTAP is subject to FDA
clearance of iFuse Bedrock Granite and finalization of the proposed
rule. Once finalized, CMS will reimburse hospitals an incremental
amount in addition to the Medicare Severity Diagnosis Related Group
(MS-DRG) payment. For more information on the CMS NTAP approval for
the iFuse Bedrock Granite Implant System, please visit the CMS
website.
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a global leader
in technology for surgical treatment of musculoskeletal disorders
of the sacropelvic anatomy. In 2009, SI-BONE introduced the iFuse
Implant System for minimally invasive surgery of the SI joint,
shown to be a source of pain in 15% to 30% of people with chronic
low back pain. Since then, more than 2,700 surgeons have performed
a combined total of more than 65,000 SI joint fusion procedures. A
unique body of evidence supports the iFuse Implant System,
including two RCT’s and over 100 peer reviewed publications that
has enabled multiple government and private insurance payors to
establish coverage of the SI joint fusion procedure exclusively
when performed with iFuse Triangular Implants. SI-BONE is
leveraging its market leadership position in the surgical treatment
of SI joint disorders, supported by this proprietary reimbursement
advantage, to commercialize other devices intended for surgical
treatment of related conditions of the human anatomy. For more
information or to join our team, please visit us at
www.si-bone.com.
For additional information about the company or
products, including risks and benefits, please visit
www.si-bone.com.
SI-BONE and iFuse Implant System are registered trademarks of
SI-BONE, Inc. ©2022 SI-BONE, Inc. All Rights Reserved.
Media Contact:Joe Powers, Vice President,
Corporate Marketingjpowers@si-bone.com
Investor Contact:Matt
Bacsoinvestors@si-bone.com
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