Carlsmed Announces Favorable Medicare Reimbursement Decision for Spinal Fusions with Custom-Made Anatomically Designed Devices
05 Agosto 2024 - 5:00AM
Business Wire
Carlsmed, the leader in personalized spine surgery, announced
today that in the Hospital Inpatient Prospective Payment System
Final Rule for fiscal year 2025, the Centers for Medicare &
Medicaid Services (CMS) assigned spinal fusion cases with aprevo®
custom-made anatomically designed interbody fusion devices to the
highest level of the new spinal fusion Medicare Severity-Diagnosis
Related Groups (MS-DRGs) it created. The new assignments and
payment rates are favorable and will go into effect on October 1,
2024.
“Carlsmed has revolutionized the standard of care for spine
surgery with our unique patient-centric approach to implant
design,” states Mike Cordonnier, CEO of Carlsmed. "We appreciate
CMS’s thoughtful reimbursement decision to ensure Medicare
beneficiary access to this important technology after the New
Technology Add-on Payment (NTAP) status concludes.”
Leveraging its AI-enabled proprietary software, Carlsmed designs
each aprevo® implant to match the patient’s unique anatomy. The
aprevo® implants are built on demand and delivered sterile packed
for surgery.
Earlier this year, Carlsmed released clinical data on its
aprevo® custom-made anatomically designed devices. The data, which
was published in the Global Spine Journal, concluded that the use
of aprevo® devices in spine surgery enabled an improvement in
achieving post-operative alignment. Prior studies have shown that
achieving optimal alignment during spine fusion surgery is highly
correlated to reduced complications.
Carlsmed’s full suite of custom interbody devices for lumbar
surgery are available in the U.S. The Company has received
Breakthrough Device designation for cervical use and anticipates
the launch of cervical custom-made interbody devices by the end of
2025.
About Carlsmed
The Carlsmed aprevo® personalized surgery platform is designed
to improve the standard of care for spine surgery one patient at a
time. Carlsmed’s implantable devices and software platforms are FDA
cleared for lumbar spine fusion.
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For media and investor inquiries, please contact Jodi Allen at
jodi@carlsmed.com