Carlsmed was granted FDA 510(k) clearance and Breakthrough Device Designation by FDA for aprevo™ patient-specific interbody devices for the correction of adult spinal deformity. The Carlsmed aprevo device is reportedly the first implant ever to receive both Breakthrough Device Designation and 510(k) market clearance from FDA.
To meet the designation criteria, FDA determined that aprevo provides for more effective treatment of an irreversibly debilitating condition than the current standard of care.
Carlsmed’s aprevo is reportedly also the only spinal device to qualify for the Alternative Inpatient New Technology Add-On Payment (NTAP) Pathway for Transformative New Devices that was enacted by CMS beginning with NTAP applications for FY 2021. Upon authorization of the NTAP, which is currently under review by CMS for FY 2022 approval, hospitals will receive an add-on payment from CMS of up to 65% of the cost of the device.
Earlier this year, Carlsmed closed an oversubscribed USD $2.5 million seed round. The financing was designated to support the clinical launch of the aprevo system of proprietary planning tools and personalized implants based on the patient’s pathology.
“Today’s announcement is great for patients, surgeons, and providers, with a major step forward towards true personalization of surgical correction for spinal disorders,” said Mike Cordonnier, CEO of Carlsmed. “Obtaining breakthrough designation means the FDA believes that aprevo could improve the standard of care and wants to provide patients with more timely access to this technology.”