Carlsmed (Nasdaq:CARL) today announced the completion of the first successful cervical procedure using its Aprevo devices.
Carlsbad, California–based Carlsmed designed the Aprevo devices to match the unique anatomical and alignment needs of each patient. The company’s proprietary AI-powered surgical planning platform and digital production system power the devices.
The company developed its AI-enabled personalized spine surgery. It already holds FDA breakthrough device designation for the Aprevo lumbar and cervical patient-specific interbody fusion devices. The implantable devices and software platforms hold FDA clearance for lumbar spine fusion. That includes anterior, lateral and transforaminal approaches.
Dr. Joseph Osorio, chief of spine surgery at UC San Diego Health, completed the procedure on July 14. Osorio already has extensive experience utilizing Aprevo for lumbar spine fusion procedures, Carlsmed said.
“Leveraging the Aprevo system for cervical fusion surgery allows a level of alignment which I believe is not achievable with traditional implants. The ability to customize each device to the patient’s unique pathology and anatomy represents a meaningful advancement for my practice,” Osorio said.
Carlsmed expects a U.S. launch for Aprevo for cervical procedures in 2026. This marks the latest positive development for the company, which went public through an IPO last week.
“On the heels of our IPO, this first cervical procedure represents an exciting milestone as we expand our personalized surgical solutions to the cervical spine,” said Mike Cordonnier, chair and CEO of Carlsmed. “We are proud to partner with Dr. Osorio and UCSD Health to bring this breakthrough technology to patients. Our goal is to reduce the need for revision surgeries, improve outcomes, and enhance value across the healthcare system as we work toward establishing a new standard of care.”
