Carlsmed鈥檚 aprevo庐 Powers First Personalized Cervical Spine Surgery
Carlsmed (Nasdaq: CARL) has achieved a significant milestone with the first successful aprevo庐 cervical spine procedure performed on July 14, 2025, at UC San Diego Health. The procedure was conducted by Dr. Joseph Osorio, Chief of Spine Surgery in the Department of Neurological Surgery.
The aprevo庐 platform utilizes AI-powered surgical planning and digital production to create personalized spine devices that match each patient's unique anatomy and alignment requirements. The technology, which received FDA Breakthrough Device designation for cervical applications, is expected to launch commercially in the US in 2026.
Carlsmed (Nasdaq: CARL) ha raggiunto un traguardo importante con la prima procedura aprevo庐 per la colonna cervicale eseguita con successo il 14 luglio 2025 presso UC San Diego Health. L'intervento 猫 stato effettuato dal Dott. Joseph Osorio, Capo della Chirurgia della Colonna Vertebrale nel Dipartimento di Neurochirurgia.
La piattaforma aprevo庐 sfrutta la pianificazione chirurgica potenziata dall鈥橧A e la produzione digitale per creare dispositivi spinali personalizzati che si adattano all'anatomia unica e alle esigenze di allineamento di ogni paziente. Questa tecnologia, che ha ottenuto la designazione FDA Breakthrough Device per applicazioni cervicali, 猫 prevista per il lancio commerciale negli Stati Uniti nel 2026.
Carlsmed (Nasdaq: CARL) ha alcanzado un hito significativo con el primer procedimiento de columna cervical aprevo庐 exitoso realizado el 14 de julio de 2025 en UC San Diego Health. El procedimiento fue llevado a cabo por el Dr. Joseph Osorio, Jefe de Cirug铆a de Columna en el Departamento de Cirug铆a Neurol贸gica.
La plataforma aprevo庐 utiliza planificaci贸n quir煤rgica impulsada por IA y producci贸n digital para crear dispositivos espinales personalizados que se ajustan a la anatom铆a y necesidades de alineaci贸n 煤nicas de cada paciente. Esta tecnolog铆a, que recibi贸 la designaci贸n de dispositivo innovador (Breakthrough Device) de la FDA para aplicaciones cervicales, se espera que se lance comercialmente en EE. UU. en 2026.
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Carlsmed (Nasdaq : CARL) a franchi une 茅tape importante avec la premi猫re intervention r茅ussie aprevo庐 sur la colonne cervicale r茅alis茅e le 14 juillet 2025 au UC San Diego Health. L鈥檌ntervention a 茅t茅 effectu茅e par le Dr Joseph Osorio, chef de la chirurgie de la colonne vert茅brale au sein du d茅partement de neurochirurgie.
La plateforme aprevo庐 utilise la planification chirurgicale assist茅e par IA et la production num茅rique pour cr茅er des dispositifs vert茅braux personnalis茅s adapt茅s 脿 l鈥檃natomie unique et aux besoins d鈥檃lignement de chaque patient. Cette technologie, qui a obtenu la d茅signation de dispositif r茅volutionnaire (Breakthrough Device) de la FDA pour les applications cervicales, devrait 锚tre commercialis茅e aux 脡tats-Unis en 2026.
Carlsmed (Nasdaq: CARL) hat einen bedeutenden Meilenstein erreicht: Am 14. Juli 2025 wurde bei UC San Diego Health erstmals erfolgreich ein aprevo庐-Verfahren an der Halswirbels盲ule durchgef眉hrt. Die Operation wurde von Dr. Joseph Osorio, Leiter der Wirbels盲ulenchirurgie der Abteilung f眉r Neurochirurgie, durchgef眉hrt.
Die aprevo庐-Plattform nutzt KI-gest眉tzte Operationsplanung und digitale Fertigung, um individuelle Wirbels盲ulenger盲te zu erstellen, die auf die einzigartige Anatomie und Ausrichtungsbed眉rfnisse jedes Patienten abgestimmt sind. Die Technologie, die die FDA Breakthrough Device-Auszeichnung f眉r zervikale Anwendungen erhalten hat, soll 2026 in den USA kommerziell eingef眉hrt werden.
- None.
- Commercial launch not expected until 2026
- Limited clinical experience with cervical application to date
CARLSBAD, Calif., July 28, 2025 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (鈥淐arlsmed鈥�), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced the successful completion of the first aprevo庐 cervical procedure on July 14, 2025 by Joseph Osorio, MD, PhD, Chief of Spine Surgery in the Department of Neurological Surgery at UC San Diego (UCSD) Health in San Diego, CA.
The aprevo庐 devices are designed to match the unique anatomical and alignment needs of each patient through Carlsmed鈥檚 proprietary AI-powered surgical planning platform and digital production system.
Dr. Osorio, who has extensive experience utilizing the aprevo庐 platform for lumbar spine fusion procedures, noted, 鈥淟everaging the aprevo庐 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鈥檚 unique pathology and anatomy represents a meaningful advancement for my practice.鈥�
鈥淥n the heels of our IPO, this first cervical procedure represents an exciting milestone as we expand our personalized surgical solutions to the cervical spine,鈥� said Mike Cordonnier, Chairman and CEO of Carlsmed. 鈥淲e 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.鈥�
Carlsmed was granted Breakthrough Device designation for aprevo庐 cervical by the FDA and expects a US commercial launch in 2026.
About Carlsmed
Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects, including statements about the Company鈥檚 current expectation of launching aprevo庐 cervical in the United States in 2026 and other statements containing the words 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥減lan,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渢arget,鈥� 鈥減otential,鈥� 鈥渓ikely,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 鈥渃ould,鈥� 鈥渟hould,鈥� 鈥渃ontinue,鈥� and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption 鈥淩isk Factors鈥� in the Carlsmed鈥檚 Registration Statement on Form S-1 on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed鈥檚 views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed鈥檚 views as of any date subsequent to the date of this press release.
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FAQ
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