Carvolix Timeline

Events

• 2026-09-22 - Regulatory - Carvolix submits TAVIPILOT Robot FDA 510(k) application - ROTAO1 completed 10 first-in-human procedures with the robot; the company reports successful robotic function in all 10. The SAIRO study has treated seven patients using the combined robot-and-software workflow. The company targets an early-2027 US launch… - source: webdisclosure.com
• 2026-09-09 - Regulatory - Carvolix submits TAVIPILOT Software dossier for European CE marking - The dossier was submitted in August 2026 after completion of the main U.S. clinical and regulatory development steps. Carvolix said CE marking is expected by year-end 2026, with a European commercial launch targeted for early 2027. The company reported an… - source: carvolix.eu
• 2026-08-06 - Market Signal - Carvolix secures up to EUR30 million structured debt facility - The facility provides up to EUR30 million across four tranches, including an immediate EUR10 million draw. A second EUR10 million tranche is linked to FDA approval of the Tavipilot robot; the financing includes convertible bonds and warrants. Proceeds are… - source: eqs-news.com
• 2026-06-24 - Funding - Carvolix secures new €10 million financing tranche - The reserved offering issues 2,976,190 new ordinary shares at €3.36 per share to existing shareholders. Carvolix says proceeds support Tavipilot commercialization in the United States and development of Tavipilot, Kalios, Artus, Artedrone and Mitrapilot. The… - source: eqs-news.com