Carvolix
About
About Carvolix
Carvolix's aortic-valve programme separates image-guidance software from robotic delivery. TAVIPILOT Software tracks the non-coronary cusp and prosthetic valve in live fluoroscopy, adding visual landmarks to the clinician's existing catheter-laboratory workflow. It received US FDA clearance in July 2025; the TAVIPILOT Robot remains investigational.
The broader development portfolio combines delivery mechanisms with implants and navigation. MITRAPILOT brings image guidance and robotics together with the EPYGON transcatheter mitral valve, whose asymmetric design is intended to preserve physiological blood flow. That programme remains under clinical investigation. ARTEDRONE addresses ischaemic stroke intervention. Across these programmes, the company is developing tools to assist difficult positioning and navigation steps under clinician supervision.
Articles
Funding
- 2026-06-24 - Financing tranche - $11.4M - Carvolix secures new €10 million financing tranche
Carvolix secured a new €10 million financing tranche, bringing total financing under its €30 million programme to €20 million and supporting Tavipilot commercialization plus regulatory and clinical work. - source: eqs-news.com
Investors
- Existing shareholders - Participant - Angel / Individual - 1 funding event - first seen 2026-06-24
- Truffle Capital - Participant - VC - 1 funding event - first seen 2026-06-24
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 subject to clearance; the robot is not yet authorized for commercial use.
Source - 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 initial U.S. commercial contract with Rush University Medical Center, where ten patients had been treated successfully.
Source - 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 allocated to commercialisation, industrialisation and market-access work for Tavipilot and Kalios.
Source - 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 tranche extends the company’s cash runway to the end of September 2026, with venture debt under negotiation.
Source
Context
Market context
Tavipilot