Carvolix

This product is under clinical investigation

Kalios is the first mitral annuloplasty device that can be percutaneously adjusted to optimize valve repair at any time after implant, repeatedly, and while the heart is beating, thus avoid the need for further surgery.

Kardiozis technology provides a major solution to the problems of type II endosters caused by existing stents and their consequences for patients: risks of re-intervention and anxiety induced by the possible increase in aneurysm that can lead to rupture and death of the patient.

Mitral regurgitation results in blood leaking through the mitral valve each time the left ventricle contracts. This potentially deadly disease is highly prevalent, and eventually leads to heart failure.

Carvolix governance and scientific advisory board brings together deep expertise in pathologies addressed and prior successful experiences in medtech companies.

Approval from the Spanish and Italian competent authorities for the launch of the Minerva pilot clinical study in the centres of Murcia and Florence. Management team strengthening with the arrival of Wenzel Hurtak as Vice President Operation for the Epygon Medical Device.

The company is a French MedTech firm in commercial and clinical stages, founded by Truffle Capital.

A French MedTech company at commercial and clinical stage, founded by Truffle Capital.

Carvolix is backed by Truffle Capital and strategic investors, including Edwards Lifesciences.

320 avenue Archimède Les pléiades III Bâtiment B 13100 Aix-en-Provence France

Leading-edge solutions that will dramatically change the lives of millions of people.

Leading-edge solutions that will dramatically change the lives of millions of people.

Company name: CARVOLIX Registered office: 900 Rue André Ampère 13290 AIX-EN-PROVENCE Legal form: Public limited company (société anonyme) SIREN No.: 837 722 560 Aix-en-Provence Capital: €20 750 202 Chair: Anne Lange CEO: Sebastien Ladet

Carvolix reports its share capital and voting rights as of October 31, 2026. The company has **62.3 million shares outstanding**, alongside **90.2 million theoretical voting rights** and **90.2 million exercisable voting rights**. The figures reflect the structure of shareholder control and potential dilution.

Nov 2026TipRanksNews article

Carvolix names Anne Lange as chair of its board of directors, reinforcing its strategic growth plans. The company also releases its 2026 half-year financial performance update, highlighting operational progress and market positioning in its core sector.

Sep 2026CarvolixNews article

Carvolix files a **510(k) premarket notification** with the **FDA** for its **TAVIPILOT Robot**, a step toward launching its **integrated TAVIPILOT platform** in the U.S. The submission supports commercialization efforts for the robotic system designed to assist in transcatheter aortic valve implantation (TAVI) procedures.

Sep 2026CarvolixNews article

Carvolix submits its **TAVIPILOT software** for **CE marking**, a critical regulatory step toward launching the product commercially in Europe. The software supports transcatheter aortic valve implantation (TAVI) procedures, addressing a key gap in cardiac intervention workflows. This submission marks progress in bringing the solution to European hospitals and clinicians.

Sep 2026CarvolixNews article