DJ Carvolix Appoints Anne Lange as Chair of its Board of Directors Confirming the Acceleration of its Ambitions and Reports 2026 Half-Year Results.
Affluent Medical Carvolix Appoints Anne Lange as Chair of its Board of Directors Confirming the Acceleration of its Ambitions and Reports 2026 Half-Year Results. 30-Sep-2026 / 17:45 CET/CEST Dissemination of a French Regulatory News, transmitted by EQS Group. The issuer is solely responsible for the content of this announcement. =---------------------------------------------------------------------------------------------------------------------- PRESS RELEASE Carvolix Appoints Anne Lange as Chair of its Board of Directors Confirming the Acceleration of its Ambitions and Reports 2026 Half-Year Results
-- Appointment of Anne Lange as Chair of the Board of Directors of Carvolix, alongside a strengthenedgovernance structure (directors, non-voting board observer and international Scientific Advisory Board);
-- Commercial expansion for the TAVIPILOT platform, with the CE marking dossier filed for TAVIPILOTSoftware and the FDA dossier filed for TAVIPILOT Robot;
-- Positive three-year clinical results for TAVIPILOT: primary endpoint on mitral regurgitation met in 100%of patients, with no device-related adverse events;
-- Strengthened financial resources: a EUR10 million tranche secured on June 24, 2026, bringing H1 equityfinancing to EUR20 million, and a EUR30 million structured bond financing with Claret Capital Partners on August 6,2026.
Aix-en-Provence, France, September 30, 2026 - 5:45 pm CEST - Carvolix (ISIN: FR0013333077 - Ticker: CVX), a French commercial-stage medical technology company specializing in the international development of breakthrough AI-driven mini-robots and biomimetic implants, announces the appointment of Anne Lange as Chair of its Board of Directors and today reports its 2026 half-year results (for the period ended June 30, 2026).
"Our first-half performance reflects continued execution of our roadmap, with a clear focus on the commercialization of TAVIPILOT, advancing Kalios towards the US market, and securing the resources needed to deliver on our commitments" said Sébastien Ladet, Chief Executive Officer of Carvolix.
Governance UPDATE: Anne Lange appointed Chair of the Board of Directors
On September 30, 2026, the Board of Directors of Carvolix appointed Anne Lange as Chair of the Board of Directors. Anne Lange joined the Carvolix Board in April 2026.
A graduate of the École nationale d'administration (ENA), Anne Lange held senior management positions within the French government and then at Cisco in the United States, before founding Mentis, a software company for smart cities. An entrepreneur, technology investor and board member of major companies, she currently sits on the boards of Pernod Ricard, Orange and Peugeot Invest.
In appointing Anne Lange as its Chair, Carvolix has chosen a leader accustomed to challenging innovation strategies in order to accelerate growth, who will open up new networks internationally and in AI while ensuring rigorous governance.
Anne Lange succeeds Liane Teplitsky, who had chaired the Board of Directors since January 2026. Having been appointed to new executive responsibilities within another group, Liane Teplitsky wished to hand over the chairmanship of the Board while remaining a director of Carvolix, whose development she will continue to support.
"I would like to thank Liane Teplitzky, the Board of Directors, the founders and the shareholders for their confidence. With Carvolix and its management team, we have the opportunity to build a global MedTech leader, developing and commercializing medical devices that can save the lives of hundreds of thousands of patients. Carvolix will bring the benefits of advanced technologies designed in France to increasingly significant markets worldwide. Carvolix has the potential to make a major difference for patients" commented Anne Lange, Chair of the Board of Carvolix.
This appointment follows on from the strengthening of Carvolix's Board initiated in April 2026, with:
-- the appointment of Rute Fernandes as non-voting board observer (censeur), bringing additional strategic,operational and international expertise;
-- the arrival of Paul LaViolette, CEO of Pulse Biosciences, and Dr. Mirvat Alasnag, M.D., on theinternational scientific Advisory Board, strengthening the Group's scientific, clinical and strategic leadership;
-- the appointment of Michel Therin as Vice-Chair of the Board.
TAVIPILOT: COMMERCIAL ROLLOUT IN THE US, REGULATORY PROGRESS IN EUROPE
Since the March 19, 2026 press release on the 2025 annual accounts, the TAVIPILOT AI-driven robotic platform has passed several key milestones.
Clinical data presented at New York Valves 2026 -SAITO program demonstrated, in 30 patients:
-- a 100% procedural success rate, with no device-related safety events;
-- valve positioning within less than one millimeter of the target in 100% of cases;
-- a reduction of up to 50% in procedure time, together with reductions in fluoroscopy time and contrastvolume, compared with reference studies (PARTNER 3, SMART BEV), while the treated population presented a riskprofile approximately 3 times higher (STS-PROM score of 5.70 versus 1.9);
-- for TAVIPILOT Robot, confirmed success in the First-in-Human study in 10 patients, with no robot-relatedsafety events, and the start of the second clinical study (SAIRO), with 7 patients successfully treated to date.
Several significant regulatory milestones: the CE marking dossier for TAVIPILOT Software was filed, with certification expected before the end of the year and a commercial launch in Europe targeted for early 2027. The FDA dossier for TAVIPILOT Robot was filed, with clearance expected in early 2027 for a commercial launch of the complete platform.
Commercial rollout of TAVIPILOT Software in the United States: as part of the controlled launch with the first reference centers, the company shared feedback from Rush University Medical Center (Chicago), together with an initial series of 10 procedures successfully performed over the summer.
Kalios mitral ring: positive 3-year clinical results
On June 15, 2026, Carvolix announced positive 3-year clinical results for Kalios, from the European Optimise II pivotal study.
-- 100% of the patients assessed (15 patients having reached 3-year follow-up, out of 20 patients at 2years, across five European centers) met the primary endpoint: mitral regurgitation of grade = 2+;
-- no device-related adverse events were reported over 3 years;
-- mitral leaflet coaptation length improved, from 3.9 mm at baseline to 6.4 mm at 3 years.
These results reinforce the positioning of Kalios, the only percutaneously adjustable mitral annuloplasty ring, in a surgical mitral valve repair market estimated at USUSD1.5 billion across the United States and Europe, growing at 3.5% per year, and which could avoid a repeat procedure for 30% to 40% of patients within a 5-year horizon.
Carvolix plans to file with the FDA, ahead of a US commercial launch targeted for 2027.
STRENGTHENED FINANCIAL RESOURCES
New EUR10 million tranche (June 24, 2026) Carvolix secured a EUR10 million tranche, bringing total financing raised in the first half of 2026 to EUR20 million. The transaction resulted in the issue of 2,976,190 new shares at a price of EUR3.36 per share, subscribed in equal parts by Edwards Lifesciences and funds managed by Truffle Capital (EUR5 million each).
EUR30 million structured bond financing (August 6, 2026) Carvolix concluded a EUR30 million structured bond financing with Claret Capital Partners, comprising EUR20 million of convertible bonds and EUR10 million amortizing bonds (maximum dilution limited to 8.6% of existing share capital).
Following the drawdown of tranche A, Carvolix's resources are secured through February 2027, and through October 2027 in the event of full drawdown.
INCLUSION IN 3 NEW INDICES AND EXPANDED COVERAGE
Inclusion in the Euronext indices (March 23, 2026) Carvolix was included in the CAC Small, CAC Mid & Small and CAC All-Tradable indices, strengthening the visibility of the share, its liquidity and its exposure to index funds.
ODDO BHF initiated coverage of Carvolix (July 29, 2026) with a target price of EUR10.50, in a report entitled "A multi-specialty interventional platform." Carvolix is now covered by five research firms: Allinvest Securities, Kepler Cheuvreux, Portzamparc (BNP Paribas Group), TP ICAP and ODDO BHF.
launch of the French-Saudi SAF-MD program
On August 24, 2026, on the occasion of the visit to France of Crown Prince Mohammed bin Salman, Truffle Capital, Carvolix SA and Carvolix Saudi LLC (newly incorporated) announced the launch of the French-Saudi SAF-MD medical exchange and cooperation program.
-- An initial three-year program, renewable by mutual agreement, covering training exchanges of 6 months to2 years between French and Saudi practitioners in the fields of interventional cardiology and neurovascularprocedures;
-- Co-chaired by Professor Stéphan Haulon (France) and Dr. Mirvat Alasnag (Saudi Arabia), the program willenable the integration of artificial intelligence and robotics into medical procedures, in line with the healthobjectives of Saudi Vision 2030;
-- Carvolix Saudi LLC is also studying the creation of a MedTech manufacturing site in Saudi Arabia,intended to serve several regions.
Events in the Middle East could affect or delay the achievement of Carvolix's objectives in Saudi Arabia.
Outlook
In the coming months, Carvolix intends to continue executing its strategy combining medical robotics and biomimetic implants. Its main priorities include:
-- continuing the commercial rollout of TAVIPILOT Software in the United States;
-- obtaining CE marking for TAVIPILOT Software and preparing its commercial launch in Europe (early 2027);
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September 30, 2026 11:45 ET (15:45 GMT)
