Carvolix submits 510(k) for TAVIPILOT Robot, advancing toward US commercial launch of Its Integrated TAVIPILOT Platform

DJ Carvolix submits 510(k) for TAVIPILOT Robot, advancing toward US commercial launch of Its Integrated TAVIPILOT Platform.

Affluent Medical 
Carvolix submits 510(k) for TAVIPILOT Robot, advancing toward US commercial launch of Its Integrated TAVIPILOT 
Platform. 
22-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. 
 
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Carvolix submits 510(k) for TAVIPILOT Robot, advancing toward US commercial launch of Its Integrated TAVIPILOT 
Platform. 
 . 510(k) submission filed with the FDA for the TAVIPILOT Robot - a key regulatory submission ahead of the 
  planned US launch of the integrated TAVIPILOT platform in 2027. 
  
 . Submission supported by the completed ROTAO1 First-in-Human study, in which the TAVIPILOT Robot performed 
  successfully in 10 of 10 procedures. Initiation of the SAIRO study evaluating TAVIPILOT Robot and software in 
  combination, with 7 patients treated successfully to date. 
  
 . TAVI market expected to expand in the US following the recent Centers for Medicare and Medicaid Services 
  coverage update. TAVIPILOT platform well positioned to support procedure expansion with safe and standardized 
  robotic valve positioning. 
Aix-en-Provence, September 22, 2026 - 17:45 CET - Carvolix (formerly Affluent Medical) (ISIN: FR0013333077 - Ticker: 
CVX), a French medical devices company at the commercial stage, specializing in the development of AI-driven 
mini-robots and biomimetic implants, announces the filing of a 510(k) submission with the U.S. Food and Drug 
Administration (FDA) for the TAVIPILOT Robot, the robotic component of its integrated TAVIPILOT platform to augment 
transcatheter aortic valve replacement (TAVI) procedures. 
This is a key regulatory submission required before Carvolix can bring the integrated TAVIPILOT platform to the US 
market. 
Continued progress toward commercialization of the integrated TAVIPILOT platform 
The TAVIPILOT platform brings together: 
 . the TAVIPILOT Software, a real-time intra-procedural AI guidance software, which received FDA 510(k) 
  clearance in July 2025 and is already in commercial use in the United States, and 
 . the TAVIPILOT Robot, which provides catheter stability and millimetric precision control under the 
  operator's supervision. 
Subject to FDA clearance, Carvolix confirms its objective of launching the integrated TAVIPILOT platform in the United 
States in early 2027. This step also brings Carvolix closer to drawing the second tranche of EUR10 million under the EUR30 
million structured debt facility secured with Claret Capital, which is conditional on FDA clearance of the TAVIPILOT 
Robot. 
"With this new regulatory step, we are executing against our clinical and commercial roadmaps, each one bringing us 
closer to the same goal: to democratize access to complex cardiovascular procedures," said Sébastien Ladet, CEO of 
Carvolix. He continued: "Our AI-driven robotic platform is not a single-feature product. Precision positioning is the 
first commercial feature we deliver, but the same software and robotic architecture is designed to host additional 
intra-procedural capabilities. Building a platform, not a single product, is how we scale value delivery to each 
cath-lab we will equip." 
Potential US market growth with supportive coverage update 
The US regulatory and reimbursement environment is evolving in favor of wider access to TAVI procedures. On September 
10, 2026, the Centers for Medicare & Medicaid Services (CMS) published its final national coverage determination for 
transcatheter aortic valve replacement, easing requirements for patients with symptomatic severe aortic stenosis: 
hospital procedural volume thresholds are removed, and coverage with evidence development no longer applies to this 
population. The updated determination also allows procedures to be performed by a single operator where previously two 
operators were required. 
In addition, coverage is extended to patients with asymptomatic severe aortic stenosis under evidence development. 
More centers are expected to become eligible to offer TAVI as a result, with a need to scale up. Against a backdrop in 
which only 17% of eligible patients are treated each year, Carvolix believes this reinforces the need for technologies 
such as TAVIPILOT that make procedures more precise, reproducible while shortening the learning curve for 
interventional teams. 
An FDA submission supported by the completed ROTAO1 study 
The filing follows the completion of the ROTAO1 First-in-Human study, which evaluated the robotic building block of the 
TAVIPILOT platform in 10 patients undergoing TAVI procedures. 
ROTAO1 was a prospective First-in-Human study assessing the feasibility, safety and technical reliability of the 
AI-driven TAVIPILOT Robot, without the software, during transfemoral TAVI procedures. 
It was conducted by Professor Stephen Worthley, MD, PhD, interventional cardiologist, and his team at Macquarie 
University Hospital, Sydney, Australia. Ten consecutive patients with symptomatic severe aortic stenosis (mean age 82.9 
years; median EuroSCORE II 3.45) were treated with balloon-expandable valves. 
"The system performed successfully in every case, which is very encouraging in a first-in-human trial. It gave us 
stable, consistent catheter control and supported precise valve positioning, while every clinical decision stayed with 
the operator. These are preliminary results, but they justify continuing the clinical development of robotically 
assisted TAVI, as only a fraction of patients who could benefit from this procedure are treated today", said Professor 
Stephen Worthley, MD, PhD, Principal Investigator of ROTAO1, Macquarie University Hospital, Sydney. 
Robotic-assisted navigation and valve positioning were successfully performed in all 10 procedures. The TAVIPILOT Robot 
functioned successfully in 100% of procedures, with no failure to connect the delivery system or the single-use 
cassette, no navigation failure, and no unexpected robot behaviour. No serious adverse event was considered related to 
the TAVIPILOT Robot. All 10 patients completed their 1-month follow-up, with no death and no study withdrawal, and 
clinician satisfaction was consistently high throughout the study, with a mean satisfaction score of 8.0/10. 
Investigators consistently agreed or strongly agreed that the robot provided enhanced stabilization of the catheter and 
consistent movements, responded accurately to commands, and facilitated precise valve positioning. 
A growing body of clinical evidence 
Carvolix is continuing the clinical development of the platform through the SAIRO study, which evaluates the combined 
use of the TAVIPILOT Robot and the TAVIPILOT Software in open-loop, AI-guided use during TAVI procedures. The software 
provides the operator with real-time analysis of anatomical landmarks and valve position, while the robot enables 
precise, controlled movements under clinical supervision. 
Interim analysis of the first 7 of 20 planned patients, all successfully treated at Macquarie University Hospital (n=1) 
and St Vincent's Hospital Sydney (n=6), showed high clinician satisfaction with the software and the integrated 
robot-guided workflow. No record of robot or software device deficiencies was reported. These preliminary findings 
support the continued clinical evaluation of the integrated TAVIPILOT platform. 
Together with the post-market data already reported for the TAVIPILOT Software, ROTAO1 and SAIRO progressively build 
the evidence base for each component of the platform and for their combined use in the cath-lab. Carvolix expects to 
complete the SAIRO cohort and to initiate a clinical cohort evaluating the TAVIPILOT platform in supervised autonomy[1] 
by the end of 2026. 
About the TAVIPILOT Robot 
The TAVIPILOT Robot is a robotic platform designed to assist with the navigation and positioning of transcatheter heart 
valves. The system allows the operator to precisely control catheter movements while retaining full control over 
clinical decisions and valve deployment. The TAVIPILOT Robot is a device under clinical development and is not 
authorized for commercial use. 
About the TAVIPILOT Software 
TAVIPILOT Software is an AI-powered real-time intra-procedural guidance software for percutaneous aortic valve 
implantation (TAVI). It provides automatic real-time detection of anatomical landmarks as well as continuous depth 
assessment during valve deployment. TAVIPILOT Software received FDA 510(k) clearance (K243884, July 2025) and 
commercial deployment in the United States began in H2 2025. A CE marking dossier was submitted in August 2026. 
                      About Carvolix 

Capital (also founder of the leading European biotechnology company), with the ambition of becoming a global leader in the treatment of structural heart diseases and strokes, the leading causes of mortality and disability worldwide. According to the Truffle 10 MedTech Index, Carvolix ranks first in Europe and fifth worldwide. Carvolix develops novel AI- and imaging-powered mini-robots that make complex procedures accessible to interventional cardiologists, as well as biomimetic heart valves. For more information: www.carvolix.eu

Contacts

CARVOLIX            SEITOSEI.ACTIFIN 
Sébastien LADET         Financial communication / Financial press relations 
Chief Executive Officer     Ghislaine GASPARETTO / Jennifer JULLIA 
[e-mail]      [phone] / [phone] 
                [e-mail] / 
                [e-mail] 
PRIMATICE - Media relations     
France Thomas ROBOREL de 
CLIMENS 
[phone] 
[e-mail] 

This press release contains forward-looking statements regarding Carvolix's clinical development, regulatory pathway, commercial plans and market estimates. These statements are based on current expectations and assumptions and involve known and unknown risks and uncertainties - including, but not limited to, those related to clinical trial results, sample sizes, follow-up data, regulatory approvals and market conditions - that could cause actual results to differ materially. The clinical results described concern a limited number of patients and remain subject to longer-term follow-up and publication following peer review. Forward-looking statements speak only as of the date of this press release, and Carvolix undertakes no obligation to update them, except as required by law. This press release does not constitute and shall not be construed as an offer or solicitation to subscribe for, buy or sell Carvolix securities in any jurisdiction.

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[1] in which the system performs the positioning sequence under the direct supervision of the operator, who retains control of every clinical decision.

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Regulatory filing PDF file

File: Carvolix_PR_TAVIPILOT_Robot_510k vFinal

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Language:    English 
Company:     Affluent Medical 
         320 avenue Archimède, Les pléiades III Bâtiment B 
         13100 Aix en Provence France 
         France 
Phone:      [phone] 
E-mail:     [e-mail] 
Internet:    https://www.affluentmedical.com/ 
ISIN:      FR0013333077 
Euronext Ticker: AFME 
AMF Category:  Inside information / Other releases 
EQS News ID:   2403420 
  
End of Announcement EQS News Service 
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2403420 22-Sep-2026 CET/CEST

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