DJ Affluent Medical announces upcoming acquisition of Caranx Medical and Artedrone, becoming Carvolix, pioneering cardiovascular therapies.
Affluent Medical Affluent Medical announces upcoming acquisition of Caranx Medical and Artedrone, becoming Carvolix, pioneering cardiovascular therapies. 19-Dec-2025 / 17:56 CET/CEST Dissemination of a French Regulatory News, transmitted by EQS Group. The issuer is solely responsible for the content of this announcement. =---------------------------------------------------------------------------------------------------------------------- Affluent Medical announces upcoming acquisition of Caranx Medical and Artedrone, becoming Carvolix, pioneering cardiovascular therapies with AI driven autonomous mini-robots and innovative implants -- In a cashless transaction, the acquisitions unite mini-robotic, AI and implant technologies that will empower interventional cardiologists to transform cardiac valve replacement and emergency stroke care for a combined market estimated at USD23B by 2030 -- Concomitant financing of up to EUR30M with a first tranche of EUR10M secured from Truffle Capital (EUR5M) and Edwards Lifesciences (EUR5M) at a 67% premium share price of EUR2.34. Other investors are expected to join this first tranche. -- TAVIPILOT Software, an AI-driven guidance system for transcatheter aortic valve replacement, received FDA clearance in July 2025, advancing Carvolix toward an expected commercialization in Q1 2026 in the US -- Closing of the transaction expected by the end of January 2026 with a shareholder general meeting convened for January 30, 2026 Aix-en-Provence, December 19th, 2025 - 5:45 p.m. CET - Affluent Medical (ISIN: FR0013333077 - Ticker: AFME - "Affluent" or the "Company"), a French clinical-stage medical technology company specializing in the international development and industrialization of breakthrough implantable medical devices, is today announcing that it has entered into binding agreements to acquire Caranx Medical and Artedrone to form a new, integrated MedTech company named Carvolix, for a closing price of respectively EUR16.6M and EUR11.4M entirely paid through the issuance of new shares of Affluent, subject to possible earn-out payments. This strategic consolidation is designed to create a company for the 21st century interventional cardiologist - leveraging world leading technology in AI driven autonomous mini-robots with a mission to democratize complex, life-saving procedures. The combined platforms position Carvolix to accelerate radical innovation, expand its addressable market, and drive long term value creation. « We're applying the proven business builder model - uniting the capabilities of Truffle-founded companies to de-risk development, accelerate innovation, and unlock value for shareholders » said Philippe Pouletty, M.D., CEO of Truffle Capital, founder of several successful biotech and medtech companies (including Abivax, Vexim and Affluent Medical). He added: "We expect to make the cardiology catheterization lab as autonomous and efficient as an aircraft cockpit so that our radical innovations could benefit to millions of patients worldwide." Carvolix will focus on revolutionizing cardiac valve replacement and stroke treatment, addressing major unmet medical needs in large markets with a total addressable value of EUR23 billion. Currently, only 17% of the 1.7 million patients annually eligible for Transcatheter Aortic Valve Implantation (TAVI) undergo the procedure, and only 5% of ischemic stroke patients (second cause of death, third cause of disability) receive mechanical thrombectomy. Similarly, just 4% of the four million patients with severe mitral valve regurgitation undergo surgery. « We are bringing together three extremely innovative and synergistic MedTech companies into one - with the goal of augmenting the cardiac catheterization lab to treat far more patients suffering from valve dysfunction and stroke » said Sebastien Ladet, designated CEO of Carvolix. « In addition, we will boost synergies in R&D and commercialization between the three companies to enable the development and delivery of additional products, such as a robotically delivered mitral valve" The combination of these companies unites deep expertise and R&D synergies across micro-robotics, AI, image guidance, catheter and valve technologies - accelerating innovation and establishing a robust, sustained product development cadence. The first product launch is expected to occur in early 2026, with the TAVIPILOT software 'already cleared by the FDA, being introduced in the US. The Company plans to keep direct commercialization rights in Europe and seek partners in the US, Middle East, and Asia. "We are building a fantastic management team and board of directors to carry out our mission: a commercial stage MedTech leader dedicated to helping interventional cardiologists treat more patients around the world" said Liane Teplitsky, designated executive Chair of the Board of Directors of Carvolix. Additional details on the structure of the Transaction and its consequences on the share capital of the Company can be found in Appendix 1, as well as below. Additional details on Caranx Medical and Artedrone and their products can be found in Appendix 2. Recent press releases and products from Affluent Medical, Artedrone, Caranx Medical are as follows: Caranx Medical: Press releases: -- Dec 2025: Caranx Medical announces first clinical use in patients of the TAVIPILOT Robot at Macquarie University Hospital, Sydney, Australia -- Dec 2025: PR Caranx Medical - Carvolix project - Successful completion of the clinical trial of TAVIPILOT Software -- Nov 2025: PR world first AI Software for real-time intra-operative guidance of transcatheter heart valve implantation -- Oct 2025: PR Caranx Medical at TCT in San Francisco to showcase TAVIPILOT Software -- July 2025: PR Caranx Medical announces FDA clearance of TAVIPILOT Soft Products: -- TAVIPILOT Software -- TAVIPILOT Robot Affluent Medical: Press release: -- PR Affluent Medical - Promising results for Epygon biomimetic valve presented at TCT cardiology congress US by Dr. Sarraf at Mayo Clinic Products: -- Kalios -- EPYGON -- Artus Artedrone: Press release: -- PR Artedrone successfully demonstrates the ability to autonomously perform end to end mechanical thrombectomy (MT) Product: -- ARTE-DRONE -- Animal Labs from March 2025 Financial conditions of the Acquisitions The binding agreement with respect to Caranx Medical provides for, in addition to the closing payment in Affluent shares of EUR16.6M, the following earn-out considerations: -- an earn-out consideration equal to EUR19.8M in the event Caranx Medical obtains, (a) on or prior to December 31st, 2025, the FDA Clearance for TAVI Pilot Software (already obtained) and (b) on or prior to December 31st, 2026, the FDA Clearance for TAVI Pilot Robot, or (y) enters, on or prior to December 31st, 2026, into a corporate agreement generating a minimum of EUR50M of upfront and milestone payments (taking only into account payments received on or prior December 31st, 2026) (the "Caranx Earn-Out 1"); and -- an earn -out consideration in the event Caranx Medical enters, on or prior to December 31st, 2026, into a commercial agreement generating a minimum of EUR30M of upfront and milestone payments for TAVIPILOT Software or Robot , equal to 5% of the cash proceeds effectively received (excluding royalties) by the Company in the context of the said commercial agreement prior to December 31st, 2030 included. The binding agreement with respect to Artedrone provides for, in addition to the closing payment of EUR11.4M, the following earn-out considerations: -- an earn-out consideration equal to EUR13.6M in the event Artedrone initiates on or prior to June 30th, 2027, a First in Human study for ARTE-DRONE (with at least 2 patients successfully recruited), or (y) enters, on or prior to December 31st 2026, into a commercial agreement generating a minimum of EUR30M of upfront and milestone payments for ARTE-DRONE (the "Artedrone Earn-Out 1" and together with the Caranx Earn-Out 1, the "Earn-Outs 1"); and -- an earn-out consideration in the event Artedrone enters, on or prior to December 31st, 2026, into a commercial agreement generating a minimum of EUR30M of upfront and milestone payments for ARTE-DRONE, equal to 5% of the cash proceeds effectively received (excluding royalties) by Artedrone in the context of the said commercial agreement prior to December 31st, 2030 included. These milestones if and when reached are expected to be significant value drivers for Carvolix. Under the binding agreement with respect to Artedrone, Affluent will also acquire from Truffle BioMedTech CrossOver FPCI a current account against Artedrone for an amount of EUR1M plus accrued interests (at a rate of 8% per annum) (the " Current Account"). Truffle funds, acting as sellers in the context of the acquisitions (the "Sellers") have undertaken to entirely roll-over the closing purchase price, the purchase price of the Current Account, and any proceeds from the Earn-Out at a subscription price of EUR2.34 per Ordinary Share (i.e., the same price as for the Edwards / Truffle financing), resulting in the issuance of a total of 26,668,455 new Ordinary Shares to the Sellers. Financing and use of proceeds The Company is further announcing the launch of a concomitant financing transaction led by Truffle Capital and Edwards Lifesciences of up to EUR30M. The first tranche of the Financing amounting to EUR10M (the "First Tranche") has already been secured at an issuance price of EUR2.34. Under the Investment Agreement, Truffle Medeor FPCI, Truffle BioMedTech Crossover FPCI and Edwards Lifesciences undertook to invest respectively EUR 1.5M, EUR3.5M and EUR5M at a subscription price
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