from Affluent Medical (isin : FR0013333077)
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 with AI driven autonomous mini-robots and innovative implants
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 €16.6M and €11.4M 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 €23 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: Press releases:
Products:
Press release: Products: Press release: Product:
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 €16.6M, the following earn-out considerations:
The binding agreement with respect to Artedrone provides for, in addition to the closing payment of €11.4M, the following earn-out considerations:
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 €1M 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 €2.34 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 €30M. The first tranche of the Financing amounting to €10M (the “First Tranche”) has already been secured at an issuance price of €2.34. Under the Investment Agreement, Truffle Medeor FPCI, Truffle BioMedTech Crossover FPCI and Edwards Lifesciences undertook to invest respectively € 1.5M, €3.5M and €5M at a subscription price of €2.34 per Ordinary Share (which represent a 67% premium versus the last closing share price) in the context of the First Tranche of the Financing corresponding to the subscription of a total of 4,273,503 new Ordinary Shares. To support the Company’s short-term runway extension, Truffle will provide a financial guaranty to the Company for a €2.5M loan from a commercial bank. Such loan would be repaid at the time of the closing of the First Tranche. The purpose of the First Tranche of the Financing is to extend the horizon of the Company’s cash position from December 2025 to the end of May 2026. The First Tranche of the Financing will allow the Company to pursue clinical and regulatory development for all its devices, and to position itself favorably as it embarks on the next steps of value creation. These steps include, but are not limited to, launching the commercialization in the US of TAVIPILOT Software, negotiating a strategic agreement with an industrial player to speed up the clinical trials and marketing of Artus, progress towards first in human for the robotic platform for stroke treatment and continue the development and clinical activities of Epygon. The allocation of the proceeds of the First Tranche between the different programs should be approximately as follows: 28% to TAVIPILOT, 27% to Artus, 23% to structural heart devices (Kalios and Epygon), 22% to ARTE-DRONE. The financing required to pursue the combined Carvolix activities over the next 12 months, according to current development plans, is estimated at around €26M, of which €10M is secured through the First Tranche of the Financing. The Company expects to secure the remainder from several international investors. The Company also expects to be able to further extend its cash runway through the proceeds that would be generated from a potential partnership deal with regards to Artus, an artificial urinary sphincter currently in Affluent Medical’s product portfolio.
General Meeting to be held on January 30, 2026 In connection with the Transaction, an Extraordinary General Meeting will be held on January 30, 2026, at the Company’s registered office in Aix-en-Provence, France in order to delegate to the Board of Directors the necessary powers to implement the Transaction and to change the name of the Company to Carvolix. Additional information and preparatory documents for this Extraordinary General Meeting will be made available in the coming weeks in accordance with applicable legal and regulatory requirements. The Board has decided to appoint Mrs. Liane Teplitsky as Chair of the Board of Directors in replacement of Mr. Michel Therin, who will continue to contribute to the Board as director, effective as from the date of closing of the Transaction. Mr. Alain Chevallier, a senior partner at Truffle Capital, has been appointed as director by the Board of Directors of the Company in replacement of Financière Memnon, represented by Mr. Vincent Bourgeois, which resigned from the Board. Mr. Alain Chevallier, a graduate from HEC MBA, has dedicated all his professional career to the life science industries. First, within Sanofi and its predecessor companies in which he has borne alternatively senior finance and country head positions abroad (Latin America, Japan, Germany). He was member in charge of finance at Aventis Pharma SA board of management (1999-2004) then CFO of Sanofi-Aventis France (2004-2007). In 2007, he joined Truffle Capital as Operating Partner. During his tenure, he cofounded Splicos (now Abivax) in 2007, conducted the IPOs of Carbios as Chairman of the Board (2013), then that of Abivax in 2015. In 2017, he joined the management team of Truffle Capital as Senior Partner. He is presently Chairman of Artedrone (microrobotic platform for stroke treatment), Vice-chairman of Evexta Bio (precision oncology drugs). He stands also as Treasurer of the ARC Foundation for Cancer Research. Advisors Dechert LLP acted as legal advisor to the Company in connection with the Transaction. Documentation The Transaction is not subject to a prospectus requiring approval by the Financial Markets Authority (the “AMF”). However, in accordance with Article 1.5.b bis) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended (the “Prospectus Regulation”), the Company will file with the AMF a document containing the information required in Annex IX of the Prospectus Regulation (the “Information Document”), with a view to the admission to trading on the regulated market of Euronext in Paris (“Euronext Paris”) of the Shares to be issued in connection with the Transaction. The Information Document is not subject to a review by the AMF. Indicative timetable
Risk factors Members of the public should take note of the risk factors relating to Affluent and its business, as presented in Chapter 3 of the 2024 Universal Registration Document filed with the AMF on April 30, 2025 under number D.25-0356, which is available free of charge on Affluent’s website www.affluentmedical.com. The occurrence of all or some of these risks would be likely to have an adverse effect on the business activity, financial position, results, development, or outlook of Affluent. Such events could have a material adverse effect on Affluent’s share price. Members of the public should particularly take note of the following risks: Raising additional capital, including as a result of this Transaction or of further offerings to finance the development or the commercialization of Affluent’s products, may cause dilution to the Company’s shareholders, restrict its operations or require it to relinquish rights to its products; Future sales of ordinary shares by existing shareholders or investors participating in the Transaction could depress the market price of the Company’s shares; The market price of the Company’s shares can be subject to significant fluctuations and may decrease below the issuance price retained in the context of the Transaction; Volatility and liquidity of the shares of the Company can be subject to significant fluctuations; The Company’s management will have broad discretion over the use of the proceeds from the Financing and may apply these proceeds in ways that may not result in an increase of the share price. This press release does not constitute a prospectus as referred to in Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended, or an offer to the public.
About Affluent Medical Affluent Medical is a French medical technologies company, founded by Truffle Capital, that aims to become a global leader in the treatment of structural heart diseases, one of the world's leading causes of mortality, and urinary incontinence, which currently affects one in four adults. Affluent develops next-generation implants that are minimally invasive, innovative, adjustable and biomimetic, designed to restore essential physiological functions. The candidate products developed by the Company are all undergoing clinical studies in humans. |