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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DJ Affluent Medical announces upcoming acquisition of Caranx Medical and Artedrone, becoming Carvolix, pioneering cardiovascular therapies. -2-
of EUR2.34 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
EUR2.5M 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 EUR26M, of which EUR10M 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
December 17, 2025 Board of Directors authorizing the Transaction and the signing of related contracts
December 18, 2025 Signing of SPAs and the Investment Agreement
Prior to January 30, 2026 Availability of preparatory documents relating to the Extraordinary General Meeting
Extraordinary General Meeting of Shareholders
Completion of the Acquisitions
January 30, 2026
Publication of a press release announcing the results of the Extraordinary General Meeting
votes and the completion of the Acquisitions
Board of Directors implementing the capital increase in favor of the Sellers, the investors
in the Financing, and the holders of Convertible Bonds
Publication of a press release announcing the definitive terms of the Financing
As from January 30, 2026
Subscription period
Information Document (Appendix IX of the Prospectus Regulation)
By 15 February, 2026 (at
the latest) Settlement and delivery of the shares and admission of the new shares to trading
Publication of a press release announcing the completion of the Financing
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.
For more information, please visit www.affluentmedical.com
About Truffle Capital
Founded in 2001, Truffle Capital is an independent European Venture Capital firm specializing in disruptive technologies in the Life Sciences (Biotech, Medtech, Bioecotech) and IT sectors (Fintech and Insurtech). Truffle Capital's mission is to support the creation and development of innovative companies capable of becoming the leaders of tomorrow , and it has notably founded Abivax.
Managed by Dr. Philippe Pouletty, M.D. and Bernard-Louis Roques, Co-founders and co-CEOs, Truffle Capital manages EUR500 million in assets. It has raised more than EUR1.2 billion since its creation and has supported more than 124 companies in the digital technology and life sciences sectors. Discover more at www.truffle.com and follow us on LinkedIn.
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DJ Affluent Medical announces upcoming acquisition of Caranx Medical and Artedrone, becoming Carvolix, pioneering cardiovascular therapies. -3-
Contacts:
AFFLUENT MEDICAL
SEITOSEI.ACTIFIN
Financial communications / Press relations
Sébastien Ladet
Ghislaine Gasparetto / Jennifer Jullia
+ 33 6 85 36 76 81/ + 33 6 02 08 45 49
Chief Executive Officer
ghislaine.gasparetto@seitosei-actifin.com / jennifer.jullia@seitosei-actifin.com
investor@affluentmedical.com
MC SERVICES AG
PRIMATICE
Media relations Europe
Public Relations France
Thomas Roborel de Climens
+33 (0)6 78 12 97 95 Maximilian SCHUR / Julia BITTNER
thomasdeclimens@primatice.com +49 (0)211 529252 20 / +49 (0)211 529252 28
affluent@mc-services.eu
Disclaimer
This press release contains forward-looking statements about Affluent and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Affluent's financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Affluent believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements are subject to numerous risks and uncertainties, including those described 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 on the Company's website (www.affluentmedical.com), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Affluent operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Affluent or that Affluent does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Affluent to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Affluent in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.
This press release does not constitute a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation"). With respect to the member states of the European Economic Area (each, a "Relevant Member State"), no offer of the securities mentioned herein is made or will be made to the public in that Relevant Member State, except (i) to any legal person who is a qualified investor as defined in the Prospectus Regulation, (ii) to fewer than 150 natural or legal persons per Relevant Member State, or (iii) in other circumstances falling within Article 1(4) of the Prospectus Regulation; provided that none of these offers shall require the publication by the Company of a prospectus pursuant to Article 3 of the Prospectus Regulation. For the purposes of the foregoing, the expression "offer to the public" in any Relevant Member State has the meaning given to it in Article 2(d) of the Prospectus Regulation.
Solely for the purposes of each manufacturer's product approval process, the target market assessment in respect of the securities offered in the Financing has led to the conclusion that, in relation to the type of clients criteria, (i) the target market for the securities is eligible counterparties and professional clients, each as defined in Directive 2014/65/EU, as amended ("MiFID II"); and (ii) all channels for distribution of the securities offered in the Financing to eligible counterparties and professional clients are appropriate. Any person subsequently offering, selling or recommending the shares (a "distributor") should take into consideration the manufacturers' client type assessment; however, a distributor subject to MiFID II is responsible for undertaking its own target market assessment in respect of the shares offered in the Financing (by either adopting or refining the manufacturers' target market assessment) and determining appropriate distribution channels.
This press release has been prepared in French and English. In the event of any discrepancy between the two versions of the press release, the French version shall prevail.
Appendix 1
Structure of the Transaction
Acquisition of Artedrone and Caranx Medical
On December 18, 2025, the Company entered into two share purchase agreements with the shareholders of Caranx Medical and Artedrone (respectively the "Caranx SPA" and the "Artedrone SPA", and, collectively, the "SPAs") relating to the acquisition by the Company of 100% of the share capital of Caranx Medical and Artedrone (the "Acquisitions") for a closing price of respectively EUR16.6M and EUR11.4M (the "Closing Purchase Price").
The execution of the SPAs by the Company has been approved by the Board of Directors of the Company in compliance with the procedure applicable to related parties agreement (conventions réglementées), i.e. Dr. Philippe Pouletty, M.D. (representative of Truffle Capital, director of Affluent and also party to the Investment Agreement), Mr. Michel Thérin (Chairman of the board of Affluent and Chairman of the Board of Caranx Medical) and Ms. Liane Teplitsky (director of Affluent and CEO of Artedrone) have abstained from participating in the relevant deliberations. In accordance with applicable laws, (i) the main terms of the SPAs and their interest for the Company will be described in a special report to be issued by Affluent's statutory auditors, which will be submitted to the next Annual General Meeting of the Company, and (ii) the information set forth in Article R.22-10-17 of the French Commercial Code has been made available on the Company's website.
The Caranx SPA provides for a closing payment of EUR16.6M and for the following earn-out considerations:
-- an earn-out consideration equal to EUR19.8M in the event Caranx Medical either (x) 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 "Caranx Earn-Out 2").
The Artedrone SPA provides for a closing payment of EUR11.4M and for the following earn-out considerations:
-- an earn-out consideration equal to EUR13.6M in the event Artedrone either (x) 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 (the "Artedrone Earn-Out 2" and together with the Caranx Earn-Out 2, the "
Earn-Outs 2").
Under the Artedrone SPA, 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"). Therefore, after closing of the Transaction, Affluent will hold an intra-group receivable against Artedrone for an amount of EUR1M plus accrued interests (at a rate of 8% per annum).
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 1 (the "Roll-Over") at a subscription price of EUR2.34 new ordinary shares of the Company, EUR0.10 nominal value per share (each an "Ordinary Share"). Proceeds from the Earn-Out 2, if any, would be paid in cash by the Company to the Sellers. Except for the Earn-Out 2, the Acquisitions would therefore be completed on a cashless basis.
The Roll-Over of the Closing Purchase Price, for a total amount of EUR28.0M, would result in the issuance of 11,948,222 Ordinary Shares to the Sellers.
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