DJ Carvolix Secures New EUR 10m Tranche, Bringing Total Financing to EUR 20m as Part of its EUR 30m Programme
Affluent Medical
Carvolix Secures New EUR 10m Tranche, Bringing Total Financing to EUR 20m as Part of its EUR 30m Programme
24-Jun-2026 / 07:30 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 Secures New EUR 10m Tranche, Bringing Total Financing to EUR 20m as Part of its EUR 30m Programme
-- Additional EUR 10m tranche marking the renewed confidence of the Company's strategic shareholders
-- Proceeds to support the commercialization of Tavipilot and strategic regulatory and clinical developments
-- Cash runway extended to end of September 2026, with a target to extend beyond 12 months through venture
debt financing currently under negotiation
Aix-en-Provence, June 24, 2026 - 7:30 a.m. CET - Carvolix (formerly Affluent Medical) (ISIN: FR0013333077 - Ticker: CVX
- "Carvolix" or the "Company"), a French commercial- and clinical-stage medical technology company specializing in the
international development and industrialization of breakthrough AI-driven mini-robots and biomimetic implants, to
revolutionize interventional cardiology and the treatment of brain stroke, is today announcing a EUR10 million offering
reserved to specific categories of investors (the "Transaction") through the issuance of 2,976,190 new ordinary shares
of the Company (the "New Shares") at a price per New Share of EUR3.36 (the "Subscription Price") to the benefit of
existing shareholders. The settlement-delivery of the Transaction is expected to take place around June 26, 2026,
subject to customary conditions.
The New Shares will be subject to an application for admission to trading on Euronext Paris on the same trading line as
the existing shares under the same ISIN code FR0013333077.
Sébastien Ladet, CEO of Carvolix commented: "The renewed commitment from our long-standing shareholders demonstrates
their confidence in our roadmap and the innovative nature of our AI-driven robotic platforms. This funding allows us to
focus our efforts on the commercialization of Tavipilot in the United States and advancing our roadmap, with key
regulatory milestones in the coming quarters. Our conviction remains unchanged: to make our technologies the standard
of care for patients requiring cardiovascular and neurovascular procedures."
Reasons for the Transaction and Use of Proceeds
The Company intends to use the EUR10 million proceeds of the Transaction to pursue the development of its various
products (30% on Tavipilot, 23% on Kalios, 21% on Artus, 19% on Artedrone, 7% on Mitrapilot) and for an amount of EUR2.5
million to repay a bridge financing made available by funds managed by Truffle Capital.
More specifically, the proceeds will be allocated to finance the following development phases (as described in the
Company's 2025 Universal Registration Document): (i) Tavipilot: US commercial roll-out of the software and FDA
clearance process for the robot; (ii) Kalios: Preparing the FDA submission and resuming the European clinical trial
with the new supply chain; (iii)
Artus: continuation of validation studies in preparation for a first-in-human trial; (iv) Mitrapilot: adaptation of
mitral valve technology to the robotic platform and preclinical demonstration.
Following completion of the Transaction, the Company estimates that its existing cash resources will be sufficient to
fund its operations until the end of September 2026.
The Company intends to extend its cash runway through the potential entering into a venture debt facility. The Company
is currently negotiating the terms of such facility with several leading European venture debt funds for an amount of
approximately EUR25 million, which would allow the Company to extend its cash runway beyond 12 months from the date of
this Transaction. In addition, multiple European and non-European investors have initiated discussions with the
Company, following the successful EuroPCR international cardiology conference.
There can be no assurance that the Company will be able to secure the venture debt facility or any other additional
financing on acceptable terms, or at all. If the Company is unable to obtain such financing, it may not have sufficient
cash resources to fund its operations for a period of at least 12 months, which could have a material adverse effect on
its business, financial condition, results of operations and prospects, and could require the Company to delay, reduce,
or eliminate certain development programs or operations.
The Company's financial needs until end of 2027 amount to approximately EUR78 million, of which EUR20 million are secured,
for product development and market access.
The Company expects to finance the remaining needs through:
-- a potential partnership agreement regarding Artus artificial urinary sphincter in H2 2027;
-- up to EUR25 million through a venture debt facility currently under negotiation with a leading European
venture debt fund; and
-- non-dilutive financings such as BPI.
Upcoming catalysts
Several key catalysts are expected to support market access and commercial ramp-up.
-- In Q3 2026:
- Tavipilot Robot FDA submission
- Communication of clinical results on Tavipilot Robot
- Mitrapilot publication of hemodynamic study
-- In Q4 2026:
- CE marking for the Tavipilot software
- Tavipilot Robot FDA 510(k) clearance
- Resumption of the European Kalios clinical trial
Key Characteristics of the Transaction
The New Shares will be issued through a capital increase without shareholders' preferential subscription rights and
reserved to a specified category of investors in accordance with Article L. 225-138 of the French Commercial Code and
pursuant to the 20th resolution of the ordinary and extraordinary general meeting held on January 30, 2026 (the "
General Meeting").
The Transaction is being carried out pursuant to the delegation granted by the General Meeting under its 20th
resolution, and used by the Board of Directors by a decision dated June 23, 2026, and is reserved to the specific
category of investors defined under the 20th resolution of the General Meeting, namely:
i. natural or legal persons, UCITS, or other French or foreign funds investing primarily, or having invested
more than EUR 1 million in the 24 months preceding the relevant capital increase, (a) in the Company's business
sector or (b) in growth stocks listed on a regulated market or a multilateral trading facility (such as Euronext
Growth) qualifying as "EU SMEs" within the meaning of Annex I to Commission Regulation (EU) No. 651/2014 of June
17, 2014, and/or
ii. business angels and family offices, whether French or foreign; and/or
iii. one or more strategic partners of the Company, located in France or abroad, having entered into or
intending to enter into one or more partnership (development, co-development, distribution, manufacturing, etc.) or
commercial agreements with the Company (or a subsidiary) and/or companies they control, that control them, or that
are controlled by the same person(s), directly or indirectly, within the meaning of Article L. 233-3 of the French
Commercial Code.
The number of ordinary shares to be subscribed, the subscription price and the list of investors that may subscribe
were decided by the Company's Chief Executive Officer, in accordance with a sub-delegation granted by the Company's
Board of Directors on June 23, 2026.
The subscription price of the New Shares was set at EUR 3.36 per New Share, corresponding to the last 30-day VWAP
preceding the date the issue price was set (i.e., from May 13, 2026, to June 23, 2026) with no discount, in accordance
with the 20th resolution of the General Meeting.
The Company's existing shareholders, Edwards Lifesciences and funds managed by Truffle Capital, each subscribed to the
Transaction for an amount of EUR 5 million (corresponding to 1,488,095 New Shares each). Mr. Philippe Pouletty and Mr.
Alain Chevallier, affiliated with Truffle Capital, did not participate in the deliberations of the Board of Directors
relating to the Transaction.
Settlement and delivery of the New Shares is expected to occur on or about June 26, 2026. As of their delivery, the New
Shares will be fully fungible with the Company's existing shares.
The New Shares will be admitted to trading on Euronext Paris on the same trading line as the existing shares under the
same ISIN code FR0013333077.
Impact of the Transaction on Share Capital
Following settlement and delivery, the New Shares will represent approximately 5.02% of the share capital of the
Company, and the Company's total share capital will be EUR 6,222,799, divided into 62,227,990 shares with a nominal
value of EUR 0.10 each.
For illustration purposes, a shareholder holding 1% of the Company's share capital prior to the Transaction will hold
approximately 0.95% of the Company's share capital upon completion of the Transaction.
Evolution of Shareholding Structure Following the Transaction
The shareholding structure of the Company prior to the issuance of the New Shares is set forth below:
Non-diluted basis Diluted basis
Shareholder Number of % of Number of % of voting Number of % of Number of % of voting
shares capital voting rights rights shares capital voting rights rights
Funds and companies
managed by Truffle 40,865,781 68.97% 54,076,269 70.30% 40,865,781 61.53% 54,076,269 64.31%
Capital(1)
Edwards Lifesciences 5,759,940 9.72% 5,759,940 7.49% 5,759,940 8.67% 5,759,940 6.85%
Financière Memnon 4,038,077 6.82% 4,038,077 5.25% 4,038,077 6.08% 4,038,077 4.80%
Other financial investors 4,174,087 7.04% 8,027,634 10.44% 4,174,087 6.29% 8,027,634 9.55%
(2)
including Series 1 1,774,104 2.99% 3,548,208 4.61% 1,774,104 2.67% 3,548,208 4.22%
Incubator Holding
Founders 126,375 0.21% 252,750 0.33% 602,799 0.91% 729,174 0.87%
Board of Directors and 689,696 1.16% 1,207,010 1.57% 1,345,468 2.03% 1,862,782 2.22%
Management(3)
Employees 28,058 0.05% 30,558 0.04% 6,056,568 9.12% 6,059,068 7.21%
Treasury shares 40,013 0.07% - 0.00% 40,013 0.06% - 0.00%
Float 3,529,773 5.96% 3,529,773 4.59% 3,529,773 5.31% 3,529,773 4.20%
Total 59,251,800 100% 76,922,011 100% 66,412,506 100% 84,082,717 100%
(1) The funds and companies managed by Truffle Capital are: FCPI Fortune III, FCPI Truffle Fortune 4, FCPI Truffle Fortune 5, FCPI Truffle Fortune 6, FCPI UFF Innovation No. 12, FCPI UFF Innovation No. 14, FCPI UFF Innovation No. 15, FCPI UFF Innovation No. 16, FCPI UFF Innovation No. 17, FCPI Innocroissance 2015, FCPI Innocroissance 2016, FCPI Innocroissance 2018, FCPI Innocroissance 2019, FCPI Truffle Biomedtech Crossover Fund, FCPI Truffle Innov FRR France, Truffle ISF PME 2017, Meningose, Corazan, and FPCI Truffle Medeor.
(2) Others: Holding Incubatrice Series I, Holding Incubatrice Series II, Hayk Holding, MyoPowers Medical Technologies SA, MitralFlex, Fondation Hôpital Saint-Joseph, Simone Merkle, Kam Lui, Zhu Jin.
(3) Including Sébastien Ladet.
The issuance of the New Shares will have the following impact on the allocation of the share capital and the voting rights of the Company:
Non-diluted basis Diluted basis
Shareholder Number of % of Number of % of voting Number of % of Number of % of voting
shares capital voting rights rights shares capital voting rights rights
Funds and companies
managed by Truffle 41,639,590 66.91% 54,850,078 68.65% 41,639,590 60.01% 54,850,078 63.00%
Capital(1)
Edwards Lifesciences 7,248,035 11.65% 7,248,035 9.07% 7,248,035 10.45% 7,248,035 8.33%
Financière Memnon 4,038,077 6.49% 4,038,077 5.05% 4,038,077 5.82% 4,038,077 4.64%
Other financial investors 4,888,373 7.86% 8,741,920 10.94% 4,888,373 7.04% 8,741,920 10.04%
(2)
including Series 1 2,488,390 4.00% 4,262,494 5.33% 2,488,390 3.59% 4,262,494 4.90%
Incubator Holding
Founders 126,375 0.20% 252,750 0.32% 602,799 0.87% 729,174 0.84%
Board of Directors and 689,696 1.11% 1,207,010 1.51% 1,345,468 1.94% 1,862,782 2.14%
Management(3)
Employees 28,058 0.05% 30,558 0.04% 6,056,568 8.73% 6,059,068 6.96%
Treasury shares 40,013 0.06% - 0.00% 40,013 0.06% - 0.00%
Float 3,529,773 5.67% 3,529,773 4.42% 3,529,773 5.09% 3,529,773 4.05%
Total 62,227,990 100% 79,898,201 100% 69,388,696 100% 87,058,907 100%
(1) The funds and companies managed by Truffle Capital are: FCPI Fortune III, FCPI Truffle Fortune 4, FCPI Truffle Fortune 5, FCPI Truffle Fortune 6, FCPI UFF Innovation No. 12, FCPI UFF Innovation No. 14, FCPI UFF Innovation No. 15, FCPI UFF Innovation No. 16, FCPI UFF Innovation No. 17, FCPI Innocroissance 2015, FCPI Innocroissance 2016, FCPI Innocroissance 2018, FCPI Innocroissance 2019, FCPI Truffle Biomedtech Crossover Fund, FCPI Truffle Innov FRR France, Truffle ISF PME 2017, Meningose, Corazan, and FPCI Truffle Medeor.
(2) Others: Holding Incubatrice Series I, Holding Incubatrice Series II, Hayk Holding, MyoPowers Medical Technologies SA, MitralFlex, Fondation Hôpital Saint-Joseph, Simone Merkle, Kam Lui, Zhu Jin.
(3) Including Sébastien Ladet.
Documentation
The Transaction will not require the publication of a prospectus pursuant to Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017 (the "Prospectus Regulation"). However, in accordance with Article 1.5.b bis) of 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 New Shares to be issued in connection with the Transaction. The Information Document is not subject to review by the AMF.
No material ancillary agreements have been or will be entered into in connection with the Transaction, other than the subscription agreements described above and customary agreements.
Advisors
Orrick, Herrington & Sutcliffe LLP acts as legal advisor for the Transaction.
Risk factors
Members of the public should take note of the risk factors relating to Carvolix and its business, as presented in Chapter 3 of the 2025 Universal Registration Document filed with the AMF on April 30, 2026, under number D.26-0330, which is available free of charge on Carvolix's website (www.carvolix.eu). 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 Carvolix. Such events could have a material adverse effect on Carvolix'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 financethe development or the commercialization of Carvolix'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 Transactioncould 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 decreasebelow 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 Transaction andmay apply these proceeds in ways that may not result in an increase in 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 Carvolix
Carvolix is a French medical technologies company, at commercial and clinical stage, founded by Truffle Capital (also founder of the top European biotech company), that aims to become a global leader in the treatment of structural heart diseases and brain strokes, the world's leading causes of mortality and disability. According to the Truffle 10 MedTech Index, Carvolix ranks number one in Europe and number six worldwide. Carvolix develops novel AI and imaging driven mini robots that make complex procedures doable by interventional cardiologists, as well as biomimetics heart valves.
For more information: www.carvolix.eu
Contacts:
CARVOLIX SEITOSEI.ACTIFIN - Financial communication / Financial press relations Sébastien LADET Ghislaine GASPARETTO / Jennifer JULLIA CEO +33 (0)6 85 36 76 81 / +33 (0)6 02 08 45 49 investor@carvolix.eu ghislaine.gasparetto@seitosei-actifin.com / jennifer.jullia@seitosei-actifin.com PRIMATICE - Media relations France MC SERVICES AG - Media relations Europe Thomas ROBOREL de CLIMENS Maximilian SCHUR / Julia BITTNER +33 (0)6 78 12 97 95 +49 (0)211 529252 20 / +49 (0)211 529252 28 thomasdeclimens@primatice.com carvolix@mc-services.eu
Disclaimer
This press release contains forward-looking statements about Carvolix and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Carvolix's financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Carvolix 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 2025 Universal Registration Document filed with the AMF on April 30, 2026 under number D.26-0330, which is available on the Company's website (www.carvolix.eu), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Carvolix operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Carvolix or that Carvolix 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 Carvolix 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 Carvolix 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 June 14, 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 Transaction 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 Transaction 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 Transaction (by either adopting or refining the manufacturers' target market assessment) and determining appropriate distribution channels.
This document does not constitute an offer of securities for sale nor the solicitation of an offer to purchase securities in the United States or any other jurisdiction where such offer may be restricted. Securities may not be offered or sold in the United States absent registration under the U.S. Securities Act of 1933, as amended (the " Securities Act") or an exemption from registration under the Securities Act. The securities of the Company have not been and will not be registered under the Securities Act, and the Company does not intend to make a public offering of its securities in the United States.
The distribution of this document (which term shall include any form of communication) is restricted pursuant to Section 21 (Restrictions on "financial promotion") of the Financial Services and Markets Act 2000 ("FSMA"). This document is only being distributed to and directed at persons who (i) are outside the United Kingdom, (ii) have professional experience in matters relating to investments and who fall within the definition of investment professionals in Article 19(5) of the FSMA (Financial Promotion) Order 2005 (as amended) (the "Financial Promotion Order"), (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the Financial Promotion Order, or (iv) are persons to whom this communication may otherwise lawfully be communicated (all such persons referred to in (i), (ii), (iii), and (iv) above together being referred to as "Relevant Persons"). This document must not be acted on or relied on in the United Kingdom by persons who are not Relevant Persons. Any investment or investment activity to which this document relates is available only to Relevant Persons and will be engaged in only with such persons in the United Kingdom.
This document may not be distributed, directly, in or into the United States of America, Canada, Australia or Japan.
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.
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Regulatory filing PDF file
File: 20260624_Carvolix EN- PR financing
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Language: English
Company: Affluent Medical
320 avenue Archimède, Les pléiades III Bâtiment B
13100 Aix en Provence France
France
Phone: +33 4 42 95 12 20
E-mail: jerome.geoffroy@affluentmedical.com
Internet: https://www.affluentmedical.com/
ISIN: FR0013333077
Euronext Ticker: AFME
AMF Category: Inside information / Issuer activities (acquisitions, sales...)
EQS News ID: 2352458
End of Announcement EQS News Service
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2352458 24-Jun-2026 CET/CEST
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