DJ Affluent Medical announces the approval of its Registration Document by the French Financial Markets Authority (AMF) as part of its proposed IPO on the Euronext Paris regulated market.
Affluent Medical
Affluent Medical announces the approval of its Registration Document by the French Financial Markets Authority (AMF) as
part of its proposed IPO on the Euronext Paris regulated market.
13-Apr-2021 / 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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PRESS RELEASE
Aix-en-Provence, 13 April 2021 - 7:30 a.m.
AFFLUENT MEDICAL announces the approval of its Registration Document by the French Financial Markets Authority (
Autorité des marchés financiers - AMF) as part of its proposed IPO on the Euronext Paris regulated market
Affluent Medical, a French medtech specialising in the international development and industrial scale-up of innovative
medical prostheses, at a clinical stage, to treat urinary incontinence and mitral cardiac insufficiency, announces
today the approval of its Registration Document by the AMF under number I.21-007 on 12 April 2021.
The approval of this Registration Document is the first step in Affluent Medical's proposed IPO on the Euronext Paris
regulated market, subject to market conditions and the approval by the AMF of the Prospectus relating to the operation.
Michel Finance, Chairman and Chief Executive Officer of Affluent Medical said:
"Affluent Medical aims to become a global player in medtech by developing innovative prostheses that address unmet
major medical needs in urology and interventional cardiology. Today millions of patients worldwide suffer from urinary
incontinence or mitral cardiac insufficiency. Our medical devices currently in clinical development aim to meet these
needs by improving the quality of life and life expectancy of patients. Our proposed IPO is part of a pivotal period in
our history with initial key development stages completed, necessary investments made and positive pre-clinical and
clinical results already achieved. Thanks to our teams' solid expertise, we are now determined to pursue our business
plan with initial revenue from Kalios sales in Europe expected as soon as 2023[1], after obtaining regulatory
authorisations, and thus to save and improve the lives of millions of patients across the world."
A portfolio of 3 innovative and minimally invasive medical prostheses for the treatment of urinary incontinence and
mitral cardiac insufficiency
Affluent Medical is developing a portfolio of medical prostheses offering innovative solutions that mimic human
physiology to treat urinary incontinence and mitral cardiac insufficiency.
These minimally invasive medical devices have the advantage of restoring critical functions and simplifying surgical
procedures while reducing the total cost of care for patients and public healthcare systems in the short and long term.
Affluent Medical's product portfolio currently includes three prostheses and one innovative technology protected by 31
patent families in all of its target markets:
- Artus: the first artificial sphincter that patients can activate via a remote control, for the treatment of
moderate to severe urinary incontinence in men and women;
- Kalios: the only prosthesis for mitral heart valve repair that allows for multiple post-operative readjustments via
a transcatheter procedure without general anaesthesia;
- Epygon: the only physiological cardiac bioprosthesis that mimics the native mitral valve and blood flow and can be
implanted via minimally invasive procedures without an "open heart" surgery.
Initial development stages have been completed for these three products with major investments made and positive
pre-clinical and clinical results already obtained.
In addition, Affluent Medical is developing an innovative technology, Kardiozis, which uses the properties of
thrombogenic fibres to treat abdominal aortic aneurysm, providing embolisation to reduce the risk of aneurysm rupture.
Affluent Medical is currently in discussions with several major players in the sector to sign a partnership agreement
to develop endoprostheses incorporating this technology in an estimated market of USD1.7 billion[2].
Product/Technology Description Clinical development [3] CE FDA
marking approval
In Europe: Clinical Stage - Study Optimise II
Kalios Mitral valve 4th quarter of -
repair - Pilot study successfully completed in 2018 2022
- Pivotal study underway in Austria, Germany, Switzerland and
Italy and to be completed in the 2nd half of 2022: 15 patients
were recruited out of the planned 62
In Europe: Clinical stage - Study Dry
Moderate to
severe - Feasibility study successfully completed in 2018 4th quarter of 4th
Artus urinary - Pilot/pivotal study initiated between the 2nd and 3rd quarters 2023 quarter
incontinence of 2021 in Spain, Italy, the Czech Republic and France: planned of 2024
recruitment of 70 patients
In the United States: Pivotal study initiated in the 1st half of
2022 with recruitment starting in the 2nd half of 2022
In Europe: Clinical stage - Study Minerva
- Pilot study initiated in the 2nd quarter of 2021 in Austria, 4th
Epygon Mitral valve Spain and Italy with the planned recruitment of 15 patients 2nd half of quarter
replacement - Pivotal study in the 2nd half of 2022 2025 of 2025
In the United States: Necessary work initiated in the 1st half of
2022 to conduct a feasibility study followed by a pivotal study
Abdominal Technology validated by clinical trials and in vivo studies.
Kardiozis aortic - -
aneurysm Partnership research
Strategic positioning in high-potential global markets
Affluent Medical targets global markets with strong growth potential, driven in particular by longer life expectancies.
Moderate to severe urinary incontinence is a major public health problem: currently more than 100 million adults[4] worldwide are affected by this disease[5], which has no effective treatment and devastates patients' quality of life and psychological well-being.
In total, the market for medical devices to treat urinary incontinence is expected to reach USD4.3 billion in 2027[6], with an average annual growth rate of 11% between 2019 and 2027.
Mitral cardiac insufficiency is a serious and fatal heart disease that affects nearly 2% of the global population[7] , with an incidence rate that increases with the age of patients.
Less than 4% of the 4 million patients who suffer from severe mitral cardiac insufficiency undergo surgery, according to Affluent Medical's estimates. In the absence of surgery, the risks of death and hospitalisation are high, with up to a 50% risk of death at five years and a 90% risk of hospitalisation for surviving patients[8].
The global mitral cardiac insufficiency market is estimated to reach USD4.7 billion in 2027[9], which corresponds to an average annual growth of more than 14%.
A clear and rapid development strategy with initial revenue from Kalios sales in Europe expected as soon as 2023
Affluent Medical's ambition is to become a world leader in the field of urology and interventional cardiology. In a competitive environment in which larger companies operate and benefit from more significant clinical, industrial and business experience, Affluent Medical has decisive competitive advantages that will help it achieve its ambition: - addressed pathologies characterised by medical needs that are unmet today; - prostheses with unique, minimally invasive characteristics that mimic human physiology and facilitate surgical
procedures to promote the rapid adoption of devices by practitioners; - the support of opinion leaders and a world-renowned scientific committee; - a team of recognised professionals with extensive experience in the development, industrial scale-up and marketing
of medical devices; - a portfolio of three innovative medical devices under development addressing rapidly growing markets of several
billion dollars each (total addressable market of USD11 billion in 2027[10]); - thirty-one patent families comprising around 300 patents and patent applications in Europe, the United States and
other major markets covering Artus and Kalios products until 2037, Epygon until 2038 and Kardiozis until 2041; - a reference founding shareholder, Truffle Capital, with many medtech successes, particularly in prostheses
(Symetis, Carmat, Vexim).
Affluent Medical will capitalise on these strong assets to deploy a clear business and industrial strategy, relying on its own sales forces in key European countries (Germany, France, Italy and the United Kingdom) and on commercial agreements with strategic partners and local distributors in the United States, China (joint venture agreements with Shanghai Zuquan Investment Management Company) and the rest of Europe.
The three products developed by Affluent Medical in urology and interventional cardiology are all in the clinical phase and are expected - after obtaining regulatory authorisations and CE markings - to quickly enter their respective target markets with initial revenue from Kalios sales in Europe expected as soon as 2023[11].
Availability of the Registration Document
Copies of Affluent Medical's Registration Document, approved by the AMF on 12 April 2021 under number I.21-007, are available free of charge and on request from the Company, at Affluent Medical's registered office, 320 avenue Archimède - Les Pléiades III-Bâtiment B, 13100 Aix-en-Provence, France, as well as on the websites of the AMF (https:// www.amf-france.org) and Affluent Medical (https://investir.affluentmedical.com). The Registration Document contains a detailed description of Affluent Medical, in particular its business, strategy, financial position and the corresponding risk factors.
Risk factors
Affluent Medical draws the public's attention to the risk factors described in Chapter 3 of the Registration Document, particularly on the liquidity risk, and the risks associated with delays or failures in the development of the group's medical devices. The occurrence of one or more of these risks may have a material adverse effect on the business, assets, financial position, results or outlook of the Affluent Medical Group, as well as on the market price of Affluent Medical shares.
Find all information related to Affluent Medical's proposed IPO on:
https://investir.affluentmedical.com
Contacts:
AFFLUENT MEDICAL ACTIFIN, financial communication Jérôme Geoffroy Ghislaine Gasparetto Chief Financial Officer +33 (0)1 86 26 68 17 investor@affluentmedical.com affluentmedical@actifin.fr ACTIFIN, financial press relations DGM, corporate press relations Jennifer Jullia Thomas Roborel de Climens +33 (0)6 47 97 54 87 +33 (0)6 14 50 15 84 jjullia@actifin.fr thomasdeclimens@dgm-conseil.fr
Forward-looking Statements
This press release contains information on Affluent Medical's outlook and areas for development.
Such information is sometimes identified by the use of the future tense, the conditional mood or forward-looking terms such as "estimate", "consider", "envisage", "think", "aim", "expect", "intend", "should", "have the ambition of", "believe", "wish", "could", or the negative forms of the same terms as the case may be, or any other variant or similar expression.
This information does not constitute historical facts and must not be construed as warranting that the anticipated events and results will actually materialise. This information is based on data, assumptions and estimates considered reasonable by Affluent Medical. It is liable to change or be altered due to uncertainties concerning the economic, financial, competitive and regulatory environment. The forward-looking information mentioned in this press release is given only as of this date. Affluent Medical operates in a competitive and constantly changing environment. It may therefore be unable to anticipate all risks, uncertainties or other factors that may affect its business activity, their potential impact on its business activity or the extent to which the materialisation of a risk or combination of risks could produce results significantly different from those mentioned in any forward-looking information, it being understood that none of that forward-looking information is a guarantee of actual results.
Affluent Medical makes no commitment to publish updates to this information or the assumptions on which it is based, except for any legal or regulatory obligation that may be applicable to it.
Disclaimer
This press release does not constitute and should not be considered as constituting a public offer or a solicitation of the public for any offer.
No communication or information relating to this operation or to Affluent Medical may be disseminated to the public in a country in which any registration or approval requirement would be required. No action has been taken (or will be taken) in any country (other than France) in which such action would be required.
This press release is a promotional communication and does not constitute an offer or a solicitation of an offer to sell or subscribe for securities requiring a prospectus within the meaning of the Prospectus Regulation No. 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the "Prospectus Regulation"), also forming part of the domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the "EUWA").
In France, a public offering of securities may only be made pursuant to a prospectus approved by the AMF. With regard to the Member States of the European Economic Area other than France (the "Member States"), in whose territory the provisions of the Prospectus Regulation are applicable, and in the United Kingdom, no action has been taken or will be taken to allow a public offering of the securities making it necessary to publish a prospectus in one of those Member States or in the United Kingdom. Consequently, the securities of Affluent Medical may not and will not be offered in the United Kingdom or in any of the Member States other than France, except in accordance with the exceptions provided for in Article 3(2) of the Prospectus Regulation, also forming part of the domestic law in the United Kingdom by virtue of EUWA, or in other cases that do not require the publication by Affluent Medical of a prospectus under Article 3 of the Prospectus Regulation and/or the regulations applicable in that Member State or the regulations applicable in the United Kingdom.
This press release may not be published, transmitted or distributed, directly or indirectly, in the United States of America, Australia, Canada or Japan. It does not constitute and should in no case be considered as constituting a public offer of financial securities, nor as a solicitation of the public relating to an offer of any kind in any country, including in France.
This press release does not constitute or form part of any offer of financial securities or any solicitation to buy, subscribe or sell financial securities in the United States of America. Financial securities may only be offered, subscribed for or sold in the United States of America following registration under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") and laws specific to each State applicable to financial securities, or as part of an exemption from this registration requirement. Affluent Medical shares have not been and will not be registered under the U.S. Securities Act and Affluent Medical does not intend to make any public offering of its securities in the United States of America.
This press release does not constitute an invitation to engage in, and is not intended to encourage, an investment activity, within the meaning of Section 21 of the Financial Services and Markets Act 2000, as amended (the "FSMA"). This document is intended solely for (i) persons outside the United Kingdom, or (ii) persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation as it forms part of domestic law by virtue of the EUWA and who are also (x) investment professionals, within the meaning of Article 19(5) of the FSMA (Financial Promotion) Order 2005 (the "Regulation"), or (y) high net worth entities or persons referred to in Article 49(2) (a) to (d) of the Regulation (companies with high equity capital, unregistered associations, etc.) and (z) any other person to whom this press release might be addressed according to applicable law (all the persons mentioned in paragraphs (i), (ii), (ii)(x) and (ii)(y) and (ii)(xz) being together referred to as the "Authorised Persons"). The financial securities of Affluent Medical referred to in this press release are intended solely for Authorised Persons and any invitation, offer or contract relating to the subscription, purchase or acquisition of financial securities may only be addressed to or entered into with Authorised Persons. Any person other than an Authorised Person must refrain from using or relying on this press release and the information it contains.
The circulation, publication or distribution of this press release in certain countries may be subject to restrictions under applicable laws and regulations. Consequently, the persons physically present in these countries and in which this press release is disseminated, published or distributed must inform themselves and comply with these laws and regulations. -----------------------------------------------------------------------------------------------------------------------
[1] Subject to the completion of additional clinical development stages and obtaining financing necessary for the Company's development.
[2] Infoholic Research - 2017: Global Aortic Aneurysm Market - Drivers, Opportunities, Trends and Forecasts 2017-2023
[3] Subject to the impact of the Covid-19 pandemic and regulatory developments (refer to sections 3 and 9 of the Registration Document) and the obtaining of the funding necessary for the development of the Company which must in particular be provided in within the framework of a capital increase on the occasion of the admission of the Company's shares to trading on the regulated market of Euronext Paris and, where applicable, additional capital increases (see also section 3.4. 1 of the Registration Document).
[4] People over the age of 20.
[5] Company estimates based on the study "New Artificial Urinary Sphincter Devices in the Treatment of Male Iatrogenic Incontinence and Severity of Urinary Incontinence and Effect on Quality of Life in Women by Incontinence Type".
[6]Urinary Incontinence (UI) Devices (Optima Insights, September 2020).
[7] Steven Douedi, Hani Douedi (August 2020).
[8] Department of Cardiovascular Medicine Cleveland Clinic Foundation - Journal of the American College of Cardiology.
[9] Transcatheter Mitral Valve Implantation Market Size (Emergen Research, September 2020).
[10] Addressable markets calculated as the sum of markets addressed by ARTUS (in 2027), EPYGON and KALIOS (in 2027) and KARDIOZIS (in 2023): Urinary Incontinence (UI) Devices (Optima Insights, September 2020)/Transcatheter Mitral Valve Implantation MarketSize ( Emergen Research, September 2020)/Global Aortic Aneurysm Market (Infoholic Research 2017).
[11] Subject to the completion of additional clinical development stages (see table on page 2 of the press release) and obtaining financing necessary for the Company's development (see liquidity risk factor, section 3, article 3.4.1 of the Registration Document) ----------------------------------------------------------------------------------------------------------------------- Regulatory filing PDF file File: Affluent Medical - Registration Document EN
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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/
AMF Category: Inside information / Other releases
EQS News ID: 1183804
End of Announcement EQS News Service
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1183804 13-Apr-2021 CET/CEST
(END) Dow Jones Newswires
April 13, 2021 01:31 ET (05:31 GMT)
