Business Wire

Affluent Medical Announces Significant Clinical Milestones with Two of Its Innovative Devices: ARTUS & KALIOS

Share

Affluent Medical, a new French medtech player specializing in innovative, minimally invasive implants designed to restore key physiological functions for patients suffering from heart and vascular diseases, as well as urinary incontinence, today announces significant clinical milestones for two of its innovative devices: ARTUS & KALIOS.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180601005256/en/

Kalios (Photo: Affluent Medical)

Kalios (Photo: Affluent Medical)

“We are excited about these key milestones since these studies are part of Affluent Medical’s clinical development plan, aiming at obtaining CE marking for each of our four products -KARDIOZIS, KALIOS, EPYGON and ARTUS, between the end of year 2020 / year 2022”, said Daniele Zanotti Affluent Medical’s CEO.

Successful start of the clinical trial with its ARTUS urinary implant

Affluent Medical has received authorization from the French regulatory agency on medical devices2 to carry out its first clinical trial in France. This clinical trial aims at demonstrating the safety and effectiveness of its urinary implant, ARTUS. This device intends on helping men and women suffering from severe urinary incontinence to recover full control of their bladders.

A similar clinical trial is already under way in the Czech Republic. ARTUS has been implanted in a first patient at the end of May 2018, at the Cochin Hospital. In this clinical trial, ARTUS will be temporarily implanted in a total of three women.

The clinical trial, entitled “Feasibility of the implantation of the ARTUS Artificial Urinary Sphincter in women,” in conducted at the Cochin Hospital in Paris. The ARTUS artificial urinary sphincter will be temporarily inserted in three women who have undergone a full urogenital tract ablation because of bladder cancer. The goal of the study is to verify, in the first place, that it is still possible to insert a catheter inside the bladder once the implant is in place. The study also aims at demonstrating the easy implementation and effectiveness of the device (adaptation to the neck of the bladder and activation of the implant).

ARTUS is an artificial urinary sphincter intended for both men and women. Fully concealable and easy to use via remote control, ARTUS will bring more comfort to patients by granting them easy control over their everyday urinary flow. Thanks to its optimized and adjustable pressure profile on the urethra, this device reduces the risk of decreased blood flow and tissue erosion of the urethra — two major complications experienced by patients with the artificial urinary sphincters currently available on the market.

A significant under-treated medical issue
Urinary incontinence affects one in four adults, with a female prevalence of 95%3. Yet, few implants are designed to help women recover control of their bladder. Men who have had their prostates removed or are treated for severe incontinence have more access to artificial sphincters; while women, who are the most affected by this pathology, are treated minimally or not at all due to a lack of products adapted to their anatomies. According to a study by IMS Consulting Group, in Western countries, only 3% of all artificial sphincter procedures involved women3.

This is therefore a large market, combined with a truly unmet medical need to date. ARTUS aims at becoming the next standard of care in this market. The total global turnover of this market, in the field of urology, is today estimated at $ 7 billion per year in 2020, with a potential annual growth rate of 26% between 2017-20204.

ARTUS, a promising implant to be launched by 2021 in Europe

Video presentation: https://www.youtube.com/watch?v=-l1W1_sgMiM&feature=youtu.be

Currently in clinical phase with ARTUS, Affluent Medical is planning a first market launch in Europe in 2021.Various studies in technical feasibility, safety, tolerance and efficiency have already been conducted both on animals and in laboratory. ARTUS has been clinically tested in Czech Republic, since February 28, 2018, at the Thomayer Hospital in Prague, under the same conditions as the upcoming study in France. A pivotal CE marking trial, which should involve 35 patients suffering from severe urinary incontinence, is planned for the end of 2018. Affluent Medical is also considering a trial in male patients by the end of 2019.

Completion of enrollment in a feasibility study for KALIOS

The implantation of the device in a fifth and last patient has been performed at the end of May 2018 by Prof. Martin Andreas, Principal Investigator of the study, at the Vienna General Hospital (AKH). The first results of the study, aiming at testing the feasibility and surgical safety of KALIOS, are expected in Q2 2018.

KALIOS can treat both residual postoperative leaks and chronic mitral insufficiency. The size and shape of the implant can be adjusted percutaneously multiple times in the months/years following the surgery, offering patients a personalized surgical treatment.

The European launch of the device is scheduled for the end of 2020, subject to the obtention of the necessary marketing authorizations. It targets a total global market expected to reach $3.5 billion by 2022 and growing at a rate of 35% per year between 2017-2022(5).

About Affluent Medical

Affluent Medical is a new French medtech player with the ambition to become one of the European leaders in the treatment of heart and vascular diseases - which are the leading cause of death throughout the world - and of urinary incontinence today affecting one in four adults, subject to the achievement of complementary steps and obtention of marketing authorization. Affluent Medical is developing innovative, next-generation minimally invasive implants to restore key physiological functions in these areas. The company’s four medical devices are currently in preclinical and clinical validation phases, and a first medical device is expected to be launched by 2020.

Affluent Medical was born in February 2018, from the combination of four technologies drawn from Truffle Capital’s portfolio: KARDIOZIS, KALIOS, EPYGON and ARTUS.

Affluent Medical announced it was planning an initial public offering on the Euronext Growth market in Paris and filed a Document de Base with the Autorité des marchés financiers (AMF) on May 28, 2018, with registration number I. 18-045.

For more information: www.affluentmedical.com

Disclaimer

This press release and the information it contains do not constitute an offer to sell or to subscribe, or a solicitation to purchase or subscribe shares in Affluent Medical.

The release, publication or distribution of this press release in certain jurisdictions may be restricted by laws or regulations. Persons in such jurisdictions into which this press release is released, published or distributed must inform themselves about and comply with such laws or regulations.

This press release is a promotional message and not a prospectus in the meaning of Directive 2003/71/EC of the European Parliament and Council dated 4 November 2003, as amended (the “Prospectus Directive”).

This press release does not constitute or form part of an offer of securities or a solicitation for purchase, subscription or sale of securities in the United States. Securities may not be offered, subscribed or sold in the United States without registration under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”,) and other applicable state securities law, except pursuant to an exemption from registration. Affluent Medical shares have not been and will not be registered under the U.S. Securities Act, and Affluent Medical does not intend to undertake a public offering of its securities in the United States.

With respect to the member states of the European Economic Area other than France (the “Member States”) having implemented the Prospectus Directive into law, no action has been or will be taken in order to permit a public offer of the securities which would require the publication of a prospectus in one of such Member States. As a result, the securities of Affluent Medical may not and will not be offered in any Member State other than France, except in accordance with the exemptions set forth in Article 3 of the Prospectus Directive, if they have been implemented in the relevant member states or in the other case which does not require the publication by Affluent Medical of a prospectus pursuant to the Prospectus Directive and/or applicable regulation in the member states.

This press release does not contain or constitute an invitation, inducement or solicitation to invest. This press release is intended solely for persons (1) who are not in the United Kingdom; (2) who are investment professionals within the meaning of Article 19 (5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 as amended (the “Order”); or (3) who are « high net worth entities », and other persons falling within the provisions of Article 49 (2) (a) to (d) of the Order (those persons cited in (1), (2) and (3) together being designated as “Relevant Persons”).

This press release is aimed solely at Relevant Persons. Any investment or investment activity in connection with this press release is reserved solely for Relevant Persons and may only be made by Relevant Persons.

Not for release, publication or distribution, directly or indirectly, in the United States, Australia, Canada or Japan.

1 Subject to the obtention of necessary marketing authorizations.
2 ANSM: Agence Nationale de Sécurité du Médicament et des produits de santé
3 Source: IMS Consulting Group Study - 2014: US Market Opportunity Assessment for ARTUS
4 Source: Boston Scientific, Presentation Investor Day 2017, June 27 2017
5 Azoth Analytics – 2017: Transcatheter Mitral Valve Repair and Replacement (TMVR) Market – Opportunities and Forecast 2017-2022

Contact information

Affluent Medical
Henri Lefebvre, Chief Financial Officer
investor@affluentmedical.com
Tel.: +33-(0)1-82-28-46-00
or
Press
ALIZE RP
Caroline Carmagnol & Wendy Rigal
affluentmedical@alizerp.com
Tel.: +33-(0)1-44-54-36-66

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

 Ipsen to Present New Data at 13th Annual Conference of the International Liver Cancer Association (ILCA 2019)20.9.2019 16:30:00 CESTPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today presents results from the matching-adjusted indirect comparison (MAIC) of cabozantinib (Cabometyx®) versus regorafenib (Stivarga®) for the second-line treatment (2L) of patients with advanced hepatocellular carcinoma (aHCC) who received sorafenib as the only prior systemic therapy. Using data from the Phase III CELESTIAL and RESORCE trials, the MAIC showed that cabozantinib offers greater efficacy versus regorafenib. Using data from the Phase III CELESTIAL and RESORCE trials, the MAIC showed that in the 2L CELESTIAL sub-population who had received sorafenib as the only prior systemic therapy, cabozantinib significantly improved progression-free survival (PFS), with an additional 2.4 months provided vs. regorafenib (5.6 months vs. 3.2 months [95% confidence interval (CI): 4.90-7.26], p<0.05). Median overall survival (OS) was also favorable with cabozantinib (11.4 months vs. 10.8 months), though statistical significance was not met

RoboSense RS-LiDAR-M1 Smart LiDAR Sensor Wins AutoSens Awards 201920.9.2019 13:30:00 CESTPress release

On September 18, 2019, RoboSense announced at Brussels, Belgium that its flagship product RS-LiDAR-M1 Smart LiDAR Sensor has been awarded the elite AutoSens Awards trophy in the “Best Automotive Safety System” category, given to only the highest-rated innovative product or technology in the automotive industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190920005309/en/ Robosense Along With Other Winnners At The Autosens Awards Ceremony At Brussels, Belgium (Photo: Business Wire) True autonomous driving requires human-like advanced sensing of the environment for driving with little or no human input. The safety of passengers and passers-by is always the priority concern for autonomous driving. When the RS-LiDAR-M1 is integrated into the current autonomous driving car perception system, it overcomes the weaknesses of millimeter wave radar and camera technologies on identifying obstacles, and eliminates car accidents, such

Boehringer Ingelheim Partners with Inflammasome Therapeutics to Develop Novel Therapies for Patients with Retinal Diseases20.9.2019 12:00:00 CESTPress release

Boehringer Ingelheim and Inflammasome Therapeutics Inc. (Inflammasome) today announced they have entered into a co-development and license agreement to develop up to three therapies for patients with retinal diseases. By combining Inflammasome’s unique intravitreal (IVT) drug delivery technologies with Boehringer Ingelheim’s compounds from its retinal disease pipeline portfolio, Boehringer Ingelheim aims to develop novel therapies for retinal diseases. In 2019 there were an estimated 82 million patients in the seven key countries (U.S., Japan, Germany, U.K., Spain, Italy, France) affected by one of the three major forms of retinal disease: Age related macular degeneration (AMD), diabetic retinopathy (DR), and diabetic macular edema (DME). Globally, the prevalence rates of these and other retinal diseases are expected to increase over the next 10 years primarily due to aging populations and the global diabetes epidemic. Despite therapeutic advances in some disease areas during the past

Visa B2B Connect Expands to 32 New Countries and Announces Integration With Infosys20.9.2019 11:00:00 CESTPress release

Visa Inc. (NYSE:V) today announced that its Visa B2B Connect network has doubled its reach – from 30 global trade corridors at launch in June 2019, to 62, with the goal to expand to over 100 countries in 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190920005082/en/ Visa B2B Connect (Graphic: Business Wire) In addition, Infosys, a global leader in next-generation digital services and consulting, is integrating with the Visa B2B Connect network to bring Visa B2B Connect platform access to their participating financial institutions worldwide. Through this new connection, participating financial institutions worldwide can take advantage of the ability to quickly and securely process corporate cross-border payments globally through Visa B2B Connect.1 “Visa B2B Connect is a fast, secure and more efficient network, designed specifically to overcome obstacles in the cross-border corporate payments space,” said Alan Koenigsbe

Open Day at ISAE-SUPAERO!20.9.2019 09:53:00 CESTPress release

As part of the Science Festival, this year organized on the theme of “Talking about Science, Imagining the Future”, ISAE-SUPAERO will open up its entire campus to the public on Saturday, October 12th from 10 am to 6 pm. Intended for families, companies, partners, journalists and alumni, this event should bring in over 3,000 attendees, as was the case in the three previous years! The program for the day includes many opportunities to discover science today and our vision of the science of the future, with the challenges this entails for the future of our planet. On the program: ➢ Visits to the laboratories and research departments with flight simulators ➢ Visit to the aeroacoustic wind tunnel, unique in Europe, ➢ Demonstrations: how to fly an airplane, Enoskelet, augmented humans, aeroelasticity, drones, use of the gyroscopic effect in space systems, piezoelectric effect, lasers for communicating at the speed of light on Earth and in space, the infinitely small in 3D, Robot Firefighter

William Priest to Step Down as CEO in 2020, Will Remain at Firm as Executive Chairman and Co-CIO20.9.2019 07:00:00 CESTPress release

Epoch Investment Partners, Inc., announced that William Priest will step down as the firm's CEO effective April 1, 2020. He will become Epoch's Executive Chairman and will continue to lead the investment team and serve as co-CIO. He will also retain his portfolio management responsibilities, including his lead portfolio manager role with Epoch's Global Choice and Global Absolute Return strategies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190920005076/en/ Philipp Hensler (Photo: Business Wire) Philipp Hensler, Epoch's President and COO, will become the firm's CEO. Hensler brings to the role extensive leadership experience at asset management firms globally. His earlier background as a portfolio manager has imbued him with an investment-oriented perspective that aligns with Epoch's investment-centric culture. “Investing remains my lifelong passion," said Priest, who helped found Epoch in 2004. “Best practice suggests a s