Affluent Medical Announces Significant Clinical Milestones with Two of Its Innovative Devices: ARTUS & KALIOS
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)
“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
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
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
Henri Lefebvre, Chief Financial Officer
Caroline Carmagnol & Wendy Rigal
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
American Airlines Announces Nonstop Philadelphia (PHL) to Orlando Melbourne (MLB)22.9.2018 01:13 | Tiedote
Glorious beaches by day and theme park fireworks by night just got more convenient for Philadelphia travelers. American Airlines announced today that it will begin nonstop flights to Orlando Melbourne International Airport (MLB) starting February 16, 2019. The Central Florida airport is conveniently located in the heart of the tourism region and is the closest airport to NASA rocket launches, Port Canaveral’s cruises and what critics call “some of the most beautiful beaches Florida has to offer.” The flights will depart Saturdays from Philadelphia at 8:05 a.m., arriving in Florida at 10:48 a.m. The Embraer 175 jet arrival time syncs perfectly with cruise ship noon early boarding. Melbourne Airport Express offers nonstop shuttle service to the port, and all major rental car companies are onsite. The return flight to PHL departs at 11:24 a.m. and arrives in PHL at 1:55 p.m., with enough time to connect to some of American’s largest international destinations, including recently announced
Amy Palladino Joins BCW as Executive Vice President, Managing Director, Corporate Practice21.9.2018 20:43 | Tiedote
BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Amy Palladino has joined the agency as Executive Vice President, Managing Director in the agency’s U.S. Corporate Practice. Based in New York, Palladino will focus on senior client counsel and executive positioning for the agency’s largest corporate clients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005507/en/ Amy Palladino Joins BCW (Burson Cohn & Wolfe) “Amy is a talented and highly experienced communications executive with a track record of solving clients’ complex challenges and building business through smart, integrated communications approaches,” said Chris Foster, President, North America, BCW. “Her creativity and judgement will be enormously valuable to our current and prospective clients.” Palladino has more than 20 years of experience advising global clients across numerous industries, including technology, healthcar
Heidelberg Engineering Announces the CE-Marking of ANTERION21.9.2018 19:41 | Tiedote
Heidelberg Engineering, the leader in diagnostic imaging known for the internationally-acclaimed SPECTRALIS ® retina and glaucoma platform, announces the CE-marking of ANTERION ® – an innovative platform designed to transform anterior segment diagnostics and workflow. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005442/en/ The new Heidelberg Engineering ANTERION® provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. (Graphic: Business Wire) The new ANTERION provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. It is a single, workflow-efficient solution that brings together corneal topography and tomography, anterior segment metrics, axial length measurement and IOL calculation to transform the day-to-day routine of busy practices and clinics. Heidelberg Engineering has leveraged its core OCT technolo
Florian Winterstein Becomes New CEO of Jedox21.9.2018 18:46 | Tiedote
The supervisory board of Jedox AG, a leading vendor of business intelligence and enterprise planning software, has appointed Florian Winterstein as Chief Executive Officer (CEO) effective October 2, 2018. This nomination will support Jedox’s international growth and a new development phase initiated by its latest fund raising in April 2018 with Iris Capital, eCAPITAL entrepreneurial Partners AG and Wecken & Cie. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005416/en/ Florian Winterstein (Photo: Business Wire) With 25 years of experience in strategy consulting and leadership in software and service organizations, Winterstein brings to the company a valuable combination of expertise in cloud solutions, business development, and value creation for customers and partners. As former Chief Strategy Officer of BravoSolution, he positioned the software-as-a-service company as trendsetting digitalization partner, extending it
Avinor to Test Autonomous Snowploughs at Oslo Airport This Winter21.9.2018 17:37 | Tiedote
Since 2010 Avinor has had a vision and a desire to automate winter maintenance. In March autonomous snow clearing was demonstrated at Fagernes Airport, and this winter Avinor is taking this a step further by testing two autonomous snowploughs at Oslo Airport. The project is one of the first globally where large machinery will operate autonomously to keep snow away from airport areas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005363/en/ Avinor to Test Autonomous Snowploughs at Oslo Airport This Winter (Photo: Business Wire) “Innovation is important to Avinor. In the future, many tasks in aviation will be resolved in other ways than today. Avinor wants to test autonomy, and does of course see a potential for rationalization in the future through new solutions for winter operations and in other areas. Avinor is at the forefront of testing this technology, but it is essential that safety is ensured in all such testing
Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib21.9.2018 16:30 | Tiedote
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food. The randomized, global Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG in patients with locally advanced or metastatic ALK+
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme