Acarix progresses with the German authorities
Press release
Malmö, Sweden September 3, 2020
Acarix progresses with the German authorities
Acarix AB (publ) today announced that the German Ministry of Health has stated that phonocardiography for ruling out coronary artery disease has potential for general use in Germany. The German Federal Joint Committee (G-BA) has outlined basic elements of a possible study to be conducted by an independent scientific institution in accordance with the guidelines from G-BA.
“The guidance from G-BA confirms the clinical value and relevance of our CADScor® technology and is the result of a persistent and constructive dialogue with the authorities during the last few years. The guidance from G-BA provides clarity and direction combined with a recognition of our clinical work to date,” said Per Persson, CEO of Acarix.
The German Ministry of Health has published guidance stating that phonocardiography for ruling out stable coronary artery disease (CAD) has the potential for general use in Germany. According to G-BA further evidence is needed and could be collected in a study, designed, carried out and evaluated by an independent scientific institution in accordance with the guidelines from G-BA. The exact scope and final design of such a study will be determined in the near future. The outcome of the study could form the basis of a reimbursement approval for phonocardiography as an alternative diagnostic technology for ruling out stable CAD.
Per Persson continues “The commercial potential in Germany is significant and we see the value of complementary clinical evidence to the already ambitious programs that we are currently running. To meet the timelines of response to the G-BA, we intend to have intense dialogue with key stakeholders to define the most relevant clinical endpoints to comply with G-BA guidance. We will submit our response to G-BA later this month.”
For further information, please contact:
Per Persson, CEO, E-mail: per.persson@acarix.com, Phone: +46 73 600 59 90
This press release has been made public through the agency of the contact person set out above, at the time stated by the Company’s news distributor, GlobeNewswire, at the publication of this press release.
About Acarix:
Acarix was established in 2009 and is listed on Nasdaq First North Premier Growth Market (ticker: ACARIX). Acarix’s CADScor®System uses an advanced sensor placed on the skin above the heart to listen to the sounds of cardiac contraction movement and turbulent flow. It has been designed to be an all-in-one system in the sense that the heart signal will be recorded, processed, and displayed as a patient specific score, the CAD-score, on the device screen. Readout is obtained in less than 10 minutes. Safe and suitable for use in both out- and inpatient settings, the CADScor®System thus has the potential to play a major role in patient triage, avoiding the need for many patients to undergo stressful invasive diagnostic procedures. Wildeco Ekonomisk Information AB (+46 8 545 271 00, info@wildeco.se) is Certified Adviser to Acarix. For more information please visit www.acarix.com.
Attachment
About GlobeNewswire
GlobeNewswireGlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
NAXS har gjort ett investeringsåtagande till Nordic Capital Fund X1.10.2020 21:00:00 CEST | Pressemelding
NAXS har gjort ett åtagande till Nordic Capital Fund X (“Fonden”), den tionde fonden som rests av Nordic Capital. Med en storlek om 6,1 Mdr SEK är fonden den största som Nordic Capital etablerat sedan verksamheten grundades 1989. Fondresningen inleddes under april 2020, tog mindre än 6 månader och när fonden nådde sin maximala storlek (”hard cap”) var den kraftigt övertecknad. Fonden kommer att investera enligt Nordic Capitals strategi att göra majoritetsinvesteringar i icke-cykliska tillväxtföretag inom sektorerna Healthcare, Technology & Payments och Financial Services. NAXS är sedan tidigare investerare i Nordic Capital Fund VII och Nordic Capital CV1. Ytterligare information kommer vara tillgänglig i NAXS Q3 rapport som publiceras den 20 oktober. Kontaktinformation Lennart Svantesson, verkställande direktör Telefon: +46 73 311 00 11 Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 1 oktober 2020 kl. 21.00. Pressmeddelanden och ytterligare i
NAXS has made an investment commitment to Nordic Capital Fund X1.10.2020 21:00:00 CEST | Press release
Not for release, publication or distribution, directly or indirectly, in or into the United States, Hong Kong, Canada, Japan or Australia, or any other jurisdiction in which the distribution or release would be unlawful. NAXS has made an investment commitment to Nordic Capital Fund X (the “Fund”), the tenth fund raised by Nordic Capital. At EUR 6.1 billion, the Fund is the largest that Nordic Capital has raised since its inception in 1989. The Fund, launched in April 2020, was oversubscribed at its hard cap, and was raised in less than 6 months. The Fund is set to continue Nordic Capital’s successful strategy of focusing on majority investments in non-cyclical growth companies in the Healthcare, Technology & Payments and Financial Services sectors. NAXS is an investor in Nordic Capital Fund VII and Nordic Capital CV1. More information will be available in NAXS’s Q3 2020 report, due October 20th. Contact information: Lennart Svantesson, CEO Telephone: +46 73 311 00 11 This information w
Major shareholder announcement – NOVO HOLDINGS A/S1.10.2020 20:16:07 CEST | Press release
Company announcement 16-2020, COPENHAGEN, DENMARK Pursuant to Section 38 of the Danish Capital Markets Act, FLSmidth has been informed that NOVO HOLDINGS A/S has reduced his holding of FLSmidth shares to a total 2,455,584 FLSmidth & Co. A/S shares, which corresponds to 4.79% of the total nominal share capital and voting rights in FLSmidth & Co. A/S. Contacts Media Relations Rasmus Windfeld, +45 40 44 60 60, rwin@flsmidth.com Investor Relations Nicolai Mauritzen, +45 30 93 18 51, nicm@flsmidth.com FLSmidth provides sustainable productivity to the global mining and cement industries. We deliver market-leading engineering, equipment and service solutions that enable our customers to improve performance, drive down costs and reduce environmental impact. Our operations span the globe and our 11,765 employees are present in more than 60 countries. In 2019, FLSmidth generated revenue of DKK 20.6 billion. www.flsmidth.com Attachment Company announcement 16 Novo HOLDINGS
RCI Banque : PLACEMENT OF A 991.5 MILLION EURO SECURITIZATION BACKED BY FRENCH AUTO LEASES WITH PURCHASE OPTION “LOA”1.10.2020 19:18:09 CEST | Press release
October 1st, 2020 PLACEMENT OF A 991.5 MILLION EURO SECURITIZATION BACKED BY FRENCH AUTO LEASES WITH PURCHASE OPTION “LOA” RCI Bank and Services announces the placement of its first securitization backed by auto lease monthly instalments (residual value component excluded) originated by its French subsidiary DIAC. FCT Cars Alliance Auto Leases V 2020-1 has placed 950m€(1) of Senior notes and 41.5m€ of Junior notes. These notes are rated AAA(sf) / Aaa(sf) and AA (low)(sf) / Aa3(sf) respectively by DBRS and Moody’s. The Senior tranche, with a WAL of 2.9 years, has a margin(2) of Euribor 1 month + 23bps. The Junior notes, with a WAL of 4.5 years, have a margin of Euribor 1 month + 100bps. This issuance is the Group first public lease ABS and a key milestone in its funding diversification policy. The success of this transaction demonstrates investors’ confidence in the quality of RCI assets and its servicing process. This transaction also confirms the diversified financing sources to which
PILLAR III RISK REPORT AS OF DECEMBER 31, 2019 (AMENDED VERSION DATED 2020-10-01)1.10.2020 19:00:00 CEST | Press release
Thursday, October 1st, 2020 PILLAR III RISK REPORT AS OF DECEMBER 31, 2019 (AMENDED VERSION DATED 2020-10-01) An amended version of the Pillar III report as of 12/31/2019 is available on our website rcibs.com under the reference “PILLAR 3 DISCLOSURES 2019-12-31 (AMENDED VERSION DATED 2020-10-01)”. Changes versus initial release are listed below: Correction on own funds, total capital ratio, CET1 ratio, leverage ratio initially reported to reflect the cancellation of € 300 million planned dividend in respect of 2019 results. Such decision has been announced in our press release dated April 23, 2020 and intended to comply with ECB recommendations on dividend payments. Error corrections on tables IX-2 AE1 “Encumbered and unencumbered assets” and IX-3 AE2 “Collateral received” in page 85 and 86. This new version cancels and replaces Pillar III report published on our website on a stand-alone basis on 30/3/2020 and integrated in our annual report published on 29/04/2020. Contact Analysts an
PILLAR III RISK REPORT AS OF DECEMBER 31, 2019 (AMENDED VERSION DATED 2020-10-01)1.10.2020 19:00:00 CEST | Press release
October, 1st, 2020 RCI Banque: "PILLAR III RISK REPORT AS OF DECEMBER 31, 2019 (AMENDED VERSION DATED 2020-10-01)" The RCI Banque group " PILLAR III Report” is now available on the website www.rcibs.com Attachment PILLAR III RISK REPORT AS OF DECEMBER 31, 2019 (AMENDED VERSION DATED 2020-10-01)