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    Gradientech starts its third FDA 510(k) clinical study site

    The diagnostics company Gradientech today announces to have started its third FDA 510(k) clinical study site in the US for the QuickMIC® system for ultra-rapid antibiotic susceptibility testing (AST).Following successful pre-clinical evaluation studies of the QuickMIC system in the US, a breakthrough device designation by the FDA and the start of two FDA 510 (k) clinical study sites in the US, a third hospital has united to ensure comprehensive clinical data collection for the regulatory FDA submission of the QuickMIC system and its gram-negative panel.The focus of the clinical study is

    Gradientech carries out a rights issue of approximately SEK 60 million

    The Board of Directors of Gradientech AB (publ) (“Gradientech” or “the Company”) decided on 17 December to carry out a new issue of shares with preferential rights for existing shareholders of approximately SEK 60 million (the “Rights Issue”). A prospectus regarding the Rights Issue has today been approved by the Swedish Financial Supervisory Authority and is available on the Company's website gradientech.se .Investor presentation on 22 Januari 2025Shareholders are welcome to participate at Gradientech’s investor presentation that is

    First QuickMIC[®] agreement signed for clinical routine use in Italy

    The diagnostics company Gradientech announces the successful implementation of the QuickMIC[®] system for ultra-rapid antibiotic susceptibility testing (AST) into clinical routine use at the Molinette Hospital in Turin, Italy.The Molinette Hospital is as part of the Azienda Ospedaliero Universitaria (AOU) Città della Salute e della Scienza di Torino, one of the biggest university hospitals in Italy and in Europe, with a mission to provide excellent patient care and conduct top-tier research. "After a successful evaluation of the QuickMIC system, we are now prepared to implement it in our

    Gradientech presented QuickMIC® performance data at the 17th National Microbiology Conference in Romania

    The diagnostics company Gradientech announces the presentation of newly published outstanding performance data on QuickMIC® at the 17th National Conference of Microbiology and Epidemiology in Iași, Romania, 7-9 November 2024.The national conference in Iași brought together experts in infectious diseases and clinical microbiology from across Romania to discuss urgent public health challenges. The sessions addressed various topics, including innovative diagnostics and infection prevention strategies. The QuickMIC® system was showcased by Biomedica Medizinprodukte GmbH, Gradientech’s

    Gradientech: Interim report January–September 2024

    Gradientech AB (publ) interim report for Q3 2024 is now available on the company's website www.gradientech.se.Third quarter 2024 · Net sales amounted to SEK 829 thousand (53). · Net profit/loss amounted to SEK -13,399 thousand (-10,968). · Earnings per share before and after dilution were SEK -0.51 (-0.62). · Cash flow from operating activities amounted to SEK -13,906 thousand (-14,435). · Cash and cash equivalents amounted to SEK 13,142 thousand (25,873) as of September 30, 2024. · Equity amounted to SEK 21,699 thousand (40,894) as of September 30, 2024. · In July

    Gradientech welcomes investment from commercial partner

    Gradientech AB (publ) ("Gradientech" or the "Company") announced on October 8 the exclusive partnership with Hardy Diagnostics for the commercialisation of its QuickMIC[®] system in the United States and Canada. Alongside this partnership, Hardy Diagnostics decided to subscribe for 1,796,571 shares in Gradientech. Through the Issue, Gradientech will receive proceeds of approximately SEK 31.4 million before deduction of issue costs.OutcomeOn September 24, 2024, the Board of Directors of Gradientech AB (publ) resolved to issue a maximum of 1,796,571 shares in total, in form of a directed

    Gradientech in exclusive partnership with Hardy Diagnostics for the US and Canadian markets

    The diagnostics company Gradientech today announces the exclusive partnership with Hardy Diagnostics for the commercialisation of its QuickMIC® system in the United States and Canada. QuickMIC is an ultra-rapid antibiotic susceptibility testing (AST) system designed to provide critical results for sepsis patients. Alongside this partnership, Hardy Diagnostics has decided to invest in Gradientech, becoming one of the company’s largest shareholders.“With QuickMIC already being implemented in several European hospitals and the 510(k) study of QuickMIC recently started at clinical sites in the

    QuickMIC® proves superior speed and performance in multicenter study

    The diagnostics company Gradientech announces a new scientific publication of the QuickMIC® system, the today fastest diagnostic system on the market for antibiotic susceptibility testing (AST) of blood cultures from patients with sepsis. The article is published in the top-tier Journal of Clinical Microbiology.The multicenter study aimed to evaluate the performance of the QuickMIC system regarding speed, precision, accuracy and reproducibility compared to the reference method broth microdilution (BMD). The study contains an extensive collection of clinical samples, including challenging

    Gradientech starts US 510(k) study for QuickMIC® at clinical sites

    The diagnostics company Gradientech today announces to have started the 510(k) clinical study for the QuickMIC® system for ultra-rapid antibiotic susceptibility testing at the first two clinical sites, both well-renowned hospitals in the US.Following successful pre-clinical evaluation studies of the QuickMIC system in the US last year, and with a breakthrough device designation by the FDA, the 510(k) study of QuickMIC and its first gram-negative panel is now initiated at clinical sites in the US. The focus of the clinical study will be antibiotic susceptibility testing results for gram-

    New QuickMIC® publication in ASM journal

    The diagnostics company Gradientech announces a new scientific publication of the QuickMIC® system by Dr. Balmis University General Hospital demonstrating an impressive concordance of 99% between QuickMIC and the reference methods in use.The study was conducted by Prof. Juan Carlos Rodriguez and colleagues at the Infectious Disease Unit at Dr. Balmis University General Hospital in Alicante, Spain. They evaluated the QuickMIC® system in the rapid diagnosis of the antibiotic susceptibility of Gram-negative bacilli in comparison to the reference methods in use. A total of 816 antibiotic-

    Gradientech receives patent rights in Japan

    The diagnostics company Gradientech reports having received a Notice of Allowance in Japan for its QuickMIC® cassette, the single-use test device in the QuickMIC® diagnostic system for ultra-rapid antibiotic susceptibility testing (AST).Gradientech announces that the Japan Patent Office has recognised the originality of the QuickMIC® cassette construction to be used in automated systems for antibiotic susceptibility testing of microorganisms. The Japanese patent application is based on the International Publication Number WO 2020/204799 and describes the design and functionality of a test

    Gradientech: Interim report January–June 2024

    Gradientech AB (publ) interim report for Q2 2024 is now available on the company's website www.gradientech.se.Second quarter 2024 · Net sales amounted to SEK 1,948 thousand (1,141). · Net profit/loss amounted to SEK -17,906 thousand (-16,837). · Earnings per share before and after dilution were SEK -0.75 (-0.95). · Cash flow from operating activities amounted to SEK -14,586 thousand (-14,399). · Cash and cash equivalents amounted to SEK 6,750 thousand (39,535) as of June 30, 2024. · Equity amounted to SEK 14,893 thousand (35,112) as of June 30, 2024. · In April 2024

    Nathan A Ledeboer joins the Scientific Advisory Board at Gradientech

    The diagnostics company Gradientech today announces that Dr Nathan A. Ledeboer, specialist within the Froedtert & Medical College of Wisconsin network, joins as new member of the company’s prominent international Scientific Advisory Board.Dr Ledeboer is Professor and Chief of Clinical Pathology in the Department of Pathology and Laboratory Medicine at the Medical College of Wisconsin, USA. He served as the Medical Director of Microbiology and Molecular Diagnostics for Froedtert Hospital and Wisconsin Diagnostic Laboratories in Milwaukee, WI for 16 years before assuming the role of Associate

    Gradientech and Momentum Bioscience in continued collaboration

    The diagnostics company Gradientech today announces the continued collaboration with Oxford-based Momentum Bioscience Ltd in the ground-breaking project to demonstrate the potential for a next-generation diagnostic workflow for patients with sepsis, together providing the fastest solution to precise phenotypic AST results directly from blood.Momentum Bioscience is developing the SepsiSTAT® technology allowing isolation and separation of bacteria directly from blood. By combining the enrichment technology from Momentum Bioscience with the CE marked QuickMIC® system for ultra-rapid antibiotic

    Promising QuickMIC® data from two US study sites will be presented at ASM Microbe 2024

    The diagnostics company Gradientech today announces that data from the successfully completed US pre-clinical evaluation of QuickMIC® will be presented at the ASM Microbe conference in Atlanta, Georgia, June 13th-17th.Organised by the American Society of Microbiology, ASM Microbe is one of the largest microbial sciences conferences in the US, bringing together thousands of scientists, researchers, and healthcare professionals. The event consists of keynote sessions, interactive workshops, and poster presentations, with cutting-edge topics ranging from how to use AI to design new antibiotics

    QuickMIC® installation for clinical routine use in Central Eastern Europe

    The diagnostics company Gradientech today announces that Biomedica Medizinprodukte GmbH, its appointed distributor for Austria, Switzerland, and Central Eastern Europe, has acquired its first customer for QuickMIC® in clinical routine use.A university hospital in the Central Eastern Europe market has now started to implement the QuickMIC® system for ultra-rapid antibiotic susceptibility testing (AST) in clinical routine, to use it in their program for hospital-acquired infections. “This is a significant milestone in our partnership together with Gradientech to implement the QuickMIC

    Gradientech: Interim report January–March 2024

    Gradientech AB (publ) interim report for Q1 2024 is now available on the company's website www.gradientech.se.First quarter 2024 · Net sales amounted to SEK 485 thousand (380). · Net profit/loss amounted to SEK -15,648 thousand (-18,063). · Earnings per share before and after dilution were SEK -0.68 (-1.08). · Cash flow from operating activities amounted to SEK -14,813 thousand (-18,068). · Cash and cash equivalents amounted to SEK 21,336 thousand (25,993) as of March 31, 2024. · Equity amounted to SEK 32,800 thousand (40,731) as of March 31, 2024. · In January 2024

    Gradientech receives patent rights in China

    The diagnostics company Gradientech reports having received a Notification to Grant Patent Rights in China for its QuickMIC® cassette, the single-use test device in the QuickMIC® diagnostic system for ultra-rapid antibiotic susceptibility testing (AST).Gradientech announces that the State Intellectual Property Office (SIPO) of P. R. China has recognised the originality of the QuickMIC® cassette construction to be used in automated systems for antibiotic susceptibility testing of microorganisms. The Chinese patent application is based on the International Publication Number WO 2020/204799

    Gradientech releases new ebook

    The diagnostics company Gradientech today announces the release of its new ebook “Stop treating all patients equally” – a future approach for individualised and improved sepsis patient management.The ebook is created together with leading experts in the field to highlight clinical challenges and needs that bacterial sepsis patient management faces today, and how this can be addressed in modern healthcare. The concept of precision-guided antibiotic treatment in bacterial sepsis entails moving beyond the “one-size-fits-all” paradigm and into an era where laboratory results, as well as patient-

    Gradientech at ESCMID Global 2024

    The diagnostics company Gradientech announces the presentation of new performance data from clinical, real-world evaluations with its QuickMIC[®] system for ultra-rapid antibiotic susceptibility testing (AST) at ESCMID Global 2024 in Barcelona, Spain, April 27th-30th.ESCMID Global, organised by ESCMID - European Society of Clinical Microbiology and Infectious Diseases , is one of the most comprehensive and influential congresses in infectious diseases and microbiology, bringing together over 16,000 professionals from all over the world. Gradientech

    Gradientech strengthens its commercial management team

    The diagnostics company Gradientech today announces that AnnaLotta Schiller Vestergren has been appointed as the company’s Chief Commercial Officer and part of the management team. AnnaLotta has extensive experience with international commercial organisations, with nearly 30 years of leading positions in life science and diagnostics.“I´m very pleased to welcome AnnaLotta to join the Gradientech team. With a background in molecular biology and bacteriology and extensive experience in international sales and business development from major life science companies as well as smaller emerging

    Gradientech unveals European clinical study data

    The diagnostics company Gradientech today announces the publication of data from the large multicenter clinical study of the QuickMIC® system in collaboration with leading European hospitals. QuickMIC is the today fastest diagnostic system on the market for antibiotic susceptibility testing (AST) of sepsis samples.Clinical study data from the multicenter performance evaluation of the QuickMIC system shows that QuickMIC is highly accurate compared to the reference testing method for AST, broth microdilution. QuickMIC provides 95.6% agreement with the reference MIC values (Minimum Inhibitory

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