Tag: Oliver Schacht
Company News: Curetis Raises EUR 12.5 Million in Series B Round Led by New Investor HBM Partners
– Co-investment of all current institutional investors as well as several private investors and management
– Company now has access to over EUR 20 million in cash for the next phase of commercial and operational growth
Curetis AG today announced the closing of a Series B financing round totaling EUR 12.5 million. The financing was led by HBM Partners, which has taken a EUR 6.0 million equity stake in Curetis. Dr. Alexander Asam of HBM will join Curetis’ supervisory board.
In addition, the company’s existing institutional investors aeris Capital, LSP Life Sciences Partners, Forbion Capital, BioMedInvest, Roche Venture Fund, CD Venture and KfW have contributed a total of EUR 5.6 million to the round on a pro rata basis. Curetis’ management as well as several of the company’s founders, private investors and board members also co-invested.
Including the latest Series B financing, Curetis has raised a total of EUR 49.1 million in equity capital to date.
Curetis will use the proceeds for the next phase of commercial and operational growth, including a prospective, multi-center FDA registrational trial with 2,000 patients and the further expansion of the company’s commercial activities and team in Europe.
Curetis anticipates a phase of rapid market adoption in the DACH region (Germany, Austria, Switzerland) where more than 50 top tier hospitals have agreed to install Unyvero™ for local testing. The inclusion of Unyvero™ in an upcoming global Phase IIb trial by Sanofi Pasteur is expected to add further momentum to the market penetration of Unyvero™.
Moreover, the company expects to continue the rapid international expansion of its commercial distribution network across Europe and the Middle East, but also towards Asia, Latin America and, following FDA clearance, to the USA.
Further upcoming milestones include the market launch of a second Unyvero™ cartridge application (ITI) together with Heraeus Medical and clinical data from a global Phase III trial in community-acquired bacterial pneumonia conducted by Cempra Pharmaceuticals.
Company News: Curetis to Present Clinical Unyvero™ Data at ECCMID 2013 in Berlin
– Company to host medical symposium on molecular antibiotic resistance testing in standard care
Curetis AG today announced the presentation of top-line clinical data from various European cohorts and performance evaluation studies of the Unyvero™ System and the Unyvero™ P50 pneumonia cartridge at the European Conference of Clinical Microbiology and Infectious Diseases (ECCMID) 2013 in Berlin. Data from the analysis of more than 1,000 patient samples and case reports will be presented in the poster session “Molecular diagnosis of bacterial pneumonia” on Monday, April 29, from 12:30-1:30pm.*
As an ECCMID silver sponsor, Curetis will also host a medical symposium on Saturday, April 27 (1:30-3:30pm) in Hall B (P.32). The symposium entitled “Does molecular antibiotic resistance testing improve diagnostics and standard of care?” will be chaired by Professors Carl-Erik Nord and Christian G. Giske (both Stockholm/Sweden). Featured presentations will be “Genotypes and phenotypes of emerging resistance” (Prof. David Livermore, Norwich/UK) and “Correlation between genotypes and phenotypes: clinical implications” (Prof. Gian Maria Rossolini, Siena/Italy). The session will conclude with the discussion of case studies in pneumonia (Prof. Antonio Torres, Barcelona/Spain, Prof. Eiman Mokaddas, Kuwait) and implant & tissue infection (Prof. Andrej Trampuz, Berlin/Germany and Prof. Olivier Borens, Lausanne/Switzerland).
Curetis will be exhibiting its CE-marked Unyvero™ System at booth no. 323 in hall 15. Several international distribution partners of Curetis will also attend ECCMID.
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*Abstract Nr. 2360: M. Klein et al., First clinical validation of a rapid molecular test (Unyvero™ P50 Pneumonia Application) detecting microorganisms and antibiotic resistances in patients suspected with severe pneumonia.
Company News: Curetis AG Initiates Clinical Trial in the U.S. Towards FDA Clearance
– Prospective Multi-Center Trial to Enroll Over 2,000 Clinical Samples –
Curetis AG today announced the start of a clinical trial of its Unyvero™ System and the corresponding LRT (lower respiratory tract) application in the U.S. The company expects enrollment completion within the next 12-15 months, followed by a 510(k) submission to the FDA in 2014.
The prospective, multicenter trial will include samples collected from more than 2,000 hospitalized patients suspected to have a lower respiratory tract infection and several hundred retrospective samples with known microbiology culture results for rare pathogens. Samples will be processed by the Unyvero™ Lysator, transferred to the LRT cartridge, and tested by the Unyvero™ Analyzer.
Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to microbiology culture (today’s diagnostics standard of care) and to a composite reference diagnosis that incorporates PCR and sequencing to determine clinical truth whenever microbiology culture results are negative.
Trial sites include Northwestern University (Chicago, IL) and North Shore-LIJ Health System (Lake Success, NY), among others. The Principal Investigator is Prof. Christine C. Ginocchio, Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System. Curetis has contracted Aptiv Solutions as its CRO and Neil Mucci of GlobalBioclinical as project manager in the US.
The LRT application analyzes 39 DNA targets simultaneously from a single patient sample. Results are available within about 4 hours. The pathogen panel has been selected for clinical relevance based on current international clinical guidelines and has been reviewed by clinical experts in Europe and the USA. Resistance genes were chosen by frequency and clinical significance. A similar product, the Unyvero™ P50 pneumonia cartridge is CE-marked and currently marketed in Europe and the Middle East.
Company News: Curetis and Scholz Collaborate to Industrialize and Scale-Up Production of Unyvero(TM) Cartridge Plastics Parts
– German family firm ‘Scholz-HTIK – High Tech in Kunststoff’ has been selected by Curetis based on systematic benchmarking process –
Curetis AG today announced a strategic supply chain partnership with German family business Horst Scholz GmbH + Co. KG for the production of high-quality plastics parts for its Unyvero™ Cartridge.
Under the agreement, Curetis will invest more than € 2 million in multi-cavity tools for all Unyvero™ Cartridge plastics parts. Curetis has already ordered several multi-cavity tools from Scholz. The first tools will be delivered in early 2013.
Scholz has been chosen by Curetis due to its unrivalled experience and expertise in medical device-grade injection molding, its state-of-the-art facilities and equipment as well as its cleanroom manufacturing infrastructure.
Scholz has a long track record and outstanding commitment to total quality management, e.g. regarding the use of CT scanners for quality control of parts. Curetis expects a smooth transition from its previous R&D phase supplier to the serial production and scale-up run by its new partner Scholz.