WE CARE FOR CONTINUOUS ACHIEVEMENTS
2018 — Raised EUR 4.1 M in Equity Offering with access to additional USD 10 M in Equity
In April, Curetis obtained commitments from qualified investors in Europe and the United States to subscribe for 854,166 new ordinary shares. Total gross proceeds from the Offering for the Company are expected to be EUR 4.1 million, before deducting fees and expenses. The Company also secured an additional USD 10 million equity facility offered by Global Corporate Finance (GCF), New York, NY, USA, allowing the Company solely at its request to raise additional equity over a period of up to 36 months subject to certain pre-agreed floor pricing.
2018 — Launched CE-IVD marked Unyvero UTI Cartridge
In April, Curetis launched the Unyvero Urinary Tract Infection (UTI) Cartridge addressing severe urinary tract infections. The Unyero UTI Cartridge covers 103 diagnostic targets, including 88 pathogens & 15 genetic antibiotic resistance markers. The overall weighted average sensitivity for the pathogens specifically targeted by the test panel was 95.6% at an overall weighted average specificity of 99.3%.
2018 — Unyvero BCU Receives Approval in Singapore
In April, Acumen Research Laboratories Pte. Ltd. (Acumen), its partner for the commercialization of Unyvero in the ASEAN region, has received approval by the Singapore Health Sciences Authority (HSA) to market the Unyvero BCU Cartridge for bloodstream infections in Singapore. The Application Cartridge is now fully registered as a Class C IVD medical device with the Singapore Medical Device Register (Device Registration No: DE0501464).
2018 — U.S. FDA Clearance of Unyvero System and LRT Cartridge
In April, Curetis has been granted a De Novo clearance by the U.S. Food and Drug Administration (FDA) to market the Unyvero System and Lower Respiratory Tract Infection (LRT) Application Cartridge in the U.S. It is the first ever multiplex molecular diagnostics test to be granted clearance by the FDA for this indication.
2018 — U.S. allowance for key patent covering Unyvero technology
In March, Curetis received a notice of allowance from the United States Patent & Trademark Office (USPTO) for U.S. Patent Application 14/232,391 (“Apparatus and Method for a Lysis of a Sample, in Particular for an Automated and/or Controlled Lysis of a Sample") covering its Unyvero Lysator patient sample preparation technology. Patents by Curetis covering this technology have been granted in Australia, China and Japan, and patent applications are pending in Europe and Canada.
2017 — Cooperation with MGI for NGS-based diagnostics
Curetis and MGI, a fully-owned subsidiary of BGI Group, one of the world's leading genome sequencing centers headquartered in Shenzhen, Guangdong, P. R. China, have signed a Memorandum of Understanding (MoU) for a broad collaboration to develop targeted Next-Generation Sequencing (NGS) IVD assays for microbial infections.
2017 — Partnering with Biotest for the clinical trial PEPPER
Under the terms of the agreement, Curetis will provide Biotest with in-house testing services using Curetis' Unyvero IAI Cartridge for the diagnosis of intra-abdominal infections. Curetis' services will comprise testing for microbial pathogens(bacteria and fungi), toxins, and antibiotic resistance markers for the clinical trial PEPPER (Personalized Medicine with Pentaglobin®after surgical source control in patients with peritonitis).
2017 — Launch of Unyvero Cartridge for intra-abdominal infections
Curetis successfully compled the clinical performance evaluation and CE-IVD marking of its fourth Unyvero Cartridge for the diagnosis of severe intra-abdominal infections (IAI). The Cartridge covers up to 92 bacteria, 13 fungi, 3 toxins and 2 resistance markers. The IAI Application was launched at ECCMID 2017.
2017 — Ares Genetics established for GEAR business
In April 2017, Curetis established Ares Genetics GmbH, a wholly owned subsidiary of Curetis GmbH. Ares Genetics builds on GEAR GEnetic Antibiotic Resistance and Susceptibility Database and associated assets recently acquired for Siemens. The Company will use GEAR to investigate the genetic foundations of antibiotic resistance and develop and subsequently commercialize novel approaches to improve the rapid detection of antibiotic resistance in patients with microbial infections as well as tools to accelerate antibiotic research. Ares Genetics has been established in Vienna, Austria, in close proximity to the Vienna Biocenter VBC and is headed by Dr. Andreas Posch, who has joined Curetis in March from Siemens as Director GEAR & Bio-IT and one of the Managing Directors of Ares Genetics. Dr. Posch headed the bioinformatics activities at Siemens Healthcare and was responsible for GEAR prior to the asset transfer to Curetis. In addition to Dr. Posch, Curetis ́ CCO Dr. Achim Plum will act a further Managing Director of Ares Genetics.
2017 — Over 150 Unyvero Analyzers installed worldwide
2017 — Filing for U.S. FDA clearance
Curetis has submitted a 510(k)applicationto the U.S. Food and Drug Administration for its Unyvero Platform and the Unyvero LRT Lower Respiratory Tract Cartridge. The submission is for the use of Unyvero for the diagnosis of lower respiratory tract infections.The LRT panel includes upto 36 analytes for all key pathogens and antibiotic resistances in this indication area.
2016 — Acquisition of the Gyronimo Platform
Curetis acquires the real-time qPCR-based Gyronimo Platform from Carpegen GmbH and Systec GmbH, joint owners of the platform. The transaction allows Curetis to transform Unyvero into a uniquely broad platform offering with capabilities ranging from rapid 1 hour testing for 10+ diagnostic targets to highly multiplexed syndromic testing panels delivering results for over 100 diagnostic targets in 4 to 5 hours. Integrating Gyronimo into the Unyvero Platform for infectious disease testing will also allow Curetis to significantly expand its product portfolio into novel application in areas such as infection control, viral testing and CNS infections, as well as applications for immunocompromised patients.
2016 — Curetis obtains EUR 25 million EIB debt financing
European Investment Bank (EIB) provides EUR 10 million immediately, with a further EUR 15 million available upon meeting certain milestones. Transaction is guaranteed by the European Fund for Strategic Investments (EFSI), the heart of the Investment Plan for Europe. Financing allows strategic expansion and further development of Unyvero Platform.
2016 — Positive Top Line Data from U.S. FDA Trial
Curetis announced top line data from its successfully completed Unyvero U.S. FDA trial. The trial was designed to compare the performance of the Unyvero Instrument Platform and the Unyvero LRT Lower Respiratory Tract Cartridge in detecting lower respiratory tract infections to microbiology culture, the current diagnostic standard of care. Additionally, the trial compared Unyvero results to a composite of microbiology and independent PCR tests plus sequencing. The prospective and retrospective study met its primary endpoint by demonstrating an overall weighted average sensitivity of 90.2% and an overall average weighted specificity of 99.3%. The trial included a total of 2,203 prospective and retrospective samples and has run 5,694 Unyvero Cartridges, including daily positive and negative controls at each site as well as reproducibility tests.
2016 — Acquisition of Siemens GEAR Databank
Under the terms of the agreement, Curetis has acquired sole commercial rights from STA to the GEAR GEnetic Antibiotic Resistance and Susceptibility platform and database with all its content, numerous GEAR-related patents and patent applications, as well as all corresponding know-how. The deal gives Curetis sole worldwide product development and commercial rights, including the right to sublicense in the fields of human and animal diagnostics as well as food safety testing. Furthermore, Curetis has secured the sole rights to leverage the GEAR assets in collaboration with pharmaceutical companies for the development of novel antimicrobial drugs for human and animal health.
2016 — Launch Next Generation Unyvero ITI
The next-generation cartridge now covers a total of 102 diagnostic targets: 85 of the most clinically relevant pathogenic microorganisms, including Gram positive and Gram negative bacteria, several fungi, and 17 related antibiotic resistance markers. Specifically, the next generation ITI cartridge has added a universal bacterial primer, several Candida species, various types of Streptococci, Klebsiella variicola, and other new diagnostic targets. In addition, clinical sensitivity has been significantly improved for many key pathogens. Unyvero ITI is the most comprehensive commercially available panel for this indication area in a cartridge-based sample-to-answer format.
2016 — CEO of Newly-Formed U.S. Subsidiary Appointed
Christopher M. Bernard has been appointed to the newly-created role of President and Chief Executive Officer of the Company’s North American subsidiary Curetis USA, Inc., effective immediately. He will be responsible for the development of the new subsidiary based in San Diego, CA, and will lead the marketing and sales initiatives for Curetis in the U.S.
2016 — Completed Sample Enrollment U.S. FDA Trial in Unyvero LRT
In less than a year, a total of 2,254 tracheal aspirate and bronchoalveolar lavage samples have enrolled at nine participating sites across the US, including Mayo Clinic, Northwestern University, Johns Hopkins Hospital, UCLA and Columbia University Medical Center. 1,698 samples were prospectively tested, and 556 were retrospectively tested with the LRT55 Unyvero Lower Respiratory Tract Cartridge as well as using standard of care microbiology culture. The Principal Investigator of the trial is Dr. Robin Patel, Director of the Clinical Bacteriology Laboratory and Infectious Diseases Research Laboratory, and Chair of the Division of Clinical Microbiology at Mayo Clinic.
2016 — Excellent Study Data and Launch of Unyvero BCU
The market launch is supported by excellent interim data from an external, prospective, multicenter evaluation comparing the performance of the BCU Application Cartridge against the performance of conventional microbiology work-up of positive blood cultures that is ongoing at three European hospitals.
The interim analysis on approximately 100 patient samples demonstrated a 98% concordance with conventional microbiology. Additional pathogens that escaped detection by conventional microbiology were found in several cases. On average, Unyvero results were available 24 hours earlier and in some cases up to two days earlier than results obtained by routine diagnostic methods. The data also confirm compatibility with most commonly used blood culture systems, namely BacT/ALERT® (BioMérieux) and BD BACTEC™ (Becton Dickinson).
2016 — CURETIS ESTABLISHES MEDICAL ADVISORY BOARD
Curetis establishes its Medical Advisory Board (MAB). Initially, it will consist of four leading experts in their respective fields: Dr. Reno Frei (former Head of the Division of Clinical Microbiology, University Hospital Basel, Switzerland), Prof. Mathias Pletz, MD (Jena University Hospital, Germany), Prof. Jean-Louis Vincent, MD, PhD(Hôpital Universitaire Erasme, Brussels/Belgium), and Prof. Robin Patel, MD (Mayo Clinic, USA).
2015 — Curetis is listed on Euronext in Amsterdam and Brussels
The final offer price for the Offering is set at EUR 10.00, corresponding to market capitalization of the Company at listing of approximately EUR 151 million. William E. Rhodes, III, will be serving as chairman of Curetis’ supervisory board, while Mario Crovetto will serve as chairman of Curetis’ audit committee.
2015 — Collaboration with Acumen for ASEAN
2015 — Distribution Agreement for Greater China
2015 — Unyvero selected for Global Phase III Antibiotics Trial
2015 — Next Phase of FDA Trial
2015 — Curetis Strengthens Executive Team
2015 — West EU Expansion
2015 — Next-Generation Pneumonia Application P55
2014 — EXTENSION OF SERIES B FINANCING
Curetis Closes EUR 14.5 Million Extension of Series B Financing and wins new investors QIAGEN and LSP-HEF, committing EUR 7 million. All existing investors participated in the extension financing, investing EUR 7.5 million on a pro rata basis. The financing brings the total amount of equity capital raised by Curetis AG to over EUR 63.5 million.