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Curetis Milestones

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

Curetis has installed more than 150 Unyvero Analyzer worldwide and reached the related milestone. Curetis has now grown its installed base of Unyvero Analyzers to 151 as of 31 January 2017. This compares with 103 Analyzers as of the end of 2015, 113 at mid-2016 and 121 as of 30 September 2016.

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

Curetis licenses Acumen’s proprietary sepsis biomarker panel for use with Unyvero Platform Diagnostics Development (DxD) Hub in Singapore to support Acumen in development and clinical validation of the panel. Acumen will distribute Unyvero product line in ASEAN countries.

2015 — Distribution Agreement for Greater China

Exclusive Unyvero distribution agreement with Beijing Clear Biotech Co., Ltd. for Mainland China, Hong Kong and Taiwan. Clinical trials for CFDA regulatory approval is in preparation.

2015 — Unyvero selected for Global Phase III Antibiotics Trial

Unyvero will be used for pathogen identification and patient inclusion at several clinical sites across Europe.

2015 — Next Phase of FDA Trial

First patient enrolled in prospective arm of IVD trial in Lower Respiratory Tract Infections. Study includes a total of at least 2,500 patient samples.

2015 — Curetis Strengthens Executive Team

Curetis Strengthens Executive Team and appoints Dr. Achim Plum as Chief Commercial Officer. The former Siemens Healthcare manager adds broad expertise in molecular diagnostics, sales, marketing, and business development.

2015 — West EU Expansion

Curetis Expands Commercial Organization. Augmented direct sales force, led by new Head of International Sales to broaden reach in key European markets.

2015 — Next-Generation Pneumonia Application P55

Curetis launched the Next-Generation Pneumonia Application P55. The clinical CE Performance Evaluation of Unyvero P55 Pneumonia Application is successful completed.

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.

2014 — MARKET LAUNCH OF THE SECOND UNYVERO i60 ITI CARTRIDGE

Additional new European markets to be addressed and further Unyvero cartridges to be developed and launched.

2013 — SERIES B FINANCING IS SUCCESSFULLY CLOSED

HBM Partners is secured as a new lead investor. To date, a total of EUR 49.1 million in equity capital has been raised. The international business is expanded towards the Benelux, Russia, Eastern Europe and the Middle East. FDA approval study starts in the USA.

2012 — Launch of the UNYVERO System

The first cartridge for pneumonia is launched in Germany, Austria and Switzerland. The CE performance evaluation study is successfully completed and a multicenter clinical study is run in Europe. Start of collaborations with Heraeus Medical and Cempra Pharmaceuticals.

2011 — OPENING OF THE PRODUCTION SITE

The manufacturing site for producing the Unyvero cartridges is opened in Bodelshausen, Germany.

2011 — EXTENSION OF SERIES A FINANCING

Oliver Schacht joins the Curetis team as CEO. In addition to the initial investors, CD-Venture, Forbion Capital Partners and the Roche Venture Fund also sign up as additional investors.

2010 — UNYVERO DEVELOPMENT MILESTONES

Initial prototypes for the Unyvero systems are developed in collaboration with Zollner Elektronik AG. The production plant for the Unyvero cartridges is implemented as a pilot system in collaboration with Contexo.

2009 — SERIES A VENTURE CAPITAL FINANCING

Curetis attracts total capital of approx. EUR 20 million from a syndicate comprising aeris CAPITAL, LSP, BioMed Invest, KfW, some local entrepreneurial families and the management and founders. The business plan and product pipeline are realigned.

2008 — INITIAL SEED FINANCING

In addition to a capital increase by the founders and the management, aeris CAPITAL AG, a Swiss family office, also contributed to Curetis with a seed funding to the tune of EUR 1.4 million.

2007 — FOUNDING OF THE COMPANY

A group of engineers, medical doctors and biologists from Philips founded Curetis. This group includes today's CTO Andreas Boos, COO Johannes Bacher, Director of Bio-Assay Development Dr. Gerd Lüdke and Medical Director Dr. Anne Thews.