Tag: Oliver Schacht

Company News: Curetis Closes EUR 14.5 Million Extension of Series B Financing

–      Curetis wins new investors QIAGEN and LSP-HEF, committing EUR 7 million

–      Curetis well financed into 2017

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced it has closed a EUR 14.5 million extension of its Series B financing round, which was originally led by HBM Partners in April 2013. All existing investors – aeris Capital, BioMed Invest, CD Venture, Forbion Capital, HBM Partners, LSP – Life Sciences Partners, Roche Venture Fund, management, a trustee-pool of Curetis employees and private angel investors – participated in the extension financing, investing EUR 7.5 million on a pro rata basis. QIAGEN and LSP Health Economics Fund (LSP-HEF) are joining as new investors, committing a total of EUR 7 million. The financing brings the total amount of equity raised by Curetis AG to over EUR 63.5 million.

In addition, Rudy Dekeyser of LSP-HEF will join Curetis´ Supervisory Board, while Hans-Guenter Hohmann will step down after being a Board member for the past six years. Dr. Martin Potgeter, Vice President Business Development of QIAGEN, will take an observer seat on the board as second representative of a corporate investor alongside Simon Meier of Roche Venture Fund and Dr. Karsten Fischer of BioMed Invest.

The financing is supported by the achievement of key milestones, e.g. several CE/IVD-marked products, an ongoing FDA clearance trial and a growing commercial distribution network across Europe. The European market introduction of both the Unyvero P50 Pneumonia and i60 Implant and Tissue Infection applications, allowing a faster and better diagnosis of life-threatening infectious diseases, has shown increasing traction. In addition, the company is in talks with several parties on granting future U.S. commercialization rights and further expanding the commercialization into Asia and other global markets.

Company News: Mayo Clinic’s Dr. Robin Patel Named Principal Investigator for Curetis’ Unyvero™ LRT Trial

Curetis adds six new trial sites, significantly expanding U.S. clinical trial network for ongoing FDA study

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Robin Patel, M.D., Professor of Medicine and Microbiology at the Mayo Clinic in Rochester, Minn., has been named Lead Principal Investigator of the company’s Unyvero™ LRT Application FDA trial. The lower respiratory tract (LRT) application is designed to detect 17 pathogens and 22 antibiotic resistance gene markers of clinical importance in patients with suspected LRT infections. The Company also announced the addition of six new clinical trial sites in the last few quarters, expanding its clinical trial network to nine high-profile testing sites.

Dr. Patel, who chairs the Division of Clinical Microbiology and Mayo Clinic’s Bacteriology Laboratory and directs the Infectious Diseases Research Laboratory, is a specialist in the clinical detection and identification of bacteria, including the characterization of their antimicrobial resistance and susceptibility, particularly for biofilm-mediated infections. She succeeds Prof. Christine Ginocchio, M.D., formerly of North Shore-LIJ Health System Laboratories, who recently left North Shore-LIJ to assume a corporate position in the microbiology field.

To bolster enrollment and to capture potential geographical differences in pathogen and antibiotic resistance gene distribution, Curetis has also expanded its clinical trial network from three to nine testing sites over the past couple of quarters.

Participating trial centers testing at least 2,000 prospective lower respiratory tract samples include:

  • David Geffen School of Medicine at UCLA (Los Angeles, Calif.)
  • Johns Hopkins University School of Medicine (Baltimore, Md.)
  • Northwestern Memorial Hospital (Chicago, Ill.)
  • Mayo Clinic (Rochester, Minn.)
  • North Shore-LIJ Health System Laboratories (Lake Success, N.Y.)
  • University of Rochester Medical Center (Rochester, N.Y.)
  • Weis Research Center/Geisinger Health System (Danville, Penn.)
  • University of Washington Medical Center (Seattle, Wash.)
  • William Beaumont Hospital (Royal Oak, Mich.)

Company News: Curetis Obtains Key Patent for Unyvero™ Technology

–      Australian patent office grants patent for integrated amplification and detection in Unyvero™ cartridges

–      Patent covers unique combination of end-point PCR with array-based detection

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has been granted a core technology patent by IP Australia, the Australian patent office, for its Unyvero™ platform technology. The patent, “Reaction Vessel For PCR Device and Method of Performing PCR,” is the first of several core technology patents filed by Curetis. Its claims cover PCR chamber vessels allowing the integrated amplification and detection of DNA sequences. Curetis has submitted patent applications covering this technology in other key regions, including Europe, the U.S. and Japan. The Company expects these additional patents to be granted in the near future.

Further patents covering additional aspects of the Unyvero™ Solution, e.g. the unique sample lysis technology, are pending.

Company News: Curetis Prepares Launch of Second Unyvero™ Application

–      Final clinical performance evaluation study for Unyvero™ i60 ITI application ongoing

–      Study data expected by the end of Q1/2014

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has completed development of its second Unyvero™ application. The new Unyvero™ i60 ITI cartridge rapidly identifies more than 90 pathogens and more than 20 resistance markers common in implant and tissue infections. After successfully manufacturing several lots and completing initial verification testing of the cartridge, the Company has initiated a pivotal study using approximately 500 cartridges to validate analytical, technical and clinical performance for CE marking.

Following the completion of the study scheduled for end of Q1/2014, commercialization of the Unyvero™ i60 ITI is expected to begin in Q2/2014. Curetis will jointly market the cartridge with Heraeus Medical GmbH, the development and commercialization partner for this cartridge. Both companies have already received pre-orders from key opinion leaders and hospitals across central Europe.

The study will use frozen patient specimens – watery/swabs, viscous/purulent, sonication and synovial fluids, and biopsy material –  for diagnosis. The study will compare the molecular test with conventional microbial culture techniques. Discrepant or unexpected results will be resolved by additional tests. The study will also test assay repeatability and reproducibility and establish limit of detection.

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