Archive: Company News
Company News: BRAIN Publication Demonstrates Significantly Improved Therapeutic Window of Deep Brain Stimulation Using directSTIM™ Directional Electrode
– Study confirms proof-of-concept for innovative DBS lead developed by Aleva Neurotherapeutics
Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease, today announced the publication of the results of an intraoperative study with its novel directSTIM™ directional lead. Data were published in the peer-reviewed journal Brain – A Journal of Neurology.*
The data presented in Brain are based on 11 patients with Parkinson´s Disease and 2 patients with essential tremor. In the study, clinical investigators assessed the intraoperative clinical effect of directional stimulation using Aleva’s directSTIM™ lead. This device features two rings consisting of three independent electrodes each. The angular position of the electrodes allows stimulation at 0°, 120° and 240° directions Directional stimulation was tested at the target determined for the permanent lead. The clinical investigators compared the therapeutic window (defined as the electrical current at which side-effects occur minus the current at which a significant therapeutic effect is observed) of directional and classical stimulation. Compared to omnidirectional stimulation, the therapeutic window in the best direction was 41% wider. Furthermore, the current threshold producing meaningful therapeutic effects in the best direction was 43% lower than in omnidirectional stimulation. No complication was observed due to the insertion and removal of the directional lead or during testing.
* Reference:
Pollo C, Kaelin-Lang A, Oertel MF, Stieglitz L, Taub E, Fuhr P, Lozano AM, Raabe A, Schüpbach M – Directional deep brain stimulation: an intraoperative double-blind pilot study. Brain 2014; doi:10.1093/brain/awu102.
Company News: Anergis to Present New COP Allergy Vaccine Data at EAACI Conference 2014 in Copenhagen
– Four scientific communications scheduled for June 8, 9 and 10, 2014 –
Anergis, a company discovering and developing proprietary allergy vaccines, today announced it will present four scientific communications on its Contiguous Overlapping Peptides (COP) allergy vaccines at this year’s European Academy of Allergy and Clinical Immunology Congress 2014 (EAACI) in Copenhagen, Denmark. The presentations focus on Anergis´ lead compound AllerT against birch pollen allergies, its house dust mite vaccine candidate AllerDM, and a general economic evaluation of allergen immunotherapy for seasonal allergies.
The following scientific communications will be presented at the EAACI Conference 2014:
Presentation Title: “AllerT™, Safety and efficacy of a birch pollen allergy vaccine based on contiguous overlapping peptides in a phase IIb study”
Presenter: Prof. Dr. Marek Jutel
Time and Date: Sunday, June 8, 2014, at 03:30pm CET
Session: Oral Abstract Session OAS12: Novel Vaccines for AIT
Abstract #: 481
Presentation Title: “Development of a hypoallergenic formulation for immunotherapy against house dust mite allergy based on Contiguous Overlapping Peptides”
Presenter: Dr. Alexander Kettner
Time and Date: Monday, June 9, 2014, at 03:45pm CET
Session: Poster Discussion Session PDS 12: AIT Mechanisms
Abstract #: 347
Presentation Title: “Effect of AllerT™ ultra-fast immunotherapy on Bet v 1 specific IgG4 and IgE levels; results from a phase IIb study”
Presenter: Prof. Dr. Christophe Reymond
Time and Date: Monday, June 9, 2014, at 03:45pm CET
Session: Poster Discussion Session PDS 12: AIT Mechanisms
Abstract #: 559
Presentation Title: “Economic evaluation of allergen immunotherapy for seasonal allergic rhinitis”
Presenter: Jean-Paul Rohmer
Time and Date: Tuesday, June 10, 2014, at 12:00pm CET
Session: Thematic Poster Session TPS64: Immunotherapy – AIT Clinics IV
Abstract #: 1411
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 Launches Unyvero™ i60 Implant and Tissue Infection Cartridge in Europe
– Successful completion of CE performance evaluation study covering more than 400 patient samples
– Sales and Marketing Program Underway in Germany, Austria and Switzerland
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has launched its new Unyvero™ i60 Implant and Tissue Infection (ITI) cartridge in Europe. The new cartridge for the Unyvero™ system was developed to rapidly identify more than 90 pathogens and more than 20 resistance markers common in eight clinical indications. Commercial launch and roll-out has already begun in close collaboration with Heraeus Medical GmbH, the development and commercialization partner for the Unyvero™ i60 cartridge. The Company has made first placements at major clinical centers in Germany, Austria and Switzerland (DACH market).
The i60 cartridge has been CE-IVD marked following the successful completion of a CE performance evaluation study involving more than 750 cartridges. Analytical sensitivity testing was conducted in 350 cartridges, while more than 400 cartridges were run with patient samples. Samples of various clinical indications were obtained for the trial, including periprosthetic joint infections, diabetic foot, catheters, surgical sites, skin and soft tissue and cardiology-related infections. The Unyvero™ system analyzed challenging native clinical sample types such as swabs, synovial fluid, sonication fluid, tissue and catheters. Among others, the i60 cartridge detected several key pathogens with sensitivities in the range between 75% to 100% at an overall panel sensitivity of 67% and panel specificity of 97.8% for the 81 analytes that have been successfully validated so far. The i60 cartridge also identified 147 clinically important pathogens not found by standard microbiology culture. In particular, in every second sonication fluid and every third synovial fluid sample, i60 detected pathogens missed by microbiology culture. Pathogens most often overlooked by culture, yet identified by i60, were Enterococcus sp., Finegoldia magna, Corynebacterium sp., Enterobacter cloacae, and Acinetobacter baumannii. Resolution of these discrepant results is ongoing.
Curetis and its distribution partners will introduce the Unyvero™ i60 ITI cartridge at the 2014 ECCMID conference in Barcelona, Spain (9-13 May 2014 – Booth 39), where the Company will also host the Medical Symposium, ”Implant and Tissue Infections – Challenges and Opportunities“ (May 10, 2014, from 13:30 – 15:30 in Hall J).