Archive: Company News

Company News: Curetis Expands Commercial Team

– Company hires Willem Haagmans as Head of Sales EMEA –

Curetis N.V. (the “Company” and, together with Curetis AG, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the expansion of its commercial and general administrative team.

As of February 1, 2016, Willem Haagmans has joined the company as Head of Sales for the EMEA region.

Willem Haagmans previously worked at Beckman Coulter as General Manager Benelux. He is a highly experienced commercial executive with a strong track record, including the successful commercialization of innovative products and solutions in the molecular diagnostics industry as well as the significant increase of top-line revenue growth. Among others, Willem Haagmans has held prior international molecular diagnostics sales management positions with Roche, Nimblegen, and Vela Diagnostics, bringing extensive leadership experience with both large and small-to-medium sized molecular diagnostics companies. He will be based in the Venlo area near the Dutch-German border, right at the heart of Curetis’ European direct sales territories, and will head all direct sales efforts in DACH, Benelux, France, UK and possibly Nordic countries.

Curetis´ recruiting activities for Key Account Managers, sales team members and Clinical Application Specialists is well under way in these Western European markets. Therefore, the company expects to hire additional key talents in the coming months to further grow its European commercial teams in sales, marketing and business development.

In addition, Curetis has made further key hires to augment its corporate and commercial functions:

Bernd Bleile joined on February 1, 2016 as in-house Legal Counsel to provide additional legal and corporate counsel support for the growing commercial operations of Curetis.

Dr. Jie Song, a Chinese native with 14 years of working experience in science and research in Germany and deep scientific and clinical expertise in microbiology, will join Curetis on March 1, 2016 as Application Specialist for China and Asia to support Curetis’ growing commercial activities in Asia. With new partnerships and the sale and delivery of 20 Unyvero Analyzers to its Chinese and ASEAN partners, Curetis in Q4 of 2015 has started to expanded its commercial reach into Asia. Preparations for a Chinese CFDA clinical trial are under way and expected to be kicked off in the first half of this year.

“The recent hires are the first steps to executing and delivering upon our expansion plans highlighted during our IPO in November 2015,” said Oliver Schacht, CEO of Curetis. “By growing our commercial team and strengthening our footprint in the EMEA region, we aim at significantly increasing the number of our direct sales accounts and to continuously grow the installed base of Unyvero Systems throughout 2016 and beyond.”

Company News: Aleva Neurotherapeutics and Greatbatch, Inc. Collaborate on Next-Generation Device for Deep Brain Stimulation (DBS)

– Agreement includes strategic investment in Aleva’s current Series C round by Greatbatch, Inc. –

Lausanne, Switzerland, February 01, 2016Aleva Neurotherapeutics, a leading company developing next-generation implants for deep brain stimulation (DBS) in major neurological indications such as Parkinson’s disease and essential tremor, today announced a strategic development, supply, and manufacturing relationship with Greatbatch, Inc. (NYSE:GB). In addition, Greatbatch will invest in Aleva Neurotherapeutics’ current Series C financing round.

Under terms of the development agreement, Greatbatch’s design and development team QiG Group, which is expected to be spun-off as Nuvectra Corporation, will provide Aleva with access to its unique implantable neurostimulation platform. Specifically, Aleva will receive a license to utilize Nuvectra’s platform in the field of use of deep brain stimulation for treatment of Parkinson’s disease and essential tremor. Aleva will incorporate its own proprietary microDBS™ technology platform, which includes cutting-edge directSTIM™ electrode technology for directional deep brain stimulation, into a complete system with Nuvectra’s proprietary 24-channel neurostimulator and paradigm-shifting programmers. The complete system is aimed to provide patients and doctors with an unparalleled, next-generation DBS solution resulting in increased efficacy and improved therapy control that may lead to improved outcomes for patients with Parkinson’s disease and essential tremor.

Nuvectra will also continue work with Aleva’s engineering team on the development of next-generation DBS technologies. In addition, Greatbatch will enter into an exclusive manufacturing and supply agreement for certain devices of the system.

“As a result of our partnership with Greatbatch and Nuvectra, we will significantly reduce our time-to-market and enhance our ability to deliver our novel Directional DBS therapy to patients in need,” said Andre Mercanzini, Chief Technology Officer and Founder of Aleva. “We are delighted to be working with some of the very best people in the neuromodulation business to commercialize our work.”

“We’re excited to be partnering with true pioneers in the field of DBS,” said Scott Drees, CEO of Nuvectra. “Aleva’s approach of building next-generation DBS therapies for this highly underserved market aligns perfectly with our plans to establish Nuvectra as an innovative player in the neuromodulation marketplace. We believe the Aleva partnership validates our strategy of developing platform technology that can be leveraged across multiple neurostimulation indications.”

Aleva is currently raising a Series C financing round, which will be led by Greatbatch. Existing investors BioMedPartners, BB Biotech Ventures, Banexi Ventures and Initiative Capital Romandie are also participating in the round. The proceeds will be dedicated to obtaining the CE mark for its proprietary directSTIM™ Directional Deep Brain Stimulation System and the completion of a chronic study in 60 Parkinson’s disease patients. The successful results of Aleva’s pilot study were published in BRAIN in 2014.

In October 2015, Greatbatch completed the acquisition of Lake Region Medical, with the combined company expected to be renamed Integer Holdings Corporation later this year (subject to shareholder approval).

Company News: Curetis Establishes Medical Advisory Board with Internationally Renowned Experts

– U.S. FDA trial enrolment on track –

Curetis N.V., a developer of next-level molecular diagnostic solutions for syndromic infectious disease testing, today announced the establishment of 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), who also serves as Principal Investigator of Curetis’ ongoing U.S. FDA trial.

The newly established MAB is expected to meet several times per year and chair roundtables with further key opinion leaders in the field to advise the company on important trends and issues in clinical microbiology as well as novel product concepts addressing high medical need questions in the diagnosis of severe infections in hospitalized patients. The company expects the MAB to provide valuable insight and guidance along the entire value chain of innovative molecular diagnostics products including concept, definition, clinical validation, and positioning.

“We are very proud to have won these outstanding, seasoned experts for our Medical Advisory Board,” said Dr. Anne Thews, Medical Director of Curetis. “They combine tremendous experience in the areas of severe infectious diseases including sepsis and prosthetic joint infections, in critical care, clinical microbiology, and further relevant areas. All of them have been working with Curetis over the past couple of years in various roles and functions, in particular in clinical evaluations and studies for our Unyvero product line, such as the ongoing U.S. study to support product clearance for our LRT55 lower respiratory tract application by the FDA.”

She explained further that by bringing together these key opinion leaders in a dedicated medical advisory board, the company expects to synergistically leverage the complementary expertise and experience represented in the board.

On the progress of the Unyvero LRT55 U.S. study, Dr. Thews added: “The trial is progressing well and on schedule with more than 900 patient samples already enrolled and tested with Unyvero.”

Prof. Jean-Louis Vincent of Brussels’s Hôpital Universitaire Erasme commented: “As rising antibiotic resistance has become an enormous threat for modern medicine, we as critical care clinicians demand faster pathogen identification and resistance detection in order to optimize our treatment for each patient. Modern, patient-near molecular testing solutions like the Unyvero System have the potential to significantly improve patient care. Therefore, I am pleased to contribute my thirty years of experience in this field to help further expand the Unyvero Solution.”

 

Biographical sketches and achievements of Curetis’ Medical Advisors are as follows:

Reno Frei, MD, was Head of the Division of Clinical Microbiology, University Hospital Basel, Switzerland, for more than 25 years. His research focuses on antibiotic resistance, microbiological diagnostics, and healthcare-associated infections including prosthetic device infections and sepsis. He has published 250 peer-reviewed articles and book chapters. Dr. Frei received his medical degree from the University of Basel Faculty of Medicine in 1980. He completed his training in infectious diseases and laboratory medicine with a research fellowship at the University of Iowa College of Medicine, Iowa City, USA.

Mathias Pletz, MD, Professor of Infectious Diseases, is Director of the Center for Infectious Diseases and Infection Control at the Jena University Hospital, Germany. Prior to that, he worked at the Department for Respiratory Medicine at Hannover Medical School (Hannover, Germany), the Respiratory Diseases Branch of the Center for Disease Control and Prevention (Atlanta, USA) and at the Chest Hospital Heckeshorn (Berlin, Germany). His research focuses on respiratory tract infections and strategies against difficult to treat bacterial infections. This includes rapid tests for antimicrobial resistance and novel approaches to eradicate biofilms. Dr. Pletz has received numerous grants and scientific awards, such as the Honor Award Certificate from the CDC, and has published more than 130 peer-reviewed publications.

Jean-Louis Vincent, MD, PhD, is Professor of Intensive Care at the University of Brussels and Intensivist in the Department of Intensive Care at the Erasme University Hospital in Brussels, Belgium. He has published more than 900 peer-reviewed articles, some 400 book chapters and review articles, 950 original abstracts, and has edited 101 books. Among others, he is the Editor-In-Chief of Critical Care, Current Opinion in Critical Care and ICU Management and a member of the editorial boards of about 30 other journals. Jean-Louis Vincent received numerous awards, including the prestigious Prix Scientifique Joseph Maisin – Sciences biomédicales cliniques. Prof. Vincent is a Past-President of the European Society of Intensive Care Medicine and presently President of the World Federation of Societies of Intensive and Critical Care Medicine.

Robin Patel, MD, Professor of Medicine and Professor of Microbiology, is Director of the Clinical Bacteriology Laboratory and the Infectious Diseases Research Laboratory and Chair of the Division of Clinical Microbiology, Mayo Clinic, USA. Prior to taking a staff position at Mayo in 1996, she completed residencies in Internal Medicine and Microbiology in Rochester, Minnesota, and a fellowship in Infectious Diseases at the College of Medicine, Mayo Clinic. Robin Patel’s research focuses on clinical bacteriology diagnostic testing, antimicrobial resistance, and microbial biofilms. She has published over 250 peer-reviewed manuscripts and has delivered numerous national and international presentations. She graduated from Princeton University with a BA in Chemistry in 1985 and from McGill University in Montreal, Canada, with an MD (C.M.) in 1989.

Company News: Molecular Health Launches Expanded Platform Strategy for Engineus™ Healthcare Decision Engine

– Expands platform to include solutions across diagnostics, evidence-based clinical decisions, and therapeutics

Boston, MA and Heidelberg, Germany – January 6, 2016Molecular Health today announced an expanded strategy for its novel Engineus™ technology platform to include a wide range of healthcare decision support products. Based on the most comprehensive biomedical data warehouse in the world, Engineus™ now offers highly-scalable precision medicine applications across the major healthcare categories: diagnostics, clinical decision support, therapeutics discovery and development.

Engineus™ is a global, unique, and integrated biomedical reference knowledge system that provides healthcare professionals the decision support capabilities they need to optimally leverage the opportunities of big data in healthcare. Engineus™ is expert-curated, quality-controlled, and constantly growing and being refined to make it optimally positioned to improve the efficiency of global healthcare, as the broadest of any data-driven platforms available today.

Engineus™ provides clinicians, lab partners and pharmaceutical companies the ability to make precise and individualized evidence-based diagnostic, clinical and therapeutic decisions by combining biomedical reference knowledge with best-in-breed analytics, data display and reporting.

Engineus™ is powered by data from 24 million scientific and medical publications, 76,000 drug-to-drug interactions, 6,000 biomarker facts for drug efficacy and safety, 85,000 gene variants, 40,000 drugs, 109,000 clinical trials, 270,000 protein interactions and 7 million patient medical records for drug safety among other data.

“Big data is changing the way healthcare is practiced today and further evolving the adoption of precision medicine,” Lutz Voelker, CEO of Molecular Health. “The market need to improve healthcare efficiency grows exponentially every day. With our Engineus™ platform, we are uniquely positioned to interpret and analyze this data for actionable healthcare decisions across clinical decisions, diagnostics, therapeutics discovery and development.”

Mr. Voelker continued, “In order to achieve this level of interpretation, our decision engine leverages the full spectrum of available data – including molecular and end-to-end NGS testing, chemical, lab diagnostics and electronic medical records data. This enables Engineus™ to improve therapeutic efficacy, deepen safety research, optimize clinical trials, and enable new biomarker discoveries.”

To meet the growing needs of the global healthcare industry for evidence-based treatment decisions, Molecular Health plans to further expand the breadth of its platform beyond cancer, continuously adding new data types, diagnostic technologies and other disease entities and therapies, for example: metabolic diseases, cardiovascular diseases and immunotherapy.

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