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Vital Therapies, Inc. is a biotherapeutic company focused on developing a cell-based system for the treatment of acute liver failure. Our product candidate, the ELAD® System, is a human cell-based, bio-artificial liver support system that operates outside the body, or extracorporeally, and is designed with the proposed intent to allow the patient’s own liver to regenerate to a healthy state, or to stabilize the patient until liver transplant. The ELAD System incorporates our human liver-derived cells, or VTL C3A cells, contained in four hollow fiber cartridges, that are combined with single use customized disposable sets and an ancillary delivery system. Data from ELAD clinical studies has shown trends that may indicate a potential to increase survival rates in patients with acute liver failure. ELAD has received orphan designation in the United States and Europe for the treatment of acute liver failure. Prior to the initiation of our ongoing Phase III clinical trial program, over 145 subjects have received therapy with the ELAD System in seven clinical trials and through a compassionate use program, which we believe collectively suggests a promising therapeutic profile. In March 2013, we initiated VTI-208, a Phase III randomized, controlled clinical trial in 200 subjects with alcohol-induced liver decompensation. We reached the midpoint in enrollment of this trial in April 2014, and anticipate the release of preliminary data in the first half of 2015. In addition, we are conducting a second Phase III randomized, controlled clinical trial, VTI-210, in 150 subjects with severe acute alcoholic hepatitis, or AAH, which is a subset of AILD, and expect to initiate enrollment of subjects later in 2014. In the second quarter of 2014, we began enrollment of a Phase II clinical trial of the ELAD System in subjects with either fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILF. We anticipate the release of data from VTI-210 in 2016 and the Phase II component of VTI-212 in 2015 or 2016.
Exagen Diagnostics Inc. is one of the leading companies in the Healthcare, Pharmaceuticals, and Biotech sector.
GENFIT is a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases where there are considerable unmet medical needs, corresponding to a lack of approved treatments. GENFIT is a leader in the field of nuclear receptor-based drug discovery with a rich history and strong scientific heritage spanning almost two decades. Its most advanced drug candidate, elafibranor, is currently evaluated in pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for nonalcoholic steatohepatitis, or NASH. NASH is considered by regulatory authorities as a medical emergency because of its potentially severe consequences, although often asymptomatic until late stages, and because its prevalence is on the rise. Elafibranor has also obtained positive preliminary results in a Phase 2 clinical trial in primary biliary cholangitis (PBC), a severe chronic liver disease. As part of GENFIT’s comprehensive approach to clinical management of NASH patients, the Company is also developing a new, non-invasive and easy-to-access blood-based in vitro diagnostic, or IVD, test to identify patients with NASH who may be appropriate candidates for drug therapy. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 170 employees. GENFIT is a public company listed on the Nasdaq Global Select Market and in compartment B of Euronext’s regulated market in Paris.
Omicia is unlocking the potential of individualized medicine. Our mission is to help researchers and clinicians understand and apply the most relevant information from personal genome sequences, to improve disease management and medical outcomes. Researchers and clinical diagnostic organizations use our solutions to analyze and identify the genetic basis of a variety of conditions, including childhood disease, cancer and cardiovascular disease. Opal™, the leading platform for fast, accurate and flexible genome analysis, enables clinicians, researchers and bioinformaticians alike to derive clinically relevant insights from genomic data. VAAST, our robust novel disease gene finder and variant scoring algorithm, is in use at more than 300 academic and clinical institutions including the NIH, the University of Oxford, the University of Cambridge, Seattle Children’s Research Institute, Institut Pasteur, University of Maryland Institute for Genome Sciences, and UCSF.
Federation Bio is a biotechnology company pioneering a novel approach to create potent, durable and safe cell therapies. The company`s first-in-class platform combines the power of genetic engineering and synthetic consortium design to control systemic immune responses and broad metabolic functions. Federation Bio`s pipeline addresses a range of serious illnesses from metabolic disorders to metastatic cancer. The company`s lead program is in enteric hyperoxaluria, a serious renal condition that affects more than 250,000 Americans and for which there are currently no approved therapies.