CardiNor AS is a Norwegian biotech company established in June 2015 to handle the commercialization of secretoneurin (SN), an important new biomarker for cardiovascular disease (CVD).
The use of SN CVD is based on research carried out by world leading cardiac authorities at Akershus University Hospital, Oslo University Hospital and Akademiska Sjukhuset in Uppsala, Sweden.
SN is the only biomarker shown to be associated with biological processes linked to cardiomyocyte Ca2+ handling. This unique biological function explains why SN presents as an independent and strong predictor of mortality in all major patient cohorts, including ventricular arrhythmia, acute heart failure, acute respiratory failure patients with CVD and severe sepsis,
We are currently developing an easy to use ELISA (enzyme-linked immunosorbent assay) blood test to address the vast and untapped market potential in CVD patient diagnosis, risk stratification and monitoring. This will also involve clinical documentation, regulatory filing and market awareness programs.
Secretoneurin therefore has the potential to become one of the gold standard cardiac biomarkers routinely used in the management of patients with heart disease.
BUSINESS MODEL & GO TO MARKET STRATEGY
The company will market and sell its first product for research use (RuO) through a network of local and global distributors covering the major markets in Europe and the US, followed by the introduction of a CE marked product. The next face in our commercialization strategy will be to seek collaborations with major diagnostics companies such as Abbott, Roche, Siemens or medical device companies such as Boston Scientific, to support the US regulatory submission and market introduction. Collaboration and/or out licensing to adopt the SN test on the high throughput diagnostic platforms of these companies will secure a global market and access to high volume facilities. In parallel, CardiNor will pursue opportunities to adopt its SN test to point of care (PoC) platforms to facilitate market uptake and gain access to the near patient testing segment. CardiNor will sell key reagents and collect royalties from such agreements.
The CardiNor team consists of Dag Christiansen, CEO, Olav Steinnes Chair with Ronny Hermansen and Torbjørn Omland as board members. The team have extensive experience from the IVD industry, covering every aspect of a company’s life cycle, from start-up phase to exit. This includes high-level business negotiations, licensing agreements, scientific marketing and successful trade sales
Dag Christiansen has more than 25 years of experience from diagnostic and pharma industry including various management positions from DiaGenic, Axis-Shield and Dyno particles. He has a very broad and strong knowledge in the field of cardiovascular biomarkers both from the technical, regulatory and business development side. Christiansen holds a M.Sc. in Biochemistry and a BS in Economics and Business Administration (Diplomøkonom).
Board of Directors:
Bjørn Fuglaas is currently a partner in GevirGroup AS (recruitment and consultancy) and CEO of LS Partners AS (consultancy). He has more than 30 years industrial and business experience in the life science industry in various leadership and board positions. Previously he was GM of GE Healthcare AS. He has extensive board experience in both listed companies and start-ups. He has also served two periods as Chairman of the Norwegian Pharmaceutical Industry Association and for the Biotech Industry Association for several years. Fuglaas holds an MSc in Microbiology/biotechnology (University of Oslo and University of Gothenburg).
Olav Steinnes is CFO in Inven2 AS, the TTO of Oslo University and Oslo University Hospital. Steinnes holds a M.Sc. Economics and Business Administration (Siviløkonom), and has 25 years of industrial experience from Nycomed Pharma and Axis-Shield. Olav has held various management positions within finance, marketing and business development. He has extensive board experience from both listed companies and start-ups.
Ronny Hermansen is CEO at Genetic Analysis AS, Oslo Norway. Ronny holds a M.Sc. Economics and Business administration from the University of Odense Denmark. He brings with him more than 20 years of experience from the diagnostics industry, including senior positions in Axis-Shield and Nycomed-Amersham.
Dr Torbjørn Omland, MD, PhD, MPH, received his MD and PhD degrees from the University of Bergen, Norway. Dr Omland has worked as a postdoctoral fellow at the Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School in Boston, and has also received a Master of Public Health degree from Harvard School of Public Health. Dr Omland is currently holding the positions as full Professor of Medicine at the University of Oslo and as a consultant cardiologist/researcher at Akershus University Hospital. His research interests include biomarkers and risk stratification of patients with heart failure and acute coronary syndromes. Professor Omland was involved in the early clinical validation of BNP and NT-pro-BNP and played a key role in documenting the clinical value of these very important biomarkers for heart disease. He also did pioneering work on the use of high sensitivity troponins. Professor Omland served as a scientific advisor for Biosite and is currently advisor for several major IVD and pharma companies. He is an Associate Editor in Circulation and member of the International Federation of Clinical Chemistry (IFCC)’s Task Force on Clinical Application of Cardiovascular Biomarkers.
In addition, CardiNor has signed on several external consultants to gain access to the know-how vital for the development of an SN ELISA: Frank Franzen VP R&D Abbott (former Alere and Axis-Shield) – Dr. Helge Røsjø, University Hospital, Uppsala and Uppsala Clinical Research Center, Cardiothoracic Research Group – Mats Stridsberg Akademiska Sjukhuset, Uppsala Sweden and Tom Soriano, CEO Docro on regulatory affairs.
Dr Torbjørn Omland, MD, PhD, MPH, received his MD and PhD degrees from the University of Bergen, Norway. Dr Omland has worked as a postdoctoral fellow at the Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School in Boston, and has also received a Master of Public Health degree from Harvard School of Public Health. Dr Omland is currently holding the positions as full Professor of Medicine at the University of Oslo and as a consultant cardiologist/researcher at Akershus University Hospital. His research interests include biomarkers and risk stratification of patients with heart failure and acute coronary syndromes. Dr Omland is the author of numerous scientific papers, review papers and book chapters, including articles in Circulation, Journal of the American College of Cardiology, JAMA, The Lancet, and The New England Journal of Medicine. From July 2016, he will be serving as an International Associate Editor of Circulation.
Dr Geir Christensen, MD, PhD, MHA, received his MD and PhD degrees from the University of Oslo, Norway. Dr Christensen has worked as a postdoctoral fellow at University of California in San Diego. He received a Master of Health Administration from University of Oslo. Dr Christensen is currently holding the positions as Professor of Medicine at the University of Oslo and as a consultant researcher at Oslo University Hospital. His research interests include mechanisms of heart failure development. Dr Christensen is the author of numerous scientific papers, review papers and book chapters concerning cardiac diseases, including articles in Circulation, Circulation Research, Journal of the American College of Cardiology, PNAS, and Nature Communications. Dr Christensen is head of Centre for Heart Failure Research, a research network in South-Eastern Norway Regional Health Authority, and Norwegian PhD School of Heart Research (NORHEART).
Mats Stridsberg, MD, PhD, is an Associate Professor at the Uppsala University and a Senior Consultant of the Department of Clinical Chemistry and Pharmacology at the Uppsala University Hospital in Uppsala, Sweden. He received his medical education and research education at Uppsala University. He also has a degree in chemistry, physics and mathematics at Uppsala University. He is a member of the Executive Committee for Endocrinology at Equalis (External Quality Assurance in Laboratory Medicine in Sweden), a former councillor of the European Society for Clinical Investigation and a member of the editorial board of the Uppsala Journal of Medicine. The main areas of interest include clinical chemistry, endocrinology, biochemical diagnosis, tumour markers, endocrine tumours, nutrition, and metabolism. He has published more than 200 original articles and spoken on his areas of specialization, at several international meetings.
Dr Helge Røsjø, MD, PhD is the Head of Research in the Division of Medicine, Akershus University Hospital and Associate Professor at the University of Oslo. He has several years of experience in translational cardiac research after finishing his PhD in 2012 on the work of the granin protein family in CVD, which included the first report on secretoneurin as a cardiac biomarker. This work has led to two patent applications, several research awards, and substantial external funding to further advance the research on secretoneurin. The work on secretoneurin is at the core of his research interest as it integrates clinical and basic science and may improve patient care.
CardiNor has teamed up with several leading technology partners to secure access to world leading expertise and know-how vital for a success assay development. We also have access to world leading expertise on CVD biomarkers. Combined, this provides CardiNor with a complete value chain from basic R&D through to production of final product.
Bioventix is a listed company on LSE. It is a world leading supplier of antibodies and among other customers we find Abbott, Roche, Siemens and bioMèriux. Bioventix has also made investments in CardiNor
Kaivogen is a Finnish company specializing in the development and production of ELISA components and finished Kits. The company is currently supplying customers in the US and Europe. Kaivogen Oy is certified according to the Quality Management System standard ISO 9001:2008 and ISO 13485:2003 by DNV GL
Mizar Bio (former Axis-Shield lab in Bodø Norway) is supporting our assay development. The Mizar scientists have extensive know-how of and a long track record in assay development and technology transfer of several important IVD biomarker assays to proprietary IVD platforms, including PoC instruments
Akershus University Hospital (AHUS) is home to the research group of professors Torbjørn Omland and Helge Røsjø, who are world leading experts on CVD biomarkers and key scientific advisors to CardiNor. In addition, Akademiska Sjukhuset Uppsala and Stavanger University hospital are supporting our clinical trial collecting blood samples from patients with ICD implants SMASH-1.