VasSol, Inc. is founded on 11 years of multidisciplinary research and clinical work conducted at the University of Illinois at Chicago. Bringing together experts in the fields of circulatory fluid dynamics and computer modeling, we have developed vascular analysis technology that helps answer the fundamental questions that clinicians confront when treating vascular disease: what is the severity, how is the condition best treated and what is the outcome? Our mission is to provide physicians with vital information on the functional consequences of reduced blood flow to guide clinical decision making and help ensure positive outcomes.
The Development of the Platform
Neurosurgeon Fady T. Charbel understood the importance of knowing blood flow in the brain to effectively treat stroke victims and was frustrated by the fact that there was no way to determine the volume of blood flow in vessels outside of the operating room. The need for a non-invasive method to quantify blood flow before and after treatment led Dr. Charbel to form a team of physicians and scientists from the University of Illinois to find a solution. NOVA has been utilized for the diagnosis and treatment of vascular conditions in thousands of patients since its first clinical application in 1997. Today, the VasSol team has successfully developed a new, easily accessible technology that works with Magnetic Resonance Imaging (MRI) data to provide not only a significantly better image of vessels, but also that previously elusive factor: a non-invasive, quantified measurement of blood flow of individual vessels. To find out more about the history of VasSol, please check out our timeline.
Rashid Riaz M.S, Quality Assurance and Regulatory Affairs Rashid has the overall responsibility of managing the quality system at VasSol. Rashid has guided the company through FDA inspection, ISO 13485 certification and CE marking process. He is trained in “Six-Sigma” methodology and brings strong technical and documentation expertise from his former employment at Motorola.
Lauren Ostergren, Business Development and NOVA Product Manager Lauren’s skills and expertise have been honed over 25 years in industry and academics, working with both small start ups and larger companies. She brings knowledge of cardiovascular, cardiac rhythm management and neurosurgery markets, with a specialization in blood flow measurement modalities. Lauren has collaborated with physician scientists in the development of new products and applications and is named on several patents. She graduated from Cornell University and began her career at Transonic Systems, an innovator in quantitative measurements for biomedical research, OEM and clinical decision-making.
Kezhou Wang, Ph.D. Director of Research and Engineering, Principal Software Engineer Dr. Kezhou Wang is the Director of Engineering & Research and Principal Software Engineer at VasSol Inc. Dr. Wang obtained his Ph. D. degree in Electrical and Computer Engineering at Auburn University in 2006. With more than 15 years experience on research and development, Dr. Wang is an expert on medical imaging, 3D modeling, image reconstruction and data visualization. At VasSol Inc., Dr. Wang took the lead to develop NOVA, the cerebral blood flow quantification medical system based on magnetic resonance angiography images, and conducted research on blood flow quantification in various organs in the body. Dr. Wang is responsible for all research and engineering activities at VasSol Inc.
QUALITY MANAGEMENT SYSTEM
ISO 13485 Quality System Certification VasSol received ISO 13485 certification in 2007. ISO registration is achieved by implementing and demonstrating that the quality system functions in accordance with the standard.
US FDA Good Manufacturing Practice (GMP) VasSol is fully compliant with 21 CFR Part 820, US FDA Quality System Regulations. These regulations relate to the methods used in the quality control of the device made by the company.
PRODUCT CERTIFICATIONS AND APPROVALS
UNITED STATES – 510(k) clearance VasSol received US Food and Drug Administration 510(k) clearance in 2002. The 510(k) clearance is an order from the FDA that “clears” the device for commercial distribution in the U.S.
CANADA- Medical device license VasSol received Medical Device License from Health Canada in 2007. The Canadian license recognizes that VasSol’s quality system conforms to all of the Health Canada standards.
EUROPE – CE Marking certificate VasSol received the CE Marking certificate in 2007. The CE Mark certifies that a product has met the European Union (EU) health, safety, and environmental requirements which ensure consumer safety.
REGULATORY REPRESENTATIVE – EUROPE
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, TheNETHERLANDS Telephone: +31.70.345.8570 http://www.EmergoGroup.com
NOTIFIED BODY / CERTIFICATION BODY – EUROPE
Intertek/SEMKO AB Torshamnsgatan 43, Box 1103 SE-164 22 00 00 Telephone: +46 87500000 http://www.intertek.com
VERiTAS results presented at the International Stroke Conference in Nashville, TN
MyRIAD study begins enrolling patients
First Installation in China
First Installations in South Korea
NOVA receives CE mark
First installations in Europe
First Installation in Canada
VERiTAS begins enrolling patients
Health Canada Medical Device License
VasSol, Inc. co-founder and President, Fady T. Charbel is a recipient of the Wall Street Journal’s 2006 Technology Innovation Awards
A flow based algorithm for the management of symptomatic vertebrobasilar disease is published in the AHA journal, Stroke.*
*Amin-Hanjani S, Du X, Zhao M, Walsh K, Malisch TW, Charbel FT. Use of quantitative magnetic resonance angiography to stratify stroke risk in symptomatic vertebrobasilar disease. Stroke. Jun 2005;36(6):1140-1145.
NOVA’s capability highlighted in NBC5 story on “Strokes Strike Young and Old” airing January 21, 2004.
Product name changed from CANVAS to NOVA (Non-invasive Optimal Vessel Analysis) to better reflect its broad-based application to the vascular system.
FDA 510k premarket certification compliance awarded.
VasSol signs exclusive worldwide license for CANVAS technology with the University of Illinois at Chicago (UIC) Medical.
Successfully conducts study using treatment planning component of core technology.
Successfully conducts first blood flow study on human patient using diagnostic component of core technology.
First model of core technology, CANVAS, Computer Aided Neurovascular Analysis and Simulation, applied to neurovascular environment.
Begin testing model concept for application on human subjects.
Fady T. Charbel M.D. Dept. of neurosurgery, teams with Professor M.E. Clark (the originator of the concept to apply fluid mechanics to the analysis of blood flow) to model the network of blood vessels in the brain.
Detroit, Michigan neurosurgeon Fady T. Charbel identifies the need to non-invasively analyze the severity of vascular disease and accurately predict treatment outcome.