NanoDx, Inc., is a privately held medical device company developing rapid, near-patient, point-of-care, in-vitro diagnostic solutions leveraging a first-of-its-kind nanowire biosensor technology to improve patient outcomes and reduce healthcare costs. The company’s flagship product, the NanoDx System, can detect and quantify biomarkers (analytes) from a small fluid specimen, blood or saliva, in less than four minutes. NanoDx’s platform utilizes a proprietary nanosensor technology licensed from IBM with a broad range of potential diagnostic applications, including traumatic brain injury (TBI), COVID-19, stroke, sepsis, infectious diseases, oncology, and other therapeutic areas.
Mr. Serafin, a Senior Managing Director at FTI Consulting, has been acting Interim CEO for NanoDx for the last seven months. During this period, he has demonstrated the leadership ability to solve complex challenges by adopting this innovative technology in collaboration with IBM and SkyWater Technology, driving strategic objectives, and transitioning the organization from product development to preparation for commercialization.
George is a 35+ year seasoned professional possessing a unique blend of industry, technology, and management consulting experience spanning R&D, engineering, supply chain, manufacturing, quality, regulatory, compliance, corporate/operations, and information technology across biotechnology, pharmaceuticals, medical device and diagnostics, and consumer healthcare. He also serves as a strategic advisor to the FDA and has worked with various international regulatory authorities across North and South America, the United Kingdom and Europe, and Asia.
“George has a broad and deep knowledge and experience of what is required to successfully drive pre-revenue and emerging companies from late-stage development through commercialization,” stated James Wylie, Executive Chairman of NanoDx. “He is an aggressive, hands-on, results-driven executive who has already made an enormous contribution to NanoDx. We are honored that he has chosen to lead our company through the critical path to commercialization.”
Commenting on his appointment, Mr. Serafin said, “I am thrilled to continue to be an integral part of the NanoDx team, realize the potential of this truly disruptive diagnostic platform, and positively impact patients’ lives. The company is comprised of highly-talented, dedicated professionals and has built an extraordinary intellectual property foundation through internal development and outside licensing.”
Prior to joining FTI Consulting, George served in various national and global leadership roles at Grant Thornton and Deloitte & Touche. He started his career at Novartis in research and development and worked for Roche and Fresenius Medical Care in engineering, manufacturing/operations, quality, and regulatory roles, before transitioning to the technology sector and leading the development of SAP’s Life Sciences solution.
Mr. Serafin received an M.S. in Technology Management and a B.E. in Biomedical Engineering from Stevens Institute of Technology with a double minor in electrical engineering and biophysics.
NanoDx is a privately-held, U.S.-based medical device company developing rapid near-patient, point-of-care testing in-vitro diagnostic products on its proprietary nanowire biosensor platform. The NanoDx™ System provides direct measurement of blood and saliva analytes normally in less than four minutes from either a drop of whole blood or a small saliva sample. The System consists of a single-use, disposable test cartridge, and an analyzer. The company is focused on two near-term indications: traumatic brain injury (TBI) and Covid-19. The NanoDx™ System offers compelling competitive advantages based on its ultra-sensitivity and accuracy, speed, value, and ease of use. Future development targets include stroke, sepsis, infectious diseases and oncology