Our leadership has over 200 years of collective diagnostics industry experience.
We have created a dynamic environment and culture where our team members, our executive leadership team, the Board of Directors and the Advisory Board seek to challenge and align company strategies to deliver maximum value for all stakeholders.
James McCullough has served as our co-founder and Chief Executive Officer since our inception. Mr. McCullough has leadership experience building emerging technology companies in both the public and private sectors with specific expertise in the life-sciences industry. From 2008 to 2014, he served as chief executive officer of Exosome Diagnostics Inc., a venture backed personalized medicine company developing non-invasive liquid biopsy diagnostics in cancer that was acquired by Bio-Techne Corporation in 2018. Since 2014, Mr. McCullough has also served as a managing partner of Renwick Capital, LLC, a management consulting firm specializing in assisting emerging healthcare technology companies with strategic planning and business execution. He received his B.A. from Boston University and an MBA from Columbia Business School.
Fergus Fleming has served as our Chief Technical Officer since our inception. Mr. Fleming has served as managing director of FF Consulting Limited, providing Product Development and Commercialization support to Medical Devices and Diagnostics companies since June 2013. Roles in this period include Head of Business Development for Oncomark Limited from November 2016 to October 2018 and from 2013, he served in various roles at EKF Diagnostics plc. He has over 30 years of experience in the life sciences sector, including leadership positions with Baxter Healthcare, Boston Scientific and Trinity Biotech plc. Mr. Fleming received a degree in Science from University College Galway, Ireland.
Thomas McLain has served as our President since July 2019. Prior to joining Renalytix AI, he held leading positions, including as Chief Executive Officer, of Exosome Diagnostics Inc. from July 2014 to July 2019. Mr. McLain has also served as President and Chief Executive Officer of Vermillion, Inc., Chief Executive Officer of Claro Scientific LLC, Chairman, Chief Executive Officer and President of Nabi Biopharmaceuticals and Vice President at Bausch & Lomb. Mr. McLain received his B.A. in Economics at College of the Holy Cross and his MBA at the William E. Simon Graduate School of Business Administration at University of Rochester.
O. James Sterling has served as our Chief Financial Officer since our inception. Since May 2015, Mr. Sterling has also served as a managing partner of Renwick Capital, LLC. Previously, he served as a managing director at SF Sentry Securities, Brock Capital Group LLC and Aleutian Capital Group. Mr. Sterling also has experience as a management consultant at Booz Allen Hamilton. He received his B.A. from Boston University and an MBA from Columbia Business School.
Michael J. Donovan, Ph.D., M.D. has served as our Chief Medical Officer since our inception. Since November 2011, Donovan has also served as a Professor of Experimental Pathology and Director of the Biorepository and Pathology core at the Icahn School of Medicine at Mount Sinai. In addition to an academic career at Harvard Medical School and Boston Children’s Hospital, Dr. Donovan has over 20 years’ experience in the biotechnology industry, serving in various senior management roles at Millennium Pharmaceuticals and Incyte Pharmaceuticals. He most recently served as Chief Clinical Officer of Vigilant Biosciences, Inc., Chief Medical Officer of MetaStat, Inc. and Chief Medical Officer of Exosome Diagnostics, Inc. Dr. Donovan received a B.S. in Zoology, an M.S. in Endocrinology and a Ph.D. in Cell and Developmental Biology from Rutgers University. He received his M.D. from the University of Medicine and Dentistry of New Jersey.
Christopher Mills has served as a member of our board of directors since our inception. Mr. Mills founded Harwood Capital Management in 2011, a successor from its former parent company J.O. Hambro Capital Management, which he co-founded in 1993. He is chief executive officer and investment manager of North Atlantic Smaller Companies Investment Trust plc and chairman and chief executive officer of Harwood Capital Management Ltd. Prior to that, Mr. Mills was a Director of Invesco MIM, where he was head of North American Investments and Venture Capital, and of Samuel Montagu International. Mr. Mills currently serves on the board of a number of public companies, including EKF Diagnostics plc, Sureserve Group plc, Augean plc and MJ Gleeson plc. Mr. Mills received a B.A. in Business Studies from Guildhall University.
Erik Lium, Ph.D. has served as a member of our board of directors since November 2018. Since March 2014, Dr. Lium has served in various roles at Mount Sinai, where he is currently the president of Mount Sinai Innovation Partners, and the executive vice president and chief commercial innovation officer of the Mount Sinai Health System. Dr. Lium represents Mount Sinai on several private company boards and previously served as a member of the investment review committee for the Accelerate NY Seed Fund. Dr. Lium also serves as chairman of the board of managers of Kantaro. Prior to joining Mount Sinai, Dr. Lium served as the assistant vice chancellor of Innovation, Technology & Alliances at the University of California, San Francisco (UCSF), the UCSF principal investigator for the Bay Area National Science Foundation I-Corps node, and assistant vice chancellor of Research. Dr. Lium served as president of LabVelocity Inc. prior to its acquisition in 2004. He pursued postdoctoral research at UCSF in the laboratory of J. Michael Bishop, M.D., earned a Ph.D. from the Integrated Program in Cellular, Molecular and Biophysical Studies at Columbia University in the laboratory of Dr. Saul J. Silverstein, and holds a B.S. in Biology from Gonzaga University.
Barbara Murphy, M.D. has served as a member of our board of directors since November 2018. Since 2013, Dr. Murphy has served as the Murray M. Rosenberg Professor of Medicine, chair of the Department of Medicine for Mount Sinai and Dean for Clinical Integration and Population Health. Her area of interest is transplant immunology, focusing on the use of high throughput genomic technologies as a means to understand the immune mechanisms that lead to graft injury and loss, with the aim of identifying gene expression profiles and or genetic variants that may be used to predict those at greatest risk. Dr. Murphy belongs to a number of professional societies including the American Society of Transplantation and the American Society of Nephrology, and has held many leadership roles at a national level. She is a past President of the American Society of Transplantation and is currently on Council for the American Society of Nephrology. Dr. Murphy earned her M.B. B.A.O. B.Ch. from The Royal College of Surgeons in Ireland and completed her postdoctoral training with a fellowship in Nephrology at Brigham and Women’s Hospital, Harvard Medical School.
Chirag R. Parikh, Ph.D., M.D. has served as a member of our board of directors since October 2019. Since July 2018, Dr. Parikh has served as a Professor of Medicine and the Division Director of Nephrology at Johns Hopkins University. Dr. Parikh also served a faculty member at Yale University where he directed the Program of Applied Translational Research. Dr. Parikh’s research focuses on the translation and validation of novel biomarkers for the diagnosis and prognosis of kidney diseases. He has assembled multicenter longitudinal prospective cohorts for translational research studies across several clinical settings of acute kidney injury and chronic kidney disease for the efficient translation of novel biomarkers. Dr. Parikh received his medical degree from Seth G.S. Medical College and KEM Hospital in Mumbai, India and subsequently completed his Nephrology fellowship and a Ph.D. in Clinical Investigation at the University of Colorado Health Sciences Center.
Chartered Accountant, Company Secretary and Head of Corporate Affairs EKF Diagnostics Holdings Plc
SCIENTIFIC ADVISORY BOARD
Director, Division of Nephrology, Ronald Peterson Professor of Medicine, Johns Hopkins School of Medicine
Associate Professor, Medicine, Nephrology; Associate Chair for Clinical and Translational Research for the Department of Internal Medicine, Mount Sinai Health System
Associate Professor of Medicine, Chief-Division of Data-Driven and Digital Medicine (D3M), Clinical Director of the Hasso Plattner Institute of Digital Health, Clinical Director of the Charles Bronfman Institute of Personalized Medicine.
Director and Associate Dean for Precision Medicine, Ward-Coleman Professor of Translational Genetics and Medicine Mount Sinai Health System
Professor of Computational Biology and Bioinformatics, Harvard T.H. Chan School of Public Health; Professor of Cancer Biology, Dana-Farber Cancer Institute
Samuel A. Levine Professor of Medicine, Harvard Medical School. Chief of the Division of Renal Medicine and Chief of the Biomedical Engineering Division, Brigham and Women’s Hospital (BWH)
John H. Felts, III Professor of Medicine and Chief of the Section on Nephrology and Executive Director of the Kidney and Dialysis Service, Wake Forest Baptist Health
Professor Division of Nephrology University of Washington, Director Kidney Research Institute, Director, Center for Dialysis Innovation, Director Kidney Precision Medicine Project
Chief Medical Officer, National Kidney Foundation, Associate Clinical Professor of Medicine, Division of Nephrology, Icahn School of Medicine at Mount Sinai
Professor of Medicine, University of Chicago, Director, Comprehensive Hypertension Center, Member Board of Directors National Kidney Foundation
Professor of Medicine and Pharmacological Sciences at Icahn School of Medicine at Mount Sinai, Irene and Dr. Arthur Fishberg endowed chair of Nephrology, Chief of Nephrology at Mount Sinai Health System.
Professor of Surgery, Division of Transplantation, Department of Surgery and the former dean, Emory School of Medicine; founding Director of the Emory Transplant Center
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We’ve demonstrated positive momentum since we opened our doors.
See all archived press releases here.
- Renalytix secures $29.1 million in funding to support the development and commercialization of two product categories for the early detection of kidney disease and accurate management of kidney transplant rejection
- Renalytix requests parallel CMS reimbursement review of KidneyIntelX with the FDA review
- Renalytix requests Breakthrough Device Designation of KidneyIntelX from the FDA
- Renalytix published manuscript outlining positive results that demonstrated the performance characteristics of our machine learning algorithm combining biomarkers and EHR data to predict fast progressing kidney disease
- FDA grants Breakthrough Device Designation to Renalytix for its KidneyIntelX test, identifying it as a breakthrough technology for which no approved or cleared alternative exists and meeting the criteria of providing a more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease
- Renalytix raises gross proceeds in follow-on financing on the AIM market, $17.3M
- Renalytix announces positive interim study results conducted with leading academic medical centers in the US
- Renalytix achieves inclusion on the Final 2020 Clinical Laboratory Fee Schedule (“CLFS”) with a set national price of $950 per reportable test for our KidneyIntelX test platform (effective January 2020 through December 2022).
- Renalytix obtains a distinct Common Procedural Terminology (CPT) reimbursement code 0105U, for its KidneyIntelX platform, effective across the U.S.
- Renalytix opens second CLIA-authorized testing facility, Utah
- Renalytix receives ISO 13485 certification for its Salt Lake City Laboratory
- Renalytix proposes dual-listing on NASDAQ
- Renalytix is granted a Clinical Laboratory Permit for KidneyIntelX from the NYS Department of Health, following an extensive review by a panel of Department of Health scientists and external reviewers of the analytical and clinical validation results
- Renalytix announces partnership with University of Michigan to extend its KidneyIntelX platform to an expanded population of CKD patients or patients at risk for developing CKD
- Renalytix raises $85.1M on the NASDAQ Global Market in the U.S.
- Renalytix signs agreement to become a provider in the America’s Choice Provider Network, one of the largest, preferred networks in the US with members and providers in all 50 states and agreement with 1700+ payers
- Renalytix announces partnership with Astra-Zeneca, teaming up to improve CKD treatments and outcomes
- Renalytix files submission with FDA, seeking clearance of its KidneyIntelX test platform
- Renalytix commences with a KidneyIntelX Multi-Center Study to monitor & predict kidney risk in COVID-19 patients
- Renalytix initiates KidneyIntelX Testing at Mount Sinai, with its first live EHR Integration
- Renalytix signs multi-geography, U.S. partnership with DaVita, an end-to-end kidney solution