The Gadolinium-Free MRI Contrast Agent
- We all know someone who has had a contrast-enhanced MRI
- Over 30 million contrast-enhanced (CE) MRI scans are done worldwide each year.
CE-MRI scans provide vital medical insight informing diagnosis and management of cancer, stroke, multiple sclerosis, myeloma, cardiovascular disease, Crohn's disease and IBD, various genetic disorders, and many other conditions.
- Current MRI contrast agents all deposit the heavy metal gadolinium in all patients
- All currently approved MRI contrast agents contain the heavy metal gadolinium, which is not naturally found in biology and is toxic in its ionic form. All gadolinium based contrast agents (GBCAs) cause cumulative deposition of gadolinium in the brain, bone, and other organs of all patients. GBCAs also trigger devastating nephrogenic systemic fibrosis in renally impaired patients. Patients at greatest risk include people with renal impairment, pediatric patients, and patients who require repeat CE-MRIs. e.g. BRCA surveillance, multiple sclerosis, cancer, chronic conditions.
- Safety concerns led to worldwide regulatory restrictions
- Responding to safety concerns, the FDA applied a boxed warning and instituted label changes for all GBCAs. The European Medicines Agency suspended marketing authorizations for the least stable GBCAs and restricted use of other GBCAs. Japan, Korea, Canada, the United Kingdom, and other countries implemented similar restrictions on GBCAs.
- No alternatives for crucial contrast-enhanced imaging
- CE-MRI provides insights not available using other imaging methods. However, all approved MRI contrast agents are based on gadolinium and face safety concerns. Physicians and patients must make difficult decisions: balancing the need for vital medical imaging with the risks posed by gadolinium.
- Reveal’s solution: the gadolinium-free MRI contrast agent
- Reveal’s gadolinium-free MRI contrast agent is a direct substitute for GBCAs.
Our agent, RVP-001, is based on the biocompatible essential element manganese.
RVP-001 produces equivalent images to GBCAs for the same indications as GBCAs using established radiology workflow and protocols.
- Our goal: safer contrast enhanced MRI for all patients.
Reveal's MRI contrast agent is a direct replacement for all current GBCAs. Our agent produces equivalent images for the same indications, using existing radiology workflow and protocols.
Reveal's MRI contrast agent was designed to be safe for all patients. This includes renally impaired patients, for whom all other MRI and CT contrast agents are contraindicated.
Reveal's MRI contrast agent is based on manganese, a biocompatible element essential for life. Manganese is naturally regulated, processed, transported, and excreted by the human body.
- Vera HoffmanFounder, CEO
- Vera has 20 years of entrepreneurial experience: setting strategy for emerging ventures; guiding the development and commercialization of novel technologies; and directing the businesses advancing these technologies. Vera led initiatives on multiple continents for enterprises ranging from idea stage startups to Global 10 corporations. Her expertise encompasses entrepreneurship, strategy, marketing, program and product management, technology development, and enterprise design. She has degrees in mathematics and chemistry from the University of British Columbia, Canada, and an MBA from Harvard Business School.
- Peter CaravanFounder, Associate Professor, Harvard Medical School / Massachusetts General Hospital
Co-Director, Institute for Innovation in Imaging, Massachusetts General Hospital
- Peter is a world leader in MRI contrast agent development and applications, with 20 years industrial and academic experience. He is co-inventor of RVP-001. Peter leads a molecular imaging lab at Massachusetts General Hospital (MGH) focused on contrast agents and molecular probes to image fibrosis and thrombosis, as well as alternatives to GBCAs. At MGH he invented two novel molecular tracers and he holds INDs for their ongoing clinical development. In industry Peter was part of the team that developed the FDA-approved blood pool agent Ablavar® (Gadofosveset), and was co-inventor of the thrombus-specific agent EP-2104R, the first molecular MR imaging probe to enter human clinical trials.
- Eric GaleFounder, Assistant Professor, Harvard Medical School / Massachusetts General Hospital
- Eric is a chemist with over 10 years’ experience in the synthesis and structural characterization organic and inorganic compounds. He is co-inventor of RVP-001 and was instrumental in the discovery of this contrast agent and its preclinical characterization and synthesis. Eric is the Principal Investigator on three NIH-funded grants. He has a PhD from the University of Georgia and was a NIH-funded Ruth L. Kirschstein National Research Service Award Scholar at the Massachusetts General Hospital.
- Christopher PaytonFinance
- Chris is an expert in finance and entrepreneurship, both of which he has taught at Harvard Business School. An author of over thirty Harvard Business School case studies, Chris has also served as a consultant and trainer to central banks, global financial institutions, and multinational corporations. Chris has served as a senior officer of five early-stage businesses and is an active advisor to founders and investors in the Boston area. Chris has a Bachelor of Mathematics from the University of Waterloo and an MBA from Harvard Business School.
- John AmedioChemistry, Manufacturing, and Controls
- John provides technical and regulatory CMC development strategy for biotechnology and pharmaceutical companies working to bring drugs to market. John has over 20 years experience in the pharmaceutical industry: he has delivered profitable and patented pre-clinical through commercial manufacturing processes for drugs including Ablavar®, Arbaclofen, Zinapar™, Zibulin™, Zymafos™, Favipiravir, and multiple NCE’s including peptides and metal-based drugs. John has authored and reviewed CMC sections for numerous regulatory filings (IND, Amendments, Annual Updates, IMPD and NDA). John has a PhD in organic chemistry from the University of Delaware.
- Thomas SteelePreclinical Pharmacology and Toxicology
- Tom is an expert in pharmacology and toxicology, with over 20 years of experience in preclinical development and toxicology of novel small molecule and biological therapeutics in multiple therapeutic areas. Tom has extensive experience in the drug discovery and development process, and regulatory document preparation, review, and submission. He had a vital role in multiple successful “first in human” regulatory applications and served as preclinical expert for two initial marketed product approvals. Tom has held positions at the FDA, large pharmaceutical companies (Roche, Eli Lilly) and small biopharma (Ariad). Tom has a PhD in Pharmacology and Toxicology from Purdue University.
- Philip GrahamPharmaceutical Development Advisor
- Phil provides seasoned, solution-oriented leadership in pharmaceutical product development. Phil is currently SVP of Strategy and Program Management at Sojournix, and was previously responsible for program development, and product and program management at Concert Pharmaceuticals. Phil has directed the development of over a dozen drugs, including the MRI contrast agents Ablavar® and EP-2104R. Phil has a BS with honors from the University of Otago, New Zealand, and a PhD in Analytical Chemistry from the University of Massachusetts, Amherst.
- Scott Reeder MD PhDProfessor, Vice Chair of Research, Chief of MRI: Department of Radiology, University of Wisconsin, Madison
Director, University of Wisconsin Liver Imaging Research Program
- Scott is a Professor, Vice Chair of Research and Chief of MRI in the Department of Radiology at the University of Wisconsin, Madison. Scott’s many contributions to radiology include development of quantitative biomarkers in cardiovascular and body MR imaging. Scott is the Director of the UW Liver Imaging Research Program; 2017 Chair of the Safety Committee for the International Society for Magnetic Resonance in Medicine (ISMRM); a Fellow of the ISMRM; a Fellow of the the Society of Computed Body Tomography and Magnetic Resonance (SCBT/MR); and a Fellow of the American Institute for Medical and Biological Engineering (AIMBE).
- Gregory Sorensen MDExecutive Chairman, IMRIS
- Greg is Executive Chairman of IMRIS, and former President and CEO of Siemens Healthcare North America. Previously he was a Professor at Harvard Medical School and Co-Director of the Athinoula A. Martinos Center for Biomedical Imaging at Massachusetts General Hospital. A board-certified neuroradiologist, Greg’s scientific career focused on developing new imaging methods to understand cancer of the brain, stroke, and migraine. Greg is a member of the Scientific Council of the National Institutes of Biomedical Imaging and Bioengineering, past Chairman of the Board of the Medical Imaging Technology Alliance, and serves on the Supervisory Board of Siemens Healthineers and the Board of Directors of Research!America.
- Michael Tweedle PhDProfessor, Stefanie Spielman Chair in Cancer Imaging: the Ohio State University
Director, Wright Center Molecular Imaging Agents Laboratory, the Ohio State University
- Mike is a Professor, Stefanie Spielman Chair in Cancer Imaging in Radiology, and Director of the Wright Center Molecular Imaging Agents Laboratory at The Ohio State University. He previously held the positions of President, Lead Scientist, and Chief Executive of Bracco Research USA. Mike is a ground-breaking and prolific innovator in contrast media: he invented and led translational development of the first generation macrocyclic MRI agent ProHance®; X ray, Optical, and US agents; diagnostic imaging pharmaceuticals for nuclear medicine; and a radiotheranostic. In 1995 Mike was awarded the Harry Fischer Medal for Excellence in Contrast Media Research.