The Gadolinium-Free MRI Contrast Agent
The Future of Medical Imaging
- 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, children, and people who require repeat CE-MRIs for surveillance, management, or clinical trials.
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.
- Learn more...
Reveal's MRI contrast agent is the gadolinium-free direct replacement for all current GBCAs.
Reveal's MRI contrast agent is designed to be safe for all patients.
Reveal's MRI contrast agent will be the platform for precision imaging.
- Vera Hoffman
- CEOVera Hoffman is the CEO and co-founder of Reveal Pharmaceuticals. She is Principal Investigator on Reveal's two Fast Track SBIR grants, which are funded by the National Cancer Institute and the National Institute for Diabetes and Digestive and Kidney Diseases.
Previously, Vera directed startups and high growth enterprises from idea stage through global scale. She developed the initial business plan for Acquia ($1B exit, 2019); led teams across six continents to identify, plan, and execute new business opportunities for one of the world's largest companies; and guided the design, development, and commercialization of over a dozen innovative technology-based products. Vera has degrees in Chemistry and Mathematics and an MBA from Harvard Business School.
- Peter Caravan
- Eric Gale
- Srinivasan Mukundan
- Medical DirectorSrini is a neuroradiologist whose expertise in Magnetic Resonance Imaging encompasses more than three decades leading magnetic resonance studies in humans, animals, and on chemical systems. Srini serves as the Medical Director of Magnetic Resonance Imaging (MRI) within the Department of Radiology at BrighamHealth, where he is also Chairman of the MR Safety Committee and Co-Director of Clinical Functional MRI, as well as Associate Professor in Radiology at Harvard Medical School. He served as Division Chief of Neuroradiology at the BWH from 2008-2017 and chaired the BWH Contrast Agent Safety Committee from 2009-2018. In addition to extensive clinical, research, and teaching experience, Srini previously worked to develop innovative liposomal MRI contrast agents. Srini has a PhD in bioinorganic chemistry and an MD from Emory University, where he completed all his training.
- Christopher Payton
- Finance and AdministrationChris 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 Amedio
- Chemistry, Manufacturing, and ControlsJohn 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 (INDs, IMPDs, Amendments, Annual Updates, and NDAs). John has a PhD in organic chemistry from the University of Delaware.
- Thomas Steele
- Nonclinical Pharmacology and ToxicologyTom 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, as well as 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.
- Carolyn McGarry
- Clinical OperationsCarolyn has more than 20 years of applied Phase I-IV clinical trial experience in multiple therapeutic areas including rare diseases, oncology, non-opioid pain management and diagnostic imaging. Carolyn advised a variety of early-stage biopharmaceutical companies, serving leadership roles including Director of Clinical Operations at Hydra Biosciences and at Tokai Pharmaceuticals. Earlier in her career she held positions in Regulatory Affairs and Clinical Operations at Genzyme Corporation for its rare disease programs. Carolyn received her BS in Biology at Boston College.
- Susan Stewart
- Regulatory AdvisorSue is an independent regulatory consultant and Chief Regulatory Officer for Boston-area biotech companies. She has over 20 years experience in biopharmaceutical regulatory affairs: devising innovative strategies for novel drugs, overseeing regulatory submissions across all stages of product development, and leading interactions with global health authorities. Sue is Chief Regulatory Officer of Kaleido Biosciences and previously served in senior regulatory roles at Tokai Pharmaceuticals, Transmolecular, Inc, and Genzyme Corporation. Sue holds a J.D. and is a Fellow (FRAPS) of the Regulatory Affairs Professionals Society, a Director of the Society’s Board, and holds Regulatory Affairs Certifications (RAC) for both the US and Europe.
- Louis Mylecraine
- Regulatory Pharmacology and Toxicology AdvisorLou has four decades of experience in multinational pharmaceutical companies. His expertise includes the design and conduct of regulatory toxicology studies and strategic testing programs, authorship and expert review of regulatory dossiers, as well as interactions with regulatory agencies. Lou contributed to or peer reviewed nonclinical dossiers for ~30 INDs, leading to submittal of 15 NDAs. He has a PhD in Zoology from Rutgers University, is a diplomate of the American Board of Toxicology, and served on the Board of the New Jersey Association of Biomedical Research for 22 years.
- Philip Graham
- Pharmaceutical Development AdvisorPhil has extensive experience in pharmaceutical product development. Phil is currently Chief Development Officer 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 MDCEO, DeepHealth
Executive Chairman, IMRIS
- Greg is CEO of DeepHealth, and Executive Chairman of IMRIS. Previously he was President and CEO of Siemens Healthcare North America, and prior to that 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.
In addition to grants and awards, Reveal's work is supported by impact investors.