Most individuals know someone who has had, or themselves had, a contrast enhanced magnetic resonance imaging (CE-MRI) scan. CE-MRI scans offer crucial medical insight for many medical conditions, ranging from cancer detection, staging, and surveillance to stroke to cardiovascular diseases. Millions of CE-MRI scans take place each year.
Current MRI contrast agents all contain gadolinium, a rare earth element that can be toxic. Contrast agents illuminate differences in soft tissue and therefore enable accurate diagnosis from the images. While the use of contrast agents has been in practice for decades, a focus has crystalized on the accumulation of the heavy metal in patients, and its potential risks within their brains and bodies. Gadolinium is known to cause devastating nephrogenic systemic fibrosis in people with kidney disease; research on gadolinium’s long-term impact in other patients is ongoing. The most vulnerable patients include children, people with kidney disease, and those who need repeat scans for screening, surveillance, management, or clinical trials.
Reveal Pharmaceuticals, under the leadership of Vera Hoffman, aims to offer a safer alternative.
Reveal aims to solve this problem with a first-in-class gadolinium-free MRI contrast agent, based on the biocompatible element manganese. Reveal’s product, designed as a direct substitute for current contrast agents, could meet the need for more than 30 million scans per year according to the early-stage company. Most recently, Reveal has developed a simple, cost-efficient, scalable manufacturing process, which produces the drug product at good yield and high purity. MLSC funding will support the startup’s U.S. Food and Drug Administration (FDA) required Good Laboratory Practice (GLP) Investigational New Drug (IND)-enabling studies.
In September 2019, the MLSC announced more than $1.9 million in grant funding to support 10 early-stage life sciences companies, including $200,000 to Reveal, in Massachusetts. The funding, awarded through the MLSC’s Milestone Achievement Program (MAP), addresses the needs of early-stage life sciences companies to execute critical, value-creating technical milestones. This program aims to fill a gap within the existing funding environment to enable early stage companies to attract additional follow on funding.
“Advances in technology and research in imaging have only increased the ability of scans to guide diagnosis, clinical decisions, and patient management,” said Vera. “However, the medical field is also grappling with the reality that patients who have this scan performed could suffer from devastating health effects due to current MRI contrast agents.”
Vera, who serves as CEO of Reveal, strongly credits the foundational research of her co-founders, Drs. Peter Caravan and Eric Gale, who invented the technology while serving in their respective roles at Massachusetts General Hospital and Harvard Medical School. She also appreciates the company’s ability to leverage the strong Massachusetts biotech ecosystem.
Vera likens the life of a startup to the fable of sharks—keep moving or you will die. Reveal has kept moving forward, gaining financial support, mentorship, and tapping into the fabulous depth of expertise the Massachusetts life sciences sector can offer. Reveal has received recognition and formal and in-kind support from various organizations, including the Boston Biomedical Innovation Center, Harvard Business School, MassBio, MassChallenge, and two Fast-Track Small Business Innovation Research (SBIR) grants from the National Cancer Institute and the National Institute of Diabetes and Digestive and Kidney Diseases.
The Reveal team has found the industry to be very welcoming and collaborative, with organizations that work together to support entrepreneurship and startups with promising ideas that can positively advance human health.
“As an entrepreneur, you need to be ready to leverage those connections, put yourself out there, and just show up,” said Vera.
Prior to receiving MAP funding, Reveal was one of the inaugural awardees of the MLSC’s Massachusetts Next Generation Initiative (MassNextGen), which was launched to ensure greater gender parity in the next generation of life science entrepreneurs. In its inaugural year in 2018, five companies received access to a network of executive coaches for a year through the program. Reveal was one of two awardees to receive $62,500 in funding in addition to the coaching.
The funding was of course very valuable. Yet the access to mentors was also vital for Vera, who was a first time biotechnology CEO. The MassNextGen Executive Coaching Network enabled her to translate the skills she had gained previously from tech entrepreneurship to the life sciences.
For Vera and many other entrepreneurs there is currency in validation and a substantive strength and credibility gained by the access and recognition, in addition to capital, MassNextGen and similar programs offer.
Accelerating its IND-enabling studies is the next step on Reveal’s critical path to a safer alternative to gadolinium-based MRI contrast agents.
“Our key competitive advantage is that we can meet the established clinical need without exposing patients to the risk of gadolinium,” said Vera. “Reveal’s growth and success will have much wider ripple effect on the broad Massachusetts biotech community.”