When Steven Frank, M.D., tackled a decades-old problem plaguing the field of prostate brachytherapy, he found himself in unchartered waters, very nearly out of his depth. But his vision resulted in the creation of an innovative device that would win Food and Drug Administration (FDA) approval and subsequently be spun off into a start-up company.
Brachytherapy is a treatment in which tiny radioactive seeds are implanted in the body to destroy cancer cells. Because the seeds are difficult to view through imaging such as computed tomography (CT) scans, which are necessary to evaluate the success of treatment, uncertainties are created that can impact the therapy’s effectiveness.
On the scans the seeds show up as black spots or cause a reflection that makes them hard to see. In 2006, Frank began work on a highly visible marker of sorts, or implantable contrast agent, which could be developed and placed between the seeds to guide treatment.
“The best analogy to describe this technology is looking at footage of machine gunners in World War I who would spray bullets everywhere and have no idea where the bullets were going,” said Frank, associate professor in Radiation Oncology. “Finally, someone had an idea to insert a tracer every few rounds to increase accuracy. That’s essentially what we’ve created.”
After discovery, an assist
Armed with this new finding, Frank’s next steps propelled him into unfamiliar — yet necessary — territory that he needed to navigate if his idea was to become reality. He needed guidance to understand the very complex process required to commercialize this technology and bring it to patients.
For that he turned to Olivier Wenker, M.D., clinical professor in Anesthesiology and Perioperative Medicine, and Tom Lee, director of Technology Commercialization’s Active Venture Development, who are responsible for unearthing innovations within MD Anderson’s walls and determining commercial potential. The process involves raising capital and obtaining financing, patents and regulatory approval.
With Wenker and Lee’s mentorship, and the help of outside counsel experienced in negotiating licensing agreements, Frank successfully transferred his discovery out of MD Anderson over the course of nine months. With an agreement in place, the institution would receive royalties and Frank would be free to incorporate a business of his own.
Navigating a maze of regulations
Three years after making his initial discovery, Frank established C4 Imaging in 2009, and immediately began the first of two fundraising rounds that would generate more than $3 million in total start-up capital.
But challenges remained. Before any new medical technology can be used clinically, it must be approved by the FDA.
After three years of discussions with the FDA, the world’s first permanently implantable MRI marker for use in prostate brachytherapy was approved. This past March, the first group of patients received the marker during their therapy. While Frank credits his success to a team of advisers and supporters, the end goal was always focused on improving care for patients.
“We can now limit uncertainty, provide optimal quality assurance and minimize side-effects,” Frank said. “This technology could change the way brachytherapy is planned and evaluated for future patients.”