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link a bunch of these chips together to create a system that mimics the whole human body, rather than just using models of individual organs (the DARPA grant was designed to fund that project). But of course, there are big hurdles Emulate has to overcome before it can really get there.
Perhaps the first, and biggest, of those challenges is that Emulate has to show pharmaceutical companies, biotechs, and most importantly, regulators, that its system is easy to use, scalable, and reliable enough to trust in preclinical tests. To do that, Emulate is going to have to amass data, and lots of it, showing that its system works.
In one such study that Emulate points to, it created a disease model for pulmonary edema—an uncommon, but potentially deadly side effect of cancer treatment with interleukin-2, in which fluid fills up the lungs. Emulate then tested a drug GSK was developing to treat the condition. The drug, a so-called transient receptor potential vanilloid 4 (TRPV4) channel blocker, reversed symptoms when tested on the chip—as well as in a separate study GSK ran in animals published in Science Translational Medicine at the same time. Additionally, Emulate says it found something that animal studies hadn’t—that breathing exacerbated the fluid leakage caused by IL-2 therapy.
Emulate will need more examples like that to help build its case to potential industry customers. Coon says the feedback he’s gotten from such companies so far is positive, and that the startup is confident it’ll have a big impact on early preclinical testing methods—in vitro studies—“right out of the gate.” It’s the animal studies further down the preclinical drug development road that’ll be tougher for Emulate to break into, he says, because that’s when regulators get involved, and “years of studies” would be required to appease an agency like the FDA.
“That’s going to take a longer period of time,” Coon says.
Then there’s the competition. Emulate is by no means the first company to try the organ-on-a-chip approach. But the technology has never been scalable, comprehensive, or user-friendly enough to really make an impact on preclinical drug testing in the pharmaceutical industry. Still, technological advances and government initiatives like the National Institutes of Health’s Microphysiological Systems Program—a wide search for methods like organs-on-chips to improve preclinical drug testing—have led to a number of academic groups and companies with competing systems that are either already on the market, or on their way. Among them: Seattle startup Nortis, a University of Washington spinout; North Brunswick, NJ-based Hurel Corp., which uses an organ on a chip method to replicate liver tissue; and Netherlands-based Mimetas. San Diego-based Organovo Holdings (NYSE: ONVO) and others also aim to use 3-D printing techniques to help speed up preclinical drug development.
What makes Emulate stand out? Coon points to a few things. First, he contends that Emulate’s chips can provide a more detailed and representative level of biological function: “Technologies that are out there, they focus on cells, they focus on a combination of cells in the matrix,” while Emulate’s chips include the cells, the blood flow, and recreating the mechanical forces that drive organ function—like breathing on a lung chip, or the compression of an intestinal tract, Coon says.
“That’s tough to do,” he says.
He also notes that some competitors are looking at individual organs, while Emulate is moving towards a larger, integrated approach (like the body-on-a-chip concept). Coon adds that the company aims to move into personalized medicine by using patient sample cells to construct patient-specific organs on its chips.
These advantages, of course, have yet to be proven with industry adoption and revenue. That’s the task that awaits Emulate as it moves out of the Wyss Institute and smack into the middle of Boston’s biotech ecosystem. Emulate has some time to get its bearings—the $12 million should last about two years, according to Coon—but now that it’s moved on from a science project to a full-fledged company with venture investors, it’ll have to deliver.