Emulate Inc., a biotech company focused on developing “organ-on-a-chip” technology, closed an $82 million Series E round on Tuesday. This latest round is intended to formulate a massive investment in a “roadmap” for developing model organ systems created to fit drug makers' needs and bring the idea of an organ-on-a-chip into use in the lab.
An organ-on-a-chip is pretty much exactly what it sounds like: It’s a recreation of a human organ (or system of human organs) scaled down into a tiny piece of hardware about the size of a AA battery. That hardware, the so-called “chip,” contains chambers where human cells (like brain cells, the kidney, lung, brain intestine, etc.), can be grown. Then the chip can be manipulated to simulate breathing, blood flow through an organ or other mechanical forces that might happen in a human body.
Ultimately, the chip is supposed to mimic the conditions within a human body, and allow drug makers to better predict what might happen when a new candidate is introduced. It’s a new model for experiments that could prove critical in the pre-clinical study process. Right now that area of research is dominated by traditional cell- or animal-based models -- though Emulate, and other similar companies are hoping to change that paradigm.
Emulate was founded in 2013 and has, so far, raised about $225 million in funding. This most recent Series E round, led by Northpond Ventures and Perceptive Advisors, is part of Emulate’s plan to invest more heavily in R&D, and create specific organ-on-a-chip applications that they’ve homed in on through conversations with drug companies. So far, Emulate counts 21 major drug companies, including Roche, Genentech, Johnson & Johnson and Gilead Sciences, as customers.
“We researched what pharma is spending their R&D dollars on -- particular types of molecules, biologics and so-forth -- then we created a roadmap, a series of applications aligned to where big pharma is spending their money,” Jim Corbett, the CEO of Emulate tells TechCrunch.
In January, Emulate announced several new products and services that are part of this roadmap. They include the Emulate brain chip, designed to aid with research into central nervous system disorders (like Alzheimer's), an immune cell recruitment application that will investigate how the immune system interacts across the lungs, liver and intestine (using lung-chips, liver-chips, and intestine chips), and a microbiome model integrated into the liver chip.
Corbett says the company will look to roll out 14 applications over the next two years, seven of which will roll out next year.
Organs on chips have been around for about a decade. The NIH has launched them into space to study the effects of spaceflight, and has been developing tissue chip testing and validation programs since 2010.
A 2020 review paper in Bioengineering notes the organ-on-a-chip industry was recently valued around $21 million, but could grow to about $220 million by 2025.
A lot of that growth will depend on the potential for an organ-on-a-chip to disrupt the preclinical side of the drug testing process. And that itself depends a lot on how the FDA views data collected on that platform.
The specific organ-on-a-chip technology itself doesn’t need to be FDA approved (it’s not a therapeutic or device), but drug companies will almost certainly seek assurance that the agency is receptive to experiments using organs-on-chips.
From Corbett’s perspective, he says the FDA has proved “very receptive” to data collected on these platforms.
There is evidence the company has worked closely with the FDA in the past. In 2020, for instance, Emulate entered into a Cooperative Research and Development Agreement (CRADA) with the FDA. A CRADA agreement allows a non-federal collaborator to provide funding and equipment for a research project conducted at an FDA laboratory. The FDA provides no funding, but does allow for the collaborator to license intellectual property developed during such projects.
Through this program, Emulate’s lung chips were used in COVID-19 research. The brain chip, liver and intestine chips were also used for individual research projects.
FDA collaboration aside, there’s also been regulatory movement that could favor companies pursuing organ chips. For instance, the FDA Modernization Act of 2021, introduced in Congress in April, would allow the FDA to use “alternative testing methods to animal testing” to evaluate safety and efficacy of drugs. The bill specifically includes organs on chips in its definition of a non-clinical test or study.
“If the Modernization Act goes through, it's clearly spelled out,” says Corbett.
Still, the field of organ-on-a-chip research is relatively new. Whether or not it will eventually help more drug candidates materialize is still theory. Though, with a new round of funding and a changing regulatory environment, we could have solid answers sooner rather than later.