What’s the worst part of getting your blood drawn? For many people, it’s thinking about the big needle or the finger prick that comes with it. Seventh Sense Biosystems is trying to replace those methods with something quick and painless. And while it’s still a long way from selling its first product—let alone supplanting the decades-old blood-drawing practices used across the globe—today it’s gotten some big industry players to buy into its plan.
Seventh Sense is announcing today that three large companies—Novartis, a unit of Siemens, and Burlington, NC-based LabCorp—have contributed to a $16 million Series B round of new financing. The three are joining founding investors Flagship Ventures and Polaris Partners to back the Cambridge, MA-based startup’s plan to scale up manufacturing, obtain the necessary regulatory approvals, and eventually roll out its so-called touch activated phlebotomy, or TAP technology—a supposedly painless method to quickly draw blood for diagnostic tests.
“We’ve been working towards a commercialization that would take place over the next couple of years, and this [cash] helps to define where, when, and exactly how we’ll do that,” says Seventh Sense CEO Howard Weisman.
Seventh Sense is built around work done by the labs of MIT professor Bob Langer and Harvard University professor R. Rox Anderson. The company has now raised about $26 million since Flagship and Polaris started it up in 2008, according to Weisman, and is putting that cash behind an effort to develop its TAP technology to the point that it can be used first to get patient samples in clinical trials, and then more broadly in hospitals and doctors’ offices.
The TAP device is a small, disposable object about the size of a stethoscope head that sticks to the skin with the help of some adhesive hydrogel. With the push of a button, tiny microneedles (each about as thick as a hair) within the device penetrate the outer layers of the skin and tap into a patient’s blood. A small blood sample, anywhere from 20 to 100 microliters worth, is then siphoned from the patient’s capillaries with the help of some vacuum pressure. The blood moves through tiny channels in the device to an internal reservoir, were it’s contained and can be transported to lab and analyzed in a diagnostic test. Weisman says patients don’t feel the prick of the microneedles, just some of the suction of the vacuum pressure, and can’t see the blood being drawn.
Right now, the TAP device is only capable of drawing blood and containing it. But the big idea is to keep adding to the technology. First, to give it the capability to say, turn the sample into a dry blood spot, or separate serum and plasma. Then, to add “on-board diagnostics” so that the TAP system can not only retrieve the blood samples, but test them too, Weisman says.
Of course, at this point, that’s all conjecture. The current iteration of the device isn’t sold anywhere yet, and likely won’t be for another one to two years, according to Weisman. While European regulators approved the TAP technology in October, the company has since been scaling up its manufacturing capabilities and hasn’t launched the product anywhere yet. Meanwhile, it still has to gain clearance from the FDA in the U.S., and faces a number of challenges once it does—most notably, Weisman acknowledges, convincing doctors and hospitals to trust and adopt the TAP system over practices that have been used for years.
“The biggest issue is converting that thinking,” he says.
That’s one of the reasons that Seventh Sense doesn’t plan to go straight to healthcare providers once it has an approved, optimized device that it’s ready to sell. Instead, it aims to start by pitching the device for use by volunteers who are taking experimental drugs in clinical trials. Weisman notes that these patients tend to have to trek back to their physician’s offices or hospitals to get routine blood tests fairly often—or a healthcare professional has to come to their house to take blood instead—to monitor the drugs’ effects. In theory, a patient could self-administer a test with a TAP device in a matter of minutes instead.
For Seventh Sense, starting with clinical trials would serve as a stepping-stone to eventually offering the TAP system more broadly. That’s why its new strategic partners are so important. Novartis’s access to customers and patients through its big network of trials, for instance, would help speed that process along, according to Weisman.
“We’re trying to set a new standard for how people perceive of blood collection and analysis, and I think that having the opportunity to have our devices used in a clinical trial setting would give us a lot of exposure in a very controlled environment, to both clinicians, patients, even to some extent hospitals and health systems that may be participating in clinical trials,” Weisman says.
Weisman notes that as presently constituted, Seventh Sense wouldn’t compete with a company like high-flying Palo Alto, CA-based based Theranos—which makes tools for performing diagnostic tests on ultra-small blood samples—because it’s focused on blood collection, rather than the testing. But if the startup’s plans to integrate diagnostics into their collection device come to fruition, it could well wind up going head-to-head with such competitors.
Still, it’s going to take time to prove Seventh Sense can make a business out of its technology. Weisman estimates it is going to take the company a year or two to scale up its manufacturing capabilities, clear its regulatory path in the U.S. (the company will probably run a series of trials to support a filing), and figure out pricing for the device. That means even though the TAP device is approved in Europe, it’s possible that the company could launch the product both in the U.S. and overseas at the same time.
“Initially, we’re going to go step-wise, one step at a time. There hasn’t been really a lot of innovation in blood collection in years,” Weisman says. “[But] people don’t like needles. They don’t like them stuck in the end of their fingers, and they don’t like them stuck into their veins. You give them an alternative, they will flock to it pretty quickly.”