Investors have pumped another $10 million into Seventh Sense Biosystems, as the company awaits FDA clearance to begin selling its device that aims to make blood draws quick and painless.
The Series C funding comes from earlier Seventh Sense backers Novartis, LabCorp, Polaris Partners, and Flagship Ventures. The Medford, MA-based firm has raised $40 million total from investors, chief business officer Stuart Blitz says.
Seventh Sense says its small, disposable device, called TAP, can painlessly draw blood for diagnostic tests. That might appeal to patients who have a fear of needles or want to avoid the discomfort of a finger prick.
“All of the ways that patients collect their blood haven’t changed in decades,” Blitz says.
Seventh Sense’s technology is based on work done in the labs of MIT professor Bob Langer and Harvard University professor R. Rox Anderson. Founded in 2007, the company was initially working on personal health monitors in the form of polymer-based imprints on the skin that would change color or appearance in response to a measurable change in body chemistry. Seventh Sense later developed the blood-draw device and dropped plans for the health monitors.
Seventh Sense was considering integrating diagnostic testing capabilities into the TAP device, but it has since decided to pare back those ambitions and focus just on blood collection, Blitz says. “There’s so many good technologies … coming out in the diagnostic space,” he adds.
One of those much-hyped diagnostic technologies was expected to come from Theranos, which has said it’s developing machines that could test for a range of conditions with just a drop of blood. But after increased scrutiny, the well-funded startup began facing questions about the accuracy of its tests, federal regulatory sanctions, lawsuits brought by consumers and former business partners, and other troubles.
Theranos’s high-profile fall from grace hasn’t hurt Seventh Sense’s prospects, Blitz says. Investors haven’t shied away from his company, in part because it’s not pursuing a medical diagnostic. Theranos’s situation has probably made the FDA more cautious, he says, “but from our point of view we haven’t found as much impact.”
“For all the troubles that Theranos is having, I thought they were right about the market trend,” Blitz says. “Patients want more convenient testing done.”
Seventh Sense wants to play a part in that trend. As Xconomy’s Ben Fidler described in a 2014 story, Seventh Sense’s device is roughly the size of a stethoscope head, and it sticks to the skin of the upper arm with the help of adhesive hydrogel. At the push of a button, tiny needles (each about as thick as a hair) penetrate the outer layers of the skin.
Using vacuum pressure, the device siphons about 100 microliters worth of blood from the patient’s capillaries. The blood moves through tiny channels in the device to an internal reservoir, where it resides until it reaches the lab for analysis. Seventh Sense CEO Howard Weisman has said patients don’t feel the prick of the micro-needles, just some of the suction of the vacuum pressure, and they can’t see the blood being drawn.
Seventh Sense’s device is similar to one being developed by Tasso, which Xconomy profiled last year. That company was founded in 2012 by three biomedical engineers who studied at the University of Wisconsin-Madison. The company has received more than $5 million in federal grants, and has since relocated to Seattle, according to its website.
Seventh Sense submitted the device for FDA review over the summer, and Blitz says the hope is the company will receive clearance to begin selling the product in early 2017. If it gets the green light from the FDA, then the challenge becomes winning broad adoption of the device.
Seventh Sense hired Blitz this year to help with that. Earlier in his career, he was the first employee at AgaMatrix, a blood glucose monitoring company that makes medical devices that can share data with smartphones. Blitz helped the company bring more than 15 products to market, grow to 750 employees, and strike partnerships with Apple, Sanofi, CVS, and Target, according to a Seventh Sense press release.
Seventh Sense initially plans to get its device into doctors’ offices, hospitals, clinics, and retail pharmacies, Blitz says. Later, it would pursue FDA clearance to sell directly to consumers so they could collect blood samples at home.
“We think that’s where the market is headed,” Blitz says. “We’re moving from a centralized model to a decentralized model” of healthcare.
The new funding will enable Seventh Sense to grow its 20-person team, particularly in research and development and business development, Blitz says. The money will also go toward expanding the company’s manufacturing capabilities and developing its products. That includes making a version of TAP that can store larger volumes of blood, as well as adding features such as being able to turn the sample into a dry blood spot, and separate serum and plasma, Blitz says.
Seventh Sense hasn’t had any of its clinical data on TAP’s performance published in a peer-reviewed medical journal, but Blitz says the company is working on it.
“We think that’ll be helpful in making sure patients, doctors, and all stakeholders feel very confident in the product,” he says.