Seventh Sense Gets Initial FDA Clearance for Simple Blood-Draw Device

Xconomy Boston — 

[Corrected 2/23/17, 12:44 pm. See below.] Seventh Sense Biosystems says it has received FDA clearance to begin marketing TAP, a device intended to make blood draws quick and painless. It’s the Medford, MA-based company’s first product approved for sale by the federal agency.

Seventh Sense says its small, disposable devices can make blood collection more convenient and less stressful, especially for patients who have a fear of needles or want to avoid the discomfort of a finger prick.

If all goes according to plan, Seventh Sense’s bigger goal is to enable anyone to collect samples of their own blood from home. But that’s down the road, and will require more studies by Seventh Sense and additional approval from the FDA.

For now, “we’re just really excited to get the product on the market,” says Seventh Sense chief business officer Stuart Blitz. That means getting it in the hands of healthcare professionals working in doctors’ offices, hospitals, clinics, retail pharmacies, labs, and other healthcare settings.

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. The whole process takes two to three minutes. (Blitz demonstrated it on himself at an Xconomy event last year. In the photo below, you can see Weisman applying the device to Blitz’s arm.)

Photo by Keith Spiro Photography

Seventh Sense’s device doesn’t perform diagnostic tests. The company considered integrating such capabilities into the product, but later pared back those ambitions and focused just on blood collection. That decision might have eased its path to the market, and it also put Seventh Sense in a different category than Theranos, the disgraced diagnostic technology firm.

Seventh Sense says the initial FDA clearance allows healthcare workers to use TAP to collect capillary blood for hemoglobin A1c testing, which is used to monitor blood sugar levels in diabetic or pre-diabetic patients.

The company plans to go back to the FDA and request approval to use the device in conjunction with additional blood tests, such as monitoring vitamin D levels, tracking thyroid-stimulating hormones, gathering comprehensive metabolic panels, and more, Blitz says.

Getting those additional clearances will require running studies that demonstrate that blood samples taken with the TAP device return the same diagnostic results as blood gathered by puncturing a vein with a needle, Blitz says.

Seventh Sense secured the initial FDA clearance after conducting a study of the device involving more than 250 patients at three clinical sites around the Northeast, Blitz says. The company submitted the data to the FDA last May, he says. The company hasn’t had any clinical data published in a peer-reviewed medical journal, but Blitz says the goal is to have data published this year.

Seventh Sense was founded in 2007, and its technology is based on work done in the labs of MIT professor Bob Langer and Harvard University professor R. Rox Anderson. The company has raised about $40 million from investors including Novartis, LabCorp, Polaris Partners, and Flagship Pioneering (formerly known as Flagship Ventures). [This paragraph updated with Flagship’s new name.]