Seventh Sense BioSystems Receives CE Mark Approval for Phlebotomy Blood Collection System

Seventh Sense Biosystems Inc. has received CE Mark approval for its Touch Activated Phlebotomy (TAP) blood collection platform, less than a year after enrolling patients for clinical trials.

Packaged in a disk device that measures under 5 centimeters in diameter, the product features micro-needles to puncture through the upper layer of the skin and take blood from the patient’s capillaries for a pain-free draw. Despite the small size, the TAP platform can draw up to 20 micro liters of whole blood, a sufficient volume for many tests. With access to the capillaries, the needles utilize microfluidic principles to extract the blood and can release anticoagulants if necessary. Once the blood is drawn, it is not visible to the patient and remains hidden inside the TAP device. This feature, along with the near  painless process, should help reduce patient anxiety, according to the Cambridge, Mass.-based company.

The TAP device was designed with simplicity, requiring only the push of a button for an extraction. Since finding a good vein no longer will be necessary for many cases, clinicians also should find blood draws considerably less painful. Seventh Sense Biosystems hopes to achieve U.S. Food and Drug Administration approval for the device this year. The company also is working to turn the device into an all-in-one blood collector/analyzer in the future.

“This first regulatory approval is a significant milestone in our goal of expanding the reach of blood-based point-of-care diagnostics to a majority of patients, regardless of geography or setting,” said Howard Weisman, CEO and President of Seventh Sense. “When fully commercialized, the TAP platform will incorporate additional capabilities for sample separation as well as dried blood spot and on-board diagnostic capabilities.”

Studies show that a positive patient experience is closely linked to compliance with a prescribed treatment. Seventh Sense will be developing and commercializing diagnostic tools that are specially engineered to eliminate the pain and anxiety that can prevent patients from receiving appropriate care. The company’s proprietary innovations in microneedle and microfluidic technology enable the collection of a stable, secure and high quality blood sample without painful lancing or the need for highly skilled medical personnel.

“We’ve surveyed patients and their physicians around the world and found a significant need for near painless, simple-to-use, and reliable blood collection and diagnostic devices that has so far been unmet,” said Weisman.