|TAP100 Touch Activate Phlebotomy device--Courtesy of Seventh Sense|
Seventh Sense Biosystems has started a pivotal trial of its novel microneedle painless blood collection device. It draws blood from the capillaries, without having to puncture a vein or fingertip. The goal is to offer a device that will easily facilitate point-of-care testing--obviating the need for standard blood draws in a dedicated diagnostics laboratory.
The pivotal registration trial for the TAP Touch Activated Phlebotomy device is expected to support regulatory submissions in the U.S. and EU later this quarter. The Medford, MA-based startup anticipates speedy FDA and CE mark approvals--by later this summer. The version of the device in the pivotal trial will be its TAP100.
The company had previously aimed for FDA approval in 2013 with a launch to follow in 2014. An early iteration of the device, TAP20-C, drew blood from the fingertip rather than the forearm. A pair of trials slated for that version of the device were withdrawn, according to Clinicaltrials.gov. An array of questions around the usability of tiny, finger-drawn blood samples have swarmed in the wake of the ongoing testing validity debacle at the once-vaunted Theranos.
"Under the current system, anyone giving blood for diagnostic tests has to undergo a procedure that is inconvenient, scary and painful," said Seventh Sense CEO Howard Weisman in a statement. "While diagnostics, treatments and therapeutics in medicine continue to advance, current blood collection practices ignore trends making healthcare more convenient and accessible."
He added, "The start of our pivotal trial moves us closer to delivering this device to patients and physicians, ultimately enabling blood collection to be performed whenever and wherever it is needed, and by anyone. Our goal is to enable clinicians and patients to get vital health and disease status information more quickly."
The 120-patient pivotal trial is at three hospitals in the Northeast U.S.; it is slated to complete in April with an FDA submission for approval in May.
The device has already been tested in more than 1,000 patients with few reports of pain, the company said. It notes that at least 20% of adults report a fear of needles, which it cautions may cause them to avoid medical testing and treatment. Venipuncture, directly tapping a vein with a needle, is one of the most common medical procedures.
The TAP100 Touch Activated Phlebotomy device collects 100 microliters of capillary blood. It is placed on the forearm and collects the blood at the touch of a button via microneedles. The device is about 1.5 inches in diameter, about the size of the bell on a stethoscope.
"Blood collection for testing with TAP100 is convenient and painless, and its availability is intended to increase patient compliance with necessary test orders, providing doctors with more timely data on which to base diagnoses and treatment decisions," said Weisman. "Increasing compliance by removing barriers to blood-based diagnostics will ultimately lead to better health outcomes."
Seventh Sense Biosystems was founded in 2008 in Flagship VentureLabs. Its investor roster is littered with strategic investors and high-profile VCs including Flagship Ventures, Polaris Partners, Siemens, Novartis and Labcorp.
- here is the announcement