Company Anticipates Filing with the FDA for Regulatory Clearance In May; Response Expected This Summer.
Seventh Sense Biosystems, a privately held health technology company developing a breakthrough painless diagnostic blood collection platform, initiated a pivotal registration trial for its TAP™ Touch Activated Phlebotomy device. The company expects to file for marketing authorization in the United States and in the European Union in the second quarter of 2016, and anticipates receiving its E.U. CE Mark and U.S. regulatory approval later this summer.
“We are excited to begin the registration trial with the company’s lead product, the innovative TAP100 blood collection device,” said Howard Weisman, chief executive officer of Seventh Sense Biosystems. “Under the current system, anyone giving blood for diagnostic tests has to undergo a procedure that is inconvenient, scary and painful. While diagnostics, treatments and therapeutics in medicine continue to advance, current blood collection practices ignore trends making healthcare more convenient and accessible.”
Weisman 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 trial involves 120 subjects at three hospitals in the Northeast U.S., and is expected to be completed in April. Seventh Sense expects to file its Premarket Notification with the U.S. Food and Drug Administration in May.
Laboratory diagnostic platforms for analyzing blood samples are evolving rapidly. Doctors will soon have access to mobile devices that can provide results in a matter of minutes. Yet the process of obtaining blood samples hasn’t changed in decades, consisting almost exclusively of inserting a needle into a vein (venipuncture) or cutting a fingertip with a lancet (fingerstick).
This leaves the $4 billion market for blood sample collection with outdated technology and poor patient satisfaction. TAP100 is intended to make it easier for physicians and patients to collect blood for testing, and to open up the markets for blood collection in the retail and home settings.
“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.”
About the TAP™ Touch Activated Phlebotomy Device
TAP is a proprietary platform that draws capillary blood in a painless, one-step process without having to puncture a vein or lance a fingertip. It can be utilized across a broad spectrum of diagnostic applications. The TAP system penetrates only the uppermost layers of skin using virtually invisible micro-needles, and collects capillary blood using a novel microfluidic extraction process. Blood is stabilized with an anticoagulant if required. The device has a visual indicator to confirm when collection is complete. The TAP platform is being developed to collect and transport blood for diagnostic testing using many of the top analytical platforms on the market.
About Seventh Sense Biosystems
Founded in 2008 in Flagship VentureLabs™, Seventh Sense Biosystem’s mission is to change blood collection to make it painless, convenient and ubiquitous, in order to improve patient health and help patients become more active and engaged partners in their own care. The company is developing an array of products based on the company’s proprietary TAP™ Touch Activated Phlebotomy painless blood collection platform. The company’s initial focus is on enabling diagnostic testing at the point of care by reducing the pain, anxiety and inconvenience of existing methods used to collect blood samples. Seventh Sense is funded by investors including Flagship Ventures, Polaris Partners, Siemens AG, Novartis International AG and Labcorp.
For more information, please visit www.7sbio.com.