CAMBRIDGE, Mass.--()--Seventh Sense Biosystems, a privately held medical device company developing integrated blood micro-collection and analysis platforms, announced today that it has initiated a registration trial for its painless TAP™ (Touch Activated Phlebotomy) blood collection device. The company expects to file for marketing authorization in the United States and in the European Union in the second quarter, and anticipates receiving its E.U. CE Mark and U.S. regulatory approval later this year.
“We are excited to begin the registration trial with the company’s lead product, the innovative TAP Blood Collection device,” said Seventh Sense Biosystems CEO Howard Weisman. “This confirmatory trial builds on previous human clinical testing that showed consistently affirmative results across an array of analytical methods. Today’s trial start puts us in a strong position to be able to bring this meaningful device to patients and physicians early next year.”
The company’s propriety TAP Blood Collection device is designed to address deficiencies in the current blood collection process, including patient anxiety that can negatively impact compliance with prescribed testing. The TAP platform is expected to offer greater efficiency over existing blood collection methods by providing a faster pathway to diagnostic results, while also increasing safety and eliminating pain.
Point-of-care market research of physicians, lab directors, nursing professionals and patients provides an addressable market estimate of over $1.0 billion by 2017, particularly in areas such as diabetes, cardiovascular disease, and infectious disease.
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 access a vein and it can be utilized across and integrated with a broad spectrum of diagnostic applications. The TAP system penetrates the uppermost layers of skin through the use of micro-needles, collects capillary blood using a novel microfluidic extraction process, and stabilizes the blood with anticoagulant if required. The device has a visual indicator to confirm that collection is complete. The TAP platform is designed for fully automated, high throughput manufacturing.
About Seventh Sense Biosystems, Inc.
Founded in 2008, Seventh Sense is developing an array of products based on the company's proprietary TAP™ (Touch Activated Phlebotomy) painless blood collection platform, with an initial focus on enabling important diagnostic testing at the point of care by reducing the discomfort, anxiety and hassle of blood sample collection. Seventh Sense receives funding from investors Flagship Venture Partners, Lighthouse Capital Partners, and Polaris Partners. For more information, please visit www.7sbio.com.