Seventh Sense launches pivotal trial for Tap100 blood draw device

Seventh Sense Biosystems said today it launched a pivotal trial for its Tap100 touch activated blood collection device.

Medford, Mass.-based Seventh Sense said it expects to file for marketing authorization in the U.S. and European Union in the 2nd quarter of 2016, with a hopeful date for CE Mark approval in the European Union and FDA clearance this summer.

“We are excited to begin the registration trial with the company’s lead product, the innovative TAP100 blood collection device. 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,” CEO Howard Weisman said in a prepared release.

The trial is slated to enroll 120 patients at 3 hospitals in the Northeast U.S. and the company expects it to finish in April, with a Premarket notification submission to the FDA by May.

“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,” Weisman said in a press release. “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. Increasing compliance by removing barriers to blood-based diagnostics will ultimately lead to better health outcomes.”

The development will pit Seventh Sense against a floundering Theranos, who’s main product is the Capillary Tube Nanotainer, 1 of 2 kinds of tiny vials used to collect blood from patients.

The company, which has a valuation of $9 billion, promises to shake up medical testing by conducting a wide range of tests with 1 drop of blood from a finger-stick using its Nanotainers, rather than the large vial typically collected.

Last October, the FDA flagged quality issues Theranos’ manufacturing plant in Newark, Calif., after inspections in August and September.

In a Form 483 issued after the inspections and released today, the FDA said that quality audits had not been performed at the Newark facility and that the company failed to document internal quality audit schedule.

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