The New York Blood Center (NYBC) trial group completed testing FreMon Scientific’s new blood, plasma and tissue products warming and thawing device and disposable: ZipThaw202™ and ZipSleeve™. Under the guidance of NYBC and the Mintz Levin’s specialists in FDA law and regulations, 14 days of tests over a 3-month period were conducted at NYBC. Test protocols called for strenuous and independent testing of actual frozen human plasma. Bags of human plasma were prepared by NYBC scientists and staff, deep frozen for 48 hours then thawed in the ZipThaw202™ device and the ZipSleeve™ disposable. Temperatures and times were carefully recorded and documented to assure accuracy and safety.

ZipThaw202™ and ZipSleeve™ performed as designed. Not a single bag of plasma exceeded 37C and every bag fell within the range as specified by the American Association of Blood Banks. New York Blood Center test results will be included in the FDA 510(k) application which is anticipated to be filed as soon as mechanical and software tests, which are now underway in Israel, are completed.

Caption: Testing materials at the New York Blood Center