From: FreMon Scientific, Inc (FMS) – Fred Thacher, CEO
Subject: Recent FDA, CE Mark, Production Engineering and Finance Activities
Date: November 15, 2017, by Fred Thacher FMS CEO and Co-Founder
Last week: Moni and I met in Israel with the FDA/CE Mark agent Qsite and with Mintz Levin FDA attorney to review production engineering requirements for compliance.
A contract was signed with an EU Notified Body to inspect documents in January; Electromagnetic and safety testing in an FDA certified engineering lab are underway; Process and software testing are done; and New York Blood Center completed predicate device comparison testing.
FMS will file a FDA 510K Class II application and for CE Mark certification next month. Certification should be forthcoming in late Q1 or Q2, 2018. In December 1 of 4 qualified engineering firms bidding to perform production engineering will be selected. Moni is scoring each.
An FMS investor recently conducted direct interviews with sales reps of Helmer and Boekel (competitors) in North America and reports that major blood bank, biobank and infusion centers will likely buy ZipThaw 202 for dry, portable, low cost, ease of operation, rapid thawing and ZipSleeve disposable to reduce labor and potential cross contamination next generation technology. FMS expects to contract with several of the same reps through their agent beginning Q2, 2018. I met this week with senior management of a major Southern California blood bank and it agreed to conduct usability testing and expressed strong interest in purchasing multiple devices for the hospitals and clinics it services and in becoming a training center. Last week the FDA released new rules which will speed the approval of regenerative medicine cell therapies: All require warming and thawing prior to transfusion.
The closing date for the current round of financing is extended to December. Currently FMS has subscriptions totalling 60% towards the current goal. Once the funds are in place FMS will commence commercial production engineering and be on schedule to begin sales in Q3/4, 2018.