January 2018 ZipThaw and ZipSleeve Status Update

January 2018 ZipThaw and ZipSleeve Status Update

Dr. Viscomi, Moni and I thank you for your confidence and investment in FreMon Scientific. 2018 portends manufacturing and sales. Your 2017 investment resulted in the following achievements:

MILESTONES COMPLETED:

  • 2 Prototype ZipThaw202™ devices built and tested,
  • 28 Prototype ZipSleeve™ bags built and tested,
  • 3 Patents filed in 7 major Global markets comprising more than 40 countries,
  • Two pre-prototype financing rounds totaling $980,000 completed,
  • FDA and CE Mark testing completed;
    • New York Blood Center completed operational tests:
      • 3 weeks over 3 months resulted in 100% test samples passing
      • Predicate device tests completed
    • Hermon Laboratories, an FDA certified independent lab, completed safety, mechanical, software and electromagnetic tests:
      • Safety tests 100% passed
      • Electromagnetic tests 100% passed
      • 8000-volt destructive tests 100% passed
      • Software tests 100% passed
      • ISO documentation 100% completed
      • Usability tests completed
      • Operating Manuel completed
      • Risk analysis and completed
    • In Process:
  • FDA 510(k) application – submission January 2018
  • CE Mark application – submission January 2018
  • Production Engineering contract agreed with ARAN R&D (an FDA certified medical device design and engineering firm).

ORGANIZATION:

  • Distribution Agreement signed for Israel and Palestine Distribution,
  • United Kingdom distribution agreement in negotiation,
  • North America distribution agreements in negotiation with 8 established blood and tissue bank and transfusion center distributors,
  • Distribution agreement with Turkey and Turkic language regions affirmed,
  • Distribution agreement with European Union and Middle East countries affirmed,
  • San Diego Blood Bank as regional training center discussions in process,
  • CEO search initiated,
  • Current round funding 2/3 completed – closing anticipated January 2018.

2017 was productive for FreMon Scientific: ZipThaw202™ and ZipSleeve™ design and engineering successfully completed; Early market response positive; Risk has been substantially reduced; Outlook for success greatly increased. With the successful closing of the current round of financing in January FreMon Scientific will begin manufacturing and sales in Q3/4, 2018.

Dr. Viscomi, Moni Shavit and I welcome your comments, thoughts and investment.

Best to All in 2018.

Respectfully submitted: January 3, 2018

Fred Thacher, CEO & Co-founder                 Moni Shavit, President & Co-founder

Salvatore G. Viscomi, MD, SVP, Chief Medical Officer