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:
- New York Blood Center completed operational tests:
- 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