FDA and CE Mark December Update

FDA and CE Mark December Update
Dear investors and prospects,
Thank you for your investment and interest to date. We have news Moni and I are excited to share about our progress towards FDA Clearance, CE Mark and financing.

  • FMS is on schedule to submit a 510(k) application with the FDA and a CE Mark application with the European Union. CE is basically the FDA of the EU. We are covering all of our bases.
  • The ZipThaw202 device has now passed stringent mechanical, electrical and engineering safety tests conducted by an independent FDA-certified testing lab in Israel. In short, ZipThaw’s advanced blood, plasma, stem cell and tissue warming and thawing technology is alive and well. We have more a detailed report to share if you like, please contact us to review it.
  • Moni has directed and completed minor modifications which will be re-tested shortly.
Overall, here’s where we stand. FreMon Scientific has built successful working ZipThaw prototypes, those have passed extensive independent tests at the prestigious New York Blood Center and at the FDA-certified Hermon Labs in Israel.
ZipThaw will soon become FDA cleared and with a CE Mark, which will permit us to fully commercialize and market our new and advanced blood, plasma, stem cell and tissue warming and thawing technology on a global basis. Many said it could not be done for as little funds as we raised initially, yet here we are. Thank you for your support. Now FMS begins the commercialization phase.
At this point we’re in the third round financing phase. We’re making excellent progress but we still have more to go to close the round. With your help we’ll get there. Once there, we will complete production engineering, begin manufacturing of ZipThaw202 and ZipSleeve disposable and will reach positive cash flow by Q4 2019.
Our investors come from the blood sciences, high technology, medicine, real estate, business and law sectors. With your support FreMon Scientific can make a big difference. Of those who have not yet, please consider joining this 3rd round of funding. Contact me anytime at fred@fremonscientific.com.
Thank you,
Fred Thacher, CEO FreMon Scientific (FMS)