Dear Friends and Investors,
I hope I find you healthy and safe from COVID and I hope each one of you is taking precautions to help minimize the spread of this disease.
I wanted to reach out to every single one of you and thank you personally. But May and June were difficult times and I fell behind. Then July got really busy in radiology and I ended up working three of the four weekends, including the 4th of July weekend. I am pretty exhausted at this time. I do hope to one day write to each of you personally and thank you for your support. We couldn't be here without the trust and support of each one of you. Meanwhile, here is a group update for all.
We have now halfway through our campaign and have reached our minimum raise of $125,000. We are on our way to reach the goal of $250,000 by October 15th which is our closing date. Thank you all for making this happen. Please share our campaign on social media with friends and family and help us get there.
At this moment, there is at least one institutional investor and one strategic investor who are interested in our technology, but we are too early for them. The milestone which they like to see is our first-in-human trial. This is a significant milestone that we have been working towards for more than three years now. At the start of this crowdfunding campaign in May, we anticipated additional 9-12 months and approximately $250K-$500 further in development costs to get there. We are now almost three months since that estimation and I believe we are still on track.
Engineering this complex and novel device has always been two steps forward and one step back endeavor. Yet we have always managed to progress forward and now we have come a long way along this journey.
Over the last six months, we have accumulated a list of nearly two dozen parts that either did not meet our requirements or needed replacements for other reasons such as vendors that needed change or specifications for the part that did not meet FDA requirements. Most of these are small parts such as couplings and cables, but the list includes an upgrade in our heater which is a significant and important component for us. We will be upgrading our heater to one that better suits our requirements and demand. We've also had a step back in that one of our four pumps which is a 2-year-old Diener pump failed in testing in July. Our pumps are world-class Swiss designed and manufactured and should not fail in 2 years. We are sending the pump to Diener labs for their diagnosis. We suspect pieces of plastic or metal parts may have entered the pump and damaged it in the course of prototyping over the last two years.
Now that we have reached our minimum goal, we are going to order all remaining new parts and I am sincerely hoping we will be happy with everything this time around. I have set the goal for our engineering to finalize and nail down hardware and software by the end of August and we are on our way there. Yet our engineers have a week of vacation coming up in August and there are so many moving parts that are significant each. Our goal for the end of August is to finish the main components of Design Output. This includes all our CAD drawings, bill-of-material (BOM), electrical engineering drawings, piping and instrumentation diagrams P&ID, software coding, and technical documentation, and hazards analysis. We are on our way to get there on these items and if further delayed, it will be in weeks and not months.
We are working separately on the side for the preparation of FDA required documentation for safety and usability testing of our device. The documentation for protocols for testing turned out to be a far heavier load than anticipated and our engineers could not handle while working on the above goals. So I starting bringing freelance engineers on the side to work on each section separately depending on their experience. Everything from alarm sounds to failure modes, to plastics to electrical and electromagnetic risks need to be tested according to FDA requirements. We intend to do the tests which require simple equipment in-house. But we will be utilizing outside labs for the more complex tests. In particular, we will be doing the ISO 60601
testing which is the main international standard detailing electrical safety requirements for medical devices at a dedicated lab in Europe. Our complete device will be shipped there once we are ready and it will take them 3-4 weeks of testing to let us know if we passed everything in the 60601 standard for the FDA. ISO 10993 testing which is the testing of all plastics that come into contact with an infant will also be done at an outside dedicated facility. Our plastics come into contact with the fluid that comes into contact with preterm infant skin which we are assuming is as thin and sensitive as a mucous membrane. Thus all our plastics need to be one grade below implant level and need to be tested by outside labs to confirm. Most of our tubes that are used are standard medical device quality used in dialysis or other equipment and already FDA approved. But the plastics in our custom made parts, especially our infant cover/harness need to be tested to be safe for an infant.
Up until now, all the testing we have done in our Pozega R&D facility has been in the form of informal bench tests in order to help us improve the prototype. Once we nail down the hardware and software, as we were planning by the end of August, then we can do formal FDA required tests called the Verification protocols. If we make changes on our device after the formal tests, we risk having to redo Verification protocols. Overall, once we start the Verification protocols, we anticipate about 3 months in order to execute them. Our goal was to do this by the end of December. This will depend on when we nail down our goals this August.
After that, we will have the Usability testing of the device by at least 15-20 different doctors and nurses. They will be using a doll to test the functionality of the device and should take us 1-2 months to complete every device functionality. Every aspect of the device from the moment the operator turns it on, to the placement of an infant, to the removal of infant and finally running the disinfection cycle and cleaning the device needs to be tested in a real-world environment. We intend to do Usability testing at the University of Belgrade. Usability testing is intended to determine whether our design meets the clinical requirements set forth by our neonatologists. It is also a requirement of the FDA to perform and document the Usability testing as part of our application.
Rule of thumb is that companies should expect changes to their device and subsequent delays in development as they move through the Verification and Usability testings. We should anticipate 2-3 months of unforeseen delays due to further design changes.
Other main items remaining in the next six months are labeling, packaging, sterilization, and shelf-life testing. Packaging and sterilization will be done at a 3rd party facility. We will have to work on labeling documents in-house and have to figure out what is required for shelf-life for our first-in-human test. We also have FMEA (Failure Mode and Effects Analysis) remaining as part of our risk analysis for the FDA. Amniotic fluid content is prepared for us by a laboratory in Belgrade and we will likely be using a German contract manufacturer which we've been in discussion with for the disposable cover which the infant sits on.
Once we have all the above items, we can submit our IDE application to the FDA and to the IRB board for the University of Belgrade under the supervision of Dr. Milos Jesic who has been a consultant on this project for us. FDA's turn-around for IDE application is 45 days and IRB turn-around should also be a couple of months. We have also put into place our Quality Management System and are on our way to becoming ISO 13485 certified to meet European and FDA requirements.
We intend to start the first clinical testing using the device as a bath for healthy term infants for up to 20 minutes. Bathing for 20 minutes is safe for infants and our device is essentially a controlled hi-tech salt and mineral bath. We can learn much about how the device works using term infants in the bath environment. Once we show that 20 minutes of device use is safe in term infants, we can move to test bathing preterm infants for 20 minutes in Amniobed. This early testing of the device as a bath will likely be an extension of Usability testing of the device and not itself a clinical trial.
Our initial first-in-human clinical trial for Amniobed Golden Hour will be a safety study of 15-25 infants for sixty-minute use and is called an Early Feasibility Study. Preterm infant's core and surface temperatures will be measured and they will be placed in Amniobed for 60 minutes while continuously measuring their core and skin temperature. We will also monitor their vitals closely to determine oxygenation use and will assess general comfort and activity. We will have both video and thermal imaging of the infants done for analysis.
We intend to do the initial safety testings which are the Early Feasibility and Feasibility studies of the device at the University of Belgrade under the supervision of Dr. Jesic. Upon proving the safety of the device, we will be ready to submit our CE Mark application for Europe (Europe's equivalent of FDA). The rule of thumb for European medical device regulation is that the company has the burden to prove the safety of a device but not necessarily its efficacy. Companies can market and sell their products as long as it is safe. For the FDA, the companies have to prove safety as well as the efficacy of the device. Thus for the FDA, a randomized controlled trial is needed to prove that Amnoibed is either non-inferior or superior to the current technology. For this FDA requirement, we will have to do a larger pivotal study of ~ 200 infants randomized into the Amniobed and control group to prove the efficacy of the device compared to current technology. We intend to do our pivotal clinical trials at multiple centers. These centers can include Dr. Jesic's team at the University of Belgrade, Dr. Hamed's team at Saitama Medical University, Dr. Narvey's team in Canada, and a future US institution partner if necessary.
There are many moving parts, but everyone is doing their share to help us get there. I am exhausted emotionally and physically. Four years of working full-time radiology
while working on Amnion's dream through rejections, skeptics, set-backs, engineering challenges, and fundraising has taken its toll on me personally.
I am going to take a few days off later this week and come back refreshed for 2nd half of this fund-raising campaign. Please help me spread the word and encourage friends and family to invest to help us get there. I expect we need $250K-$500K to get us to the first clinical trial. Raising the $140K thus far has been huge, but it is not over for us. In addition to successfully carrying out this crowdfunding campaign, my goal over the next three months is to establish interest from institutional investors to help us get there faster. We have a long way still to go, but with every step, we are a bit closer to our goal.
P.S. We made a short flash video of the best testimonials from our investors. Please enjoy the video below.
Amir Fassihi M.D.
2618 San Miguel Drive Suite 149 | Kralja Petra 92
Newport Beach, CA, 92660 | 31210, Pozega, Serbia
+1 949 438 3273 | +381 31812 444
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