Amnion Life LLC

Update on Amnion

founder @ Amnion Life LLC

Published on May 8, 2020

Image on the top is Radovan, our 66 year old engineer. Serbian government had placed severe quarantine measures for all above 65. Yesterday was the first time he was allowed outside of the house and was allowed to visit our  R&D facility since the quarantine.


Dear Friends and Investors,

I hope you are safe and healthy.

Here at Amnion Life, we've had to do some adjustments and changes in order to abide by pandemic guidelines, but work is progressing and moving forward.

Work at our R&D facility in Pozega, Serbia had to be halted due to quarantine restrictions put in effect. Some of those restrictions have been relaxed over the last few days and we've resumed limited work in our facility and on our prototype. We had planned fundraising events in Los Angeles and Orange County in March and April which we had to cancel. Instead, we are launching another crowdfunding campaign on Wefunder.com to help raise the funds needed for 2020.

In the last year, we've made significant progress on Amniobed. In summer of 2019, we made a decision to split the work on Amniobed onto two separate products, Amniobed 24Hours and Amniobed Golden Hour and placed most of our focus on moving forward the work on Amiobed Golden Hour.

Amniobed 24Hours is what we had envisioned when we launched the company in 2016. It is intended to be an incubator in the NICU for preterm infants for 24 hours to 28 day use. Amniobed Golden Hour is an incubator intended to be placed in the labor and delivery ward for use of up to 60 minutes immediately after birth and prior to transport of the infant to the NICU. It is a simpler device with far less risk and easier regulatory pathway.

In the fields of neonatology and trauma, there is the concept of ‘golden hour’. Medical care in 60 minutes after birth or trauma is extremely critical and adverse events in the golden hour have been shown to have long-term consequences for infants and trauma patients.

Unfortunately, the incidence of hypothermia in the golden hour for very preterm infants has been reported in 25% - 78% range in some of the best medical centers in Europe and North America. Large studies have shown averages of up to 50% for very preterm infants. Hypothermia in the golden hour is called ‘transitional hypothermia’ and has been linked to increased mortality and morbidity in preterm infants. Our goal is to prevent transitional hypothermia in these infants by placing them in a fluid environment similar to the mother's womb prior to their transport to the NICU.

Amniobed Golden Hour does not have the dome structure and nor the air purification,heating and humidification needed for long term stay of infants which was part of the Amniobed 24Hours design. Clinical trials to show safety of the device are going to be simpler and less risky as preterm infants are routinely given up to 20 minute baths which have been shown to be safe. Our initial trials will be more like a sixty minute bath, >6 hours after birth and will be performed in term or late preterm infants to show safety of the device. We will then test the device in younger gestational age infants and closer to birth until we prove safety for use immediately upon birth.

Over the last year, we’ve done a considerable amount of work on engineering documentations and drawings needed for CE mark in Europe and for our eventual FDA application. We designed two printed circuit boards (PCB) and worked with a medical device contract manufacturer specializing in PCB boards in Finland to provide our prototypes for testing. These circuit boards serve as the on-board computers for Amniobed. We also prepared the software for necessary operations of our device. Our device has more than 140 custom and off-the-shelf parts and components which were sourced and procured for its assembly. Over the last year, we’ve changed several parts as we’ve progress in our design and will continue working to ensure all the parts meet our safety and performance requirements.

In the last year, the US patent office granted us our patent application for Artificial Placenta which we hope to one day bring to market to maintain more natural oxygenation and nutrition for preterm infants via umbilical cord as opposed to current method of use of underdeveloped lungs and GI tract leading to significant lung and Gi injuries for preterm infants. We were issued a second US patent on Amniobed and expanded our claims to include adult-sized patients such as burn or recovery patients. We were also granted our patent for Amniobed in China which was great news for the company as China will be one of the largest markets for Amniobed.

We got third place in the 2019 Stanford-UCSF Pediatric Device Consortium Competition (gold award) and 2nd place in the 2019 Cleveland Clinic Amp’d Arena Medical Innovation Summit (gold award).

In 2020, our focus is on safety testing of the device. We must meet the European and FDA safety testing requirements for electrical safety and electromagnetic safety for the device. We must also prove that every plastic or component that comes in contact with the fluid which comes into contact with the infant meets the biocompatibility safety standards and is safe. Our software needs to be debugged and validated in 2020. We must also perform tests and verify all functional and performance requirements of the device such as fluid temperature, electrolyte, mineral, pH and osmolality. We also have to do usability testing of the device which is the use of the device by doctors and nurses without the infants in order to test device functionality, glitches and potential issues with the design. Once we prove the device is safe for clinical trials, we will request the FDA to allow us to perform our first clinical trial which will likely be in 2021.

I am grateful to you and all our investors and supporters in this endeavor who have helped us get this far. As we were forced to cancel our fundraising events in California due to the pandemic, we will be relying on our crowdfunding campaign in order to raise funds for continued operation and progress on our device in 2020.

Please visit our campaign page at wefunder.com/amnionlife and share our campaign with friends and family on social media. We will continue to rely on generous investments of people like you in order to bring this project to its fruition.

Thank you.

Amir Fassihi M.D.

CEO/Founder