Invest in Amnion Life

Amniobed is the first step towards an artificial womb for preterm infants

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Public Launch on Jun 22 @ 9AM EST

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LEAD INVESTOR

General Manager at Start Fresh (early-stage investment fund) and President of Envision Foods

I am a past board member of March of Dimes and familiar with the unfortunately high rate of death and long term injury in babies who were born prematurely. The infant incubator and radiant warmer technology used today for preterm infants are outdated and insufficient. In the first hour of life otherwise known as the golden hour, preterm infants are at significant risk, particularly the risk of hypothermia. Preterm infants have very little fat on their skin and can dehydrate quickly. They have very poor insulation against heat loss and can lose body heat very quickly. A drop in the core temperature of humans is associated with significant stress on the body and in preterm infants is associated with brain hemorrhages, sepsis, and death. We can do far better by placing the preterm infant in warm fluid incubators, thus eliminating environmental heat loss and water loss leading to hypothermia in these infants. Dr. Fassihi's dream may seem like science fiction and is certainly "thinking outside the box" intended to solve this a significant problem in preterm infants. Dr. Fassihi has done an unbelievable job bringing the project along and now the project is very close to coming to life. Once approved by the FDA and other regulatory bodies across the world, this invention can save thousands or hundreds of thousands of babies from dying and just as importantly, prevent further complications that can harm a child for the long term and limit a child’s potential in life. I also believe that once Amniobed gains FDA and regulatory body approvals and is commercialized, we as investors can be financially rewarded for believing in this invention and Dr. Fassihi’s vision. No one has come close to thinking or inventing an incubator like the Amnionbed. I believe if you invest in a start-up, you need to first believe in what it is all about. I truly believe Amniobed will save many human lives. Secondly, you need to trust and believe in the individual who leads the project and aims to bring the vision to life. And that I strongly do. Dr. Fassihi dreamt of this Incubator and has spent the last 4 years bringing it to life. He has been incredibly diligent in seeing the project through to this point, building a company, team, R&D facility, and the prototype while managing the financials fantastically. He has received many recognitions and awards thus far... and he's not done yet. What is also incredible about Dr. Fassihi is that he feels very strongly about his investors, and always very appreciative of the trust and support that has been extended to him and Amnion Life. I am very happy to be part of this incredible journey to see a revolution in the incubator’s technology and science. I have very high hopes for the future of this company as we save preterm babies and make money doing so!

Pitch Video

Investor Panel

amnion.life

Newport Beach CA

Hardware Technology Main Street Healthcare Social Impact

Highlights

In Amniobed, the preterm infant is partially submerged in synthetic amniotic fluid.

Amniobed is intended to prevent hypothermia in preterm infants and decrease environmental heat loss.

Hypothermia leads to poor medical outcomes and an increased chance of infant death.

Strong patent portfolio with multiple patents in the US, China, and Japan and pending in Europe.

Studies have shown 40% of infants admitted to the NICU from L&D are hypothermic in 1st hour of life.

Significant calorie loss in the NICU leads to diminished weight gain and longer hospital stays

3 Years of R&D. Designed, sourced, procured, and assembled Amniobed Golden Hour plus software.

The project was placed on pause in 2020 due to COVID-19. Raising capital to finish the prototype.

Our Team

A little girl in our family was born extreme preterm and spent months in the NICU. Complications from her preterm birth led to life long neurodevelopmental and ocular injuries. Soon after seeing her, I had a dream that preterm infants suffer and need a fluid environment life similar to their mother's womb. I soon became obsessed and passionate.

Premature Birth is the #1 Cause of Infant Death

Current infant incubators have shortcomings

Every year, 15 million babies are born before their due date. With very thin skin, little subcutaneous fat, and underdeveloped organs, preterm infants are highly vulnerable to heat loss, which can lead to hypothermia, a drop in their core body temperature of more than one degree Celsius. Hypothermia in preterm infants is a serious concern which can lead to significant stress reaction and is directly associated with subsequent increased incidence of respiratory distress, apnea, convulsions, anemia, sepsis, periventricular leukomalacia, necrotizing enterocolitis, meningitis, brain hemorrhage and death.

In the U.S., complications from premature birth is the leading cause of death for infants.

The first hour of care in the field of neonatology and trauma is called the 'golden hour'. Proper medical care in first sixty minutes after trauma or birth is highly consequential in determining the short term and longer term outcomes. Infant hypothermia in the golden hour of care is called 'transitional hypothermia' and is a great medical concern. In large European and American studies, the incidence of 'transitional hypothermia' in very preterm infants has been reported as much as %53 and as high as 78% in extreme preterm infants. (Wilson et al. 2016) (Bhatt et al. 2007)

Transitional Hypothermia in the golden hour is linked to increased chance of negative outcomes and increased chance of subsequent infant death. It can be and it must be prevented. Prevention of transitional hypothermia in infants is what Amniobed Golden Hour is being designed to prevent.

Amniobed Golden Hour is the first incubator utilizing synthetic amniotic fluid designed to prevent transitional hypothermia in preterm infants.

The Solution: AmnioBed

We believe we can build a better incubator. Our patented solution, the AmnioBed, recreates the natural in-womb environment to nurture critical ongoing development, decreasing the short and long-term complications common in premature births.

How it Works

AmnioBed is a new approach to incubation. We submerge the infant partially in specially crafted fluid that mimics a mother's amniotic fluid in temperature, electrolyte balance, pH and minerals. This way, the infant can stay warm upon birth in a fluid environment just like they would in the womb, instead of use of humidified incubators or radiant warmers.

Our Journey

Over the three years, we've done tremendous amount of research and development to design and develop our first product, Amniobed Golden Hour. Below is time-lapse video of our engineers in Serbia building the device.

Over the next six to 12 months, we plan to do the necessary safety testing of the device. All plastic that come into contact with fluid that comes into contact with infant needs to be tested for safety. All electrical components needs to meet international ISOstandards and FDA requirements for testing. Software needs to be tested and validated and finally, doctors and nurses need to perform usability testing to ensure the device is safe prior to our first clinical trials.

April 2016

Founded Amnion Life

October 2016

1st Round Seed Funding Secured

With funds raised, began R&D and feasibility study.

February 2017

Cleanroom R&D facility built in Pozega, Serbia - Amnion Life Pozega LLC Established

April 2017

US AmnioBed Patent Application Granted by USPTO

International Patent Application Through PCT Approved

July 2017

Proof of Concept Design Completed

February 2018

Parts and Material for Prototype Sourced and Procured

April 2018

2nd Round of Seed Funding Secured

June 2018

Prototype Built and Prepared for Initial Testing

July 2018

Quality Management System in Place

September 2018

Initial Risk Analysis Completed

December 2018

Comprehensive clinical review of device User Needs completed by Clinical Team

Initial Clinical Evaluation Report prepared

January 2019

Artificial Placenta R&D Completed –Patent application drafted and submitted

February 2019

Second Patent on Amniobed obtained - Expanded claims to include adult size patients

March 2019

Awarded 2nd place out of 100 competing companies at Stanford-UCSF Pediatric Device Consortium

April 2019

Completed Reg CF Crowdfund Round [raised $305K from 186 investors]

January 2020

Amniobed’s Patent Application granted and issued in China.

Other Applications of Our IP

Our patent portfolio now includes multiple patents on Amniobed. Our patent claims on Amniobed were broadened on subsequent application to include adult size patients. In addition, we were awarded a US patent on Artificial Placenta. Below is the roadmap for our future product development:

Dear Investors,

Nothing in the world is as precious as life. When a new infant is born, as a society, we take collective responsibility to protect their lives and ensure that the necessary resources for a nourishing and comfortable environment are in place. Our infants and children are vulnerable – they require and deserve tremendous care. Specifically, preterm infants are the most vulnerable, and therefore require the greatest care.

Preterm infants have bodies accustomed to and in need of the warm and nourishing world of mother's womb. Outside the womb, they cannot survive without great effort to keep them warm, oxygenated and nourished. Virtually any environmental issue during this early stage has the potential to lead to life-long difficulties and disabilities. To date, our health care system has done a tremendous job caring for and nourishing preterm infants until they are safe enough to be discharged home. But the healthcare we currently provide is not enough. There are still too many preterm infants leaving hospitals with life-long disabilities. Others endure lengthy stays in the NICU that can last 110 - 140 days, or more, causing tremendous psychological, social and economic hardship for families. Our goal is to get preterm infants discharged and home – healthier, quicker and with fewer complications.

We as a company feel honored and blessed to shoulder the responsibility to help improve the lives of our preterm infants. I am also honored and excited to be working with a team of individuals from across the world who share the same passion and dedication to this project. As a team, we are determined to build a safe and effective incubator, significantly superior to the 20th-century technology still in use today. We believe the environment found “in the womb” is the gold standard of care at this stage of human development, and progress towards a fluid environment for these infants is natural and expected. We are proud to be at the forefront of that progress.

We realize that our path is long and difficult. Yet we have already come a long way and will remain focused because our goal is too critical for humanity to allow it to go unrealized. We believe that our investors will be financially well rewarded for their support - but the greatest reward for us will be to witness the countless lives improved and saved, and the countless number of families that get to spend a lifetime together because of this new technology.

Sincerely,

Amir Fassihi

Downloads

Amnion Life Pitch Presentation.pdf