# Amnion Life LLC

Amniobed, a Ground-Breaking Medical Device to Save Preterm Infants Lives

## Elevator pitch
Nearly 15M infants worldwide are born premature. Due to underdeveloped organs, the dramatic shift from amniotic fluid to air puts them at risk for hypothermia, dehydration, and infections which can lead to sepsis, organ injuries, and even death. To substantially improve preterm infants' chances of survival and reduce the time needed in intensive care, we designed AmnioBed, a patented, cost-efficient, fluid-filled solution that can mimics a mother's amniotic fluid environment.

- Canonical URL: https://wefunder.com/amnion.life
- Entity ID: wefunder:company:27822
- Last updated: 2026-07-25T05:01:01Z
- Generated at: 2026-07-25T14:41:19Z

## Quick facts
- 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.

## Active fundraises
- wefunder:fundraise:29623: 4(a)(6) successful (USD)
- wefunder:fundraise:19271: 4(a)(6) successful (USD)

## Story
Amnion Life LLC has the mission to develop novel devices to decrease mortality & complications in preterm infants. As part of its mission, Amnion Life is developing the Amniobed™ - a novel, patent-protected1, neonatal incubator system intended to recreate the core conditions of an in- womb environment. Amniobed can provide a more natural incubator environment for continuous critical organ development, improve preterm infants' thermoregulation and fluid management, and help prevent hypothermia in critical care settings.Reasons to InvestProtected by multiple issued patents in the US, China, Japan, and pending in Europe.Successful earlier rounds of over $1.8M in investment and crowdfunding.Lead by our founder Amir Fassihi, M.D., an experienced neuroradiologist, our team is made up of experts in regulatory matters (particularly applications to the FDA), medical device commercialization and roll-outs, QMS implementations, and European regulatory affairs.Giving premature infants a better chance at lifeAt Amnion Life, our mission is to develop novel devices to decrease mortality & complications in preterm infants.Our patent-protected flagship product[, the AmnioBed™[1] is a neonatal incubator system utilizing a proprietary, synthetic amniotic fluid, intended to create an environment that more closely resembles a mother’s womb to encourage ongoing, and critical development. The technology is designed to protect, hydrate, and nourish these vulnerable newborns, providing safety and comfort during their most sensitive, vital hours.The above is a rendering of a future Amniobed. Images are computer-generated demo versions. The product is still currently under development.THE PROBLEMPremature birth is the #1 cause of infant mortality across the globeIn the United States and across the world, one out of every ten infants born is preterm —and each and everyone requires immediate attention.[2]According to the World Health Organization, premature birth is the leading cause of death for children under five years old across the globe.[3]For those who do survive early infanthood, inadequate treatment in the first days and weeks of life can put them at risk of long-term health problems, leading to a lifetime of emotional and financial challenges.[4][6]Preemies, due to their heightened sensitivity, are very susceptible to heat loss, resulting in possible hypothermia and dehydration. This, in turn, can introduce other ailments such as weight loss, brain hemorrhage, hypoglycemia, and sepsis. In the first critical hour of a preterm infant’s life, he or she is at significant risk of what is called ”transitional hypothermia.” [7]An infant may ultimately end up spending over 100 days in the NICU.[8] The overall impact can be devastating, and current health technologies for addressing the issue are inadequate. THE SOLUTIONPatent-protected technology that keeps preemies safe, warm, and stabilized after birthThe Amniobed is designed to improve health outcomes for preterm infants while also reducing their time spent in the NICU. We’ve created a revolutionary proprietary medical technology that leverages the power of fluid as a source of heat regulation, transfer, and hydration. Designed to replace current incubators, wraps, and warmers, the Amniobed partially surrounds a preterm infant in synthetic amniotic fluid to simulate the womb, thereby easing their transition into the world.Amniobed™ Golden Hour - is intended to replace the use of radiant warmer/plastic wrap in the labor and delivery room to allow optimal temperature regulation of the infant immediately upon birth and to prevent transitional hypothermia very preterm and extremely preterm infants).Amniobed™ 24Hour - is intended to replace convection incubators for use in the NICU for up to 28 days. It is intended to improve temperature regulation, fluid management, skin protection and general comfort for preterm infants.This leads to healthier babies and substantial reductions in both short-term and long-term emotional and financial stress for everyone involved. The above is a rendering of a future Amniobed. Images are computer-generated demo versions. The product is still currently under development.THE MARKETBillions of healthcare dollars are spent on preterm infantsThe US spends over $26 billion each year on costs associated with premature births.[9]The average cost per day for an infant in the NICU exceeds $3000.[10]Extremely preterm infants can spend 110 days or more in intensive care[11]—earning them the nickname “million-dollar babies.”[12]There are 985 NICU facilities in the US[13]with 22,721 total beds[14], serving the hundreds of thousands of preterm infants in the US each year. The US is in the world’s top 10 based on its number of premature births, with the overall global estimate for premature births per year tallied at 15 million.[15][16]OUR TRACTIONAward-winning medical innovationsAmnion Life has been thrilled to receive multiple Gold Awards for our flagship Amniobed, including second place in the 2019 Cleveland Clinic AMP’D Arena Medical Innovation Summit and third place in the 2019 UCSF/Stanford Pediatric Device Consortium Competition. We’ve secured multiple issued U.S. utility patents, with several foreign patents pending.The above is a rendering of a future Amniobed. Images are computer-generated demo versions. The product is still currently under development.This round of funding will enable us to perform pre-clinical verification, usability testing, and pilot studies. The Amniobed will then be ready for clinical trials, FDA and CE mark approval, and from there, manufacturing and commercialization.WHAT WE DOWe’re building a much better incubatorThe Amniobed™ is a rigorously researched and carefully designed incubator that partially submerges the infant in fluid. Our uniquely crafted synthetic fluid mimics a mother's amniotic fluid in temperature, electrolyte balance, pH, and minerals. The Amniobed was conceived with particular consideration to an infant’s first hour of life, at which point they are especially vulnerable. As premature infants make the dramatic transition from amniotic fluid to air, they are at elevated risk of hypothermia and dehydration. Negative outcomes during this first “golden” hour of life are associated with higher incidences of mortality, as well as the development of comorbidities and long-term disabilities.The above is a rendering of a future Amniobed. Images are computer-generated demo versions. The product is still currently under development.The infant is safely supported by an ergonomic seat and harness, which ensure the head is always above the level of fluid and allow movement of the arms and legs. The infant is also outfitted with a cap that tracks skin temperature and contains an electrocardiogram. A 24/7 audio and video feed connects to a smartphone app for remote observation at all times, allowing the mother and/or other caregivers to talk directly to the baby.The above is a rendering of a future Amniobed. Images are computer-generated demo versions. The product is still currently under development.THE BUSINESS MODELEquipping hospitals across the world with our state-of-the-art AmniobedWe are pursuing a model that enables hospitals access to Amniobed either for purchase or lease. We project an average selling price of $150,000 per unit in the US and at a discount in Rest of World, and will also offer a leasing option accompanied by lower upfront costs. Our model plans to have recurring revenue through a $150-$250 price per use fee for supplies such as the amniotic fluid cartridge and sterile cover. Each Amiobed can be used >300 times per year meaning we can generate greater than $60,000 revenue per device. Cost of Goods Sold is estimated at $45,000 for parts and $1600 for labor for assembly. The Company estimates approximately $25,000 to $37,500 in costs associated with sales and distribution of each unit and $5000 for shipping and installation.. The costs of goods sold for daily supplies is estimated at $50 per unit use. Total cost for each unit is estimated at $76,600 to $89,100 per unit. Thus the Company estimates margins of 40% on capital equipment costs and margins >70% for supplies.Regulatory StrategyWe have developed a network of medical device professionals and resources in the Republic of Serbia, Macedonia and Bulgaria. Bulgaria is part of European Union and has a Notified Body. As such,we intend to seek CE Mark approval for marketing and sales of Amniobed Golden Hour and Amniobed 24Hr in Bulgaria.Once we have regulatory approval for Amniobed Golden Hour in the European Union, we plan to seek distribution partnerships in the EU, followed by distribution partnerships and regulatory applications in U.K, Canada and Australia, followed by Israel, UAE and SA the MIddle East and China, S. Korea and Japan in the Far East. We also intend to design and develop a lower cost Amniobed for India and developing countries.We intend to submit a Presub Application to the FDA upon reaching Design Freeze and will be in close coordination with the FDA as Amniobed is approved and utilized worldwide. The Real World Data generated is intended to be used to prove safety and efficacy of the device for our application to the FDA.Similar to Amniobed Golden Hour, Real World Data (ROW) from use of Amniobed 24HR win ROW will be used to prove safety and efficacy of the device to the FDA. Thus, it is expected that FDA approval will lag ROW approval by at least one year.HOW WE ARE DIFFERENTAmniobed will be the incubator that recreates a fluid environmentConvection-warmed incubators, which rely on artificial humidification, can take up to one hour to reach optimal temperature and humidity levels. Their incubator ports are opened and closed as often as once an hour, allowing in drafts of cold, dry air and subsequent temperature fluctuation. The box-like design can result in pressure sores and skin injuries, and is not well suited for keeping infants with very low birth weights warm. Radiant warmer beds, on the other hand, distribute heat unevenly across an infant’s body parts and can result in excess evaporative water loss in addition to skin injuries.Our Amnionbed replaces humidified incubators, plastic wraps, radiant warmers, and chemically heated mattresses with a holistic system that reduces the risk of hypothermia and dehydration. Our fluid-based technology regulates temperature, reduces friction, and enables body movement, all in a safer, more comfortable, and more comforting way.The above is a rendering of a future Amniobed. Images are computer-generated demo versions. The product is still currently under development.THE VISIONThe new standard for intensive careAmnion Life is ready to revolutionize modern intensive care. Stationed in hospitals across the world, the Amnionbed will transform the quality of care and patient outcomes in the NICU, improving the immediate and long-term health of preterm infants. In doing so, we will be reducing the time, cost, and intense emotional distress associated with drawn-out hospital stays for families and their preemie newborns, as well as hardworking healthcare workers. But we won’t just stop there. Looking ahead, we’re ready to design and deliver superior outcomes for infant and adult patients alike, with intensive care beds and accompanying technologies built for all critical use cases. Amnioburn, Amniotransport, AmnioICU, will address other areas in need of increased support and technological innovation.In ten years, we’ll be looking back on today’s incubators and hospital beds and wondering how it took so long for them to earn an upgrade.The above is a rendering of a future Amniobed. Images are computer-generated demo versions. The product is still currently under development.OUR LEADERSHIPMedical expertise meets technological know-howAmir Fassihi: Founder and CEOA neuroradiologist and entrepreneur, Amir Fassihi is the founder and visionary behind Amnion Life. His dedication to developing this new and innovative incubator was spurred by the experience of witnessing a very preterm birth within his family. The Amnionbed aims to address the many physical and emotional challenges that accompany such early births. The Amnion Life team also includes experts in cutting-edge medical technologies, biomedical engineering, regulatory affairs, and medical device commercialization. In its next phase, Amnion Life will continue to onboard top talent in these fields to supervise the company through its next stages.WHY INVESTA commitment to future familiesThe challenges facing premature infants are here to stay—but we can bring change to our technologies and solutions. We are overdue for a system that ensures better outcomes for the most vulnerable newborns at their most vital hours. We’ve created the Amniobed do just that, and we’d love for you to join us in making an unwavering commitment to future families around the world.The above is a rendering of a future Amniobed. Images are computer-generated demo versions. The product is still currently under development.[1] US Patent No. 9,662,257, issued on May 30, 2017 https://patents.google.com/patent/US9662257?oq=US+Patent+No.+9%2c662%2c257%2c+issued+on+May+30%2c+20... Patent No. 10,166,161, issued on January 1, 2019https://patents.google.com/patent/US10166161B2/en?oq=US+Patent+No.+10%2c166%2c161%2c+issued+on+Janua... Patent No. 201680064293.7 issued January 8, 2020 https://patents.google.com/patent/CN108289780B/en?assignee=Amnion+Life+LLC&oq=Amnion+Life+LLC Patent No. No. 2018-521506 issued August 28th, 2020https://patents.google.com/patent/JP6755949B2/en?assignee=Amnion+Life+LLC&oq=Amnion+Life+LLC[2] Retrieved April 03, 2021, from https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htmContent source: Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion[3] Retrieved from World Health Organization https://www.who.int/news-room/fact-sheets/detail/preterm-birth#:~:text=Key%20facts,and%20this%20numb... L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, et al. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet. 2016;388(10063):3027-35.(2) Blencowe H, Cousens S, Oestergaard M, Chou D, Moller AB, Narwal R, Adler A, Garcia CV, Rohde S, Say L, Lawn JE. National, regional and worldwide estimates of preterm birth. The Lancet, June 2012. 9;379(9832):2162-72. Estimates from 2010.[4] Bissinger, Robin L. PhD, APRN, NNP-BC; Annibale, David J. MD Thermoregulation in Very Low-Birth-Weight Infants During the Golden Hour, Advances in Neonatal Care: October 2010 - Volume 10 - Issue 5 - p 230-238doi: 10.1097/ANC.0b013e3181f0ae63 [5] Source: World Health Organiation https://www.who.int/news-room/fact-sheets/detail/preterm-birth#:~:text=An%20estimated%2015%20million%20babies%20are%20born%20too%20early%20every,of%20preterm%20birth%20(1).&text=Globally%2C%20prematurity%20is%20the%20leading,the%20age%20of%205%20years.[6] Source: World Health Organiation https://www.who.int/news-room/fact-sheets/detail/preterm-birth#:~:text=An%20estimated%2015%20million%20babies%20are%20born%20too%20early%20every,of%20preterm%20birth%20(1).&text=Globally%2C%20prematurity%20is%20the%20leading,the%20age%20of%205%20years.[7] Bissinger, Robin L. PhD, APRN, NNP-BC; Annibale, David J. MD Thermoregulation in Very Low-Birth-Weight Infants During the Golden Hour, Advances in Neonatal Care: October 2010 - Volume 10 - Issue 5 - p 230-238doi: 10.1097/ANC.0b013e3181f0ae63 [8] Florida AHCA Facility Report, 2016[9] Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. 12, Societal Costs of Preterm Birth. Available from: https://www.ncbi.nlm.nih.gov/books/NBK11358/[10] MANAGED CARE January 2010. © MediMedia USA “How Plans Can Improve Outcomes And Cut Costs for Preterm Infant Care” Michael Kornhauser, MD: Alere Women’s and Children’s HealthRoy Schneiderman, MD : Alere Women’s and Children’s Health[11] Florida AHCA Facility Report, 2016[12] Florida AHCA Facility Report, 2016[13] Vermont Oxford Network https://public.vtoxford.org/[14] American Hospital Association https://www.aha.org/statistics/fast-facts-us-hospitals[15] Lancet Glob Health 2018 Published online October 29, 2018 http://dx.doi.org/10.1016/S2214-109X(18)304)30451-0[16] Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. 12, Societal Costs of Preterm Birth. Available from: https://www.ncbi.nlm.nih.gov/books/NBK11358/

## FAQ
1. **I know the life of infants in NiCU. This is a great innovation ,Would there be a chance of bringing minimum to $100 or $200.**
   - Yes. Thank you for your suggestion. I will lower the minimum investment so its more accessible to all investors. We have requested the change to Wefunder and they will be lowering the limit in the next few days.
2. **This is great for savings precious lives indeed. Will Amnion Life make money from the one-time sale of each incubator or will incubators be leased for multi-year revenue and other products like filters increase revenue also?**
   - Our revenue model is based on a combination of capital equipment sales and consumables. There is an initial purchase or lease of the device by the hospital. It then requires daily, weekly and quarterly accessories and consumables such as amniotic fluid cartridges which are used daily, sterile infant cover and harness which are changed every 24-72 hours, infant monitoring accessories specially designed for the fluid environment of the incubator such as infant skin temperature sensors, O2 monit...
3. **The terms state a 10% discount but the SAFE agreement that I received has a 0% discount (because the discount rate is 100%). Can you clarify?**
   - Hi Carl. Thank you for your support and investment. The SAFE agreement has discount of 10% which applies only if the next round for Amnion is funded at less than the cap value of $22.5/$25 million. If the next round is funded at greater than the cap value, the SAFE investors will receive the shares at $22.5/$25million valuation and discount will no longer apply. For example, if the next round closes at $40 million, the SAFE investors will receive their shares at the cap rate of $22.5/$25milli...
4. **Very interesting idea, but I have a lot of questions that I hope you can address: 1. How much money do you need to get this through FDA approval in 2020? $1 million through crowdfunding won't get you there. 2. Why did you decide to go this route instead of VC? 3. What was the ...**
   - Hi Nico, These are great questions which I am sure other investors may also have. Please see below: 1) 1. How much money do you need to get this through FDA approval in 2020? $1 million through crowdfunding won't get you there. $1 million via crowdfund is the maximum allowed by SEC to be raised by companies via Regulation CF. This is only part of capital needed in order to get this through the FDA. The remainder of investment capital will come from institutional investors with $500K minimum i...
5. **I'd like to know the current price per share before I invest.**
   - Hi Fernando, The equity purchased is in the form of SAFE agreement for future equity. The price per share for the current Wefunder SAFE investors will be determined upon close of the next round by institutional investors. Based on our projections and numbers, milestones achieved and our potential market, we believe we will be valued above $25 million. If we do get valued in the $25-$50million range, the current investors will be rewarded by having their shares purchased at the cap of $25milli...

## Team
- Amir Fassihi (Founder and CEO)
- Michael Drues, PhD (Regulatory Advisor)
- Molly Ferris (Consultant for Product Rollout, Marketing, Sales)
- Aleksandar Siskovic (Quality Manager)

## Q&A
- Q: I am concerned about developmental positioning. We now know that the infant’s position in the womb directly correlates to positive brain development, and that pushing against the amniotic sac assists in bone development. The neonate’s in your incubator don’t appear to have any boundaries. As a NICU nurse, this concerns me. Being at the bedside, we see a direct correlation in stable vital signs and lower oxygen needs when our infants are positioned correctly. They are more comfortable, they sleep better, and their weight gain is improved. I even personally feel like it aids in digestion, as I see less reflux and residuals when my infant is calm and contained. We use a z-flow pad and tube to position all our micropreemies; this keeps their position as close to the womb as possible while also providing them a boundary to push and kick against. How will we provide boundaries for an infant surrounded by fluid? Of course I am also wondering how we will safely secure umbilical lines, PICC lines, peripheral IVs, and PALs, and then also be able to position that limb correctly to provide comfort and security to the baby. What about kangaroo care? We start kangaroo care on day five of life, even in a 23 weeker who is intubated, if they are stable enough. What will be the ramifications of an infant having to be removed from that environment possibly one or more times daily? Will there be a way to weigh the infant each day without draining the fluid? How will we maintain temperature stability if we are constantly draining and re-filling the fluid? Won’t it disturb the infant if every time he/she stools, the fluid drains and then re-fills? It’s definitely a neat concept, but be sure to involve nursing. I can personally say our unit has rejected new incubators because the development team didn’t think nursing, the primary users of their product, were important. I know our development specialists and respiratory therapists like to be involved as well.
  - A: Hi Laura, Thank you for your thoughtful and expert questions. These are matters which have preoccupied our research and thought for three years and I am glad you are addressing it as well. As far as positioning of the infant, we are currently working on an ergonomic comfortable seat with special head rests made for the infants. We are currently trying to do some R&D on adjustable head and neck rest so that a nurse can adjust the head and neck rest similar to a car seat. However, please note that the current design will likely be significantly changed and redone as we progress through usability studies and clinical trials. We are currently projecting a pilot study of 5-10 infants for a maximum of 60 minute bath. We will learn many things from such a trial. However, we have a long way to go with usability testing of the device by nurses (without an infant) followed by potential animal studies before we can do the final design of the seat and neck/headrest. We will add some photos of the current neck and head rest design on our website under FAQ (amnion.life/faqs) . Regarding your question about fetal in-womb push against amniotic sac which aids in bone development, this is also something we've taken into consideration. Our challenge in this regard is similar to the current incubator technology. In the current incubators, the infants also don't have the natural amniotic sac to push against which aids in musculoskeletal development. What we've considered is a slightly heavy see-through plastic cover on the infant which can simulate the pressure and comfort of the amniotic sac. But since our initial trials will be in 60 minute or later on on less than 24 hour stays, we are going to tackle that issue when we further design the device for longer AmnioBed stays of >24 hours. Regarding your concerns about central lines and PICC lines, this is perhaps our most important challenge and something we've done significant work on. This is a very important point you have raised. Please refer to Dr Hardy's questions on our website under FAQ. Regarding Kangaroo care, our device will have the same restrictions for removal from the incubator as the current convection incubators. Infants can be removed for kangaroo care and placed back into the incubator at any time if kangaroo care is deemed safe by the nurse and medical staff. Regarding nursing consultants, that is on our wish list at the moment for the company, but we are limited on funds and still early in the product development. I've had the opportunity to discuss our concerns and seek input from NICU nurses unofficially, but with the limited budget we've had, we decided that we need expert neonatologists first to make sure all medical needs and concerns are addressed prior to working on the details of the nursing requirements and needs such as positioning and device everyday usability and ease of use. Hope I got all your questions addressed. Thank you for your insightful questions.
  - A: Hi Laura, Thank you for your thoughtful and expert questions. These are matters which have preoccupied our research and thought for three years and I am glad you are addressing it as well. As far as positioning of the infant, we are currently working on an ergonomic comfortable seat with special head rests made for the infants. We are currently trying to do some R&D on adjustable head and neck rest so that a nurse can adjust the head and neck rest similar to a car seat. However, please note that the current design will likely be significantly changed and redone as we progress through usability studies and clinical trials. We are currently projecting a pilot study of 5-10 infants for a maximum of 60 minute bath. We will learn many things from such a trial. However, we have a long way to go with usability testing of the device by nurses (without an infant) followed by potential animal studies before we can do the final design of the seat and neck/headrest. We will add some photos of the current neck and head rest design on our website under FAQ (amnion.life/faqs) . Regarding your question about fetal in-womb push against amniotic sac which aids in bone development, this is also something we've taken into consideration. Our challenge in this regard is similar to the current incubator technology. In the current incubators, the infants also don't have the natural amniotic sac to push against which aids in musculoskeletal development. What we've considered is a slightly heavy see-through plastic cover on the infant which can simulate the pressure and comfort of the amniotic sac. But since our initial trials will be in 60 minute or later on on less than 24 hour stays, we are going to tackle that issue when we further design the device for longer AmnioBed stays of >24 hours. Regarding your concerns about central lines and PICC lines, this is perhaps our most important challenge and something we've done significant work on. This is a very important point you have raised. Please refer to Dr Hardy's questions on our website under FAQ. Regarding Kangaroo care, our device will have the same restrictions for removal from the incubator as the current convection incubators. Infants can be removed for kangaroo care and placed back into the incubator at any time if kangaroo care is deemed safe by the nurse and medical staff. Regarding nursing consultants, that is on our wish list at the moment for the company, but we are limited on funds and still early in the product development. I've had the opportunity to discuss our concerns and seek input from NICU nurses unofficially, but with the limited budget we've had, we decided that we need expert neonatologists first to make sure all medical needs and concerns are addressed prior to working on the details of the nursing requirements and needs such as positioning and device everyday usability and ease of use. Hope I got all your questions addressed. Thank you for your insightful questions.
- Q: Hi. I have a few questions. -What was the valuation for your previous raise? Old comments mention $25M but if that's accurate why did it go all the way down to 7.5M? -How will you make money? -Once you get approved to go to market, what are your revenue goals (not projections) for the first 5 years?
  - A: Hi Leonardo, I just noticed that this qurestion is in 'unanswered' list and I never submitted an answer to these questions. My apologies. Here are some answers. -What was the valuation for your previous raise? Old comments mention $25M but if that's accurate why did it go all the way down to 7.5M? The valuation on previous raise was initially at $25M, but then we amended the round to new valuation of $!2.5M which was more appropriate and I wanted to make sure our investors get a good value. We were planning on raising at $12.5M valuation again this year, but we got the lockdown and concerned about funding due to COVID19 situation. We decided to take a safer route and provide the discount to $7.5M valuation for the $250K we absolutely need for ongoing operational cost and raise the rest at the $12.5M valuation. - How will you make money? Revenue model is similar to HP model where there is upfront capital equipment cost which we intend to get to market as low as possible and possible on lease or per-use model. Then there are the single use items of disposable bath cover and amniotic fluid cartridges plus filter and other maintenance costs. We estimate that each operational unit can generate $60K in annual revenue. Thus 1000 operation units can generate $60M in recurring revenue. -Once you get approved to go to market, what are your revenue goals (not projections) for the first 5 years? - My goal is to have 1400 operational units in the US and 2000 in rest of the world. That would provide about $144M in revenue from both capital equipment and recurring revenue with up to 50% profit margin and earnings of $70M. With medical device companies trading at 10x earnings, that would place the company well in the $500M-$1B valuation for acquisition. Amir
- Q: Is it possible to still invest in Amnion? I joined Wefunder and you had already closed but after looking into it I would love to support.
  - A: Hi Mark - As of May 14th, 2020 we have started a new campaign. We would love to have you join us. Thank you
- Q: Do you intend to pay a dividend?
  - A: We are still very early in development phase and are at pre-revenue stage. Once we get the FDA approval, we will start revenue and will have to decide how to spend the funds for the company together with approval of the board. We have not made any decisions on dividends at this time.
- Q: What is the role of primary care in improving the quality of life? Do primary care physicians guide the patients about their as https://www.manhattanmedicalarts.com  minor health issues?
- Q: Is there any way that minimum investment could be reduced?
- Q: Hi Amir. I am glad to see that you recognized the need to step back and rest. Burn out is not fun. My question pertains to those of us who invested early. I received a note that said you were shutting the doors and my investment was lost. Now that you are re-opening, do you plan to honor earlier investments?
  - A: Hi Theresa. We did shut out R&D facility doors for a few months because of a lack of funds. But your investment in Amnion is only delayed and not lost. As soon as we have the new campaign and additional funds, we will be opening our doors again to continue our design and development. All intellectual property of the company (such as patents, designs, engineering, and research) is safely secured, maintained, and saved. Our equipment is also safely secured and insured until we are back up again. There is delay and time lost, but no dilution event for the investors and no significant setback in your investment because of the delay.
- Q: Do you plan on incorporating respiratory therapists into design and testing? As a NICU respiratory therapist, I feel that we are also an important role to consult with for patient safety and multifaceted care. Thank you!
  - A: Hi Stephanie, It will be essential for the device to allow adequate access to the infant for respiratory support. As such, we've incorporated design requirements for easy accessibility to the infant by our neonatologists on board. We don't have a NICU respiratory therapist consultant on board at the moment. The Amniobed Golden Hour model is essentially a device intended to prevent hypothermia and does not interfere in respiratory support. Except that hypothermia and heat loss are associated with increased oxygenation demands and fetal stress. Essentially, the device must allow easy access to the infant by neonatologists or respiratory therapists for respiratory support. This feature we have incorporated in the design. But we still have to do usability testing by actual NICU staff members to ensure the design meets the requirements. Once we move to more advanced stages of work on Artificial Placenta, there will be additional input needed in regards to respiratory support. But our focus right now is Amniobed Golden Hour.
- Q: Dear Mr. Fassihi, We do not have questions at all about this project and your enthusiasm. We only need to know when are you planning to close this round. We look forward to hearing from you at your convenience. Best regards, Mionk Inv.
  - A: Hi Arlet,We are planning on closing the round on October 15th, 2020.Thank you,
- Q: How infants going to Urinate & Deficate in the artificial womb? Taking into account it’s going to be filled with liquid.
  - A: Hi Dmytro,Infant urinating in the Amniobed is not a problem. The natural amniotic fluid in the womb is actually mostly made of fetal urine combined with sloughed off cells from the skin and lungs.  Regarding defecation, we have designed a fluid sensor placed beneath infant anus which detects stool in the fluid. If the infants defecates, it will signal to automatically flush the bath and replace the fluid with fresh synthetic amniotic fluid.Hope
  - A: Good afternoon - we answered the same question with another comment further down. Please see the answer posted there. Thank you.
- Q: Hi Amir, your concept of developing an Amnion Bed is incredibly interesting but I do have concerns regarding the infant's safety to start. What are the chances of an infant drowning? If an infant is not positioned properly or securely, how would a drowning incident be avoided? Would 24/7 monitoring of the infant in the fluid be needed? What are the costs of maintaining Amnion, with the replacement of amniotic fluid?
  - A: Good afternoon - we have another person who aready asked this question. Please see the question posted by Laura Seehausan from Feb 1st 2019. We have additional insights on our webpage. www.amnion.life thank you
  - A: Hi Nanthini, The risk of infant drowning is the most common question we get and naturally has been on top of our minds from day one. We have designed both mechanical and electronic mechanism to prevent infant drowning. The mechanical mechanism is comprised of chest and pelvic harnesses which are attached the single use bath cover. These harnesses are intended to keep the infant in place safely and securely similar to an infant car seat. The harness and cover are intended to maintain the infant in a proper and secure position at all times. The electronic mechanism consists of sensors on the infant shoulder and chin. The shoulder sensor is intended to ensure the fluid level does not drop low and the chin sensor is intended to ensure fluid level does not go above the chin line. Both sensors are connected to the device computer system and the device can automatically lower and increase levels and alarm the operator as needed. Don't forget that Amnoibed Golden Hour is intended for up to 60 minutes of use. It is intended to be used for a short period of time to prevent hypothermia immediately upon birth and prior to admission to the NICU or to replace radiant heat warmer during examination or procedures. The infant will not be left unattended on Amniobed Golden Hour model. Amniobed 24 Hour model however will be designed with the intention of incubating the infant for 24 hours or more with the possibility of leaving the infant unattended. The data from Amniobed Golden Hour and infant observations on thousands of infants for up to 60 minutes can help prove the safety and proper functioning of the sensors and computer system. That data will help us design trials for 6 hour and ultimately 24 hour testing and ultimately reach our goal so that we have a device that can safely incubate an infant for 24 hours or more without risk of drowning.
- Q: What were the results of the RedCrow financing?  Is there something about the company and/or business model that makes it less attractive to traditional institutional investors?  What's been the most common objection you've encountered?
  - A: Hi Howard, We were on Redcrow for only a few days. It wasn't the right platform for us as I was looking to rely on crowdfunding, while it turned out Redcrow is more crowdsourcing and it did not have the larger audience that a crowdfund site like Wefunder has . The Reg D offering on Redcrow we were pursuing was only available to accredited investors and there was a lot of limitations from SEC on us advertising for non-accredited investors. Each investor would have to go through a 3rd party accreditation confirmation which was a lot of work for small investments of less than $25K. Ultimately, I decided that I did not want to invest the time and energy to meet all the SEC requirements for Reg D raise there when we could do another Reg CF filing like we are doing here on Wefunder and freely advertise to general public without all the risks and limitations required for a Reg D raise. Top two most common feedback in terms of objections from institutional investors which I have gotten are 1) The management team (which means me), is working part-time and without salary. They want to see a full-time paid CEO in place. I don't think its necessary yet. It will become necessary when we do the institutional round and I am prepared to work full-time then or hire a full-time CEO when we do our Series A. 2) Market acceptance and penetration will be lengthy and difficult. Amir
- Q: hi if when you do another start up with this company please let me know when and with oh like wefunder etc etc ok i would love to invest in this company
- Q: Hi Amir, You have an excellent vision and product roadmap - Amniobed™ Golden Hour, Amniobed™ 24Hour, Amnioburn, Amniotransport, AmnioICU. You also have a good regulatory strategy. My question is: With a small and part-time executive team (even you yourself are part-time for Amnion Life), how can this startup’s vision, product roadmap and regulatory strategy be implemented? What is your overall plan to fulfill the slide “Projected Revenue & Operational Units” in your “Amnion_Life_Pitch_Presentation_2021_updated” presentation deck? Thank you! -John Hwung
  - A: Execution of this roadmap will require a full-time CEO to lead the endeavor and as you have mentioned, I have always worked part-time on Amnion and without salary to help focus resources on R&D. We never raised enough for us to do R&D plus hire an executive team. For the roadmap to happen, like any medical device company, we will need to get to a point where the product is developed enough for the institutional/VC funding round for clinical trials and regulatory undertaking. Finishing the prototype is the most important developmental step to get there which unfortunately was placed on pause during COVID and which we need to get back to ASAP. In order to undertake clinical trials and get regulatory CE regulatory approval in Europe, FDA approval in the US plus a full-time executive team, we will need a $5-$10 million raise. My goal is to get Amnion Life positioned for that larger raise by finishing the prototype. I intend to bring on board a CEO who would be willing to work without salary and as equity on compensation until our larger raise or if we can't find that person, do the raise and hire a CEO with our funding. Amir
- Q: Hi Amir, Very glad that you are back! I have invested in your prior round. You are one of the few shining & truly transformational medical technology startups that I have seen. I would hate to see your startup disappear. I also like your presentation. It’s better than the last round, especially with the references. But there are some errors (Several places where “The above is a rendering of a future Amniobed. Images are computer-generated demo versions. The product is still currently under development.” is mentioned, but there is no picture or rendering.) I have some questions on your patents and IP: How long do your patents last? How many pending patents do you intend to file? What is your patent strategy? How do you deter theft and encroachment of your IP? Wish you the best! John Hwung
  - A: Hi John, First, my apologies as I did not notice your two questions here from August. I must have missed the notification and I happened to be browsing here. Regarding picture or rendering of our product development, yes I should add an image of our prototype. We made this time lapse film in our facility in Serbia during our work which is even better but it was too large to place on the Powerpoint. Take a look. https://amnion.life/#1585589918991-ee2e94f5-385b . Thanks for the heads up. Regarding our patents, our first patent on Amniobed which was filed in 2015 will expire 2036-11-03. Other patents will expire after this date. Thank you for your investment and support. Amir