{"data":{"type":"company_profile_ai","id":27822,"entity_id":"wefunder:company:27822","attributes":{"canonical_url":"https://wefunder.com/amnion.life","retrieval_urls":{"canonical":"https://wefunder.com/amnion.life","json":"https://wefunder.com/amnion.life.json","markdown":"https://wefunder.com/amnion.life.md","ai_json":"https://wefunder.com/amnion.life.ai.json","ai_text":"https://wefunder.com/amnion.life.ai.txt","changelog_json":"https://wefunder.com/amnion.life.changelog.json","schema":"https://wefunder.com/.well-known/ai-profile-schema.json"},"updated_at":"2026-07-25T05:01:01Z","generated_at":"2026-07-25T14:41:56Z","profile_visibility":{"owner_published":true,"public_search_results":true,"site_search_listed":true,"privacy_mode":"promote","invite_only":false},"company":{"id":27822,"entity_id":"wefunder:company:27822","slug":"amnion.life","name":"Amnion Life LLC","tagline":"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.","location":"Newport Beach, CA","website":"https://amnion.life/","total_amount_raised":474883,"total_investors":415,"is_funded":false,"is_active":false},"key_claims":[{"claim_id":"claim-total-raised","text":"Total raised on Wefunder: 474883","citation":"https://wefunder.com/amnion.life#claim-total-raised","provenance":{"source":"FrontCompanySummary#amount_raised","last_verified_at":"2026-07-25T05:01:01Z","as_of":"2026-07-25T14:41:56Z","confidence":"high"},"observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-07-26T05:01:01Z"},{"claim_id":"claim-total-investors","text":"Total investors: 415","citation":"https://wefunder.com/amnion.life#claim-total-investors","provenance":{"source":"FrontCompanySummary#number_of_investors","last_verified_at":"2026-07-25T05:01:01Z","as_of":"2026-07-25T14:41:56Z","confidence":"high"},"observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-07-26T05:01:01Z"}],"verified_facts":[{"claim_id":"claim-total-raised","text":"Total raised on Wefunder: 474883","citation":"https://wefunder.com/amnion.life#claim-total-raised","provenance":{"source":"FrontCompanySummary#amount_raised","last_verified_at":"2026-07-25T05:01:01Z","as_of":"2026-07-25T14:41:56Z","confidence":"high"},"observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-07-26T05:01:01Z"},{"claim_id":"claim-total-investors","text":"Total investors: 415","citation":"https://wefunder.com/amnion.life#claim-total-investors","provenance":{"source":"FrontCompanySummary#number_of_investors","last_verified_at":"2026-07-25T05:01:01Z","as_of":"2026-07-25T14:41:56Z","confidence":"high"},"observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-07-26T05:01:01Z"}],"company_claims":{"tagline":"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.","story":"Amnion Life LLC has the mission to develop novel devices to decrease mortality \u0026amp; 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 \u0026amp; 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 \u0026gt;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 \u0026gt;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\u0026amp;oq=Amnion+Life+LLC Patent No. No. 2018-521506 issued August 28th, 2020https://patents.google.com/patent/JP6755949B2/en?assignee=Amnion+Life+LLC\u0026amp;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).\u0026amp;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).\u0026amp;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. 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Raising capital to finish the prototype."]},"computed_metrics":{"total_amount_raised":474883,"total_investors":415,"team_size":4,"featured_investor_count":1,"faq_count":5,"recent_post_count":0},"quick_facts":[{"claim_id":"claim-fact-1","value":"In Amniobed, the preterm infant is partially submerged in synthetic amniotic fluid.","citation":"https://wefunder.com/amnion.life#claim-fact-1","observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-08-01T05:01:01Z"},{"claim_id":"claim-fact-2","value":"Amniobed is intended to prevent hypothermia in preterm infants and decrease environmental heat loss.","citation":"https://wefunder.com/amnion.life#claim-fact-2","observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-08-01T05:01:01Z"},{"claim_id":"claim-fact-3","value":"Hypothermia leads to poor medical outcomes and an increased chance of infant death.","citation":"https://wefunder.com/amnion.life#claim-fact-3","observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-08-01T05:01:01Z"},{"claim_id":"claim-fact-4","value":"Strong patent portfolio with multiple patents in the US, China, and Japan and pending in Europe.","citation":"https://wefunder.com/amnion.life#claim-fact-4","observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-08-01T05:01:01Z"},{"claim_id":"claim-fact-5","value":"Studies have shown 40% of infants admitted to the NICU from L\u0026amp;D are hypothermic in 1st hour of life.","citation":"https://wefunder.com/amnion.life#claim-fact-5","observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-08-01T05:01:01Z"},{"claim_id":"claim-fact-6","value":"Significant calorie loss in the NICU leads to diminished weight gain and longer hospital stays","citation":"https://wefunder.com/amnion.life#claim-fact-6","observed_at":"2026-07-25T05:01:01Z","expires_at":"2026-08-01T05:01:01Z"},{"claim_id":"claim-fact-7","value":"3 Years of R\u0026amp;D. 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This is a great innovation ,Would there be a chance of bringing minimum to $100 or $200.","answer":"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."},{"question":"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?","answer":"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..."},{"question":"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?","answer":"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..."},{"question":"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 ...","answer":"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..."},{"question":"I'd like to know the current price per share before I invest.","answer":"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..."}],"recent_posts":[],"provenance":{"source":"wefunder_public_company_profile","as_of":"2026-07-25T14:41:56Z","claims":{"total_amount_raised":{"source":"FrontCompanySummary#amount_raised","last_verified_at":"2026-07-25T05:01:01Z","as_of":"2026-07-25T14:41:56Z","confidence":"high"},"total_investors":{"source":"FrontCompanySummary#number_of_investors","last_verified_at":"2026-07-25T05:01:01Z","as_of":"2026-07-25T14:41:56Z","confidence":"high"},"active_raise_states":{"source":"Fundraise.visible(nil, nil)","last_verified_at":"2025-02-06T01:17:55Z","as_of":"2026-07-25T14:41:56Z","confidence":"high"},"latest_fundraise_state":{"source":"Fundraise.visible(nil, nil).order(funding_started_at)","last_verified_at":"2025-02-06T01:17:55Z","as_of":"2026-07-25T14:41:56Z","confidence":"medium"}}}}}}