Amnion Life: Safer, fluid-filled incubator to keep premature infants healthy

Molly Ferris

Business & Market Development Consultant

Expertise in strategic planning, pre-commercial regulatory, market entry alignment, medical industry

Mohamed Zitouni

Procurement and Supply Chain Specialist

17 years experience in supply chain, Focus on technology, consumer products, and industrial systems

Joginder Mittal

Risk Management and Analysis, Hazard Identifion

Pharmaceutical/Medical Device Consultant, 15 years experience implementing Quality Management System

Investor Q&A

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What does your company do?

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 mimics a mother's amniotic fluid.

Where will your company be in 5 years?

The world is in desperate need of more sophisticated infant care. Despite ongoing technology advancements, current incubators have many deficiencies that put preterm infants at risk for serious organ injuries and even death. We believe our patented AmnioBed design can save lives, reduce complications, improve short- and long-term outcomes, and decrease costs for millions of infants born preterm every year.

What is Amnion Life?

Amnion Life is a company that was established in 2016 to create a new set of medical devices for preterm infants, particularly very preterm and extreme preterm infants. These infants are very vulnerable to the environment when they're born. We aim to create medical devices that are closer to the environment they resided in before birth.

What is your background?

I'm a medical doctor. I went to UCLA for my undergraduate work and to UC San Francisco for medical school. I went to Keck USC to do a specialty in radiology, and later a sub-specialty in neuroradiology.

Why did you create Amnion Life?

In 2013, on a long family trip, I had a dream where an imaginary medical school classmate told me that his daughter was born preterm and she suffered in the NICU and should have been in synthetic amniotic fluid and he is developing a device for it. I told him, that's great, I wish I had thought of it, what are you calling it? He said Amnion and I woke up. Since then, I became obsessed and passionate about developing the next generation of medical devices for preterm infants to make their NICU stay more comfortable.

What complications can arise after preterm birth?

During the last month of pregnancy, significant organ development is happening. Some of the organs are very underdeveloped, everything from brain to lungs to GI tract, but skin is particularly very significant because that's our connection to the environment.Preterm infants have underdeveloped skin, so they lose a tremendous amount of heat. They don't have the subcutaneous fat that insulates them and protects them from heat loss. Their skin is permeable to water, so they're losing insensible water to evaporation, and that's a tremendous amount of heat. They don't have shivering mechanisms to keep them warm. They don't have the muscular-skeletal movements. They don't have the brown fat that is used to generate heat. So, they have episodes of hypothermia, and when they do, they start burning calories in order to stay warm. They’re burning up calories for heat that are actually intended for growth and development. And they can't maintain their temperature, which leads to all kinds of complications, from brain hemorrhages to chronic organ injuries. These could be both acute and long-term.

How many babies suffer from preterm birth complications?

About 388,000 infants are born preterm every year in the United States, and about 110,000 of them are very preterm, which is less than 32 weeks, and about 30,000 of them are extreme preterm, which is less than 28 weeks. On average, these infants are staying in the hospital about 46 days. The reason it's so high is because the very preterm and extreme preterm are having disproportionately long stays in the NICU. In the state of Florida, for instance, the average length of stay for an extreme preterm infant is 110 days. So, these infants are in the hospital all the way to 46 weeks of gestation, when they should have been discharged home at 36 weeks. They don’t have the growth rate that is expected in the womb, and then there are all the complications we talked about. The cost of NICU for 110 days is extremely high. The average cost is estimated to be about $3,500 to $4,000 a day, but it can range anywhere from $2,000 to $8,500 a day. The economic cost for society is tremendous. We've realized that if we can reduce the length of stay for these infants by just three days, about $1.1 billion will be saved. That's just the savings on the short-term care. That's not including all the long-term chronic injuries that require health and social care in the future. As far as the complications with these infants, the highest cause of cerebral palsy in society is preterm infancy. It can cause cerebral palsy, infant death, chronic lung injuries, and chronic developmental injuries in the brain that are less severe but still debilitating. Therefore, the device creates not only an economic positive aspect, but also a social positive aspect and direct medical benefits.

What is being done now to care for preterm infants, and where did you see a need for improvement?

So, the solution is to try to keep the infants as warm as possible after they’re born. Right now, they wrap them up in what looks like plastic wrap. In the U.S., they basically slide them into plastic wrap. In Japan, they wrap them up like a sandwich. However, it's a very unnatural environment for these infants, and there’s a risk of skin injuries while you're putting the plastic on, putting them in the bag, or taking them out. After being wrapped, they are placed in a radiant warmer, which is a heat lamp that is one form of an incubator. This is a short-term solution and allows you to examine the infants and make sure they’re stable and don’t need direct intervention. Once the infants become stable, you remove the plastic wrap in order to prevent hypothermia, and then you move them into boxes with portholes that are warm and humidified. The issue with that is the fluctuations in temperature inside of the incubator. Sometimes, these infants need to be accessed once an hour. Every time you open the portholes, drafts of cold air come in, and it takes about 20 minutes for it to rebalance to the perfect temperature. In developing nations, where they don't have access to the advanced technology, the mother just keeps the infant warm. That’s called kangaroo care and is often quite effective. Unfortunately, in the extreme preterm, it’s not adequate at times. You can lose a lot of heat in the handling of the infant.

How does Amnion Life improve preterm infant care?

The most important thing that we're trying to do is to create an environment that keeps the infant at a perfect 37-degree Celsius temperature, which is the mother's amniotic fluid temperature. We set out to build a device, the AmnioBed, that is safe to put an infant in and effective in preventing heat loss. We think that if we can decrease the episodes of hypothermia, we can decrease the length of hospital stays for the infants.We want to increase the velocity of growth for these infants in the hospital. They are born at 50th percentile height and weight. They weren't born because of anything that was wrong with them; something just went wrong with the pregnancy. It could be multiparity, twins, triplets, or events that are dangerous to the mother's health. So, these infants are born in the 50th percentile, and by the time they leave the hospital, they're in the lowest 10th percentile in height and weight. They go home much smaller in development and are behind their peers. That's if they didn't have any of the organ injuries that may have been caused. We think that we can build a device that's safe, effective, and superior that will keep the infants warmer and will decrease the length of hospital stays. Other potential advantages of our device would be food management for these infants. Right now, they are getting a lot of IV saline through their veins, to replace the water that they're losing. However, IV saline has been associated with chronic lung disease for these patients. It’s problematic when infants are given large amounts of water and sodium chloride without the other minerals and things needed for their proper plasma combination. We're creating fluid that actually replicates the amniotic fluid and the minerals and electrolytes it contains. This is a new way of approaching it, where we're submerging the infant partially in fluid for temperature regulation and fluid management, as opposed to a heated box.

What is the history of incubator development for preterm infants?

The first incubator was invented in Paris in 1882 by Stéphane Tarnier. Before then, about 90% of preterm infants died. He showed that we can decrease the mortality of these infants from 90% to less than 20%. The incubator was taken to world fairs and to Coney Island. They'd put these preterm infants on display for people to see. There are actually a lot of historical photographs of them. In the 1930s, they tried to humidify these incubators, and then realized that once you do that, you're actually developing bacterial colonization. This is very dangerous to the infants. So, by the 1950s, incubators weren’t incubated more than 50%, which is right now the current standard. In the late '90s, more computerized incubators were created. Right now, the top of the line incubator, GE incubator, Giraffe OmniBed, is a combination of a humidified chamber and also a heat lamp. It can change into a radiant warmer, so it's a combination of the two. That's the main one. The main European company doing incubators is Dräger, and the main Japanese company is Atom Medical. Then there are a number of smaller Chinese and Indian companies making incubators for the less developed markets.

When water is known to transfer heat much more efficiently than air, why has nobody else done this? Were you the first to think about actually incubating a baby in an environment similar to the womb?

There have been attempts at the university level on goats and sheep, but no one has taken the step to do a commercial version. I think commercially, this is one of those projects that is too big for an individual entrepreneur. Also, maybe the bigger companies like GE and Johnson & Johnson don't invest in these very early-stage ideas. Somebody has to do this, and say, "Okay, I can take this to the FDA globally. I can create a business model, and I can make a company from it." I had this dream that woke me up one night about four years ago. There was passion inside me that was a driving force to make me do it, where others were too afraid to take a step, perhaps. That's the best explanation I can think of.

Can you explain the details of the AmnioBed?

The AmnioBed is a new technology in incubators. It’s more complicated than most medical devices that come onto the market from an entrepreneur with an idea. They’re usually much simpler medical devices that you can use in the surgery room and things like that. This is a very complex medical device. It has more than 13 systems. The device is connected to a hospital water supply and waste line, just like a washing machine or any other appliance is. We are basically using the same technology that is used for dialysis machines. The device purifies the hospital water by taking it through five or six medical grade filters. It completely eliminates all harmful substances, bacteria, and viruses that may be in the water supply, including any hard minerals, heavy metals, and things like that. The purified water is the same quality as the dialysis water that can actually touch the blood. That water is warmed to the proper temperature, and using a dosing pump, it is mixed with a solution that is a concentrated electrolyte and mineral solution. In pregnancy, the electrolyte mineral content changes over 23 weeks to 36 weeks. So, with our computer system, we have to give the operators, the doctors, the option to choose the level of osmolality they want in that fluid, according to the age of the infant. Infants will be absorbing nutrients through the skin, instead of through IVs, as is done now. The solution is used to prepare a bath for the infant. This bath has a sterile cover that comes on first. The infant sits on the sterile cover. It has a harness that straps the infant’s chest and pelvis in place, so the infant can never be submerged into the pool. It's similar to a child's seat on a car, where you don't have to worry about your child falling off the chair if you look away. This is the same idea. Then a cap is placed on the top of the infant's head. It covers most of the scalp, and there's a strap that goes around the chin. This cap has EKG monitoring and EEG monitoring, if you're planning on using that. EEG monitoring is not routinely used in the NICU, but we think routinely monitoring the brain waves could be beneficial. That's going to be in the design, and we'll see what happens in the clinical trials. There's also a skin temperature sensor on the cap, as well as an O2 monitoring sensor. Then there's a fluid sensor that comes under the infant’s chin to make sure that the fluid in the bath never goes above the chin level. If it does, a computer will automatically lower the infant, and alarms will go off for the nurses, basically. The infant is sitting on a comfortable, donut-shaped pad, in a semi-flexed position, where the head is above the fluid level. Beneath the pelvic area, there are fluid sensors that will detect the clarity of the fluid. If there's defecation by the infant, there's automatic detection of the stool in the fluid, automatic flushing of the fluid, and an automatic replacement with fresh fluid. This has many advantages. One is that one of big issues that these infants have is diaper dermatitis. Their stool is very alkaline, and it causes alkaline burns that are really difficult to treat and can become chronic. They can cause infections in the skin that go into the blood and may cause sepsis and death. Also, nurses usually need to change the infant’s diaper and clean them once an hour. We're actually helping a lot with nursing in this. When the infant's not in the bath, a cartridge goes in to clean and disinfect the whole thing. Then there's a computer system with a touch screen where the doctor can choose the osmolality or other functions that are associated with it. You can also close the dome on the top of the infant’s head to protect her/him from noise. So, it's a quieter environment. Also, we’re designing an audio/video direct feedback inside the incubator that can be placed on an app for the mother to be able to be in constant contact with the infant. This is designed to help with the emotional pain and stress that these mothers are under, and also helps with the infant’s brain development.

Are you planning to create other products as well?

We are actually designing a second device right now. We’re currently just calling it an artificial placenta. It's a nutrition and oxygenation machine that will be hooked up to the umbilical vessels. It will replicate how the fetus is oxygenated through the umbilical vessels. The current technology attempts to oxygenate the infant through underdeveloped lungs, and it is causing short-term, acute, and chronic lung injuries. Also, the fluctuations of oxygenation levels are causing brain hemorrhages and other neurological issues. Our artificial placenta device is going to be entirely changing the whole oxygenation and nutrition system that is currently used. We're also going to be redesigning all the monitoring devices for the AmnioBed, from the EKG monitoring to the EEG monitoring. Everything has to be changed to fit the fluid incubator. The catheter system is going to have to be redesigned to meet our incubator needs. So, we're going to be doing all that. Another device we’re considering further out is an AmnioBed for adults. We think there could be a need for the same technology in the burn units, the IC units, and the long-term care units, where patients may have issues with nursing, pressure sores, bed sores, and ulcerations in the back.

What has been the timeline for developing the AmnioBed prototype, and what will it look like going forward?

I started the company in April 2016. In order to create such a complex product, I knew I needed to have a new way of thinking about how a company could be run. Really, the new thing is the gig economy. The freelance, contract work economy. Basically, that's how I've been working. I've been working with engineers across the world on this. I found a lot of good engineers in Serbia, for instance, who were very dedicated to this project. One person in particular, Milos, had quite a talent for getting things done. He became my lead engineer. We created an R&D facility in the town that he is in, which is Požega, Serbia. We have about three or four full-time engineers now over there, and we have about five or six other engineers across the world. Over the last year, we completely designed the device. We basically sourced procurement of the parts. We've done the CAD drawings (computer-aided design), and we actually built the first prototype in April. So, we have the first working prototype right now. Over the next six to 12 months, we're going to be doing the engineering testing on this prototype. We’ll do all the electromagnet testing, all the electrical testing, all the things that can be done in our R&D facility in Serbia. We're planning on submitting our first pre-sub application to the FDA in the fourth quarter. In these pre-sub applications, there are two things that we're going to be discussing with the FDA. First, we're going to go over the design and all the safety testing that we're planning over the next six to 12 months for the approval. We need to make sure we meet all the American and European standards and guidelines. The second thing is that we're going to be proposing the clinical trial protocols, how we're going to be going about testing this with the FDA. They need to approve it as well. That's a 90-day turnaround for the FDA. Once they give us those approvals, then we're going to be presenting our first investigational drug exemption application to the FDA. This is the first application that allows us, for the first time, to test the device on a human being. We are hoping that will be next June, about 11 months from now. We have to decide on where that will be. Once that is done, over the six months to 12 months after that, we're going to be doing a pilot study to show this is safe and effective in a small cohort of patients. That study will consist of 10 patients. Then, for the pivotal study, we will repeat it for 100 to 200 patients. That study will need a budget of at least $2 million to $5 million. Right now, we have money for the next six months or so. We've raised a million dollars through two rounds, so we foresee that we have enough of a cash cushion until the end of 2018. We now want to raise $500,000 for the first six to 12 months of 2019, or until we’ve done the first human trial. We’ll have the 10-patient pilot study, and then, when we get to the pivotal study of 100 to 200 patients, we’ll need the big money. At that time, we're going to show it to the investors and say, "Look, we've proven that we can build this safe device that's effective and superior in 10 patients. Now we need the money to do this with 100 to 200 patients." That pivotal study will be about six to 12 months. Then we'll be ready to send in another FDA application, and should get the FDA's response four to six months after that.

When would you expect for investors to see a return on investment?

After three to five years, we're going to know whether we've built a safe, effective, and superior product and whether the market has accepted it. We’re starting with a market in the U.S. That timeframe is when we're going to be ready for an acquisition, or the next steps for the company. That's when I think investors will see the return on the investment. We need one or two years of further research and development, and then two to three years to take care of the reimbursement mechanism and also get the market share that's needed.

Do you have competitors with similar devices?

GE is currently not doing any further research. The kind of technology they have, they acquired from a startup like ours in 2003. As far as I know, none of the other incubator makers are really doing R&D in this field. There is only one other group that has been working on this idea. It’s a University of Pennsylvania group at The Children's Hospital of Philadelphia. That's a very interesting story, because they created a device that was a little bit different than our device, but they actually tested it on lambs. They showed that these lambs can thrive in the fluid environments for weeks. There was a paper that came out in Nature Journal last April that got tremendous publicity. All the major news outlets picked it up, from NPR to CNN to The New York Times to the L.A. Times. This was a big deal, that for the first time, basically preterm lambs were placed in a fluid environment. Their technology is different from ours, as it is a closed incubator system, as opposed to our open incubator system. In their closed incubator system, the entire infant is submerged into a closed bath, where there's no access to that infant anymore except for portholes. They designed it this way because there's a risk of infections going into the infant’s mouth and into the lung, since the head in their system is submerged. In our system, the head is never submerged. We have safety mechanisms to ensure that, so then we can take the infants in and out. They're the only other group that has done anything similar, but they are a university group. They're not a company, and they're not after commercial aspects. Also, although they have applied for a patent, they have not been able to get it yet. We are way ahead of them, both in terms of technology and Intellectual Property. We were able to establish a very strong patent. We're represented by Knobbe Martens, which is one of the premier IP healthcare patent firms in the country. Still, one of the worries is always somebody trying to do a knockoff. They won't be able to do it in the U.S., Europe, or Japan, but there are other places where somebody could attempt it. There are some horror stories out there.

Do you have any other worries?

The most important concern is for safety. We have to make sure this is a safe device. If you're going to put thousands of infants in this device every day, it has to be done perfectly right. So, I worry about making sure we don't miss anything in our risk management and quality management. Another worry would be not having enough investor support to get through this. I think that it's a long road ahead. Things in life always take longer and cost more than you expect. That's just a fact of life. You always come across that, and you have to be prepared for it. Luckily, I've had a tremendous amount of investor support thus far, in very quick spurts of fundraising. I’m hopeful that I can continue having that, but that's what really keeps any CEO awake at night, "How am I going to fund the next milestone? Am I getting to the next milestone? Am I going over budget or over time?" That's the biggest day-to-day worry.

What does the life cycle look like for a company like you? Let’s say it's all working, and the FDA's fast-tracking you. What happens then?

There are several exit points for a medical device company. The earliest exit point is once you file your patent. Some people get to that point and say, "I'm willing to sell this. I can't handle this myself." Then there are people like me who come in and say, "I can take care of this. I can build a company." Then the next big milestone at that point is FDA approval. A large percentage of medical device companies decide to exit as soon as they get their FDA approval, because they don’t feel they can take it to the next level. The next level after the FDA approval is the reimbursement approvals from CMS, which takes another year. Then you can bill, and insurance companies can pay. That's a big milestone also in acquisition. Then, if you're going to stay in the business after that, you have to do marketing. Usually they say you need to do a $3 million to $5 million raise for a U.S.-wide marketing campaign. If you can market it and you can sell it, the valuation goes up significantly. The next exit point would be one or two years into marketing, where you can actually show the earnings that the acquirers are looking for, strategically anyway.

What gave you the confidence to start this company?

As I mentioned, I'm a medical doctor by background. I'm still a full-time radiologist. I work mostly from home, in the evenings and weekends, and I don't take a salary from Amnion. I have the medical understanding of what needs to be done and where this company needs to go, but also, my passion has always been managing teams and managing people, which is what I'm doing right now with Amnion. I love getting people to be the best they can be, creating an environment where they can blossom and create things. Luckily, everybody loves working on this project. It's a wonderful project to be a part of, and the environment is healthy for my engineers. They're comfortable, they can think, they can be creative, and they can be organized. I also spent a lot of years working on the side as an activist for Iranian freedom. I spent my 30s reading a lot of books, and I wrote a long book on Iran, non-violence, and violence in humanity. So that process gave me the wisdom and maturity to make sure I realize what's important and what's not important, and how to take care of people and take care of a company. In my early 30’s, I didn’t have the wisdom I have now. Even if I had the same talent, the same time, the same energy, and the same passion, without the wisdom, I don’t think I could be doing what I’m doing now. I’m at the right place in life now where I can focus on this, and I'm passionate about it. I'm in the unique position of having the talents and passion to start this company, and it's the right time for me to do it.

1	Raised $1M in two previous rounds.
2	Key innovation: partially submerging infant in synthetic amniotic fluid that replicates the temperature and environment of the womb.
3	Built prototype in April 2018. Currently in pre-clinical tests.
4	Conservatively, 3-day reductions in the NICU will result in over $1.1 billion in savings associated with preterm infants worldwide.

1	The medical device being developed may not pass the FDA requirements for safety and efficacy and may not receive the required regulatory requirements for sales and marketing of the device.
2	The Company may never receive a future equity financing or elect to convert the Securities upon such future financing. In addition, the Company may never undergo a liquidity event such as a sale of the Company or an IPO. If neither the conversion of the Securities nor a liquidity event occurs, the Purchasers could be left holding the Securities in perpetuity. The Securities have numerous transfer restrictions and will likely be highly illiquid, with no secondary market on which to sell them. The Securities are not equity interests, have no ownership rights, have no rights to the Company’s assets or profits and have no voting rights or ability to direct the Company or its actions.
3	Our future success depends on the efforts of a small management team. The loss of services of the members of the management team may have an adverse effect on the company. There can be no assurance that we will be successful in attracting and retaining other personnel we require to successfully grow our business.
4	The anticipated clinical trials do not confirm the safety and efficacy of the device. There is considerable harm and danger realized associated with the device which cannot be mitigated.
5	Competitors successfully challenging Company's patent and other intellectual properties and entering the market with similar devices.
6	Clinical Trials for the device do not meet Superiority classification requirements compared to previous devices currently on the market.
7	Amir Fassihi is a part-time officer. As such, it is likely that the company will not make the same progress as it would if that were not the case.
8	We have not commenced commercial operations to date and our future profitability is uncertain.
9	We are primarily dependent on the success of our lead product candidate, AmnioBed, which is still in clinical development, and this product candidate may fail to receive marketing approval or may not be commercialized successfully.
10	We are an early-stage medical device company with no approved products and no historical product revenue, which may make it difficult for you to evaluate our business, financial condition and prospects.
11	We expect that we will need further financing for our existing business and future growth, which may not be available on acceptable terms, if at all. Failure to obtain funding on acceptable terms and on a timely basis may require us to curtail, delay or discontinue our product development efforts or other operations. The failure to obtain further financing may also prevent us from capitalizing on other potential product candidates which may be more profitable than AmnioBed or for which there may be a greater likelihood of success.
12	We depend on third parties for clinical and commercial supplies, which could affect our business. We also rely on third parties to conduct our preclinical studies and clinical trials.
13	If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
14	We may be exposed to claims and may not be able to obtain or maintain adequate product liability insurance.
15	We depend on skilled labor, and our business and prospects may be adversely affected if we lose the services of our skilled personnel, including those in senior management, or are unable to attract new skilled personnel.
16	Our employees and our independent contractors, principal investigators, CROs, consultants or commercial collaborators, as well as their respective sub-contractors, if any, may engage in misconduct or fail to comply with certain regulatory standards and requirements, which could expose us to liability and adversely affect our reputation.
17	We may acquire businesses, products or product candidates, or form strategic alliances or create joint ventures, in the future, and we may not realize the benefits of such transactions.
18	System failures may disrupt our business operations and delay our product development programs and commercialization activities.
19	The marketing approval processes of the FDA and comparable regulatory authorities in other countries are unpredictable and our product candidates may be subject to multiple rounds of review or may not receive marketing approval.
20	We may be unable to continually develop a pipeline of product candidates, which could affect our business and prospects.
21	Our preclinical studies and clinical trials may not be successful and delays to such preclinical studies or clinical trials may cause our costs to increase and significantly impair our ability to commercialize our product candidates. Results of previous clinical trials or interim results of ongoing clinical trials may not be predictive of future results.
22	We are planning to pursue the FDA De Novo pathway for all of our current product candidates. If we are unable to rely on the De Novo regulatory pathway to apply for marketing approval of our product candidates in the United States, seeking approval of these product candidates through the PMA pathway would require full reports of investigations of safety and effectiveness, and the process of obtaining marketing approval for our product candidates would likely be significantly longer and more costly.
23	We may encounter difficulties in enrolling patients in our clinical trials, which could be detrimental to business.
24	We have conducted, and may in the future conduct, clinical trials for our product candidates outside the United States and the FDA may not accept data from such trials.
25	Our facilities are subject to extensive and ongoing regulatory requirements and failure to comply with these regulations may result in significant liability.
26	Our current pipeline product candidate, AmnioBed, requires extensive clinical data analysis, regulatory review and additional testing. Clinical trials and data analysis can be very expensive, time-consuming and difficult to design and implement. If we are unsuccessful in obtaining regulatory approval for AmnioBed does not provide positive results, we may be required to delay or abandon development of such product, which would have a material adverse impact on our business.
27	Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval.
28	Even if we obtain marketing approval for our product candidates in the United States, we or our collaborators may not obtain marketing approval for the same product candidates elsewhere.
29	The terms of approvals, ongoing regulations and post-marketing restrictions for our products may limit how we manufacture and market our products, which could materially impair our ability to generate revenue.
30	Our products may not achieve market acceptance, which would be essential to our company's success. Furthermore, We may not be able to respond effectively to changing consumer preferences and demand.
31	The commercial success of our medical device products depends on the availability and sufficiency of third-party payor coverage and reimbursement.
32	Our products may be subject to reduced prices negotiated by certain group purchasing organizations that could adversely impact our product revenue.
33	We may not be able to build our marketing and sales capabilities or enter into agreements with third parties to market and sell our medical device products.
34	The off-label use or misuse of our products may harm our image in the marketplace, result in injuries that lead to costly product liability suits, or result in costly investigations and regulatory agency sanctions under certain circumstances if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
35	Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review.
36	If our product candidates are approved for commercialization outside of the United States, we may be exposed to a number of risks associated with international business operations.
37	If the FDA or comparable regulatory authorities in other countries approve generic versions of our product candidates, or do not grant our product candidates a sufficient period of market exclusivity before approving their generic versions, our ability to generate revenue may be adversely affected.
38	Our medical device products may be subject to recalls, withdrawals, seizures or other enforcement actions by the FDA or comparable regulatory authorities in other countries if we fail to comply with regulatory requirements or previously unknown problems with our medical device products are discovered after they reach the market.
39	We may not be able to engage third-party CMOs to manufacture our approved medical device products on a commercial scale to meet commercial demand for our medical device products.
40	Our commercial success depends largely on our ability to protect our intellectual property.
41	If we are unable to protect our trade secrets, the value of our AmnioBed technology and product candidate may be negatively impacted, which would have a material and adverse effect on our competitive position and prospects.
42	We may become involved in litigation to protect our intellectual property or enforce our intellectual property rights, which could be expensive, time-consuming and may not be successful.
43	We may be subject to claims that our employees or consultants have wrongfully used or disclosed to us alleged trade secrets of their former employers or other clients.
44	We may be subject to claims from third parties that our products infringe their intellectual property rights.
45	Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
46	If we fail to comply with various procedural, document submission, fee payment or other requirements imposed by the USPTO or comparable patent agencies in other countries, our patent protection could be reduced or eliminated.
47	Changes in patent laws or interpretations of patent laws in the United States or elsewhere may diminish the value of our intellectual property or narrow the scope of protection of our patents.
48	We may not be able to enforce our intellectual property rights throughout the world, which may be problematic.
49	We need to protect our trademark, trade name and service mark rights to prevent competitors from taking advantage of our goodwill.
50	We are subject to various laws and regulations, such as healthcare fraud and abuse laws, false claim laws and health information privacy and security laws, among others, and failure to comply with these laws and regulations may have an adverse effect on our business.
51	Our failure to comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
52	Legislative or regulatory reform of the healthcare system in our target markets may affect our operations and profitability.
53	Healthcare laws and regulations may affect the pricing of our medical device products and may affect our profitability.
54	Our management has broad discretion in using the net proceeds from the initial public offering and may not use them effectively
55	We may never receive a future equity financing or elect to convert the Securities upon such future financing. In addition, we may never undergo a liquidity event such as a sale of the Company or an IPO. If neither the conversion of the Securities nor a liquidity event occurs, the Purchasers could be left holding the Securities in perpetuity. The Securities have numerous transfer restrictions and will likely be highly illiquid, with no secondary market on which to sell them. The Securities are not equity interests, have no ownership rights, have no rights to our assets or profits and have no voting rights or ability to direct the Company or its actions.

Date	Amount	Security
	$5,000	SAFE
04/2018	$761,000	Convertible Note
09/2018	$250,000	Convertible Note

$200,000	50% Engineering and Pre-clinical Safety Testing, 25% Clinical Trial Protocol and Preparation, 20% Regulatory and Risk Management, 5% Wefunder Intermediary
$1,070,000	50% Engineering and Pre-clinical Safety Testing, 25% Clinical Trials, 20% Regulatory and Risk Management, 5% Wefunder Intermediary

Class of Security	Securities (or Amount) Authorized	Securities (or Amount) Outstanding	Voting Rights
Class B Units	292,812	292,812	No
Class A Units	1,000,000	1,000,000	Yes

Why you may want to support us...

Our Team

And Our Major Accomplishments

Some of our investors

we've raised $1,316,892 from 184+ investors since our founding

In the news

Premature Birth is the #1 Cause of Infant Death

Current incubators aren't good enough.

The Solution: AmnioBed

How it Works

Our Journey

Other Applications of Our IP

Let's Build a Better Solution for Premature Infants

Investor Q&A

Financials

At a Glance

Risks

Details

The Board of Directors

Officers

Voting Power

Past Equity Fundraises

Outstanding Debts

Related Party Transactions

Use of Funds

Capital Structure

Form C Filing on EDGAR

Thank you!

Thank You To Those Who Invested - Campaign Is Closing Soon

Our Wefunder Campaign Ends April 15th - Hurry Up And Invest Today

Recent Interview With Our Founder, Dr. Amir Fassihi - Building A Foundation For Success.

Join Us For A Live In-Person Presentation - March 17th in Orange County, CA.

Campaign Update #8 - Rocket Dollar Featured Amnion Life's Wefunder In A Recent Article

Campaign Update #7 - Amnion Life Chosen To Attend MedTech Innovator 2019

Campaign Update #6 -We were chosen as a finalist in the UCSF-Stanford Pediatric Device Consortium competition.

Campaign update #5 - Our Founder Was Nominated As A Top Entrepreneur...

Campaign Update #4 - Join Us For A Live Presentation in Costa Mesa, CA

Campaign Update #3 - KingsCrowd Recommends Us - Top Pick!

Campaign Update #2 - Exciting News! Read All About It...…… Announcement:

Campaign Update #1 - We reached over $100,000 dollars. Thank you...

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Notes from investors

In the news

Amir applied to Wefunder

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