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.

This is my passion, to create medical devices that help these infants. When they're born, they are very susceptible to heat loss, fluid loss through evaporative water loss, and skin scaling. These lead to significant acute and chronic morbidities in these infants, such as chronic lung disease, brain hemorrhages, and sepsis.

The leading cause of death in the United States for infants is complications that arise after preterm birth. These infants are born healthy, but by the time they leave the hospital, many of them could have acute or long-term complications.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.