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Many have asked if there are any other groups working on an artificial womb, like we are doing at Amnion Life.
The answer is' yes'. As far as we know, there are university groups working on an artificial womb for preterm infants. The first group is at U. Pennsylvania (Children's Hospital in Philadelphia) led by Dr. Partridge and Dr. Flake. Another group is at the University of Eindhoven in Holland led by Dr. Oei. Here is a recent article on their work. There are also projects to build an artificial placenta at UCSF and the University of Michigan. All these groups however are University research-based and as far as we know, their work has not spun off into medical device companies.
The University of Eindhoven received a 3 million Euro grant last year to work on an artificial womb. Of note is that they estimate 8 years to clinical trials.
"Over the next eight years, we're going to develop these technologies, and come up with the first prototypes of the artificial womb. Once these have been carefully tested, we want to help the first extremely premature baby in our artificial mother in eight years' time in the first clinical tests. That's quite the challenge," says Dr. Oei."
As most of you are aware, there are two main components to an artificial womb, The first component is the fluid sac in which the infant is placed. The simulated amniotic fluid needs to be temperature and osmolarity controlled. Amniobed is such a device. I am proud to say that we started on this path nearly 4 years ago and we are at the tail end of our work and preparing for clinical trials for Amniobed for 2021.
The second component of an artificial womb is an artificial placenta for oxygenation and nutrition of the infant. In 2018, I diverted Amnion Life's focus and resources for about 6-9 months to work on an artificial placenta. At the time, I was rather nervous about this diversion as I was told repeatedly that startups should just try to do one thing and should not lose focus. Yet, despite the university level research, there were no groups actively working on a commercial artificial placenta device and there were no good patents on the topic. During those months, with Milos Radovanovich and the help of our team in Serbia and feedback from our neonatologists in Canada and Japan, we designed an artificial placenta as a natural extension of Amniobed to complete an artificial womb.
In the article above, it states they will spend a year on computer modeling of birthing procedure on how a preterm infant is placed in an artificial womb upon birth. I would do deep meditation on this topic, placing myself first as the fetus/infant, then the doctor, nurse, respiratory therapist now trained on the artificial placenta, and finally the placenta itself leaving the womb and how it should be treated. We went through all the required elements of a device and came up with solutions to every challenge. In January 2019, we submitted our design as a patent application to the US Patent Office and the world body WCT.
We were happy to find that both the USPO and WCT found our claims to be novel and non-obvious on the first review and we were granted US Patent 10441490B2 which expires in 2039. But that project is on hold again until we have a larger round with more money and can devote the necessary resources. With the engineering and design and development process which we have in place at Amnion, it should take us 18 months to build our prototype and be ready for animal trials. We can then start clinical trials in extremely preterm infants, far shorter than 8 years anticipated by U. of Eindhoven. I don't know how far along other groups are on this.
I sometimes feel like that one day in the future, there will be a PBS Nova episode on the competition to build the artificial womb and I wonder how the story for that episode will shape itself and how we will play our part in this endeavor.
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Amir Fassihi M.D.