James McGlone 0:04
There's a healthcare crisis across the world, which does not get a lot of talk. And it affects millions. And that's prematurity. There are 15 million babies born a year premature. And you may in fact know some from your indirect or direct family experiences. It's a leading cause of death in children less than five. And the complication rate if that child does survive last their lifetime, and the economic burden and just in the US is 26 billion for the care of these children annually. So it's a big problem.If we can give just these children, four more weeks, in an environment, it's going to make a lifetime difference. I show you here mortality rates of an extreme preterm at 23 weeks, most children don't make it. If they do make it, they're faced with major morbidities for the rest of their life. So 23 weeks, if we just give them four more weeks, and a safe, nurturing environment, we can change the course of their life, reduce the mortality rates by 81%. Additionally, on the Biddy side, we can reduce rates by 45%. Our technology creates a supportive and fluid filled environment. The image on the left is a stark current standard of care. This child obviously is not ready for this world and is going to have a torturous journey. Recognize the healthcare providers are doing their best with the standard of care available today, the viatera treatment, we would be able to maintain a baby in a vial pod for up to four weeks. And what I'd like to do right now is show you how this technology can work.
Video playing 2:08
By a pod system is transformational, reducing the reliance on mechanical ventilation and reducing the economic burden of lifelong morbidities. Our unique oxygenator assumes the role of the mother's placenta by providing oxygen. This allows the baby to continue using its own circulatory system, giving the lungs more time to develop. Inspired by nature, our pumpless oxygenation circuit allows the baby's heart to drive circulation as it would normally in the womb. contact with the outside world compromises a premature infants health. Our bio pod system aims to reduce this exposure by keeping them in a supportive fluid filled environment. The biopod is filled with a warm solution that mimics the function of amniotic fluid to reduce the risk of infection and protects the baby. The system supports normal fetal activities that are essential for development, like breathing and swallowing. Here is how it works. At the time of birth, an intramuscular injection is administered to ensure the baby does not take his first breath and is then delivered by C section. The baby is placed into the bio pod which will be its home for the next few weeks. Here the umbilical cannulation procedure is performed. Conditioned blood flows through the cannula which serves as the connection for the umbilical vein and arteries to the pumpless oxygenator. After blood flow is established, the top of the pod is secured, warm fluid is added to ensure the baby is surrounded and protected. The pod, baby and oxygenator are then transferred to the console table. Next, the canopy is closed and secured to shield the baby from light, sound and temperature changes. The baby will remain in the nurturing environment of the bio pod for the duration of the therapy. Parents will have the ability to watch their child throughout the course of treatment, and clinicians will continuously observe and monitor without invasive IV lines, pulse oximetry monitors or needles. The pod allows clinicians to gently move and rotate the baby as needed. While the flexible membrane allows ultrasounds to be performed by accessing the pod through the portholes of the canopy. care teams will receive status updates and physiological data in real time. With our bio pod system, routine blood samples can be taken without ever touching the baby. samples can be drawn directly from the device. The pod is designed to accommodate the natural increase in size that occurs during development. At the conclusion of therapy, the clinicians will lift the canopy and remove the baby from the pod to be transferred to the NICU. With our device, premature infants can have the additional time they require If potentially reducing the need for ventilators and other invasive therapies, improving their outcomes for a lifetime of possibilities.
James McGlone 5:11
That is truly revolutionary technology. And I'm delighted to be able to have the opportunity to lead this charge. Also want to give you an update of where we sit from the pretty clinical regulatory and business fronts. On the preclinical side, we've been able to demonstrate and establish this works in two animal models, the lamb and the pig. So we're confident as we work with the FDA going forward. This will work foundationally to their 17 peer reviewed research publications. And previous to the biopod was a bio bag. And you'll see this is a famous sheep that was actually shown in the 2017 Nature Communications paper showing the normal semantic growth of the animal you go from left to right, development of wall animal level, normally, Oregon's developed normally as well. Regulatory milestones, we've received breakthrough designation from the FDA allows us to establish a normal dialogue with them on a regular basis. We continue to do that we're preparing to submit an IDE submission this fall. And with that we anticipate first in human 2023. On the business side, we've been able to hire an inspired management team and an experienced management team. We've been there before. I'd like to know Dr. Flake is a co inventor of this technology. He's also recipient of the Richard P. Johnson award by the March of Dimes for development biology, is the first surgeon to ever have won that award of the award recipients five have also received a Nobel Prize. So it is Dr. Flake and perhaps you'll be number six. We're also developing a robust IP portfolio. We've licensed the technology from Children's Hospital Philadelphia, and we're building a robust IP portfolio. In addition to that, we have many patents, both domestic and international. currently seeking a series B funding. We've secured a term sheet a little over a week ago, we're seeking $60 million in funding, and the following funds will be used to get us to finalize our preclinical work, anticipate and filing an IDE this fall with the FDA. We anticipate about five to six months for approval, and then going into first in human. We anticipate this funding allows us to get through first and human into 2024. So with that we have an opportunity to make a huge difference in health care at the earliest age. And with that I cannot go in my mind as I present to you the words of my mother who once said leave the world a better place than you found it. This is an opportunity for all of us to do exactly that. Thank you have a nice day
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