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In today's smiled -- his big idea is to -- labs is developing an artificial heart about specifically designed for kids.
After three years of development there and NASA about is expected to be on the market by the end of the year to Bernstein has been involved in the project -- -- -- He's the CEO.
Doug thank you for being with us I loved in your notes that you said it doesn't matter that we I have food food titles we still clean the toilets every now and then because you guys are on a shoestring budget aren't -- -- that's the way that it is you know you have to keep that win in order to get these devices up to the small markets that need them.
OK so let's talk about this you guys are in college together at Carnegie Mellon you're actually not even amidst student great -- -- engineer.
And how did this idea come to fruition for you guys.
So you know I was actually born with a congenital affirmation that nearly resulted in my death of birth.
And during my time -- kind of you know I'm actually just send it obviously became involved in this project.
That was really started by -- pediatric cardiac thoracic surgeon.
Could develop -- -- conduit that he used as part of the surgical procedure.
That was already saving kids' lives but it couldn't be used outside of Pittsburgh because there wasn't a device it was an FDA approved.
You know be realized the opportunity there we realize that we needed to get this out to the people who needed it.
And that's when you know we started pushing and we made the start -- allowance we've been doing in every sense.
When you say we there's three of you and you guys -- like.
I mean dare I say children you're all in your -- -- he's still right and you're coming out of this lifesaving device.
Do you have it -- I thought I heard that you brought it with you.
That -- yeah -- -- you -- citizens whatever size says.
That's good it is yet this is.
Connecting between the heart and the lungs for children who -- that connection replaced.
And so you know it's definitely providing providing a -- in connection for them.
Wow and you guys now.
Just got it who chunk of change right he's from -- little Angel investor.
Dollars from innovation works and they committed money -- -- how much you looking for.
Well by the by the time we get -- FDA approval we're going to be looking to have raised about two million dollars total.
Now how is that when it takes about seventy million.
Dollars typically to bring a new medical device market how come you're doing this on two million.
So there's three main aspects that make it work for us.
You know first we have a lean -- business model you know like you said -- -- -- literally three people putting in every waking hour to make this work.
For the tasks that are better suited to a larger company you know we outsource them for instance.
All of our production and all of our manufacturing is being done but one of the major players in the medical device industry.
In the facilities where they produce better class -- devices so we don't have to incur the costs to build our -- A second -- utilizing recent changes to the FDA's humanitarian device exemption program.
Which provides an expedited regulatory pathway to approval for pediatric humanitarian use -- -- while still allowing them to be profitable.
Concern we're not inventing devices from scratch.
We're translating surgeon created five cents to because of the nature of working with rare pediatric disease and it's very there usually aren't sufficient solutions available to treat these patients well and so doctors are having to innovate in the clinic.
And that and we're -- what you guys are -- -- -- -- to the market.
3200 kids -- -- going to be really grateful for the fact that you guys with no wife no mortgage are working around the clock to get this out -- -- -- thank you so much -- bringing it to us.
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