CoapTech | Howard Carolan, CEO

CoapTech has developed a minimally invasive ultrasound for use in creating gastrostomies. The PUMA-G system is FDA-cleared to guide enteral feeding tube placement at the bedside.
Howard Carolan
Howard Carolan
Co-Founder, CEO, CoapTech

Howard Carolan  0:01  
My name is Howard Carolan, and I'm the CEO and co founder of CoapTech. We are commercializing the PUMA platform, which is an entirely new category of minimally invasive devices.

Our company's mission is to become the new standard of care for several different clinical interventions. This technology was invented by a real world ICU doctor who I met while working at Johns Hopkins solving a real clinical problem. And the PUMA platform is a series of high margin catheters, which enable us to do entirely new things in the body with ultrasound. We have four patents granted, in the US and EU, we're growing that portfolio. And the company has raised about $15 million to date, 11 from private funding, and 4 million in NIH grants. The first thing we're doing is a new procedure called ultrasound gastrostomy. The product that goes along with this is called the Puma G, and it's the first and only way in the entire world to place a feeding tube using just ultrasound. What that does is it empowers the frontline team, rather than specialists to place these tubes, the device is 510 K cleared, CE mark has been awarded. And we have a CPT code from from the AMA. And importantly, we've established a very attractive price point for this product, almost outrageous for a disposable at $19.95 USD. We've been enrolling a set of hospitals in a limited launch. And we've done about 400 procedures to date, we've had no device related adverse events, all cases have been safe. And most importantly, we've demonstrated significant economic impact that we're going to talk about later, including reduced hospital costs, and improved ICU and hospital length of stay. So the wave we are riding is point of care, ultrasound, and its breakthrough growth in medicine. You may know, but many may not that ultrasound has become the most widely used imaging modality in all of medicine today, more than CT, MRI, scopes, you name it. And that's because of a lot of true advantages that it has in the clinic. And while Doc's are doing more and more things all over the body with ultrasound, since its inception, it's had a fatal flaw. Ultrasound is effectively useless in hollow parts of the body. There's a expression in medicine that air is the enemy of ultrasound. The reason for that is the way ultrasound works is sort of like a dolphin send sound waves through fluid, they bounce back and you can form a picture. If those sound waves hit a hollow part of the body, though, they get lost, they scatter, and they don't come back to make an image. And so very important regions in the body had been completely offline for ultrasound in the past, the stomach, the airway, the lungs, and other parts of the GI system.

The PUMA system enables ultrasound in these hollow regions. And when doctors see this, the first thing they tell us is why didn't I think of this. The second thing they tell us is, oh wow, you could do this and that and this with it. It's a very straightforward and simple technology consisting of an external bar magnet. This is not an electromagnet. This is just a mechanical bar magnet and magnetic balloon catheters that go inside the body. And together these enable a razor, razor blade business model where the external magnet is kept on the shelf in the hospital unit. The internal catheters, every time a case is performed, a new one is opened and the company gets a very attractive price point for that case. And the way it works is those catheters are fed inside the body into any hollow region. You can see here in the first pin and that external magnet will pull the catheter up to the internal interface of that fluidic tissue. So here we're looking at the stomach and we're seeing that catheter on the anterior stomach wall. When that balloon is filled with fluid from the port outside the body, it will light up under ultrasound. And so what we've done is we've effectively simulated a fluid filled organ within a hollow cavity of the body. We trick ultrasound into thinking it's looking at a fluidic vessel. And so those sound waves can come in, they can bounce back, and if you can see, you can take action.

You can infuse therapeutics You can take biopsies, and you can do procedures. The first device we've built is called the Puma G system. And it enables the world's first and only ultrasound based method for putting in a feeding tube. About 300,000 patients each year get feeding tubes, and that number is growing. They are associated with conditions like stroke, cancer, Alzheimer's, conditions that are unfortunately on the rise. And importantly, feeding tubes, G tubes, in today's world, are placed by specialists. So it's a trip from the ICU, where the patient typically presents the need for a feeding tube down to the surgical suite. Whether that's the or the endo suite, or IR, it's a lot of run around for the staff. And it's incredibly inefficient. The ICU typically waits two to seven days for a feeding tube to get placed. With our device, they can take the ultrasound probe that's in the unit, and they can take one of our kits off the shelf, and they can put that feeding tube in under an hour. Typical case time is between 20 and 30 minutes, we've gotten them as low as seven minutes. This is a truly disruptive workflow, we're taking the specialists out of the equation, they're not needed to put in feeding tubes. And other devices that have followed this similar model of bringing procedures out of the specialty suite to the bedside, have, by and large, been enabled by new technologies like ours. And those technologies have typically won up to 90% of the market share for those procedures. It's simply more efficient medicine, to do procedures at the bedside. It's better for patients, it's better for providers, and it's much better for hospitals. I'm happy to share today with you the results of a clinical study we just concluded over the winter.

I worked at Johns Hopkins for about a decade in clinical innovation and economic analysis of things that have been clinically successful. ICU throughput and ICU length of stay are one of the key metrics that hospitals look at in terms of ways they can improve their bottom line. And the results we're sharing here are truly exceptional. This is the first hospital that used our product for one year. And they compared our device and our procedure to the typical standard of care for feeding tube placement. hospital costs were reduced by $27,000 per patient, driven by a five day ICU length of stay reduction and eight day hospital cost reduction. These are very significant numbers and hospitals have very significant need to improve their ICU throughput. This is especially important in the era of COVID. We've enrolled a tremendous early roster of clinical users. And we've established that this device serves a need both in small and regional hospitals in the US, as well as in some of the towering AMCs we're working with. We've also been bringing a pediatric device to market and we have some incredible clinical partners there as well.

So at this stage, we have established safety, we've established a significant clinical ROI on the device, and we've established a willingness to pay by hospitals at a very, very attractive price point for our device. So we are raising funding to scale this, both in the US and EU. We're going to expand our commercial team and we're also going to bring future PUMA Platform products to the market in other hollow organs. It's fantastic to be here with you all. I really appreciate your time and thank you very much. My name is Howard Carolan, if you would like to reach out about investment. You can find us on the web or email me. Howard at co Thank you for your time

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