Talal Sharaiha presented Aspisafe Solutions at LSI USA ‘24

Talal Sharaiha  0:03  
Hi, so I'm Dr Sharaiha. I'm the founder and CEO of Aspisafe Solutions. We're a company disrupting the feeding and nutrition space in hospitalized patients. Now, I'm sure by the end of this presentation, you're able to understand why I left my clinical career in medicine to pursue this venture full time, and why? By reducing the patient length of ICU stay in the hospital, we are positioned to be a unicorn in this ignored market. I'm going to start with a true story that happened to us, a patient of mine, 75 year old, Eleanor, gets wheeled into the ER with left sided paralysis, Eleanor is unable to speak. She's unable to swallow, so we intubate her, put on life support, and send her up to the neuro intensive care unit. Now there's a few issues when it comes to Eleanor's nutrition. We put a feeding tube all the way through the stomach, through the mouth, down into the stomach. And the issues is one, we don't know how many calories Eleanor requires. We use predictive equations like the Harris Benedict that are no longer recommended and outdated. Frankly, we should be using something called indirect calorimetry, which is figuring out Eleanor's oxygen consumption, her CO two production, and then we're able to decipher her resting energy expenditure. This currently doesn't happen in the hospital because it's an expensive and cumbersome process. Now the other issue is, even if we do know Eleanor's nutritional requirements, we have no idea. We have no means of driving this nutrition into Eleanor. So the I could tell you firsthand, the first 40 hours in an ICU, patients don't get fed. There's a lot of interruptions between going into tests, MRIs procedures, and even once we start getting the feeding, there's still constant interruptions and no means of tracking the amount of calories that these patients get. So 70% of them end up being malnourished in the in the ICU, which contributes to their morbidity. Now, even eventually, Eleanor did get feeding, and the feeding is continuous, but she's paralyzed, and she's on all these sedative medications, so the stomach doesn't empty as well as it should. So the feeding is going into the stomach, and you have increased volume, increase in pressure, and then you're seeing the reflux, reflux, reflux. A lot of that food ends up traveling back up and down into the lungs, and that's how it causes pneumonias. So Eleanor day three or four spikes a fever, her oxygen requirements go up. Instead of her going off the ventilator and into, eventually into rehab that she desperately needs. She ends up staying in the ICU on the ventilator for another seven days, receiving IV antibiotics. And at this stage, her mortality is her mortality risk is 50% now imagine this situation. Eleanor gets a stroke. She's wheeled into the intensive care unit with a diagnosis of a stroke. And instead of putting a normal feeding tube, we put the ASPE safe ng plus. This is our novel feeding tube with a dynamic, communicating balloon technology that prevents reflux and works with the motility of the gastrointestinal system. So as you can see, we've demonstrated safety and efficacy with our feeding tube. You could see on the left, 72 hours post animal intubation, there's a pristine, clean esophagus. This is an endoscopy. And on the right, you could see a hemorrhagic esophagus from the amount of reflux that's happening, which is facilitated by the feeding tube itself. Now we're still Day Zero in the intensive care unit, Eleanor gets connected to our smart nutrition management system called Sammy. Sammy gets plugged into the ventilator. Is able to figure out Eleanor's oxygen consumption, her CO two production. We figure out Eleanor's resting energy expenditure, and this information is communicated to the intelligent pump that starts delivering the feeding rate gradually, without causing any massive, massive volumes into the into the stomach, and even if there is reflux, then we have the feeding tube that prevents the reflux of the balloons. The analogy I like to make is that we're going from a 1982 Nokia to a 2024 iPhone. This is how ignored this market is. It hasn't been innovated on for decades. So who's in this market? Well, Cardinal is a market leader. They own 80% market share of the feeding tubes and the feeding pumps. Baxter just signed a deal with cosmet, so they are able to for the distribution of their indirect calorimeter, but that doesn't include any intelligent pump or any means of driving the nutrition. So the only two companies that are solving the malnutrition and pneumonia in hospitalized patients are us and art medical. Art medical raised $60 million and they just, they just came out with their first in human clinical trial. So. Yeah, and I'd like you just to focus on the next two slides for because there's some big takeaway messages. Art medical has a feeding tube with a sensor that detects reflux and a balloon that inflates to prevent the reflux from getting into the lungs. So they started with a 200 patient clinical trial, 100 in each arm. They stopped halfway through, so you had 50 patients with the art medical devices and 50 patients with the control. And with that small number, they were able to show a length of ICU stay reduction by 3.3 days. This is enormous because of the small numbers, and enormous because of the amount of length, the amount of savings the hospitals are going to have with this reduction. Now why did this happen? How could they do that with such a small number of trial Well, for the first time, we have reflux detection in real time of stomach contents back into the lungs. So our medical has a sensor. And let's look at day one, they have 48 patients, and there there was 27 episodes of massive reflux in day one. And remember, day one, they're not even being fed yet. Day six, you look at day six, you have about 123 episodes of reflux with just 33 patients. So that's about four massive reflux episodes per patient per day. Day 13, three, four patients, 90 episodes of reflux. So now we can, we're able to say safely with and with certainty, this is a massive problem that we're trying to solve. So how are we different? Well, we're selling the feeding tubes and the intelligent pumps separately so hospitals who do not want to buy the nutrition management system can operate the feeding tubes manually, because the balloon self regulate, and the hospitals will get reimbursement for the indirect calorimeter, and they will they will need many less dieticians because the whole process is now automated. And last but not least, they're going to save lots of money with the reduced length of ICU stay and better patient outcomes, of course. So the internal device market is a $5 billion market, and most of that is in the feeding tubes and in the feeding pumps. The feeding pump is owned by an oligopoly like cardinal and Abbott and Nestle up in Europe. So once we create a pump that's way better than anything out there, we're going to create some tension between the big players, to simulate an acquisition. Now, in terms of the revenue of the feeding tube, just looking at the neuro Intensive Care Unit, which is the smallest out of any of the ICUs, and this is our lowest hanging fruit, because they have the large, the highest rates of pneumonia, we're looking at peak revenues between the US and Europe of $325 million and this is with the lowest price point that we're selling for the feeding tube. And just to get a picture with the intelligent nutrition management system, a 1% penetration in both continents is equating to revenues north of $400 million so where are we? We have four patents with the feeding tube. We are filing for a 510, K this year. We want to start our first in human trials next year with the intelligent pump. We are finalizing the software, and we're building our first prototypes. We need more money to hire more engineers to finalize this project. In terms of our team, it's myself and Stefan gabron, who's a seasoned executive who's been in the industry for 20 years, started as an engineer and has taken multiple devices to markets. We've got, we just signed the head of nutrition at Columbia, and he's going to facilitate the clinical trials. In terms of funding, we raised two and a half million. We are currently in the midst of a bridge round with a 40% discount, and this will take us to a 510, K so the bump at the bump in valuation afterwards is going to be two to 3x that. And then afterwards, we're looking for a Series A of $15 million to run the trials and finish the development of the nutrition management system. Thank you very much. Applause.