Video Transcription
Yan Ostrovski 00:02
Hello everybody. Very nice to be here. I'm the CEO of Neshima Medical. Neshima Medical is developing novel life-saving treatments for severe respiratory diseases, and I want to start by briefly introducing our team of multidisciplinary experts. I have a PhD in Biomedical Engineering, specifically in respiratory drug delivery, and I've been investing privately for over 20 years, mostly in medical startups and real estate. Avi Talal has experience in regulatory and in preclinical. Rami also has a PhD in respiratory drug delivery. Jose is the dean of Biomedical Engineering at the Technion in Israel, and our active chairman, Nissim, was previously the senior managing director of Orbit VC. We also have strong advisors, including Professor Paul Moore, head of Harvard Dean's Critical Care, and Professor Lavacek, who is a clinical leader in a large global pharma company. Neshima Medical's Lift technology, liquid foam therapy, can be used to either clean the airways of mucus or as a drug delivery platform. It delivers a large variety of therapeutics, from small molecules, proteins, biologics, and even cells. The photo of the prototype you see here can deliver the therapeutics deep into sick lung regions beyond obstructions, and it distributes them throughout the lungs. Our first product, Lift Rapid Wash, is a device without drugs. It is intended to pull mucus out of the airway. It's relevant for over 6 million COPD patients in the US who suffer from mucus plugs, and it was shown that these increased mortality from 34% to 54%. It is also intended for 1 million Americans who are ventilated annually, where their airways are cleaned several times a day, as the standard of treatment today. Lift Rapid Wash breaks the mucus quickly; it reaches the small airways in the lungs, and because the foam is a special high viscosity, non-Newtonian shear thinning fluid, it's able to penetrate through mucus plugs, bypass them, and scrape them off. Then the mucus is trapped between the bubbles, and they are pulled out together, pulling pathogens along the way. The procedure is fully automated. It's very easy to use. It's safe and it's repeatable. Our main competitor is suction today. A suctioning tube is put through the endotracheal ventilation tube, and it doesn't reach the small airways. It doesn't reach much further than the trachea, and it's not effective at reaching the mucus. It pulls air mostly from regions without the mucus. Even when it does reach the mucus, it's not very effective at pulling it because the shear stresses are quite low. It uses a vacuum which has a risk of alveolar collapse, and it's not effective at breaking whole mucus plugs, which block fully airways. Here you see a quick example of what our process looks like. So here is, this is an adult size human airway model. We put the mucus into the branches, we push the foam in, then we pull it out, and you can see the before and after pictures. Our second product is called Lift Rapid Heal. It's a drug delivery platform, and it's intended for severe pneumonia patients. Today, these patients in the intensive care unit are treated with intravenous antibiotics, and the drugs don't reach sufficient concentrations and don't kill the bacteria. These patients are hospitalized for over a month. 15% of them die, and of those who survive, many suffer from debilitating side effects for years, and also many of them suffer from dementia. Our solution, Lift, penetrates deep into the infection. It reaches the bacteria; it creates a concentration 100-fold higher compared to intravenous delivery. And we know from the literature that this concentration kills even the most resistant bacteria in the dish. In this example, what we did, we took pig lungs. Is there a laser pointer? Yeah, no, can't see it. Okay. So we took pig lungs and we administered mucus into the upper lobe of the lung, and we delivered green tissue dye. I compare here our competitor, the nebulizer, and our system, Lift. So in the bottom part where there was no mucus, the nebulizer reached poorly, but it reached everywhere. In the top part where there was obstruction by the mucus, it did not reach at all. Our system, on the other hand, you can see the story is completely different. It fills both parts of the lungs, and I want to emphasize that in both experiments, we used the same amount of green tissue dye, and where this takes six hours to deliver, our system takes only 20 seconds. So to summarize our competitive advantage in drug delivery compared to nebulizers: we can bypass obstructions and reach the diseased regions. We deliver up to 1000 times faster, and we can deliver 10 times larger particles compared to intravenous delivery. We can reach 100-fold higher drug concentration in the lung, in the diseased site, and as it is a topical delivery, we can dramatically reduce the systemic side effects. We also run preclinical trials in rats and pigs, and we saw that large doses of foam did not suffocate the animals. It did not interfere with the oxygenation or with the ventilation pressures. And now we're running another trial in pigs where we don't use a disease model; in the previous one, we used a severe disease model. Here, we use healthy pigs. We deliver antibiotics, we wake them up, and afterwards, we follow them for a few days, and we saw that there were no signs of stress and no breathing problems. And we know that the antibiotics reach the alveoli because we measured the PK, and we saw that it reaches the blood. We will sell to hospitals our device and kits, which include a sterile set, the foaming solution, and for Lift Rapid Heal, also the drug. As I mentioned, it's very simple to use, so it requires minimal training, and the treatment only takes 30 seconds. But to increase safety, we're also doing pre-oxygenation. Our business model is B to B to hospitals, and we have a patent which is approved in Australia, and our experts estimate that it will be approved in the US, Europe, and China within a year. We're targeting enormous markets. We estimate that for the airway wash market, we can reach sales of several billion dollars. And for the first antibiotic that we're delivering, it's another half a billion dollars. And for infectious diseases in total, it's another $5 billion. After that, we aim to treat severe chronic respiratory diseases with advanced therapeutics by delivering gene and cell therapies. We validated our solution with hospital heads, and they were very enthusiastic, and they said that we're on track to solve numerous unmet clinical needs because we can deliver many kinds of therapeutics. Our material is already FDA approved for inhalation. We're forming it, but we're not changing its chemistry, and our existing formulation is already clinical grade, cGMP, USP; it's manufactured in the US. The device will be regulated as a class two medical device, de novo, and in terms of reimbursement, the airway wash for ventilated patients doesn't require a CPT code; for the COPD patients, it will require a CPT code, and for the antibiotic delivery, again, no CPT code is required. And I want to mention that because of our cost of goods being very low, we have flexibility in pricing to make sure that we get reimbursement and payment. So we recently received an $800,000 grant from the Israel Innovation Authority, and we are less than one year away from clinical trials. We are now raising either $500,000, which will help us complete the first proof of concept clinical trial, or $2.4 million that will allow us to complete the entire safety clinical trial. I hope you will join us and help us help these severe respiratory patients. Thank you. Applause.
