Craig Davis Presents NovaScan at LSI USA '24

Craig Davis  0:04  
NovaScan is an oncology company, we have a new modality for the assessment and treatment of cancers. Today, cancer is typically detected through pathology to qualitative art, it takes time, it's hard to do it up iteratively it's expensive and especially within medicine that takes years to master destroys tissue by definition, and it works chemically and biologically, we have a new modality. It's quantitative, it will give you a number that will inform on the presence of cancer, how aggressive that cancer is likely to be. It's ideally iteratively and done very rapidly. It's very, very inexpensive, and that's inexpensive in two dimensions, and expensive in terms of clinician time, then expensive in terms of cost of goods of the devices. It's simple and easy to do. And clinicians can learn to do this in minutes, not yours. We don't destroy anything. We work electrically. Nova skin was founded by Dr. Bill Gregory, who's a physicist out of MIT did pioneering work. In this neat discovered one parameter called the coal frequency increases 100x is cancer develops and advances. The novice scan team has taken that and built upon that, and leveraged bioimpedance and machine learning on top of it to make extremely active assessments, we do disease progression, and we have lots and lots of IP around this. Lots of data here more than 750 patients in multiple clinical trials, we have trials in pancreatic and lung biliary skin, esophageal colon, sensitivity in every case is very, very high. And specificity is also high too. We have close to a dozen publications in peer reviewed some of them and top ranked peer reviewed articles. We presented at conferences in several different medical specialties. The Novocaine system, depending on easy can look very differently. But there's always the same base components, they're all the same, they don't change. We have the lowest cost spectral impedance bridge in the world. We have firmware to operate our device, we have an analytics engine to make the computations. And then we need some way to communicate with the operator be that display or even auditory or hardware is inexpensive cost and size advantages. This is a razor razor blade model we have a disposables business to disposables are extremely low cost, highly accurate. We have a electrochemistry of Caltech that has built us there, the margins are very attractive. And we have a team of data scientists that manage our software on it. We think longer term, there's a data play here as you do more and more patients and you go back and look retrospectively and develop additional insights from this and we've done this a few times. We are a pan cancer solution. Our initial focus is on gi lung and skin. This can be used in vivo and ex vivo. Our initial focuses are in vivo, or ex vivo apologies can transcend the luminal the NS Canarios. Our lead product problem that we're solving is fairly straightforward, you know, in Tosca Mr. Smart, they are good at visually assessing whether cancer is present or not. That's great. But you can't treat that patient until you have pathological confirmation for it. And that's really hard to do. You are getting the quality and quantity of cancer in a biopsy CT is difficult. And depending upon the area you are in, in healthcare, it's more difficult or less difficult. In fact, we have to biliary and robotic bronchoscopy, it is extremely difficult. This is the unmet need that we address. And this is the solution. The small product called NS Canary, it's affordable, it's inexpensive, it's compact, it resulted in less than 10 seconds of whether there's cancer there or not. It's fast enough that it integrates seamlessly into your workflow. You'll learn to use it in a few minutes. And it's available next year. In the clinic, you can see Dr. Reichman is one of the clinicians we work with.

Take the biopsy basin on the tissue, you press go it'll be less than 10 seconds, and you will get the answer. We don't impact the tissue in any way you can take it straight to pathology right afterwards. There's your answer. Take it, send it off to the pathlab. Our initial results in pancreatic, obviously, sensitivity and specificity are high they're getting better if we do more than just tell you if there's cancer there or not. We can inform on disease progression. It's really powerful and that is frankly new. And I'll give you an example of this. And we've done this a few patients here. This is a patient that presented with chronic pancreatitis was initially assessed in July of last year. The patient was symptomatic though the symptoms didn't abate they continued presented again six months later and you could see the disease's advancing. If you compare this to what it looks like for invasive ductal carcinoma, it's very close. Intercepting pancreatic cancer before it occurs is a big deal. You will save lives with it. We think we can help do that. This is a low cost thing it is easy to use it is simple and straightforward. You can learn to do it in minutes. We don't see this as something that will be limited to academic hospitals, the United States, we see this as something that can be used globally everywhere. And you see leading clinicians from around the world have spoken positively about it, they think they would love this to be integrated quickly. That is our offering in GI the same exact product can also be used in lung procedures. Dr. Hogarth is a luminary interventional pulmonologist that leads are less than the interventional, pulmonology space. We think robotic microscopy and E bas are very attractive for us. This clinic is just started, we have initial data in thoracic, your sensitivity and specificity were very, very high. We're excited by this, we hope that perhaps continues. And you can see these points. The interesting thing, if you take our data, and you overlay it with our earlier breast data, you see the door CamelBak comps, everything that we do, we see that way, it's natural separation between the two, the transition point will change based upon the type of tissue but it follows the same pattern. Virtualization schedule of our device, we're excited by this, it's not too long. And we've got three After trials, look for your starting clinical trial and the end of q4 or SKU three, and launching next year. We're also active we are a platform technology, we're also active in skin. Surgical skin skin treatment is very straightforward, the most common way you just cut it out. And you make that decision. You don't assess margin during the procedure. So you compensate by taking wide margins. And they're disfiguring. And they tend to recur, there is a gold standard something called most this case you exercise just the tumor itself. Think of something your face is gonna be like that. And you do frozen section histology while the patient stays there with an open wound, where you have cancer in the margins. You go back and you take more and you continue this process until you get it all it is the gold standard. But it takes a long time and it's expensive. There's no way to know ahead of time how many times you're going to have to do that. And it takes 40 minutes each time you do the frozen section histology. We sort of combine both you would cut it out as if you would do most but instead of doing all that you put it on a device and we scan it you provide intraoperative information on whether there's cancer in the margin if so, where we look for FDA approval next year our initial publication was in the journal The American Academy of Dermatology. See this is some of our data you know see there's clear separation between cancer and no cancer you know scanning takes less than four minutes as opposed to 45 minutes. There is no lab there is no has to technically go straight to the doctor. specificity and sensitivity are 95% we are backing from across the space in dermatology because actually investors in the face no doctor eagles are top melanoma surgeon in the world. Dr. cockerel is the top amount of pathologist in the world. Dr. Siegel is the leading voice on the rockin dermatology Alden think this will become standard of care. This follows a similar track record except we have a partner. Panasonic healthcare is our contract manufacturing partner and a pretty a division of Panasonic healthcare is also our commercial partner. You receive beta devices for them in November we'll start a quick pivotal trial. The team has accomplished across the senior members of the team and we have seven exits both commercial and pre commercial. And then it's you know, I've been doing this for 25 years is the best scientific team I've ever established. So in summary, we have a great technology with really good data products of cost, size and ease of use advantages over alternatives. IP is a strength of the company. We benefit all the constituents in this space depending on how you're using it. med tech companies like this that have gone deep here. And we service large billion dollar plus markets with capital efficient. We're looking for $10 million for clearance for these two devices. Thank you very much.