Gulam Khan and Vikash Goel Present Centerline Biomedical at LSI Europe '23

Transcription

Gulam Khan  0:05  
My name is Gulam Khan. I am the CEO of Centerline Biomedical. And I've asked Vikash Goel to join me Prakash is our founder and chief technology officer. And since he was here, there's nobody better than him to talk about our technology. That being said, we're going to talk about some future initiatives we're working on. So we have our Safe Harbor statement here. So again, for myself, I've been in the medical industry for about 25 years, variety of different specialties have been served by the companies that I lead. But one of the common themes for me is product development and bringing innovation to the caregivers. Vikash started out on this journey as a researcher at the Cleveland Clinic, and transitioned from a researcher into an entrepreneur, and you'll hear more from him very shortly. Not here today is Sonia Schneider. Sonia is our Senior Vice President of Operations and program management. And Sonia, among other things, has brought more than 40 products to market over the course of her career. So at some point in the future, I'm sure you'll have a chance to hear from her. So Centerline Biomedical, just a overview here, and then we'll bring on some some more depictive graphics here. But it's a non radiation, 3d image guidance technology, targeting transcatheter procedures. The company, as I mentioned, spun out of the Cleveland Clinic, in that happened in 2015. And we are a standalone business located in in downtown Cleveland. We received our initial 510K in 2019. And we had our first and human usage in 2020, we have over two dozen patents, pretty high technology barrier, both on the IP side, and also on the overall know how and what it takes to deliver our system. We have an experienced leadership team, as I've mentioned, and we also have a world class advisory board. We've had very good support from both the US government in terms of getting grants, but also from the investment community. So in June of 2022, we closed our series B round of financing. And that has enabled us to continue our product development and also prepare for a greater commercial launch as our second generation portfolio is getting ready to launch in 2024. And, and beyond. The reason we're here talking to you is we do anticipate as we ramp up to to a greater level of commercial activity, moving from our current target focus in the US market to a global launch and also bringing on our new products and targeting new specialties, we will be seeking an additional round of financing. So that's why we're here. It's not the need at this particular day, but it will be in the near future. So our clinical advisors, much like the other presentations we've seen, we've been able to get the support and guidance from key opinion leaders in their respective specialties. What's interesting to note here is we have not only vascular surgeons, supporting us and helping us in our in our current commercial application. But we also have different advisors depending on other specialties that will hopefully have the be target markets as we release our technology in the different areas. We have launched commercially in the US, as I've said, and we have more than 10, early adopters who are using our product. And this has been obviously a critical step. So in terms of derisking, we have been able to take that jump from not only getting our initial clearance from the FDA, but to get usage and that you should is so critical as we evolve our technology. So our second generation portfolio that we're working on and we'll be launching shortly is going to be infused with real actual usage. And so we're grateful for these early customers. And it's given us a lot of absolutely critical feedback on what the next steps should be for us. As far as strategic initiatives I've alluded to these already but really critical for us is our the release of our next generation portfolio. Our technology as Vikash will explain further. It involves a series of different types of technologies coming together capital equipment, overarching software platform, and consumable devices like guide wires and catheters that are purpose built for our system. We are going to increase the strength of our commercial organization going forward. And then the expansion of our portfolio and regulatory indications is also part of our of our roadmap that we'll talk about. So with that, I'm going to ask for cash to come up and step over and talk a little bit more. Thanks

Vikash Goel  4:52  
Thanks Gulam, so we can talk a little bit about the need the use case here. And we're talking about endovascular procedures using wires, catheters, balloons, stents, you know, fixing arteries and veins from the inside out. Many of you may be familiar with fluoroscopic image guidance, but just in case, this is what it looks like right now, when they're doing these minimally invasive procedures, it's miraculous, right that we can do these without an open traumatic invasive surgery. But it's really actually a challenging way for physicians to see what they're doing. This is a doctor trying to access this patient's right renal artery with a guide wire and a catheter used to guide and so you can kind of make out the tools if you're kind of squinting, you can see there's a lot of trial and error slipping the wire in and out. So this ends up being a time consuming process, a lot of trial and error. And every frame of this is an x ray. So it's a lot of radiation and adds up to a significant occupational hazard. And so now we're going to look at the same task being done with our IOPS technology. So immediately, I hope you can appreciate this is a vivid three dimensional color view of the anatomy being navigated This is made with the data already in the patient's chart, they can customize the view, you see here, the doctor aiming the catheter directly at the target vessel, and now don't blink, you're gonna see that wire getting pulled back into the catheter. And on the very first try slipping right into the target. And the whole time this was being done, that pedal that activates the X ray was alone, no one was standing on it. So this is what we're about trying to improve the quality of image guidance, as well as radiation safety at the same time. And so how do we do that? Oh, so we've got kind of a standard razor and blade model in terms of the components of our system with the addition of some really high tech software. So there's this computerized cart, you know, kind of computer on wheels that can be wheeled in and out of a room as as needed. An electromagnetic tracking system attaches to the table stowaway on the cart when not in use. So very easy for the customer to adopt. And then we have our sterile single use devices. There's a fiducial patch that tells our system where the patient is on the table. And then our custom wires and catheters with our special sensors embedded in them so that we can localize them in this field. And our software can generate that navigational view that map and the interactive guidance that I showed you earlier here. And so this software is really where a lot of our magic and IP lies, and all the physical components are what allow it to achieve what it can do. So I hope that the value proposition is becoming kind of apparent, by improving the quality of image guidance, making it possible to see what you're doing, making possible for intentional actions to take place, you know, we're looking at reducing procedure times reducing radiation exposure, that flow also depends on this contrast dye that's actually toxic to the kidneys. So by adopting this technology, you can actually improve access to care for your patients. So we see benefits, really for every stakeholder in the health care system, thanks to simplifying these complex procedures by improving efficiency, or getting better use out of these really expensive Interventional Suites. And ultimately, we hope that this type of navigation will achieve better outcomes and fewer complications. So this is the busiest slide I've ever made. And please don't don't take the time to read all the words on here, you won't have the time. But the point I want to make with it is, you know, in addition to that support that Guillaume was talking about, that we got from the federal government, the investment community, the scientific and clinical community, as well has given us tremendous support. We were on the cover of the Journal of vascular surgery earlier this year, at the vascular annual meeting, we had our first clinical study presented in a really prestigious session. I'm also going to talk really quick about our roadmap here, you know, we're cleared in the descending aorta, but we're also starting to explore other ways to use our platform, expanding to other parts of the body, but other indications as well. And I think structural heart is a really interesting example. So this is just a peek. I know I'm running out of time. But we're making more of these interesting high tech sensor equipped smart catheters. And these are from animal studies where we actually use them to successfully navigate through different parts of the structures of the heart. And you know, now I'm out of time, but Gulam and I will be here the rest of the conference and we'd love to share more in one on one session. So thank you