Dan Chambers, CleanSite Medical - Preventing Bloodstream Infections | LSI USA '24

CleanSite Medical is developing a novel connector disinfecting cap to prevent bloodstream infections associated with intravenous (IV) fluid and drug delivery.
Speakers
Dan Chambers
Dan Chambers
, CleanSite Medical

Dan Chambers  0:04  
Hi, I'm Dan chambers. I'm the CEO of CleanSite Medical. We're an early stage medical device company based in San Diego. Our mission is to help reduce the risk of bloodstream infections in order to enhance patient safety. We do this by addressing what is again a huge problem. It basically the catheter related bloodstream infection, as shown in this illustration in the upper right corner, that contaminated microbial contamination of needle free connectors, whether in the central line or peripheral space is a huge problem. And if those surfaces are not properly cleaned, microbial contamination gives you pushed into patients and those resort and that results in again, a bloodstream infection that can be incredibly costly is often deadly, and again, with the right tools can be prevented. And again, our our objective is to again prevent the nosocomial type infection due to catheter related bloodstream infection, as it relates to cost. These kinds of problems can cost the healthcare system over $10 billion a year. And from a hospital perspective, which is the primary financial driver for this market. There's no reimbursement from the Centers for Medicaid and Medicare Services, and now many private providers as it relates to central line related bloodstream infections. And as noted, several 10s of 1000s of people a year in this country alone are killed as a result of these kinds of infections, many more are made sick. And again, as I noted, many of these are preventable by use of the right tools. And we've developed a suite of products to address this problem. And again, it is a big market. In both the central line space and peripheral space, as shown by this illustration, central lines are a smaller part of the market. And again, that's been the focus of the CMS in private payers. Because again, these are incredibly sick patients to begin with, and many of them are made sick and die of it as a result of these this problem of bloodstream infections. In the current market, there are about 800 million accesses through valves that are used in central lines, the peripheral space is much larger, the they're probably 30 to 40 times more peripheral lines placed a year than central lines. And the access though is much more frequent in the central line space. And again, so dealing with the chemical contamination of these valves in both those contexts is important. But again, in the central line space, it's about 800 million units in the US that the same size as x us. And in the peripheral space, it's over 4 billion accesses potentially, and in the US in the same size, basically abroad. So again, it became to be a very large market. And the peripheral space is currently presently, basically untapped. There's very little capping and disinfection that goes on there except via scrubbing with an alcohol swab, which is the conventional standard of care in the peripheral space, particularly whereas passive only cap is currently the mark the standard of care in the central line space. And again, the overall market potentially is two and a half billion dollars. Just to this, this is a picture that illustrates really the magnitude of the problem. And how many of these connectors are present on inpatients in hospitals. This was taken in August of 2020. at Cedars Sinai have a COVID patient, there are 11 IV pumps here and over 40 connectors, all of which need to be kept in order to protect the patient effectively. And they are so again, there's a lot of real estate here. And this illustrates it. So the operator opportunity that we're pursuing is, again to develop a system which we have, that includes what we call our active cap, as well as a prevent technology that would be used for basically during the manufacture of IV sets and things. So again, it's together our system of active cap and prevent can really reduce the risk of this type of infection in the hospital context, as well as other other care settings such as alternative sites, home care, etc. It's a large growing and recurring market. It's a highly profitable, disposable space in terms of the the business model. Our technology is proprietary we have patents issued as it relates to both active cap as well as prevent. And there's a differentiated value proposition as it relates to the active capture and also when we think of regard to prevent. So this is a brief overview of our active cap basically integrates both an active scrubbing function as well as a passive disinfection and capping function. And it does this by allowing the outer housing of the device to rotate in relation to the inner once it's been screwed on to a needle free connector most of which are Luer type valves. And again once placed, the scrubbing function allows for disruption of bacterial contamination on the surface to better expose those those organisms to alcohol which can then kill them and and things which again will ultimately better protect patients. In terms of the competition, there are some people already in the space. Three M is the leader here they they have a product called Kairos, which was developed by a company from San Diego called Live Vera company was acquired by 3am in 2015, for about $200 million at a 6x Multiple. But again, curious like the other end, the curious knockoff, such as swab gap, and then dual cap, which have small parts of the market, they're all passive only products they do not scrub, so a nurse needs to effectively wipe with an alcohol swab, a cap a connector before installing a cap or making a fluid access. Our device integrates again, both the scrubbing function and the passive protection in a single device. streamlining workflow, making a nurses job easier, also better protecting patients, our efficacy is much higher with regard to our product, we can achieve eight logs of microbial reduction with just a few seconds of scrubbing. Whereas for example, a curious cap only can achieve a four log reduction which is again comparable to the other products in the market as it relates to the swap cap and dual cap. This is a basically a brief overview of our milestones to date, with less than a million dollars basically raised so far via convertible notes we've achieved effectively the research and development objectives necessary to get the product into the five into the 510 K processes, which we're currently pursuing. We hope to get clearance in the next couple of months for our first product, again, active cap. And at that point we will commercialize later this year. And what we are doing now is trying to raise an a round. So we can effectively ramp up our manufacturing capacity to be able to meet the needs of the market. And that's based on discussions we've had with a number of large commercialization partners that we'd like to perhaps pursue this device with down the road. The next aspect of our system is the prevent product, which is basically a single piece dry cap that would be placed on a connector during IV set manufacture or during the manufacture of the connector of itself, it's not part of an IV set. And that way the device can be the valve surfaces can be maintained in a sterile condition, when they're placed initially on a patient, which again will better protect patients. Because right now, as is illustrated in this little cartoon today, effectively, this shows an IV set with two basically white sites in it. And the white side is certainly no free connectors, those are not kept. And so those valves services are exposed to the environment. As a result they rub against patient's skin, they get dragged through the bedding, they can be dragged along the floor, stuff can fall out of the air. In fact, they get they get dirty, almost invariably. And there's a lot of literature that actually supports that our proven solution would actually cap those and protect them, basically from manufacture up until first access that way. Again, better protecting patients also making nurses jobs easier because they won't have to basically cap or clean devices. Prior to first access, there'll be ready to go. This is our product portfolio map in addition to active cap and prevent, we have a couple of other products that are much earlier stages of development. One is actually a software product called touch point, which would help to integrate the in terms of real time, the use of infection prevention procedures and tools at the bedside currently that's not tracked, well tracked if tracked at all. And this device, or I should say the software would allow that to happen. And with the EMR agnostic, we have a couple of other products as well. In earlier stages development. As I noted, wiped and secure wipe is a fancy alcohol swab, and secure is a securement device. This is financial stuff we don't need to get into. This is leadership team. Again, I'm the CEO I was formerly a patent attorney. I've been doing this now full time for the past two years. John Grant is my co founder. John was a senior sales executive of VB bra and he has about 30 years of experience in this space. And he and I together basically invented these these devices and had been prior basically what pioneering what we think is a better system for again, patient protection. Rick Bluth is our VP of Operations. Rick has experience vast experience in medical device manufacturing development, it done at least 10 of them. And Todd Austin is our medical director and he's a practicing anesthesiologist. So again, we're raising in a round basic terms, we want to raise $6 million. And again, we also have a note round that's open as well leading into that because it'll take a while to obviously get our a round circle and closed and if there's any interests, we'd love to talk to anybody who would like to learn more about the company. Thank you

 

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