Lora Allemeier, Cerulean Scientific - Infection-Resistant Devices | LSI USA '24

Lora Allemeier  0:02  
Hi, I'm Lora    Allemeier, CEO of Cerulean Scientific. You may now when implantable medical devices fail, they frequently fail to clotting obstruction and infection. And when that happens, health care costs balloon and patients suffer. As a team, we've had the experience of launching products that change the standard of care and that's our ambition. Here. We are developing and commercializing implantable medical devices that resist clots, obstruction and infection. In terms of our progress, we are focusing upon end stage renal disease with hemodialysis catheters and vascular grafts. You may know it's an absolute horror show in that category in terms of what those patients experience. And we're also working on hydrocephalus shunt another area with a 50% failure rate associated in the first two years. Our technology was originally licensed from Harvard's VESA Institute, we have a team with a track record of experience in both large and small companies. And our progress we have multiple large animal studies 23 issued patents with 16 pending and have been to FDA three times across applications for confirming a 510 K without clinical The first product that we're focused upon is hemo dialysis catheter with a planned 510 K submission and q2 of 2026. You may know over a million Americans need dialysis to live. Here is the crazy part. 85% of these patients start with a hemo dialysis catheter and one in three of these patients have a catheter failure each month. You may ask what's our magic, we have a durable Omni phobic surface on the left you see an untrue uncoated surface and on the right you see the civilian treated surface. It prevents all forms of adhesion and it's 15 times more slippery than Teflon. We deliver the trifecta of addressing clotting obstruction and infection resistance. This is a 90 day shift study that was completed with a leading human dialysis catheter you see on the left 100% clog 67% fibrin sheath after 90 days, and on the right you see the civilian catheter which is completely paid and after the 90 days. We've tested and evaluated this and multiple animal models including with vascular grafts we do have a feasibility agreement in place with a fortune 200 medical device companies for the graphs we've demonstrated with pic catheters 100% reduction in thrombus, and then just mentioned the HEMA dialysis catheter work. We know that it's growing globally and there are strong markets and strong needs across these markets. We've established the basis for value based pricing within the market and the reimbursement that's required. Our business model is based upon current pricing for these and we have an upside potential in our business model for higher value based pricing. We'll get of course demonstrate what we'll need to do to achieve that. We've estimated through our pricing and reimbursement work that was completed a $5 billion annual cost related to the complications of infections and thrombosis. Second area that we're focused upon is hydrocephalus. This is a fully funded program through CD MRP. All the way through the to the 510 K submission. We've talked to patients whose families have had 14 shunt revisions. One parent I met last week in Washington had have had over 100 By the time they were in their teens, and these are special needs kids at that point in time. This will be our first product to achieve 510 K submission and that's targeted at q2 of next year. This is an example of what an obstructed shunt looks like and it's largely due to inflammatory cells that cause a clogging in the shunts. This was published in the Journal of neurosurgery last year in a large animal study of piglets we did this in conjunction with Washington University in St. Louis. We demonstrated a high degree of survival versus the current standard of care shunts improved health of the animals through the program, and most importantly significantly reduced number of inflammatory cells found upon x plant which is the underlying root cause for what causes these, these obstructions. As a team, we have extensive experience in both developing and launching products. Our Chief Product Officer led r&d development at Bard for their now standard of care pick access devices. And as a team we have extensive experience both including launching these products in the end. We are committed to building value for investors in strategics. We have tremendous optionality. In this plan and program, there are applications that we are planning to take to market and some that we are planning is that we will work with strategics to bring those to market. We're in the process of doing a $10 million raise at this point in time, which includes $1.5 million convertible note already raised. And that will take us through hydrocephalus launch and two quarters of sales, human clinical data to support the human dialysis catheter and CO development and licensing options for some of the other applications we have in development in terms of our history, we've raised right at eight port 8.4 million again, heavy level of grants and non dilutive funding that have been part of that. And we have 7.7 million and non dilutive funding to carry us forward over the next two years. So in summary, we are creating a new category of medical devices resistance to clotting, clogging and infection. We are building an equity financing round I'd love to talk to you about that. And we're targeting our first 510 K submission for next year. Thank you