Joelle Tudor, CathConnect - Improving the Safety of Urinary Catheters | LSI USA '24

Joelle Tudor  0:04  
Hello, everyone, I'm Joelle, the CEO of CathConnect. And we've made a device that will transform the urinary catheter. I'm sure some of you may be a bit confused why? I a woman started a company at the age of 22 primarily addressed patients that are older males and with enlarged prostates. Well, when I was an engineer at the University of Washington, a urologist presented to my team of engineers, how patients were ripping out their urinary catheters with no viable solution. I also learned that the cat or the catheter hasn't changed in nearly 100 years. And so together we built calf Kinect. My team and I are passionate about solving this problem. Yes, we may be young, but we each have experience from manufacturing quality management, working with patients and commercialization. I'm proud to say we've been recognized by the Forbes 30 under 30 list and Seattle and are under 25 for a success so far. So over 30 million catheters are placed in the US each year. Of course, I have one of my pocket. It works by being inserted into the bladder, where a balloon is inflated so it can drain urine for days or weeks at a time. The problem lies with the excessive length of external tubing that can easily be caught or snagged. That means this balloon is ripped out of the bladder tearing through the surrounding delicate tissue. This happens about half a million times in the US each year. And This commonly occurs with patients with delirium or dementia, usually pulling out a state of confusion or agitation. Sometimes this even happens with patients that are in transport or they are highly mobile and it gets snagged. After traumatic removal, the hospital stays extended to almost 10 days on average, increases the cost by about $10,000 increases the risk of life threatening infection and adds to the caretaker burden. Our solution at calf Connect allows the catheter tubing to disconnect when polled. This is a simple independent accessory that gets installed into the existing urinary catheter at any location for any patient. It takes about a minute to install, and it transforms this hazard into a safe and effective treatment. Currently, in hospitals today, nurses must resort to physically restraining the confused or agitated patients. This actually adds to their supervision their paperwork, and poses an ethical concern. This also doesn't address the risks that all catheter users face. Other common workarounds are MIT's diapers or even taping a decoy catheter to their leg. One other method of prevention is to have a nurse constantly sit with a patient that may be delirious or confused. But this means the nurse has to be taken out of the rotation just to sit one on one with the patient. This is no longer an option with a nursing shortages today. We developed our device alongside nearly 200 clinicians. And the feedback has been overwhelmingly positive. We made sure to interview a range of roles care centers, and also conduct usability studies. Clinicians who have used it or vice have said things like I would use this on all my patients and every catheter should have one of these. While there's a strong clinical need, there's also a great market opportunity. The we will initially target the most at risk patients, those being those with dementia and geriatric. And this makes up about 10% of catheter users just in the hospital system. We will also expand to additional patient populations that are also at risk those being highly mobile pediatrics, and those outside the hospital setting that would like our device for the added peace of mind and freedom it provides. We will price our product as a high cost specialty device, we have a very low cost to manufacture. So this gives us significant price flexibility. And let us lets us maintain strong margins. We also provide a real value to hospital purchasers. It cost about $10,000 to treat this injury. And so by purchasing our product, there is a quick cost savings by eliminating these adverse events. We will also improve the hospital quality scores by reducing readmission and hospital acquired infection and for time saved physicians after this injury have to revisit the patient reinsert a catheter and in some cases, reconstructive surgery If you have an enlarged prostate, this treatment is not easy. We will save caregiver time with things that actually matter instead of treating avoidable injuries. Here's our FDA five year timeline with my major milestones identified and exit opportunities as well. We have a fully functional 3d printed prototype that we're currently transitioning to an injection molded wall design. We have an international patent application pending and we will be continuing to expand our patent portfolio. We are currently running a couple of studies in parallel right now one is a patient satisfaction study and one is a health economic case study. We will have clearance in the with the FDA in 2025. And we will continue to work with the University of Washington for studies and initial sales. We are prepared to commercialize prior to an exit. As for FDA strategy, we have a clear pathway with a existing predicate device as a class to product. We also have an existing CPT code for reimbursement to fall under. We will continue to work with the clinicians in our network for studying the efficacy and safety our device provides. We're grateful to be advised by a growing list of industry experts with lifetimes of experience bringing medical devices like ours to market. They help us develop the best strategies each step along the way from their experience in IP, regulatory and business development. So we formed our company just over a year ago. And since then we've raised or sorry, we have won numerous competitions and participated in some of the best accelerators. We received about 350k and non dilutive funding with grants from the NSF and NIH. And we are about 75% Complete with our pre seed round. I'd like to thank LSI for the opportunities be here today. And if you'd like to join us at Kath, connect, we'll be improving the lives of patients and providers, one connection at a time. Thank you