Video Transcription
Rhodel Dacanay 00:03
So I want to tell you about a parent's 18-year-old son. He's brought to the emergency room. He's actually too weak to walk, he can barely breathe, and he's coughing up blood. He has fevers, chills, and chest pain. He's found to have blood clots in his heart and his lungs. He is not suffering from a disease process; he is suffering from a medical error. His chest X-ray shows a retained guide wire from a vascular catheter that was placed two months ago during a prior hospitalization. He becomes one of 15,140 patients that suffer from a retained guide wire each year, a very unfortunate part of the five and a half percent mortality and 10% serious morbidity rate associated with retained guide wires. NEVENT was created to eliminate guide wire retention. The solution is a patented safety sheath, and the following video will demonstrate that it is intuitive to use, non-obtrusive, and functional. This is NEVENT's patented solution to the problem of retained guide wires. The next portion of this video will demonstrate the only effective method of preventing the migration and inadvertent retention of a guide wire into a patient with NEVENT's removable safety sheath within the catheter. Even minimum insertion of the guide wire into the sheath ensures that the guide wire will not be lost, even if a procedural error occurs.
Rhodel Dacanay 02:07
I'm Rhodel Dacanay. I'm a private practice and academic anesthesiologist. I'm joined by Kieran Dacanay, former strategy consultant for KPMG. Our legal team is led by Mr. Ralph Dengler at Venable. Engineering and design are led by Stephen Murray at Aerotech, and our business development advisors include Arun Radhakrishnan and Vasily Kotlob. Together, we are going to bring NEVENT safety sheaths into the hands of the clinicians as efficiently as possible, and we need to note that all current methods of preventing guide wire retention simply identify that the guide wire has already been lost and that the error has already occurred. A NEVENT safety sheath is the only device that physically captures the guide wire. It prevents its loss at the point in the procedure where the error occurs. We developed a clear path forward. We partnered with Aerotech, a specialty catheter design and engineering firm. Our regulatory consultants all agree that we will be eligible for 510(k) and breakthrough designation, as well as FDA fast tracking, and the clinical trials will not be necessary regarding market capture as the only device that effectively prevents this potentially fatal complication. We will become a higher standard of care, making market capture straightforward, rapid, and complete. The market is broad. These vascular catheters are used across the entire spectrum of medical care, everything from trauma resuscitation, where large bore catheters are used to infuse fluids and blood rapidly to resuscitate trauma patients, to catheters that are used centrally to infuse caustic medications as well as parenteral nutrition in the intensive care unit setting. These catheters are used in the placement of dialysis catheters and chemotherapy ports, and the growing number of minimally invasive procedures, cardiac, vascular, and neuro, all begin with a vascular catheter placed via technique and using a guide wire. This leads to a market that's large and growing. Currently, the North American central venous catheter market stands at about $1.28 billion and is projected to grow to $1.8 billion by 2030. The global market is about three times that, and it's a problem that's costly for all shareholders. The cost to our patients and their families is large, and it's real. The cost to the hospitals and physicians, based on a Harvard Foundation review, adds up to about $830 million each year. The problem is so large that in 2018, the United States Joint Commission declared retained guide wires a never event. This imposes additional fines per incident, and it extends the culpability for each incident beyond just the operator to now also include the hospitals and healthcare systems in which they occur. NEVENT's solution provides value for all involved; at a markup of $145 per catheter, NEVENT will realize an annual additional revenue of $725 million while still saving hospitals and physicians over $100 million each year. Our reimbursement strategy is currently being developed. The very best time to put an end to guide wire retention was years ago, before this young 18-year-old patient suffered from this fatal complication. The next best time is now. We are looking for collaborations to assist us with FDA approval as well as business development, and if you share our vision of safer patient care and a higher standard of care, I would love to meet with you. Thank you. Applause.
