Video Transcription
Sorin Grunwald 00:00
Good morning, everybody, thanks for being here. I am Sorin Grunwald, and I'm a serial medical entrepreneur. I am the founder and president of Dialyfix, which develops implantable devices that hopefully will get rid of arteriovenous fistulas for hemodialysis access. This is just to set the stage for the first few questions. Why exactly Dialyfix? As we all said, because we want to solve problems. We were confronted with a real clinical problem affecting patients in a significant way. We think that the problem is worth addressing, in the sense that we have many problems and not so many resources. So how do we choose? We choose by trying to solve the problem with the most acceptable return on investment, and more than that, we choose, as Sun Tzu said, to battle wisely, which means we try to solve those problems that we think we can solve. So we have the knowledge, we have the resources, we have the team, and we have the appropriate funding to do that. In the end, it all matters that we find a solution that's user-friendly because we have to keep the users in mind, and they will only adopt our solution if it's friendly enough.
Now, just for the stage, a background for those of you who are not familiar: end-stage kidney disease patients require hemodialysis to clean their blood because their kidneys don't work. This is a typical hemodialysis procedure. A machine is cleaning the blood, and these sessions take several hours, several times a week. In order to do that, to connect a patient to a hemodialysis machine, an arteriovenous fistula needs to be created, which is a connection between an artery and a vein. This is fundamental; today it is the recommended method of vascular access, and it is causing several issues because
Sorin Grunwald 02:17
of this, in a way, unnatural blood flow. Here are the issues. Here is a real problem: many fistulas don't match, right? They can be used in about 60% of the cases, and they have to be redone. Complications related to fistulas are many, and they include hand ischemia, aneurysm, and so on and so forth. So healthcare costs related to these problems are pretty high in the United States only, and then worldwide as well. So this is a problem. Now, why is it worth solving? Because, from a market standpoint, it affects a lot of patients. From a business standpoint, it's a pretty active field. Many companies are trying to solve it and are looking into different solutions for it. From our point of view regarding that solution we're going to talk about, we estimate a market of about 10 billion.
What does our solution consist of? It's very simple in a way. If we eliminate the fistula, we eliminate all related complications. So if we can create a device that allows vascular access for hemodialysis without fistulas, then we have eliminated all those related complications. Our device consists of, for whoever is curious, I have the device here. The device consists of an access for the catheter, anastomosis anchor. The catheter is anastomosed, connecting directly to the blood vessel. It provides long-term vascular access. It can replace and provides for the blood flows required by hemodialysis.
How is this device deployed? It's a regular surgical technique; a procedure sheath is introduced into the vein, and the device is then pushed through the sheath. It expands in the blood vessel. We pull it back, we retract the nano self-expandable anchor, which anchors the catheter to the blood vessel wall. We can see that on the ultrasound imaging, and then we connect the catheter to the implantable port, and we're done. For the hemodialysis procedure itself, we can access the implantable port through regular IV catheters or a hemodialysis needle, and then we can check the blood flow using ultrasound as well.
Now, our claim to fame: why is that unique? As I said, to eliminate the need for fistulas, we get the ability, because of the cost of goods, the production costs are low. We get the ability to position the system accordingly and reduce healthcare expenditures. It's simple; it's simple deployment, and it allows for placement pretty much everywhere in the vasculature.
What are its competitors? It's pretty much state of the art today. Mostly, the fistula is performed by open surgery. It takes up to six months to mature. There are also systems that provide new methods to create fistulas endovascularly or percutaneously; they still are fistulas. So even if the creation procedure is easier, the complications related to it are higher. This is a table showing the different benefits. We have been granted a patent; the regulatory strategy we are planning to do is to go first in human. We are working towards first in human, then use predicate devices to go for the 510(k).
This is pretty much what we've done so far: animal studies; we showed hemodialysis capabilities. We showed the anastomosis to the vein and to the blood vessels. We are based in France, and we are relying on what we call just-in-time knowledge. It's a minimal, viable core team, and we rely on external resources. We do strategic management in terms of setting the right goals. We definitely choose user-friendliness, using just-in-time knowledge, and we work with key opinion leaders to define the requirements.
Well, I don't have time to do that. These are people that we are working with on risk management. We have a six-year action plan. We are raising two and a half million dollars to do first in human and regulatory submission. This is pretty technical; it's how the milestones are, the go/no-go decisions, and based on the revenue assumptions, we are hoping to do first in human in year one and two. One possible exit strategy is to sell the technology at that time or continue raising money for regulatory submission, at which time we again have a choice of raising more money for product launch or selling that technology after obtaining regulatory approval.
Thank you very much for your attention.
