enVVeno Medical Corp (NVNO) September 2026 Conference Transcript

Hello, everyone, and thank you for joining us. It's my pleasure to introduce Robert Berman, CEO and Director of Inveno Medical. Robert has more than 25 years of experience across healthcare, finance, acquisitions, and emerging technologies. He has led Inveno since 2018, overseeing the company's transition into a publicly traded company focused on the treatment of venous diseases. uh earlier in his career he served as ceo of itis uh corporation now in nixa biosciences and this c uh coo and a general council of acacia research robert holds a degree in entrepreneurial management from the wharton school and a jd from northwestern university uh with that i'm going to hand the presentation over to you thanks again robert thanks jan and thanks for joining us today I am Rob Berman, the CEO of Infino Medical, and we are a late-stage medical device company

focused on the treatment of deep venous disease. In today's presentation, we're going to talk about the disease that our company is focused on, which is called deep venous insufficiency, which has cost the U.S. about $20 billion a year in direct medical costs. We estimate there's about 3 million patients in the U.S. that have the type of deep venous insufficiency that we're focused on with a TAM of about $90 million at $30,000 per valve. Our device is called Envy, and it's a first-in-class non-surgical replacement venous valve, which I'm going to talk to you a bit about. We're currently starting an IDE study called the TAVI study. That study is actually de-risked because prior to having the non-surgical replacement venous valve, we had a surgical valve that we took through a pivotal trial. For the TAVI study, we have reached alignment with the FDA on the pathways to approval. We're going to talk about the stakeholders for a medical device being patients, physicians, and insurers and what they will think of our NV system. We recently published a peer review article in the Journal of Vascular Surgery, which talks about the economics and healthcare savings of the NV system. We manufacture the devices at our Irvine-based facility. And so we'll talk about our capacity for doing that. But we'll reach out and talk about our competitive mode, which is who else is working on replacement venous valves and what type of a head start do we expect to get? Also, we will characterize what we're doing and make comparisons to some cardiovascular companies who had similar types of technologies that were recently acquired. and finally we'll end with some both short-term and long-term milestones to look forward to and finally why we think Inveno Medical is a great investment for you at this time. So starting off with the disease, I mentioned the disease is called deep venous insufficiency. Deep venous insufficiency occurs when the valves inside the veins of the leg don't operate as they anatomy quickly. If you remember, arteries take bloods away from the heart. Veins bring blood back to the heart. The way that the blood gets back from your lower leg to your heart and lungs to get re-oxygenated and then recirculated is that your calf muscle serves as a pump. So that's why they tell you when you sit too long, you should get up and walk. When you get up and walk, you're flexing your calf muscle. And the calf muscle starts the blood cascading up the veins of the leg. In those veins are what are supposed to be a series of one-way valves. So the analogy I like to give is think about it like you have a ladder that goes from the top of your foot to your waist. In a healthy person, hopefully like you and I, blood is supposed to advance from valve to valve up the veins of the leg against gravity as if it's climbing the rungs on a ladder. mostly because of blood clots, DVTs, deep vein thromboses that a patient may or may not know that they have. The veins in the leg become diseased and then the valves within those veins become permanently damaged. So what happens is when the calf muscle pushes the blood up, if the valves don't hold, the blood flows backwards down the leg in the opposite direction, what we call reflux. And that's when the leg swells up two to three times the size of the other leg. You can get pain that'll wake you out of a sleep. And in severe cases, you could get venous ulcers. I think everybody knows somebody who suffers from leg swelling and whose leg turns funny colors. Chances are that person may have deep venous insufficiency that we're talking about. What we know about patients with deep venous insufficiency is there's approximately 3 million of them in the U.S. that have the severe type of disease that we're focused on. We know that those patients spend on average $30,000 a year on wound care. As I mentioned earlier, it costs about $20 billion in direct medical costs a year. We know for those patients that have venous ulcers, these sores that open up, 30% of ulcers are still not healed at one year, and even those that they get to heal have a 20% to 40% recurrence rate. The reason for that is because the existing treatments just focus on the symptoms, not the underlying cause of the disease, which are the permanently damaged valves that I just spoke to you about. Now, when I talk about existing treatments, for deep venous CVI, they are basically compression garments. So garments that you wear on the leg to try and help squeeze that blood up the veins and against gravity and leg elevation, literally go home and put your legs up. That's the only thing that's available for the 3 million patients with severe deep venous insufficiency that's the focus of our market. Our device is called the Envy system. It is a transcatheter or non-surgical replacement venous valve. Because it's transcatheter, it means it's minimally invasive, so it gets implanted via an outpatient procedure. It follows, it's our second generation device, the first generation being a surgical replacement venous valve that was called the veno valve, the transcatheter valve will appeal to three times the number of physicians than the surgical valve because not only does it appeal to vascular surgeons, it appeals to interventional radiologists and interventional cardiologists. And because it is transcatheter and less invasive, it's likely to generate significant strategic interest down the road. I do have a video that talks about the NV implantation procedure, but we don't have audio capabilities today. So why don't I skip by that? And let me talk to you about our first generation valve that was called the Venovalve. The Venovalve was studied in a pivotal trial called SAVI. So the transcatheter valve is TAVI, and the surgical valve was a pivotal trial called SAVI. That enrolled 75 patients across 21 sites. It provided us with proof of concept that a single replacement venous valve in a patient with severe DVI can result in significant clinical improvement. It validated the worldwide need and demand for a replacement venous valve. And because we did the surgical valve study first, it actually de-risks the TAVI study, which is, again, our follow-on product. Now, what the VenoValve study showed was that 92% of the patients that received the open surgical valve improved clinically. The average improvement among patients was 7.4 points in what's called RVCSS, which stands for venous clinical severity score. That's a grading system that clinicians use to track the progression or regression of venous disease. We saw pain decrease 75%, and we saw 87% medium ulcer healing. This was all from the SAVI study for the surgical valve. Now, to give you an idea of just how debilitating this disease is, these are actual pictures from patients from the SAVI pivotal trial. The picture on the left, right here, this patient has bilateral disease. So this patient has deep CVI in both legs. The leg on the right here was the leg that was treated with our valve. The leg on the left was not. And you could see the remarkable difference. And these pictures on the right show what it looks like when you have severe deep venous CVI. And you can see the progression of the ulcer healing after receiving our surgical valve. Now, despite these very good clinical results, we did not receive FDA approval on the surgical valve basically for three reasons. Number one, because the valve was an open surgical product, we had some open surgical post-operative bleeding where certain patients had to be readmitted to the hospital in order to get a drain, to drain the blood from their surgical cavity. That was reason number one. Number two, because the surgical valve was made of stainless steel, we weren't able to image into the valve itself in order to give the type of hemodynamic efficacy evidence that the FDA was looking for. And then number three, it was not a comparative study and the FDA was concerned with respect to potential placebo or study effect. And so those were the three primary reasons why a surgical valve was not approved by the FDA, even though we had very, very good clinical results. That brings us to TAVI, which is our follow-on study for the transcatheter or non-surgical replacement venous valve. We've already received FDA approval for that study. It'll be enrolled in 40 sites, 165 patients in the treatment arm, and 55 patients in a control arm who will receive standard of care treatment. Primary safety endpoint 30 days, primary efficacy endpoint 12 months. Now, if you recall, when I just talked to you about the venovalve and why it wasn't approved, the first reason I gave you was because there was some post-surgery bleeding. So let's talk about how the TAVI study and the ENVY valve addresses what were the FDA concerns for the veno valve in the SAVI study. Again, surgical pocket bleeding, well, this isn't a surgical product. There's no open surgical procedure. So there will be no surgical bleeding. The second point that the FDA raised was lack of hemodynamic efficacy confirmation. As I mentioned earlier, the vino valve was stainless steel, and so we weren't able to image into the valve. The ENVY valve, the transcatheter valve, is made of nitinol. So we'll be able to image into the valve and give the FDA the type of hemodynamic regurgitant flow volume data that they're looking for. So that is taken care of. And then finally, the FDA was concerned about a potential placebo or study effect, and the TAVI study does have a comparative group. So it is a randomized comparative study. So the TAVI study addresses all three concerns that the FDA had with our surgical valve and with the SAVI pivotal trial for the surgical valve. Now, in order for a device to be successful, a medical device, you really need to appeal to three different constituencies. The first is patients. And in this case, the patients, other than having compression garments and going home and put your legs up, there really is no effective treatment option for these patients. So that's why Envy will certainly appeal to patients. The second group that you want to appeal to for a successful product is physicians and hospitals. Will the physicians and hospitals adopt your product? The NV procedure is a user-friendly procedure. It can be done by either vascular surgeons, interventional radiologists, or interventional cardiologists. And frankly, it's a new billable procedure for a patient group for which the hospital is currently making nothing. So that's why ENVY will appear to hospitals and physicians. And finally, the third constituency that you need to approve to is reimbursement. And as I said at the outset, Deep Venus CVI currently costs the medical system up to $20 billion a year. And so we have, through our economic analysis shown that there'll be a cost savings of approximately $32,000 over five years after a patient is treated with our valve, and that includes the $30,000 cost of the valve. So for insurers like CMS and private insurance companies, the economics will be very, very favorable. I mentioned earlier, we manufacture our products at our 14,000 square foot facility here in Irvine. We have the capacity to manufacture probably 30,000 valves per year at an ASP of $30,000. That gives us plenty of room to grow and build a market with revenue capacity just at this manufacturing facility of approximately $900 million. Competitive landscape. What does the competitive moat look like? Well, we have a multi-year head start. There's currently no other company that we're aware of that is developing a transcatheter replacement venous valve. So we will have a multi-year head start, assuming that our trial is successful and that we move to FDA approval. We also have a robust patent portfolio of patents that have just started to issue for our transcatheter valve. We just got our first patent issued and we have several more on the way. So we will have quite a large competitive moat. We like to say our competitive moat will be as an ocean, meaning that we'll be the only player in the replacement venous valve space for quite a while. Looking at other companies that had cardiovascular devices similar to the potential that we have with the Envy brings to mind Inari, who had the flow-triever-clot-triever for taking blood clots out, Shockwave, and Silk Road. And we've been comparing ourselves to those companies for quite a while. Now, over the past year or two, each one of those companies was acquired by a strategic. We're not saying that we're going to be acquired tomorrow. What we are saying is that we have the same potential when you look at the size of the market, the margins, the competition. We have the potential of what Anari, Shockwave, and Silk Road accomplished, and we will also be appealing or appealing to a potential acquirer down the road. Our company and upcoming milestones. We have already received FDA approval for this study. We are already working on site activation. We intend to initiate enrollment in the study in Q4 of this year. We should have an early readout for the first handful of patients that we do, hopefully before the end of the year or beginning of the first quarter at the latest. We expect it to take approximately two years to enroll the whole trial, and then it'll take about six months to eight months once we're ready to hopefully get FDA PMA approval. We burned about $4 to $5 million a quarter, currently have a cash runway into 2027, no debt, and about 700,000 shares outstanding. We have an experienced management team that has taken several products through development stage, through FDA approval, and our board of directors consists of members who have experience at the type of strategic companies that would potentially be interested in purchasing us down the road. Why invest in Inveno? Well, frankly, our current valuation is based upon the failure to get FDA approval on our surgical valve. That's when we went from a $70 million market cap to our current $7 million market cap. That means the market is not valuing, is valuing us just on that failure and not giving any value to the potential of Envy, our transcatheter replacement venous valve. That creates an arbitrage opportunity. There's a disconnect. The market is still focused on the failures of the surgical valve and is not focused on the upside of the non-surgical valve. That's why Inveno is an excellent investment opportunity at this time. Now, we're not saying that the stock's going to go to whatever overnight. This is the type of stock that you, if you're interested, should buy some and put it away and see what happens. Don't let this be an opportunity. So often you hear people say, oh, if I only would have bought X or if I only would have bought Y, I could have retired by now, whether it's Apple or whatever successful company. what we're suggesting here for those people that are interested buy a little bit of stock put it away and don't let the same thing happen to you don't be the person that says oh man i could have bought in vino at ten dollars a share and if i would have done that i would have had this or i would have had that um take advantage of the arbitrage opportunity before the market catches up and understands hopefully what you now understand as well. So that is our presentation for today. Anybody that has any follow-up questions, by all means, able to reach out to us. And I'll turn this back to our host and take it away, Jan.

Robert, thanks again for joining us today and for walking us through Nveno's approach to treating severe deep venous insufficiency. It was especially helpful to hear about the evolution from vena valve to the less invasive NV system. You know, in addition to the clinical and regulatory path forward, we really appreciate your time and the discussion. Again, thanks. Thanks for the opportunity, guys, and have a great day.