Video Transcription
Gil Rosen 00:02
Good afternoon. I'm Gil Rosen, CEO of Convergent RnR. About Us. Convergent RnR's mission is to democratize a safer, more precise radiation therapy, the kind of radiation therapy that as of today is only available to patients who are lucky enough to be near a proton beam center. And that means that the kind of radiation therapy that only half a percent of the cancer population actually gets. We do that by offering patients a focused, low-energy beam that we deliver through a low-energy source. And that also means that we can do that outside of a radiation bunker. We have raised 25 million to date, and we have a massive IP portfolio of 11 patents and patent families. We have an agreement with the FDA on the regulatory 510(k) pathway. And since 2016, we have been partnered with MD Anderson, the leading cancer center in the US.
So radiation therapy is one of the three pillars of cancer treatment. Surgical oncology is, of course, one. Medical oncology drugs are the second one, and radiation therapy, which is the kind of treatment that over 50% of cancer patients receive, is the third one. It's a well-tested modality in many cancer fields; over 90% of patients are responsive to radiation therapy. The problem with radiation therapy is that it is a bit transactional. You want to kill the tumor, but you don't want to hurt the nearby organs at risk. What you see here is a two-centimeter lung lesion that is fully radiated with 56 gray, but you also see the heart, which receives 9% of the heart at 10 gray. Why is that a problem? The problem is that these days, thankfully, screening programs enable earlier detection of cancer, and that means that patients live longer following treatments. And that means that 10 to 15 years following treatment, which is the time frame that it takes for secondary cancer to develop, sometimes if there is toxicity after the radiation therapy to nearby organs. Now more and more patients have to deal with that. This is also why proton beam therapy was introduced and invented three decades ago.
What you see here is the same plan with proton beam therapy, and you can see that the heart is nicely spared. The problem is, of course, the ticket price between 30 and 100 million dollars for the system and a basketball court-sized facility for each one of these centers. Again, this is why, to date, since the 90s, fewer than 300,000 patients have actually received proton beam therapy. That's why kids from Israel and from Canada have to be flown to the US to receive proton beam therapy. This is where Convergent RnR comes in. We're looking to deliver a similar dose distribution to proton beam therapy through our revolutionary beam, and we will do that at a price point that is competitive with Linac, in other words, a fraction of proton beam therapy.
This is what our system looks like. In this case, you can see it's delivered robotically through AI-generated treatment planning software. The beam is delivered in what is referred to in history as pencil beam scan mode. In other words, we populate the target, the tumor, with dozens of small fields that fill the tumor with just the right amount of energy. But since the beam itself is actually hollow, the tissue before the target and the tissue after the target are non-impacted. This is at the heart of our system. It is this lens that much like we all did as kids with a magnifying glass for daylight, our lens can focus the X-rays, the low-energy X-rays, to a narrow spot, one to five millimeters wide, using a low-energy source. That means that all of this can happen outside of the radiation bunker or the cancer center.
We're going to be going from metastasis in the liver, brain, bone, and lung, head and neck lesions, ocular lesions, pediatric lesions, and, of course, prostate and breast down the road. In addition to this proton beam-like dose distribution that we are very proud of, we also have three different additional innovations that are currently held back by the limitations of high-energy Linacs. These are: the SFR, the ability to actually preserve the tumor's microenvironment, which has a synergetic effect with radiation if you don't actually kill it; the ability to radiosynthesize nanoparticles. Nanoparticles are used when a tumor is radiation-resistant. However, only low energy can actually excite these nanoparticles sufficiently. And another area, which is currently undergoing research at MD Anderson with us, is the higher synergy between our radiation and immunotherapies—very important areas.
These are our clinical partners. In addition to MD Anderson, we're working with Brigham and Women's. This is our go-to-market plan. We are looking to be FDA-approved by late 2026 or early 2027. We have, as I said, an agreement with the FDA on the pathway. We already have four LOIs totaling 10.5 million dollars, representing four orders of these systems. Two of them are from proton beam centers that understand what our beam can actually do. We're looking to offer a lower-cost option to developing markets. And on top of that, we actually have a secondary product line in the market, which is our incisionless denervation of chronic pain and refractory epilepsy that adds another $80 billion to our otherwise $9 billion addressable market.
This is just a little bit on our pipeline product. So what you see here is the current standard for ablation of BVN; this is a condition that 5.3 million Americans suffer from, in other words, what is known as chronic low back pain. This procedure calls for drilling of the vertebrae and ablation of that nerve. The company was recently bought by Boston Scientific for $850 million, and what we are offering is a completely incisionless ablation of the same nerve. What you see here is a beautiful plan that actually ablates the same target in 40 minutes without touching the skin of the patient. The second pipeline product is refractory epilepsy. Today, 1 million epilepsy patients don't respond to the initial line of treatment, and again, we can offer these patients the ability to pinpoint just the right area in the brain to be ablated, which is otherwise done today by drilling.
This is our team, highly seasoned veterans, totaling dozens of years of industry experience. And in our Medical Advisory Board, we have Dr. Stephen Hahn, former chair of the FDA, and several top KOLs. We are raising $30 million on top of the 25 million that we've raised to date. We're looking to use the money to bring the product to FDA approval, and we are projecting to reach break-even on the sale of 18 units, the four already ordered, and we're happy to follow up with anybody in the crowd who wants to hear more. Thank you. Applause.
