Henry (Chip) Appelbaum Presents Novian Health at LSI USA '23

Transcription

Chip Appelbaum  0:05  

Thank you all for your time today. Yeah, I appreciate that. I'm Chip Applebaum, President CEO of Novian Health. And here to talk to you about our laser system that destroys tumors, NoviLase. And our first application is breast tumors. This is Breakthrough Therapy. That's a minimally invasive alternative to lumpectomy. And we're at a very exciting time right now, we have full approval in Europe, we have a CE mark for treatment of both benign and malignant breast tumors. In the US, we have K clearance for treatment of benign tumors. And actually, based on the data from our last study, FDA switched us from a PMA to a 510 K, and asked us to do a confirmatory study, in essence, do what you just did do it again. And if you get the same answer, you'll be on the market. So as you all know is not often you get switched from a PMA to a K. That's a measure of what FDA thought of our data. We've developed a great team that's taken products from the bench all the way through to market we've protected this through many, many patents and designs. And right now we're raising 15 million that has a primary commercial focus. The round, we did last pretty much covers the trial. But over the next couple of years, we expect to complete the trial get on the market in the US will actually this year starting to generate revenue in Europe. But let's take a step back for a minute and think about breast cancer, breast cancer is a life changing diagnosis, it's a very, very serious thing, as we all know, it means the woman's going to have to have surgery. lumpectomy is the most common type of surgery, going to an OR cuttings involved, everyone has some level of scarring, or third enough to justify reconstruction, then it's a week or more postprocedure before she feels like herself. But the real sad part is a quarter to half of those women have to go back and do it again, because they had positive margins. This is what we're going to change and improve the treatment of breast cancer. This is not going to be done in the OR under general, this is going to be done in the procedure room where the biopsy is done under all only under local, we go in through a needle instead of a knife, keep that tumor till it dies. With far higher efficacy and getting that tumor in a single pass than surgery, we closed with a bandage instead of sutures, and the woman can practically get off the table and go right back to what she was doing. It's just gratifying to see the reaction of the women and their physicians to this procedure. We think payers will love it too, because we dropped the cost roughly in half. It truly is about improving outcomes, lowering costs with a vastly superior patient experience. And it doesn't take too many degrees of separation to know someone who's had an impact from breast cancer. When we look at the European and the US market, there's over a million procedures being done today that could be done with our laser. And this is a razor razor blade model most of the revenue is going to be from the sterile disposable used in each procedure. Given that we expect the ASP of that to be between 2000 2400 US the higher end in the US towards the lower end in Europe. That translates into over a $2 billion market potential. So it's nice to be playing in a very large market. And the Breast Center has created our distribution channel, which actually gives us good focus. So here's the system. What you see on the on the left is the console housing, the laser and the computer. But the real key is what you see in the upper right, two probes one to deliver the laser energy to the center of the tumor and a saline drip. The saline drip prevents historic issues with lasers of charring lets us control the temperature and actually improves heat transfer efficiency. The other probe has multiple temperature sensors, and it's well understood at what temperature tissue dies. So you place that at the periphery and you actually get to true parametric control. I'll show you how this works. You would place localize the tumor with ultrasound just like a biopsy, same physician is doing this that does image guided biopsies placed the laser like an image guided biopsy, we have a little probe guide that positions the thermal probe with the temperature sensors at the appropriate place. You have a screen that gives you real time feedback for parametric control, that when the periphery hits the target temp, the system shuts off, you cannot over treat. We think this is one reason we can have a great safety profile. We've done this hundreds of times never had a serious adverse event. So bottom line efficacy is pretty important. We talked about having to redo this because of positive margins. A recent meta analysis looked at 7000 lumpectomies and determined that the positive margin rate was 32%. That translates to a success rate of 68%. The American Society of breast surgeons actually realize this and 2020 set a goal knowing they weren't there. So go To hit 80%. And our last trial, all comers we were over 90%. And with the smaller tumors, we were at 98%. So what we've done is taken a procedure from the O bar and moved it to a procedure room, we don't need the anesthesiologist, we save a lot of cost. By doing that, it's far easier, you can turn that room far quicker. It's a far better patient experience closing with a bandage instead of sutures much faster recovery. And one thing I'll just mention briefly is, what you see at the bottom data indicates that the thermal ablation induces an immunotherapeutic benefit. We've done preclinical work with actually very promising results. And we've seen recurrence rates about half of what you would normally expect, even though our main business is getting rid of the tumor you see like surgery, knowing within a few weeks, did I get it or not? Can I send her on to adjuvant therapy. We're blessed with a great cadre of investigators all around the world that are excited about this and really looking forward to adopting this technology. And some of the sites we're at, you'll recognize this as a sample of of the sites where we're at in the US, RPI is at Yale. Now we're actually doing the trial in Europe as well. And that's a way to introduce this to the KOLs. We've seen that there's a one procedure learning curve, it really is just one procedure. And it's more about comfort and skill. They already have the image guidance skills from doing biopsies. So we've signed up three of the largest breast centers in Germany, the largest private, the largest public Breast Center in Switzerland, Oxford, in England, and depending on who you ask either the largest or second largest center in Israel. And competition, that's an area that as much as you peel the onion, the better we look, we have advantages in the technology and the process. But it really all comes down to data. And we've put the best data out there. I'm fortunate that actually independent of us, Frost and Sullivan has twice studied this area, and twice came to the conclusion that NoviLase was best in space. And again, this I'm willing, very, very happy to have a detailed discussion in this but it would take more time than we have right now. But we've also received other accolades that really put us at the top of the game. Small team again, but again, vast experience. I joined Amgen when Amgen got their very first approval and help them launch that product, built their business development department, and then led the team to launch their third product. After about a decade, I went with a group out of Amgen to start a molecular diagnostics company. And then later on was recruited here. Gene, my head of operations was the first LASIK employee in the US and rolled out the western half of the US for LASIK. I could go on and on. Julian helped bring visual aids to market. So where are we today, we have a first mover opportunity. We're the only thermal ablation device with a specific indication for breast cancer in a major market. We have well positioned both from a personnel from the sites we're at from the team we've built. We're ready to go. We're funded for the trial. We're looking now for the funds to really make that commercial push and prove out the commercial model. And we're going to be doing also a post marketing study in Europe, which will then help and feed back to helping us in the US. So basically two years from now we expect to be on the market in the US and have generated revenue in Europe. So if any of you are interested in improving breast cancer for millions of women, I'm going to be around the rest of the day and would look forward to speaking with you. Thank you for your time