Luminelle | Allison London Brown

Speakers

Allison London Brown

Allison London Brown

CEO, LUMINELLE
Read Biography
Luminelle is a fully integrated hysteroscopy system for in-office diagnostic and therapeutic gynecological procedures. The device has received 510(k) clearance from the US FDA for hysteroscopy and cystoscopy.

(Transcription)

Allison London Brown  0:03  

Good afternoon, you all seem very sedate in this room. So we're going to try to wake you up a little bit, too. So today I'm talking to you about women's health. And I want to ask you some very important questions as we go through this. So I expect a little interaction with the audience, if you don't mind. So Luminelle, many of you may have heard me speak before about our transformational and novel approach to endoscopy. And our focus is really around visualization for both diagnostic and operative procedures. And our focus is within no pun intended, our focus is within women's health, and really at the earliest point of care, which is preferred by both physicians and their patients. So we're talking about the doctor's office. So this is the management team, we're very tenured. Some of us have more white hair than others. But we're very experienced, not our first startups in many cases. And we've been at this for about six years and raised only $6.3 million. To do this, we have a endoscopy platform, we were the first scope to get his philosophy and Cystoscopy approved by the FDA in the same submission, we have for 510 Ks, we have a robust IP platform that we own outright. And most importantly, our product is cost effective. It's easy to use, it takes less than a minute to set up. And we have a single use portfolio of shapes that are very versatile, and really designed to meet the needs of the procedure, the patient and the physician. So I really want to talk to you today, not just about endoscopy, because there's a lot of scopes out on the market. What I want to talk to you about is this problem. How many of you in this audience have ever heard of abnormal uterine bleeding? Okay, so we got a couple people, how many of you in here have ever had abnormal uterine bleeding? Right? So it's not something we talk about generally in most common language, but it's a serious problem with real implications. So the rate of uterine cancer is 14% with people who have a UB, but women are missing out on the treatment, and why are they missing out? We're going to tell you a few reasons why. So about 40% of the 36 million women who may experience a UB actually go to their doctor. And this is because they need to identify what is a UB and when you talk to your girlfriends, maybe you don't realize there's something wrong. And then when you go to your doctor, they may tell you, there's nothing wrong with you. And the real challenge is that the standard of care to actually diagnose endometrial issues, so whether it's cancerous, precancerous fibroids, polyps, these types of pathologies that we're talking about, the standard of care is visualization. That's right, it's just all about being able to see it, sample it simultaneously. And the standard of care today is a blind biopsy. And what that means is doctors go in with a scope. They take the scope out, and they go in with a straw like suction device, and they think that they're getting what they saw. But they're not being properly diagnosed. So 42% According to the data, 42% of the samplings fail. If you talk to many pathologists, they'll tell you it's much higher than that. Because either a they're not getting the right tissue, or B, they're not getting enough tissue. And why is that? Because this is what they see. How many of you would accept going to a doctor and saying, I'm going to diagnose your cancer? And I'm going to do it blindfolded. Would we accept that, but this is what women have been accepting for years, and it really hasn't changed. And what's really sad to me is that in 2017, our reimbursement rate to provide women first point of care, first diagnoses in the office went up 575%. So you can get an RVU that equals a reimbursement of 1800 to $2,300. And yet, they're still doing it blind. And because it's easy, it's low cost, and it doesn't require anesthesia. But the other reason it's very difficult, and many of us over the last 20 years that I've been doing this, have tried to teach physicians to use a two handed approach and that means I go in with this scope, I have an operative channel, which by the way Luminelle does offer and use instruments like scissors like graspers to take the the suspicious tissue. And by the way, again, we offer these, but I just told you 70%, or more still do it blind. So they're leaving money on the table. So we're introducing our new sheath, which will be coming out later this year called The luminal. BX or biopsy, it will be the first and only device that allows the physician to not only accurately visualize the product, or the the cells and the tissue, but to adequately sample what they're looking for. This is equaling 4 million women who get diagnosed the first time. But that's not all we're doing to provide access. So we have to currently today as a reusable scope called Luminelle sustain on just spoke to you about the biopsy later this year will be or next year, we'll be coming out with soltera, which is using our still proprietary lighting and autofocus technology. But it's a single use product so that the patient contacting portion does not have to be reprocessed. And then lastly, the Versa, which is a portable or battery operated product that allows us to reach rural areas and areas that are needy, needy, either needing immediate care, or can't handle a larger system in their office. And why is this? It's because physicians care about kind of two things. And it doesn't matter what product we're talking about. This could be a scope, this could be a knee, this could be a hip, it doesn't matter. We all face this, it's two verticals, does it work? And how much does it cost? Right? How many of you in this audience hear that all the time? Does it work? How much does it cost? Where's your data? So that's what they're looking for? Can I see what that's the visualization? Is there enough fluid because you have to distend these organs? And can I actually get to the tissue I need? And then of course, how much does it cost. So there's other players on the market. And these are good products, but they either cost too much, or they're not doing everything that a physician needs them to do in their office, we will be the first and only again, for IP that we have patents that we own, that cover all of these products. Additionally, we have a robust commercial platform to move forward. So first and foremost, we've got to get this in the hands of physicians that they can treat their patients. So we have a comprehensive commercial approach that includes reducing the sales cycle, and really driving revenue. Secondly, we will be launching Luminelle, which gets them over this hurdle of not meeting the standard of care. And remember, I told you it was 4 million procedures, just on the sheath alone. 100,000 procedures is $17 million for us. And we want to improve access to care. So again, it's not just about the biopsy, it's about the other products we discussed. And it's about more reps, more feet on the street and working with patient advocacy groups, like the uterine cancer foundation to actually help women to understand what their symptoms are, and match them to a physician that can help them. And this will help us to achieve growth of over $20 million within the next five years. So what are we looking for? We're looking for money. Of course, everybody's looking for money, right? So we're looking for a series C somewhere between that 10 to $20 million to fund infrastructure. It's just people. We have the IP, we have the 510 K's, we need revenue, we've talked to strategics. We have a banker. We just need revenue. And so coupled between our commercial playbook, and launching and leveraging that that sales team with our new products, we will value create value to trigger this acquisition. So we're ready, we're ready for the market. We have a strong IP portfolio. With 510 K cleared we're in the market now. We have contracts, we have contracts with one of the largest associations of clinics in the northeast and in the southeast, and I don't have reps. So what we're missing is revenue. And so I really hope that you will come and talk to us and see how you can partner with us to really help us to achieve our mission of delivering solutions to help our physicians and our patients. Thank you

 

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