Abtihal Raji-Kubba, Empress Medical - Fibroid Treatment and Fertility | LSI Europe '22

Transcription

Abtihal Raji-Kubba  0:07  

So before I start, when I left Becton Dickinson in the year 2019, and that is that was after they had just acquired CR Bard. I had spent the last seven years at CR Bard running low tonics with Onyx was the biggest acquisition of a startup company for the for CR Bard at the time. And it was in they had just completed a first in human phase study. And they were just getting ready to start enrollment in their pivotal study. That small business continued to be the most highly profiled, little piece of the big CR Bard, because of the towards the first of its kind technology. And that we were basically we were being the it was, the analysts were all after us trying to find out what's going on how the investment is going. So it was it was a very exciting time. And to put that through a PMA and also panel review, first of its kind technology in the US. It was really a huge accomplishment with an amazing team. So in 2019, I'm looking back at that point, I had launched eight of the biggest, the 10 biggest launches in the history of CR Bard in terms of products. And I was wondering, and you know, what is the next thing going to be? And I knew for sure, it wasn't going to be just a job. It had to be something that created impact. And this is really where we are today. So in that same year 2019. It turns out that there were 226 million women worldwide that were that were diagnosed with having the condition of uterine fibroids, that is almost 6% of woman in the world. And 70 to 80% of them will do 70 to 80% of women, no matter where you look will develop uterine fibroids by the age of 50. Now, 20 to 30% of women of those who develop the fibroids will be symptomatic their fibers will be symptomatic. So what are uterine fibroids? They're basically benign tumors, but they're the leading cause of hospitalization. related to any gynecology, gynecological disorder, black women have more severe symptoms, and they tend to have it the onset of the condition is earlier in younger ages and black woman. In the US alone, there is more than 1 million women treated. In fact, some numbers for them close to 2 million every year are being treated in the US alone. And 70% of those women who are receiving treatment are actually on some sort of therapeutic plan. So that's mostly hormones, otherwise, some sort of management of pain. There are 400,000 surgeries specific because of uterine fibroids in the US alone. And 70 to 75% of the surgeries for uterine fibroids are hysterectomy is in fact the average age for hysterectomy in the US is between 40 and 42 which is very young. I hope you agree. There are 26 million women in the US today between the ages of 15 and 50 who have uterine fibroids. Now I don't know when was the last time you looked at a condition medical condition or disease state where you saw numbers this Hi. So again, what are uterine fibroids? They are basically benign tumors but they can't get large enough where and they get in Multan, a female a woman may get multiple tumors that they actually become problematic and symptomatic, they can be as small as a one centimeter in diameter, it can be as large as 10 centimeter in diameter. And there are many symptoms just to name few of them here the normal menstrual cramps that woman cramps that woman and then suffer the pain monthly with their cycle, the heavy bleeding which leads to severe anemia. And truly perhaps the most impactful is when it interferes with fertility, which it does. And often it actually causes a lot of blood, bladder and bowel disorders. So these symptoms cannot be neglected for too long. Once a woman becomes symptomatic So most prevalent treatment as I just showed you is actually hysterectomies. The other treatment options are not that great, they have limitations and their limitations is they have very high risk of complications number one, and we I can go in details about what they are, but I'm gonna touch on the main ones. And most of them offer very poor outcomes, either temporary relief, or basically high risk that basically a price to be paid for having a treatment. Emerging Technologies are very difficult to use. They are not widely adopted because they are just very difficult to use by an average gynecologist, which is where a patient goes to seek help. And that's why you see so many hysterectomy is what are the treatment options? Well, I mentioned that already. More than 70% of women who are diagnosed are on some sort of therapeutic treatment, the majority of them and our hormone therapy. There is you you probably have heard about either they call it UAE or Uterine Fibroid Embolization, where the blood supply to the uterus is basically blocked. There is ablation, which doesn't even treat the fibroid itself, it just relieves some of the bleeding. And as I mentioned, there's hysterectomy, the most dominant and actually most offered surgical option for women. And then there is myomectomy. myomectomy is actually the golden standard of care for your children present future preservation, specifically for women with childbearing in childbearing age, meaning if they want to preserve their ability to have children, so not only preserve their uterus, but they want to make sure they're able to have children get pregnant after that. It's a minimally invasive procedure. It could be abdominal could be laparoscopic. So the abdominal procedure was first described in the 1800s. And today we're in the year 2022. So I hope you see that the gap is quite huge. Laparoscopic myomectomy was first described in the late 70s. And really, there was not much written about it. There were some truly brave physicians trying it. And then and then that I think the last publication around it or anything happened with it was in the early 90s. In fact, it was 91 or 92. So why aren't more physician gynecologist doing laparoscopic myomectomy or myomectomy in general? Well, it's a very difficult procedure you're going in, and you have to basically cut resect the fibroid, so you're creating a defect on the wall of the uterus. So then you have to have some very high suturing skills, where you're actually going to go on and try and repair the defect you just created. So you are not compromising you've already compromised the integrity of the uterus wall. So you're trying now to suture that that defect you created to make sure that the uterus actually is maintaining some sort of structural integrity. Well, that is very difficult to do. And even more difficult to do laparoscopically. There's limited options of removal of fibroids. Why is that some it? Again, some of you may have heard about the big warning around morcellators. So morcellators used to suck these basically chop them off the fibroids and suck them out. But the problem is that if there is any cancerous tissue, then you're spreading cancer, and there was a case that was very publicized. And then after that FDA issued that warning for a surgeon herself who went in to have the surgery end up with having a sarcoma tissue basically being going everywhere, and she died shortly after as a result of that procedure. So one thing you will notice there's definitely since then a trend in the US exact specifically and then Europe followed a decrease decrease in the use of morcellators and also scalpels. The one made really the may be produced from so even if these if the defect is sutured really well, you still have a wound and there will be adhesions, these adhesions could basically obstruct the fallopian tubes. So basically it makes pregnancy impossible. And then the last but not least, the risk of rupture of the uterus itself. So this is the golden standard of care if a woman goes through a myomectomy today, this is what she walks away with. I hope you feel you agree with me that this is unacceptable for a woman wants to preserve her options for having children And this is what she has said this is what she has to go through. This is a public health issue. There are many nonprofit organizations who are who are tackling the issue are talking about it. There is actually a Senate bill in the US that speaks to it, that is on the floor has been on the floor for a year. And this data I show you from 2011, the direct cost just of uterine fibroids procedures is is you know, 24.9 billion, but if you talk about the down down the road complications, it's up to $34 billion that's in the US alone. So this is what we're doing about it. Some press procedures involves no cutting, and therefore no defects, no compromising of the uterus wall. Truly what we believe the most important thing is designed for gynecologist it builds on the skill sets that gynecologist already have. So if they know how to do laparoscopic surgery, this is going to be much is in the myomectomy These are not my words. These are the words of some key opinion leaders in the US I interviewed very simple steps is again, it's semi automated the sutra, the actual when we say suturing here, we are not trying to close the defects were actually were suturing around the fibroid to cause ischemia. The very same principle that's done by with embolization. So what's happening we're depriving the by applying pressure on the circumference, sacrificial circumferential circle surface of the fibroid, we're actually depriving it of that blood supply and we're increasing the pressure. And it is similar what happens when you do embolization of the main artery to the uterus. That's to actually what happens with the fibroid itself. We have done a first end and human study in the Dominican Republic. And we have demonstrated and by the way, this study was actually published in a peer reviewed journal, just like this this August, and that's reproductive sciences. We've demonstrated at three months a reduction, more than 36% and the volume of the fibroid, and at one year, more than 60%. That 60% is actually higher what's in the literature with with the win when you compare it to you a so it's pretty significant reduction in some patient, that reduction of volume was up to 80%. We had 100% procedural success. So we had five different physicians actually try the procedures on the 16th between the 16 patients, and we had 100% percent procedural success. patients reported improvement in quality of life different in different aspects. We had zero adverse events and there was a very short recovery time and very positive safety profile with the device and improved quality of life, as I said, at three months. So what does that look like in terms of opportunity in the US? So there's over 1 million I said there are close to 2 million actually. So but if you just look at the over 1 million women receiving that treatment, that's an opportunity of 3.5 billion US alone, bottom up market opportunity initially, if you just look at the surgeries of the surgical surgery surgical portion of the market, that's 1.4 billion in Europe, they're actually a 24 million women who are diagnosed with the condition and Worldwide there are 7 million women actively receiving treatment. This is where we are we are actually gearing up to start a clinical trial. It's an IDE denoble and we will run the trial primarily in the US. We are looking at a center in Europe, and we are on track to start this clinical trial early in 2020. Three, this round serious A we're raising 10 million and it will take us to approval and making the process so the clinical trial approval of the IDE and releasing the device for commercialization. Our team I already told you a bit about myself, the team is actually the team that the team that worked on the initial design of the product is based in Televive. I am a US employee and the clinical team and the commercialization team is coming from the US. Board of Directors we have Dr. Arbok himself was the president of Cooper surgical that's very active in the space of women's health. And then I must mention that Dr. Tao himself was actually he's an interventional radiologist. He's a serial entrepreneur. This is his fifth company, I believe, if not six, and he's developed number of, you know, medical devices. He himself has performed hundreds of UA embolization procedures. So he has he has dealt with the fibers themselves. He's actually seen the patients, he's heard their complaints. He's watched them. Basically agonize with making a decision decision, what is the best treatment option I have? I showed you basically what we are doing. And now what why are we doing it? We're really doing it because we want to change the standard of care for the treatment of fibroids and make fertility preservation an ongoing option and not the exception. You can look us up at Empressmed.com Thank you