Gavin Cooper, AltaScience - Minimally Invasive Permanent Contraception Device | LSI USA '24

Gavin Cooper  0:00  
Good morning, everybody. My name is Gavin Cooper, and I'm CEO of an Irish company called autoseal. And we're on a mission really to redefine permanent female contraception. I'm just gonna give a very quick overview of the organization itself and dig in a little bit more detail as we go on. But number one, we have a highly experienced team. We have a large and growing market opportunity with over 219 million women relying on permanent contraception. They're very clear, differentiated technology we have so far up to seven years worth of data, zero pregnancies and 92 patients have a very strong core IP position, and a very clear regulatory pathway. They always say, surround yourself with the best people you can to make your technologies work. And that's something we've been able to achieve. And I'm going to start with my medical advisory board because this really is the creme de la creme of women's health. You have Dr. Barbara Levy, past president of the AGL Dr. Linda Bradley, past president of the AGL Kelly right future president of the AGL Andreas Virco, past president of ESG and Dr. Edward Aven. Tash, past medical director for whole logic for Uddiyana. And for pharmacists. Let me go to a small team. And it's been very interesting to see a lot of the discussions that take place. Some companies have these great massive teams, and it's like, I can't afford to have the kind of team that I want. So I've got my core group here of five people. James Coleman is the founder. He He's a clinician himself. And he designed a technology called Celt, which is a femoral artery closure. And that's in about 200,000 patients. This is the same technology, the same material, pretty much the same delivery mechanism as well as now being used in the fallopian tubes. So we know that the material works, we know that there are no issues. And we formed a separate company about 10 years ago. So 1936 It's always good to go back for the past and then look at the future. Surgeon by the name of Bosch did the first recorded laparoscopic female sterilization procedure in 1936. Now, they brought Bosch forward 100 years almost to an operating theater today. Yes, it would look nice. So yes, there'll be more lights. Yes, it would be cleaner. The carpark would be bigger. The nurses would have more attitude? Definitely. There's no question about that. But the instrumentation and the procedure has not changed. And I'm sure we scratch his head and go, but everything else has improved. Everything else has become more efficient, better. And we're still treating women with a highly invasive surgical procedure. So we know this 290 million women roughly rely on permanent sterilization worldwide 24%. I see it as a problem. And I see it as a problem because it's an invasive surgical procedure, but requires a general anesthetic that includes scarring, risk of infection, risk of damage to vessels and organs. We know patients are getting bigger, so they're going to be less suitable for for surgery. And we have a three to four day recovery. So my solution is the protocol Delta seal. So it's non invasive is an office procedure. It's walk in, walk out, it's a lunchtime procedure. It requires no pain relief, no anesthesia, and it's half the price. When we work out price, normally of new technologies, everything's more expensive than the current standard. But delays bringing those technologies to market, we are half the price of the standard that's taking place at the moment, there must have cost to the facility. The patient on average in the US if they're paying for a laparoscopic tubal sterilization, or paying $18,000 We can do that the half with better outcomes. So, let's talk to us as we're here right now because over 800,000 women a year are undergoing an invasive surgical procedure, general anesthesia. And those of you that are really good, but numbers are gonna go 800,000 doesn't equate to 425 procedures an hour. It does if you take 45 weeks of a year, eight hours of operating a day and five days a week. Okay, so by the time I finished my talk, there's going to be roughly another 50 to 60 women having to have a general anaesthetic with trocar insertion on a procedure that was designed in 1936 45%. Right now, of the annual 6 million pregnancies in the US are unintended. That's a big, big number. Because it isn't the forms of types of contraception available. Now with the Roe v. Wade judgment reversal. We're going to see an even bigger increase in permanent contraception needs for patients. But sadly, too nomination is not an option, it will not be an option. So we are going to see far more births, but patients have unwanted. We did a small slip survey last year 68% of the women in the US in that survey would want to consider permanent hysteroscopic contraception instead of having to go under an invasive surgical procedure device itself very simple two parts delivery mechanism and the implant itself the implant is made of stainless steel, biocompatible material, very straightforward to use to place in the history scope for the vagina cervix and into the actual uterine cavity and I'll show you some video in a second but overall, what you can see here, the green light does not work on this point, right okay implant in the tube. Imagine your cocktail umbrella paper cocktail umbrella that pops open. We've got two of those effectively in stainless steel, but one distal on one proximal for the cludes and blocks would you replay the video, you see two parts. As you can see, cocktail umbrella pops open and blocks are clues mechanically achieved. This is in a real life patient. You can see the opening of the fallopian tube you see the device being inserted. Remember condition will clockwise rotate the handle one way to deploy one set of wings and then counterclockwise the other way to deploy the second set of wings. Press the release button number we have a cluded job. We can see some other patients here because I said we did 92 patients. Okay, we've captured all their images. And if you see on the left was a an HSG which is a radio contrast medium in the fallopian tubes. The tubes that are open, follow through the tubes that are closed with the autoseal device are blocked. Therefore we do not get pregnancy. So can't birth control options. This speaks for itself. This is permanent. It's an office procedure. No one sees you're required no hormones. IVF still possible 92 Women seven years worth of data, zero pregnancies. So when we talk about risk, we're hopefully devaluing you know the risk for potential investors because we've already proven that this technology works. Another sideline with this device is IVF. There is a condition called hydrocele pinks. I just saw Pink's affects up to 30% of women that undergo IVF. And it's a toxic fluid that leaks from the ovary through the fallopian tube. And it hates sperm, it kills sperm. It's like no sperm, you're not coming here, I'm killing you. With this toxic fluid. The only way to prevent that is to remove the tube, again another invasive procedure, but we can block the tube with the autoseal device. And so in the small study of 17 women, we had 10 Healthy Babies born to eight women, and quite a high percentage of success in the IVF field and the reach of ablation contraindication to endometrial ablation is pregnancy because there is no endometrial lining left in the uterine cavity. Therefore you can't have a fetus embedded in there. So another 500,000 patients a year in the US will require permanent contraception after an endometrial ablation. We've got one minute left or speed up. We're starting our regulatory pathway. Q sub goes in in the next four weeks, and we're intending on starting. Our first case is August, September of this year, we've already established our centers, we'd be looking for around 400 patients that will be the final number with a 12 month follow up. And outcome measures will be pregnancy rate. Obviously, we want a zero pregnancy rate. We don't want a high pregnancy rate, reliance and safety. What am I here for not just to tell you about how wonderful the product is, but I'm looking for funds. I need 5 million to get us partway through our ID study. And to take us all the way to commercialization to 2027. I'm looking for 25 million for a market that's worth in excess of $2 billion with a massive unmet need. Currently no alternative to surgery. It's no scarring. It's it speaks for itself. You know, women deserve a better option, but at the end of the day instead of having an invasive surgical procedure, so thank you. Thank you putting himself first