Video Transcription
Patrick MacCarthy 00:00
Pat. My name is Patrick MacCarthy.
Patrick MacCarthy 00:04
I'm the CEO of Butterfly Medical, and I'm here to talk to you about our vision for improving the lives of men with prostate cancer disease. So as an overview, what we're here to talk about is BPH, benign prostatic hyperplasia. This is the growth of the prostate to the point that obstructs the flow of urine out of the bladder. BPH represents a very large market globally with a significant unmet need. There have been a number of minimally invasive devices developed in the past several years to address this growing need. And there's clearly a need for increased levels of less invasiveness, less pain, and less cost to allow men to live better with this condition. We are currently raising money, $25 million; $17 million is already raised, and we're seeking another $8 million. So what is BPH? Benign Prostatic Hyperplasia? Again, this is the growth of the prostate that is really a natural growth. Men over 50 have a 50% chance of having symptoms of BPH. By the time you're 80 years old, you have an 80% chance of having BPH. The good news for the ladies in the audience is you don't have a prostate, so you don't have to worry about BPH, but you don't get off quite so easily. For those of you that happen to live with a man, one of the symptoms of BPH is getting up two, three, multiple times during the night to urinate. That affects their sleep, but it can also affect your sleep if that's something your partner is dealing with. 15 million men in the US suffer from the symptoms of BPH. Over 90 million men globally deal with this. 4 million men in the US are seeking treatment, and there's a 9% CAGR for the BPH market. Beyond getting up during the night, which is termed nocturia, there are other common symptoms, such as the need to urinate frequently and urgently, as well as essentially a weak stream—things that people just generally love to talk about, especially men. So while those seem like lifestyle conditions, they can really have a truly detrimental effect on men's health. I had, unfortunately, a close family friend that, just a couple of months ago, was suffering from these symptoms but wasn't willing to go to the doctor, wasn't willing to tell anybody about it, and ended up going for between two and three days without actually urinating because of the enlarged prostate. He ended up in the emergency room, catheterized, almost in kidney failure, and is now dealing with kidney dialysis because of BPH. So how is it treated? Historically, it's treated with drugs. The first line therapy includes FloMax, which is tamsulosin, an alpha blocker that helps relax some of those muscles. Then you also have finasteride. Typically, you'll start with one drug. If that doesn't work, then they'll do a combination of the two drugs. They can work in some men, not in others. Unfortunately, they have both short-term side effects, including depression and lack of sexual drive and ejaculatory function, and also long-term side effects, including dementia. Because of these side effects, many men are simply non-compliant with their drug therapy. So before, a few years ago, the next step really was if it got worse, you either get catheterized, which nobody wants to stay on a catheter permanently, or you go in for surgery, and the surgery is called TURP, T-U-R-P, transurethral resection of the prostate. Essentially, you're going in and you're carving out the prostate. Very effective at reducing the obstruction and increasing the flow of urine, but extremely painful, with lots of complications and significant side effects both from a sexual and urinary function standpoint. Now, as I mentioned, in the past several years, there have been a number of minimally invasive treatments that have come to market, certainly UroLift being the most successful of those. UroLift uses sutures and T-tags to laterally retract the lobes of the prostate and allow flow of urine without having to remove tissue. The other treatments that are out there either cut or burn the prostate to remove that obstruction. But really, there's nothing out there right now that does not appear to cut or burn the prostate to relieve the symptoms of BPH. So what's the solution? Our solution, the Butterfly Medical device. You see it right here; it's a nitinol, nickel-titanium device. It's implantable. You can think of it almost like a vascular stent, except it's going into the urethra as it goes through the prostate. It's delivered through a catheter, so it's minimally invasive. It's basically the same as getting a standard cystoscopy. I know for the men out there, that may not sound minimally invasive, but it's a relatively straightforward procedure. It's intended to be a permanent implant and can stay in for the remainder of your life, but it is fully reversible. If there's any reason you want to take it out, if a patient progresses to prostate cancer and they need radiation therapy or things like that, you may want to take it out in the future. We've implanted this in over 350 patients. We have patients beyond five years, and we've removed it after over three years. So the device gets placed into the prostatic urethra, it expands. And really, that's it. It's as simple as that. So we believe this is better for patients, with fewer complications and reversible. It's better for providers; there's no capital equipment cost here. It's a delivery device and the implantable, and there is a well-established reimbursement pathway in the US. The business fundamentals are very strong, with very strong IP and three patent families, and certainly favorable manufacturing costs and what we project to be a very high gross margin from a clinical standpoint. Over 100 patients have been treated in Europe as part of a pilot study. These are the results here, which show very strong safety and efficacy relative to UroLift, which is the standard of care from a minimally invasive standpoint. We are 90% recruited in our pivotal trial in the US. This is a 245 patient trial. It's a randomized control, double-blinded, sham control trial, which again, we will complete enrollment in the next two to three months, and then there's a 12-month follow-up before we submit to the FDA. Here's our management team. I joined earlier this year. Most recently, I was running the urology and gynecology business for Olympus as the market leader in surgical treatment for urology. Prior to that, I was with a startup called Nine Point Medical, leading the commercial and clinical functions from inception through acquisition. Idan Geva is the founding CEO based in Israel. Vardee Segal heads our clinical and regulatory efforts and has experience with multiple PMA devices. Steven Camper heads our medical affairs. Our Medical Advisory Board is really a who's who of urologists, from a urinary function and BPH standpoint, with amongst them over 700 publications. This is our board of directors, with deep expertise in devices and urology. As I mentioned, we are currently raising $25 million; $17 million is in, looking for another $8 million. If you'd be interested in partnering with us and improving the lives of men, I would absolutely love to speak with you. In conclusion, we have a procedure and a technology that is clinically de-risked, again with over 350 patients treated, a pivotal IDE study that is nearing completion of enrollment, technically de-risked, and we believe, vastly superior to other treatment options. So thank you to LSI. Thank you to all of you for your time and your attention, and enjoy the rest of the conference. Applause.
