Idan Geva presented Butterfly Medical at LSI USA ‘24

Idan Geva  0:06  
Hi, thank you all for being here. My name is Dan, I'm the CEO of butterfly medical. In the next few minutes I'm going to share about our novel approach to treating BPH or enlarged prostate. So BPH is the non cancerous enlargement of the prostate. Normally, the urine flows through the prostate through the prostate to the urethra and outside, the prostate grows, it causes obstruction in urine flow, leading to a nation symptoms like slowing interrupted stream, frequency and urgency and affect the quality of life. It has nothing to do with prostate cancer. It's just one of the many flaws that we have as men. And that's what we're treating a drugs and surgical interventions are widely used and have been the main cause of treatment for many years. Both carry risks and side effects. Drugs have limited efficacy and affect the sexual quality of life. surgical interventions require hospitalization and recovery. Generally, they're not very a widely preferred by most men. In the last few years, there's been a new kind of treatment generally referred to as mixed or minimally invasive surgical therapy, you will lift has been the predominant player, it's a set of ankles that inserted into the prostate tissue and retract the lateral lobes. Resume is a vapor permeable meeting needle that burned through the tissue, it is a temporary stent that cuts through the tissue. And the optimum is a balloon that tells through the part of the prostate tissue. This is the next big thing generally in BPH therapy, because it's less invasive, so it's better for the patient, better for the physician, because in most cases, they are paid higher for these procedures. And in general, every ologists wants to have at least one or two of these options available to offer their patients. And therefore there's been quite a lot of m&a deals over the past few years ranging from 300 million to $1.1 billion, all of these single product companies once they reached the US market, and if we look at the market, in general, every company that is in urology or wants to get into your ology has to have any spare in its bag, a solution, a minimally invasive solution for BPH and there are quite a lot of these. What we've developed developed is the only one in its kind implant that is designed to fit the anatomy of the prostate and retract the lateral lobes of the prostate. The procedures is very intuitive, the ologists uses it is his own system so upset, blowing the implant initially into the bladder and then under vision, retracting it into the prostatic urethra. And unlike current minimally invasive solutions, this solution does not require cutting or burning or piercing the tissue. So it's less invasive procedure is more elegant and more intuitive, easier to learn. And it's fully reversible. So, why we see it as a next generation minimally invasive treatment one, it's an atomically ship shaped and does not require a piercing over or cutting to tissue making a truly minimally invasive and therefore, easier procedure, easier extraction if needed. It can be done in any site of care whether the hospital, the hospital, ASC or a physician's clinic. And we enjoy very low manufacturing costs. So what we've done so far, on the clinical side, we've treated roughly 250 patients in in several clinical trials, the Israeli long term trial and now reaching five years, what we're seeing is that the way patients respond to the treatment in one year, maintains its efficacy and safety to them through the next years. And in the US. We're now running a pivotal trial. We enrolling patients in 20 different clinical sites and we're getting nothing but very enthusiastic reactions from physicians. on the regulatory side, you already have the CE mark. And with a pivotal trial running, we are on route to getting FDA clearance in early 2026. We have three patents registered in the US and in various other countries another a patent on the way and we've already passed freedom to operate examination. And we've been extremely capital efficient so far over the next Now, last nine and a half years we've burned through $12 million all through regulation. Chevron r&d And roughly 250 patients in clinical trials. We just won the EAC grant the European Union grant which is which includes non dilutive grant and participation in in the next rounds of fine finance and we just completed the first closing oversee around. On the commercial side, if you look at the US it's a very attractive monitor because mostly ologists concentrated in large Rowlett urology groups, meaning you can reach a large portion of the market with very a small amount of coal points. So you don't need a huge sales thing to get into this market. The market already knows minimally invasive, so we are just introducing a better approach to minimally invasive treatments. Reimbursement already exists in very high numbers for minimally invasive for BPH. So we are riding along on these, this trend. And we're already building there are commercial activities in the US here in the US. If you look at Europe and other places in the world, it's actually a much lower hanging fruit for us. Because even though minimally invasive treatments have been around for several years now, they have very low presence in Europe and in other countries because of high pricing. In our case, because of the low manufacturing costs, we can actually adjust to local reimbursement policies and reach out to a lot of new markets. For for the reason of reaching the commercial side of the business and turning the company from purely r&d to commercial company, we're just now bringing on board a new CEO Patrick McCarthy until recently he was the head of Urology business in Olympus, he actually led the launch of a minimally invasive BPH treatment in the US until recently. I've been leading the company for the last nine and a half years. My background is 20 years in medical devices, mostly in building early stage product companies. I will an engineering undergrad and MBA from UC Berkeley. One of our founders is Adrian is a neurologist by training. So he is He has years of experience in treating BPH patients and he already launched several medical device companies. First Invesco and currently our chairman is Shimon Eckhaus is one of the biggest names in medical device in Israel he founded luminous was with a world leader in BPH lasers and SR one and many other companies. And are also on board we have Stefan Hove out he used to lead the intervention and ecology business in Coloplast, one of the largest medical devices, medical device companies focused on you ology, so in, in urology is, is a very known figure. So in summary, we've we've, we are launching a next generation minimally invasive, improvement on the current minimally invasive, less invasive, more elegant procedure. In fully reversible treatment. We have a we have a very strong commercial planning on how to reach the market and we are actually building all these capabilities in house with our own team. We already have manufacturing established. We have a very strong and growing body of clinical data and a very strong group of investors who support us. Thank you very much.