Mike Kujak Presents Francis Medical at LSI USA '23

Transcription

Mike Kujak  0:05  

Thank you for coming. Many of us have experienced either brothers or grandfather or father who have had prostate cancer. In the mission of Francis Medical, it's actually named after our co founder's father who actually circum to prostate cancer. His name was Francis Hawaii, in our mission is to develop cancer therapies that are tough on cancer and gentle on patients. And I'm going to walk you through our story. Next year was founded in April of 2018. It was a spin out from the purchase of NextThera by Boston Scientific. They purchased the product called resume, and we spun out the development of both prostate, kidney and bladder cancers into a new coal called Francis. To date, we've raised $80 million and have a post of 108 million you can see who our investors are. This is the smiles that we saw on our first two patients that were treated with water vapor. The man on the left you can see was 45 minutes after the procedure. He had a catheter removed, did a voiding voiding trial and went home that afternoon. It's an outpatient simple outpatient procedure done in anywhere from 20 to 30 minutes. The gentleman on the right, had the procedure that the evening before spent the night in the hospital, got up and walked out the door. This is how large the prostate cancer market is. It has a very large TAM. This is just the US I wanted to point out. And this is the highly experienced management team. I've been in urology for over 25 years. Michael Hawaii who is our founder. This is the seventh vapor company that he has developed and he owns all the base patents for using water vapor throughout the entire body. And then we have other members of the management team who have a number of years of doing early stage medtech startups. We're also have an advisory board of over 10 physicians from all of the key cancer institutions across the United States. We were proud to be mentioned as one of the top 10 Medical Device startups last year in 2020. And if you look at how large the prostate cancer market is, overall, it's the second largest diagnosed cancer Worldwide there's over 1.4 million men who are newly diagnosed every year with prostate cancer and about a fourth of them have succumb to the disease over time. And something that's important is either prostate cancer is contained within the gland or it is moved outside the gland and has become metastatic in our vapor therapy is geared in fashion to treat those men where prostate cancer is still contained within the gland. And you can see a large number of those men are initially diagnosed with cancer within the gland itself. So for those of you who are familiar with seeing a man go through prostate cancer treatments, I myself my father went through it so I'm eventually going to have prostate cancer, I believe. And my father in law is currently living with prostate cancer, and they have difficult choices. My father in law right now is sitting on the sidelines. He's had prostate cancer for over for over six years and will not get treatment because he does not want to have a erectile dysfunction and urinary incontinence. My father on the other side, went and had radiation he had breaky therapy and eventually succumb to the disease. And so these men have really good difficult decisions to make. Do I live with urinary incontinence and ED and I got, but I don't have cancer, or do I live with cancer inside me knowing someday it could metastasize. And we believe there's a huge unmet need in the middle, to treat focally those men who have cancer anywhere in the prostate, but maintain their quality of life and that's what Vanquish will be have the ability to do. We've done some market research, and looking at the needs of both patients and physicians, you can see patients are looking at can they kill the cancer? Can I maintain my quality of life? And will I have a good experience? Physicians, on the other hand wants something that's very easy to use low complexity. If you talk to any physician who's done it intuitive robot, it takes them over 100 procedures to really get good at something that's efficient in something that's economic and This is what we've been able to demonstrate year today to date since 2018. This is an ambulatory procedure done in the ambulatory surgical center or hospital outpatient department, we've shown and demonstrated we can reliably kill cancer, we have treated over 50 Men 15 in the US in 35. First and man down in Central and South America, we have seen zero urinary incontinence, we've only seen one patient with Edie, out of all of those, we're a flexible treatment, we can treat a spot or we can treat the entire gland. And you also because the way vapor works in the prostate, you can keep all other options open both radiation and radical prostatectomy, we've showed we've been able to avoid or delay these radical treatments. And there's a very quick recovery time with minimal pain. In fact, one of our early feasibility patients here in the US in our EMFs study went back to work the next day. And so this is really how what we're doing, we're heating the water, converting it to steam, and that creates a lot of energy and we're injecting that steam in a 10 second treatment into the prostate. And our secret sauce is compared to everything else out there. That's an ablation technology, whether it's thermal hot or thermal cold, is water vapor stays where you put it. The prostate is built up of pseudo capsules and it has a capsule around side of it. So you put water vapor is shown on vapor ablation on the right, it's a convective delivery of energy, where traditional ablation is on the right. This is the procedure itself. It's a transurethral procedure done under ultrasound guidance and direct visualization. And we also have a needle guidance system that helps guide the needle tour towards the cancerous lesion. The urologist administers it via Thister scope and a small plastic needle is put out to the where the cancer is located and a 10 second set 10 second treatment is administered. This is to show you some MRIs to prove to you that water vapor stays where it is put within the prostate. upper left is a left peripheral zone ablation across from it is a bleeding both the left and the right peripheral zones not going outside the prosthetic capsule. It stays where you put it in the lower right is a whole gland ablation. Next slide I'm showing you here what it looks like seven days post ablation what the prostate does at three months and six months post ablation, you can see that almost 100% of the tissues resorbed and the prostate shrank from 38 grams down to six grams and had a six month biopsy or negative biopsy result. This is what the delivery device looks like. It's put on a stabilizer attachment. This is a hands free procedure. Once you insert the transrectal ultrasound and you put the sister scope in everything is done with a remote control no bigger than this right here. The needles advanced vapers fired and everything and then the surgeon would then move the Thister scope to another location but it's all hands free, done under direct visualization, trans urethra really and then we created electromagnetic field over the top of the patient to show where the needle would be go inside the prostate. Our early EFMs results we're very proud of it allowed us to raise a $55 million Series B oversubscribed. 13 of the 15 men actually had negative biopsies after one year. Two men had the excess cancer in each in one core we went back in ablated those men also and you can see the site of adverse events that we had. If you ask how does this compare to other ablative treatments, I have next to the pivotal data of both transrectal and transurethral HIFU prostatectomy and radiation. You can see how how the efficacy looks. Just going to wrap up here real quick. We are going into our pivotal study right now a unique design a single arm study. The first 120 men who get treated with six month biopsy in one year safety will actually be submitting a 510 K and we'll launch with a general tissue ablation. The entire data set will follow for out to five years but at three years we will submit three year biopsy and three year safety and upgrade our indication to the management of prostate cancer. And also we're able to retreat those patients who are cancer shows up during that five year period anywhere else in the prostate. We have reimbursement rustled down pretty strong. The first thing we did in 2018 was get a category three code we went to CMS and they've had a proposed payment up there. As you can see here there's a level, a level seven urology code at the time or a new tech APC. This is our timeline. We'll be kicking off a series C of 60 million this summer. With the close of next April. We'll have all of the 510 K data available for whoever invests in the series C and thank you for your time.