Transcription
I think we need to do a round of applause for everyone who agreed to come to Thursday afternoon late presentation. The other speakers are talking. So thank you very much to the folks that I don't know. So we have a new device for improving the safety of biopsy procedures. And most of the time we view biopsy procedures as short and safe and uneventful. But this threat of bleeding creates incredible anxiety for patients and clinicians, because you're not sure who's going to bleed, and why they're going to bleed. So when we first took a look at this project, we began by interviewing clinicians who did biopsy procedures, and we got mixed feedback, we couldn't get much agreement on what they felt were the outcomes. So what we did, we hired an independent third party company called superior medical experts. And they did a PubMed search of everything they could find on the results of biopsy procedures. So in over 150 articles that they found with biopsy procedures that covered almost 400,000 biopsy procedures, they tabulated the primary and secondary outcome results. And when we saw this, we don't easily there was room for improvement, that this could be improved. One thing that everyone was in agreement on from the data that was in the literature, plus the physicians we interviewed, there's this automatic four to eight hour hold period, after every biopsy procedure, just to make sure nothing is wrong before you send patients home. And in some facilities like Cleveland Clinic, they keep every single biopsy patients for kidneys overnight, just checking on them. So the whole period doesn't fix anything, or it doesn't prevent anything. It just lets you catch complications sooner. And even with this whole period, the data shows that between one and 5% of these folks end up being admitted, because they have a complication. So how do we improve this, we have a new single use disposable electrocautery biopsy closure device, the only device that can cauterize tissue through a biopsy guide needle. So the device is pretty clever, we just use two double A batteries that are in the handle, that sends current to the tip of our device that is superheated. And that superheated tip cauterizes or heat seals a tissue that's damaged by the biopsy tools. So it's small enough and long enough to fit through an 18 gauge guide needle or larger which is used in almost all biopsy procedures. So advantages of doing this, of course, we can prevent adverse events that are caused by bleeding. And then this patient observation time that's automatic, we believe we can either reduce that, or eliminate that time to save hospital bed space, and to save expensive nursing time. And also, we've got some feedback from clinicians that this may indeed prevent tumor seeding or the spread of cancerous tissue cells after a biopsy procedures. We performed a clinical study on the device starting late last year finished it in q1, we went to two centers, one in Europe and one in the US. We treated 60 patients we had 100% Clinical success. And we had zero device related adverse events. But most importantly, for every patient, we were able to confirm a duplex ultrasound that the biopsy channel was completely sealed, so there was no fluid in the channel. So this this thing works. So I have a picture here of a dinosaur Pregnancy is a good friend, but he was the PI in our European Center. And we have this picture because before we went to Europe, Dr. Kevin Somi, we will not do kidney biopsies because they bleed too much. So just be prepared. We'll do liver in lung biopsy is only and after the first day of using the device. They started doing kidney biopsies, and in fact 10 of the 30 patients they enrolled were kidney biopsies. So he was we really met his requirements and he even exceeded his expectations. So we submitted our technical file two months ago in January. Our us submission is going in literally next week. So this puts us on pace for commercialization worldwide in probably late q2, or sometime in q3 this year, or yes, at which time we go global limited market release in both territories. And right out of the gate though we're going to do a clinical registry in both Europe and the United States to collect more data. The device is already covered by two issued patents. One patent covers the device design. The other patent covers the method of using a cautery device after a biopsy procedure. We have a couple other design patents pending as well. This is the Co-Founding team. It consists of the two inventing clinicians that you see on the right, and then two of the four technical team members. The technical team is all med tech engineers. between the four of us we have over 100 years of experience designing and developing medical devices. Collectively we have over 150 issued patents on medical devices. And previously we've gone through four years tech startup exits. These are our clinical advisors, all of them either contributed by participating in the clinical study, or they had significant contribution to the design and development of the device. Biopsy market is huge. So this year was over a billion and a half dollars, it'll be double that by 2034. Mostly because the population is aging, people are living longer, so you just have more of a chance to get a biopsy. Also, there's a high prevalence of cancer. And with improved imaging, they're performing more biopsy procedures. So these are revenue projections, we think these are reasonably attainable just see the benchmark $50 million in annual revenue for us, which would be a 3% global procedure penetration, or an 8% us procedure penetration. So we believe those are attainable. The company is less than two years old. So we started 23 months ago, we raised a Series A on a convertible note. All those notes have now converted, so there's no more debt in the company. And in mid February, we close the series, a round of two and a half million dollars on a $5 million pre money valuation. So our post money as we sit here today is his $9 million. With that money with the cash we have in the bank right now. We can get through both regulatory approvals, we can build our launch inventory. We can do the global commercial launch us in the US, and we can initiate both of those clinical registries. So thanks to all of you who came for the late presentations. Thank you.