Mark Forchette 0:03
Good afternoon. I'm Mark Forchette, President CEO of Delphinus. Thank you so much for being here. So this is an incredibly exciting time for our company because we created the soft view automated whole breast ultrasound system to find more cancer than mammography alone. We put it into a clinical trial massive clinical trial to show that it does what we say it does got the data that we wanted, submitted a PMA in October, the sixth of last year, we got our PMA. So that's an incredible moment for the company. So let me just take you a little bit further we're we're here seeking to add to our series D, because we believe we have a comprehensive solution to an unmet clinical need. And we're positioned with soft view to transform clinical thought and practice. We have a portfolio of approvals, we've got three 510 case. And now the dense breast screening PMA, this is very patient oriented technology, no compression, no radiation very comfortable for patients. And that we have an extensive set of data that shows that we do what we say we do. Additionally, the existing codes for reimbursement apply to soft fees. So it's rare to have a blue ocean technology there's reimbursed software was reimbursed. And the way that we designed the system with a platform and a per patient consumable recreates an incredibly compelling business model all to be executed. by a very strong management team that demonstrated what they could do in the clinical trial So, SofU was created to address a clear unmet need. Women want a better dense breast imaging solution because the current options are flawed. It's important because about 40% of women in the United States have dense breasts 70% In Asia, and with dense breasts, finding cancer in dense tissue is like trying to find a snowball in a field of snow, it's very difficult to see. So as a result, mammography misses about half the cancers in dense breasts. Additionally, the patient experience with the current options is not very good patients hate compression. And patients fear radiation exposure. So 10s of millions of patients that should be screened every year do not show up. That prompted a keynote speaker at the Society of breast imaging recently to say we need a new technology for women with dense breasts. And we certainly agree with that, as well as legislators agree there's now 38 states that have breast density notification laws that say when you get your mammogram, you should be screened with some other technology to see the cancers in dense breasts. So that created the backdrop to our co founders that had a vision to address these unmet clinical needs with the new technology and that technology is soft few. We would like to believe that soft tissue is the solution to dense breast screening. So as a result of this massive data that we did for the PMA, we can say things like this, SofU does find more cancer than mammography alone due to improved sensitivity, or improved set specificity demonstrates the potential to reduce callbacks and initial unnecessary biopsies. The system is designed with no additional compression or radiation in the indication allows the screening to happen the same day as the mammogram. Additionally, you have a new blue ocean sort of technology think he might have to have an expensive person to operate it. But Safi requires the operator requires no specific degree or licenses required and only takes about three minutes of breast to scan with this technology. The SofU system is a synthesis of innovations. So this bed that you see here's the entire system, it has the reconstruction engine in it, the patient lives face down they put their breasts in a warm water bath water so the coupling agent, the breast is engaged using an acoustically transparent gel pad the secure breast interface that engages the breast elongate, stabilizes and centers it and then the ring transducer moves from the nipple to the chest wall, capturing information in two millimeter increments. The Triad transducer captures reflection, sound speed change in sound speed as the sound passes through the tissue in the attenuation data and outputs it into four unique imaging sequences. So this technology I just described is called triple acoustic technology. And as you can see, the ring transducer moves from the nipple to the chest wall, and at each plane, it's sending sound signals through the tissue captures reflection. It passes it through we Because of the unique ring design, we can catch it. On the other side calculate change in sound speed. And we capture the scatter of the sound. And that allows us to have incredible tissue characterization understanding with information that you just can't see with anything else. A unique part of this in a really critical part is the single use secure interface. This is the acoustically transparent gel pan. It's QR protected, so that can be counterfeited. Each one is peeled out for the case in this place in the water tank, on a telescoping pedestal, to allow the patient to then come in and be positioned with their breast in the tank in engaged by the secure interface using easy to use software. The technologists can visualize it because there's two cameras inside the tank. And then they simply press go to scan this and it takes about three minutes per breast. The data collected is then output in four unique imaging sequences, reflection and reflection images enhanced with this additional trust triple acoustique detection data that is gathered. And it is then sent to an image review software set that's at existing workstations that are in place in the reading room. One of the things that's typically a barrier to technologies like this is a new technology may have to come in and have its own special monitor. But we made SofU flexible, adaptable and very efficient to integrate, which helps us with adoption. So you know, we worked really hard to generate this technology and create it. And then we put it to the test. We engage 10 sites enrolled 8500 patients analyze 3 million coronal plane images and submitted that for our PMA. And we got that PMA approval on October the sixth. So I'm from South Alabama and like any good redneck, I put a sign in my front yard. That's exactly what I did when we got this. But I did it because I was very proud of the proven outcomes that we got. We demonstrated we find more cancer with the potential to reduce unnecessary biopsies in callbacks, because we demonstrated a 10% improvement in accuracy, a 20% improvement in sensitivity, and an 8% improvement in specificity and that 95% of women would recommend it. So these are incredible results for us to be able to proceed with so think about adoption. What is not to like about this technology, it's almost indefensible, not to one it finds more cancers, exceptional patient experience, same day screening indication for use, efficient with operators flexible software, it's reimbursed. And it's a platform for future innovations. So the one thing I can think of somebody may say, well, we don't have the money to buy this. So we took a very novel approach to this and created some versatile purchase options for customers. There's two ways that they can buy software, you the software, your own program, which is a capital equipment, sort of cafeteria plan to purchase or the software you now program which is an all inclusive pay per use pay per patient procedure that includes everything. This transforms the way that this market is sized based on this per patient consumable. The equipment opportunity in the US market alone for Sofu few is $3.2 billion. The annual revenue potential for secure is almost a billion dollars. And that's annual revenue potential. So soft view is a pretty fantastic technology as it is but we have future indications to come AI, CAD X, CAD E, breast density assessment. So this will be a platform with continued applications to layer on top, there was 42 issued patents with soft view. So we've done a great job of protecting this technology. And it really stands alone versus competition. There's simply nothing else like it. So in order to execute this, we need an incredible team here we've got one very experienced people to execute this as we saw on our clinical trial. And an incredible group of sophisticated investors and board of directors were seeking to raise up to $50 million in this round. Most of it is spoken for, but we have opportunity for people to still step into this. I'll be at a table after this. I'd love to talk to you because I believe this is the solution for dense breast screening with very patient centric technology that addresses a critical unmet need. And we are positioned to transform clinical thought and practice with Sofu. So we'd love to talk See if you're interested. Thank you.
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