Mark Forchette Presents Delphinus Medical Technologies at LSI USA ‘23

Transcription

Mark Forchette  0:05  

Thank you Good morning. Every year, consistently 40,000 women in the United States die for breast cancer, year after year after year after a year 2020 to 43,000. How could that be? Well, 50% are mammography, the gold standard misses about 50% of cancers in dense breast tissue. That's a problem because 40% of women in the United States have dense breast tissue. And that means that in the United States alone, there's 38 million women exposed to this risk every single year. Only half of those women get screened is just because they don't like the options and they don't like the outcomes. So it's really time for us to think differently about this. And one of the issues though, is that the sites that do the screenings are really in a corner patients want a better experience. And now they're facing there's a federal mandate that says those patients must be informed about their dense breast tissue so they can consider other options. But then when those sites turn to the technology options for them, those options are flawed, the mammograms that Miss 50% of the cancers, the workflows, not necessarily great for those those dense breast patients, and then the staffing to populate those technologies that are available now or not. That's a really difficult issue. So that's the backdrop that created the vision for Delphinus. And for soft view. These are two co founders, Dr. Deb Zurich, and Dr. Peter Lynch, ribbit Karmanos Cancer Institute. And they created this prototype in 2010. That was spun out into Delphinus in 2010, as an independent company, and when that project was spun out, that technology was surrounded by Delphinus with an incredible group of talent, people that are very experienced in disruptive medical device technologies and development, breast ultrasound, automated breast ultrasound, that team worked on the SE system. And we believe we have created the solution for dense breast screening. It's an automated 3d Ultrasound tomography system. And there's really four key pillars of uniqueness to saw a few. Number one, it finds more cancer in dense breast patients. Number two, it's an innovative workflow where the patient can be screened according to our indication for use the same day as the screening mammography. It's also financially appealing rarely do you have a blue ocean technology where you can leverage an existing code we can in it satisfies patients, because it's no compression, no radiation. Soft view is a epic and rare opportunity to transform this dense breast screening category. And we're doing it with a cascade of innovation. So this is really critical because in the world, there's 2.1 million breast cancers seen each year. And soft tissue is an amazing solution for those dense breast patients. Why? Because it's no compression, no radiation. It's PMA, approved by the FDA for dense breast screening and adjunct to mammography. It's reimbursed. We delivered game changing clinical data in our study. And we have implemented that very innovative series of business model options executed by a team that understands how to manage disruptive new technologies. At the core, Safi is the way that it improves tissue characterization. So it's a novel approach that uses the system. You see here, a bed with an opening, the patient lies facedown they put their breasts in a warm water bath, the breast is engaged by an acoustically transparent gel pad that goes up, engages the nipple along gates stabilizes and centers it in a novel ring transducer goes from the nipple to the chest wall. But it captures a unique set of data, it captures reflection off the masses. Because of the ring design, we pass sound through the tissue, catch it on the other side, calculate the change in sound speed, and the attenuation data. And then we output all that data into unique sequences that are incredible for tissue characterization, and deliver additional information about the breasts. It's an efficient, comfortable two to three minute scan, the patient's simply positioned, engaged with the breast interface, and then a medical assistant because this is highly automated can press a button and execute the software scan. It's a very simple process. And then that data is output into four unique imaging sequences that gives much more informed Think about dense breast tissue than anything else that is available. So we believe we created something unique novel, something that delivers amazing new capabilities. But we knew we had to prove compelling evidence provide compelling evidence to radiologists, so they would understand that does what we say it does. So we went out, we got 10 sites, we enrolled 8500 patients, we analyze 3 million coronal planes. We took 70 radiologists from zero experience with soft view to incredibly proficient in a short number of cases they read, and we improve sensitivity and specificity in our study, submitted it to the FDA. And we got our PMA approval, that's the sign the day it happened. I'm a redneck from South Alabama, I put a sign in our yard. It was a proud moment. But um, but what we're most proud of is the data and what it means for women. So we showed in the study, a 20% improvement in sensitivity, and an 8% improvement in specificity. We're the first to ever do this in a study. And that means for women for patients, that we find more cancers, with the potential to reduce unnecessary biopsies and patient callbacks. That's an incredible position for us to be in. And we know it because the patient posted this on the website. It's one of the patients from the study that said thanks to that new Wonder soft view, I found a type of cancer that hides behind the tissue could not be seen in other exams. If you have the opportunity to this exam, do it. That's a incredible testimony to what soft few does. So we believe soft view addresses all the issues, finds more cancers, patient experiences exceptional, same day screening indication, efficient operator use its reimbursed future innovations that will layer on this platform. And we also created versatile purchase options, including an all inclusive pay per use model to help accelerate adoption. If you take that all inclusive model and look at the opportunity just in the US the 38 million patients in the US, the annual opportunity for soft tissue is $3.6 billion annual. First and foremost, we're about finding more cancers. But that makes this a very appealing to adopt technology. So with the position the approval or structured programs, saving lives with Safi starts right now. We're in commercial sites. And we screened our first commercial patient October 13 of 2022 at Karmanos Cancer Institute in Detroit, so huge moment, and the media picked up on this. Every network covered it. Katie Kirk's team was in a meeting with Karmanos within within 48 hours. And so those sites get a lot of attention. The new sites, University of Rochester is the President's society breast imaging, they just put the system in, and they're surrounded in good company with the sites that are a part of our study. So this is not only a platform for now, but a platform for the future. Following this is non ionizing breast density assessment, risk assessment, AI capabilities with CAD X for Region of Interest lesion analysis, CAD II for AI detection. So this is a very robust platform for the future. In a class by itself with offensive and defensive patents. We have 42 patents for this technology. And it is supported by an incredible group of investors, board of directors that have funded the company to the tune of $130 million to this point. So soft view is poised to absolutely transformed and spread screening. And we're doing it right now in commercial sites. So what's our ask at this meeting? We're funded, we're funded through to profitability at this moment. However, if you're an investor, you're interested in this technology. We'd like to know you for the future because this is going to become an iconic company. If you're a patient, we'd like you to ask your site about soft tissue. If you're just someone that is just interested in this category. We appreciate it tell all your friends because when the standard of the world so dramatically changes, it should be of interest to everyone. So thank you for being here.