Breast Cancer Screening: Enhancing diagnosis with FDA-cleared ATUSA(R) an AI-driven 3D ultrasound.

Did you know that up to 50% of women that are going to mammography, their cancers might be likely missed because they have a dense breast cancer? This number is shocking. We believe we can reduce the annual cost of the cancer. Breast cancer. For a lot of women with early cancer screening.

It is an honor to introduce you to one of my country women, Neda Razavi. Neda did her undergraduate degree at Azad University in Tehran, Iran in molecular biology and microbiology. She then came to United States, did her MBA at Pepperdine University, and she has joined various very important companies in healthcare such as Illumina, Amgen, Baxter and so on. And I'm very impressed by her career trajectory. And she is now CEO of Isano Health. I'm going to let her tell you more about Isano Health and what they're trying to accomplish at the company.

Thank you so much, Ron, for inviting me here and thank you so much, Emery Pharma, for having me as a guest. I can't wait to tell you what I know and have learned in the breast screening spectrum. My name is Nada Rezavi, as Ron just mentioned. And there was a fact when I learned the impact of what we don't know about breast care and things that are complete misconceptions and the healthcare system has failed a lot of women throughout the time of the breast care. Did you know that up to 50% of women that are going to mammography their cancers might be likely missed because they have a dense breast cancer? This number is shocking because depending on the breast density, the mammography sensitivity goes down to 30%. That means from 100 women that go through screening, 70 of them might have a cancer that's masked through mammography. This is a shocking number. I also want to expand a little bit more. When I said sensitivity, I meant the ability of the system to pick up when one has a cancer or a tumor to be concerned about. We Americans have spent $7.8 billion annually on mammography. Not only is it a painful process, but it's also ineffective in half of our population. Beside being painful and ineffective, if you think about mammography is only available in rural areas, only available in radiology centers that are in like either academic medical centers or in urban areas. There are 28 million women in rural America that have no access to these radiology centers. Therefore they're not getting their breast care annually. With that, our company was born. And you see the title of my slide says what if she had a Tusa? Our two smart co founders, the PhDs from Carnegie Mellon and Stanford. They both live lost their loved ones because the usual screening programs, the mammography, missed the cancers of these loved ones. And by the time they identified those cancers, it was too late and they lost their battle in few months after diagnosis. Our hope and our mission is to catch cancer early and save more lives. Less than half of us eligible women that needs to get mammography scans are getting their Scans today from 84 million population that should do their mammography every year. Only half of them do it from that half. Half of them have the dense breasts and they're not getting the effective screening. Again, the problems are the three key problems that I mentioned. Ineffective, that misses the cancer up to 70% of the time because dense breast is present as poor patient experience. It's painful, cold, room and very uncomfortable. And also access is a big issue. It is part of our standard of care when a woman goes for mammography and they are told you have dense breasts. Luckily in the US we have a new FDA initiative starting last year where the woman gets a letter and says you have a dense breast, your cancer likely missed. Seek supplemental imaging. Well, the good news is as a supplemental imaging ultrasound is available to patients, a lot of women don't know that's their right and a lot of insurances decline paying for the supplemental imaging because they can. I feel like there's a lot of need for patient advocacy in this area. The options today for supplemental imaging are either ultrasound or mri. MRI is an expensive modality, is a fantastic modality, but requires injection and also access is another issue. When coming down to mri, majority of time ultrasound is the best option. And if you look into available ultrasound out there, and I wish I had a picture of available ultrasound, you either have a card based ultrasound that has so many knobs and so many different things and it's a big gigantic machine and that could only be run by an advanced sonographer. Usually breast sonographers have additional degrees on top of or additional training on top of normal sonography that they're able to operate. This beside having a sonographer people to person to person, there is a variation in how this scan is acquired. So each person has a way of acquiring images. The location of the image varies, the pressure varies, and not only operator to operator, you have variation, but also patient to patient. The same patient that comes back might have variation because they have been positioned different way or the other. There has been some great initiative in the US and across the world that are concerned for female breast health and these initiatives Open the doors for a lot of innovation and a lot of new thinking to come forward and to catch cancer early. You might ask, why would you catch cancer early? If you catch cancer in stage zero, when it's localized, it will cost 48,000 on average based on a study published on WebMD. And it could be treated per American Cancer Society. If you catch cancer early, there is a 99% five year survival rate. So. But if you catch the cancer in stage four or later, the cost goes up to $200,000 and the patient loses the chance to live. That's why it's really important. There's a lot of initiative across the different countries to do the breast care and cancer. Breast cancer is the first cause of death among women and it is a big burden on the society from the cost standpoint. So the first initiative has been FDA mandate in 2023. Now if a woman goes to the radiology and they have a dense breast, they're told you have a dense breast, you may seek supplemental imaging. Second, Katy Curry is putting forward a bipartisan act called Find It Early Act. And this act is focused on no cost screening for dense breasts or increased race patients and that hopefully this act goes forward across all the states and there would be no out of pocket for supplemental screening. Right now, 28 states have accepted this act. USPSTF, which is the U.S. department of Task Force Services and decides on the national screening programs, have reduced the age of breast cancer screening to 40. So starting this year, women age of 40 are recommended to do their breast care and breast screening every year. And some states or some insurance companies is every two years. But this is a fantastic initiative. But at the same time, a lot of dense breasts women are coming to the pipeline. That is really important for them to know their rights. And who, the World Health Organization has a global breast initiative that outlines the framework of early cancer detection. There are a lot of second and third world countries scrambling. How do they screen their population? America and some of the highly developed world, they already have national cancer screening initiatives in place, which is fantastic. We are blessed to be living in this country. And breast cancer is one of the five cancers that nationally is screened, which is a good thing that allows us to have a national program in place. One thing I want to point out here on the slide is over 70% of breast cancer death are in low and middle income countries and are premature. The age is young. Also black women, 40% are more likely to die from breast cancer and get aggressive cancers at young ages. So there is a vulnerable population that the screening is really important for them, but they're not getting the screening because they can't afford it. They don't have access or they don't have the information at hand with that. Say hello to a Tusa Atusa is the name of our product. She was a Persian princess, lived 500 B.C. and she's the first known case of breast cancer in the history that was mentioned in Melody of Selbot by Sidrat and this princess gave birth to Darius the Great and she was in the history says she had a bleeding from the nipple and they cut her breast, took out the tumor and she survived. So she's per history she's the first breast cancer survivor. So this is a twosome. It's the world's first AI powered automated portable and 3D ultrasound that does 1, 2, 3 scans of the breast very quickly. It's comfortable and easy to put on. It takes two minutes to scan the breast and and the reports can be seen and read by a radiologist anywhere they decide to. And this device could be sent to locations of choice by any healthcare professional. So you can scan the breast in any location by any healthcare professional you desire. The benefits of having a device like this is first increasing accuracy because the automation takes the guesswork from the operator standpoint. So for the first time you can have an image that is taken from the same location over.