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Tara Ghazi, MALCOVA - Computed Tomography Technology | LSI USA '24

MALCOVA is utilizing proprietary computed tomography technology to provide a safe, comfortable, and effective imaging solution for the early detection and diagnosis of breast cancer, particularly in women with dense breasts.

Tara Ghazi  0:03  
Tara, hello everybody. I'm Dr Tara Ghazi, a co founder and CBO of malcova. Malcova is an early stage company looking to bring about a paradigm shift in breast cancer radiology. So breast cancer is a massive problem. One in eight women in the United States and globally will get breast cancer in her lifetime. In the United States, we implement a widespread screening program, as do many other countries, in order to detect cancer as early as possible when treatment outcomes are best. The US alone has a $1.9 billion breast radiology market, 8.5% CAGR, and the screening segment makes up 1.4 billion. There are more than 40 million screening exams performed each and every year in the US at over 8000 imaging clinics and hospitals nationwide. So screening in the US is performed using mammography. In mammography, a woman's breast is positioned between two plates, it is compressed, and a two dimensional image called A mammogram is taken. You can see two examples of these on screen here. For this woman on the left, mammography is effective. Cancer can be readily detected and diagnosed. But for this woman on the right, who has what's described as a mammographically dense breast, cancer can be an incredibly difficult, if not impossible, task to detect. This is a major problem, because up to 50% of women in the United States have mammographically dense breasts. So what happens for these women? So if mammography isn't sufficient, women are often called back for rounds of imaging with a different modality, frequently, ultrasound. Now, ultrasound is considered relatively low cost, low harm, but in the breast cancer imaging space, it's insufficient on its own as a standalone modality. It cannot detect small details and early traces of cancer, so it can never be used without mammography. Ultrasound can, at times, be ambiguous as well. So women then go back for additional rounds of imaging. It's not uncommon to go through four or more rounds of imaging before a diagnosis. In a recent study, they showed that of all imaging cases in the US, only about 5% occur with breast MRI. Breast MRI is incredibly costly in both dollars and time, procedure can take about 30 to 45 minutes. It is not a widespread screening solution for our population. Every year in the US, about a third of cancers are diagnosed at a late stage, when treatment is more severe, chances of survival are lower. There are more than 100,000 mastectomies performed complete removal of a breast, and more than 43,000 women die each and every year from breast cancer. Four dense breast imaging, three dimensional imaging is most effective so that you can view the tissue from multiple angles. CT is an incredibly powerful and well familiar technology. It's in hospitals nationwide. In CT, a beam is passed through the object being imaged and detected at the other side. A problem with conventional CT is that when that beam hits the object being imaged, many particles scatter. When those are detected, they create noise, contamination in the image. We call this scatter contamination. Malcova has invented an entirely new method of CT imaging that leads to a 90% reduction, reduction in that scatter contamination. What this means is that we're able to detect incredibly tiny details at high quality imaging, and do this at very low levels of exposure. Unlike conventional CT, this technology was developed entirely in house. Is protected by a patent family owned entirely by makova. Here you can see our second generation prototype in action, so that you can look at this architecture in the center. Here you see a white object that represents a breast. There's a detector that rotates rapidly around it and a source that rotates in a single arc slower on the outer perimeter. This is a first in its kind technology that paves the way for us to have add on solutions and be first to market with technology specific, advanced viewing software and AI based computer aided detection and diagnosis. Beyond screening, we're able to also move into the diagnostic imaging market and offer advanced imaging specific features that only CT can deliver. I showed you the engine. This is our product vision the breast monarch. This is a standalone imaging device meant to be a replacement for mammography in screening for women with dense breasts, this device allows a woman to position herself comfortably on the device for imaging, no compression required. Our company was founded in 2019 received its first seed funding in 2020 and since that time, we've established a strong IP portfolio. We're currently in our third generation. Prototype technology development, we've published extensively to demonstrate that this technology resolves the critical need in this space, and we've conducted extensive customer discovery to validate product market fit. Our steps ahead are finalizing development of the breast monarch device and our initial software solutions and moving into our first in human demonstration. Beyond that, we have a clinical trial, a screening device such as this has a PMA pathway, and we anticipate market launch in 2029 the most recent and relevant comp was Mobius imaging acquisition by Stryker in 2019 for 500 million on initial entry into market. To date, we've achieved all we have on founder investment and over 4 million in non dilutive funds raised. We're here raising our Series A a $6 million round to enable us to achieve these milestones. Shown here. Our market projections are modeled based upon a predecessor example. In this market, we anticipate over 6 million in annual revenue after ramp up, coming from capex, device sales and recurring revenue that'll increase over time from our software solutions. We have a great team behind the scenes. Our team is led by CEO, Dr peman Ghazi. He's a deep expert in the physics and engineering of CT has experience in the medical robotics industry and has successfully raised 4 million for the company. My own background before pursuing a path of science, I had an extensive career in both technical and managerial roles in the insurance and service sectors. Dr Eric Chell, our VP of R and D, over 25 years in the medical device industry, has deep expertise in the development of software applications for medical devices and on team building in this space, we have an amazing Advisory Board, key opinion leader, our clinical advisor, Dr Daniel copens, there are few names better known and well regarded in this field. He writes the textbooks that radiologists are trained on in this space. Ed Bullard has successful exits in this space, fantastic entrepreneur. Dr Michelle spados, incredibly well known and regarded throughout Silicon Valley and the San Francisco Bay area where our company is located. She's been amazing at helping us with team building and Dr Kai Yang, highly regarded Harvard professor and board certified medical physicist. So we're here today raising our Series A we're very interested in connecting with both investors and strategics, and very happy to engage and talk with anyone who's interested in learning more about what we're doing. Thank you. Applause.

 

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