SmartBreast | James Hugg, CEO

James Hugg  0:00  
Hello I am James Hugg, CEO of SmartBreast.

We empower women with dense breasts to defeat cancer. Let me draw your attention to the logo, the owl, the owl is able to see her prey in the darkest of nights. Likewise at SmartBreast with our technology, we can see cancer in the densest of breasts.

Let me tell you about Nancy. Nancy had her annual mammogram faithfully every year. Then one year, several months after her most recent mammogram that was read as normal, she discovered a lump

that was already a stage three C cancer.

Nancy required very dramatic treatment, including a mastectomy.

Why did this happen? Because Nancy had dense breasts 50% of women have dense breasts and

their cancer can be hidden by by that breast density.

In 2008. Nancy formed the advocacy group Are You Dense, and in 2018, Nancy succumbed to cancer. Four months later, the FDA finally required all mammogram reports to include breast density.

Now the problem that we address at SmartBreast is that mammography fails in dense breasts.

The cancer risk for breast for dense breast is six times greater. And the recurrence rate is four times greater 70% of cancers are unseen on standard mammograms.

breast density can also mimic cancer, which leads to a number of false positives, extra unnecessary biopsies.

And every woman who's had a mammogram knows that they can be very painful. And in fact, half of women don't return for their annual mammogram just because of the pain.

Now the large imaging companies have tried to address this problem. And they've improved incrementally. The ability to detect cancer in dense breasts. You see an ultrasound, 3d mammography and contrast enhanced mammography. They've they're up to 50% detection of cancers but there are only two techniques that we can truly call dense breast solutions. That would be MRI, and MBI.

And BI stands for molecular breast imaging. And in many studies performed by the led by the Mayo Clinic, it is shown to be the best solution for dense breasts.

Now diagnostic MBI is currently reimbursed and screening MBI is in clinical trials.

You see on the left a mammogram a dense breast mammogram which was read as normal. Now the same breast examined on MBI shows clearly that there's an invasive cancer.

We have in the past year bought two product lines that are FDA cleared. The first on the left, you see the e 750. product line we bought from General Electric. The second we bought the e 680. From Dillon technologies.

Now, our technique is painless, requires very little compression. And it assures both the patient and the doctor that cancer has not been missed.

During the pandemic, we raised the capital required to acquire the MBI assets, including 17 patents. We have been transferring the technology for manufacturing these to our contract manufacturer. And we pivoted recently to become not just an equipment company, but also supply AI software that will help women so that we can become a dense breast management company.

Our board of directors here

Are

and executives represent at least 30 years of experience each. And

I and and Brad Pat, the chairman have between us us seven successful acquisition exits. We have a board of business advisors with a wide range of experience. And our Medical Advisory Board has two breast surgeons, four breast radiologists and a biomedical engineer.

The market is predicted to be $10 billion by 2029. In global breast imaging of that we expect that we can service with dense breast hardware and software, 4 billion. And if we capture just 10% of that market, we're looking at $400 million in revenues. Now we recognize that the true customers are the women with dense breasts. Our target users are breast radiologists, surgeons, and oncologists. And of course the people who make the decisions are the the buyers and decision makers in the hospitals and clinics.

james hWe have a we operate in a blue ocean market segment with a full menu of both software and and hardware. We're going to be able to,

to experiment in different markets with with different revenue models. For example, we are going to choose a market where we can use celebrity endorsement and direct the patient's social media to test this as a way of convincing women that they need

molecular breast imaging and see if that additional pressure from the market pool will increase our sales.

So how will SmartBreast succeed in the MBI market that GE and Dylan established? Well, they laid the foundation they did in missionary marketing over the past 10 years, there's an installed base of 217 Global MBI units.

Both are FDA cleared,

including

biopsy guidance on the Dylan unit. A number of clinical trials have been completed, there's there's reimbursement for diagnostic use,

and many publications.

We need to build on that we need to scale up, we have the experience, we need breast imaging guidelines as the standard of care, we need to test the idea of director women and social media marketing.

We need to target very, very carefully the users and see if they can become the champions in the hospitals so that we can increase sales and we need to look at how to integrate AI software into dense breast management. And of course we need to build a next generation of these instruments.

In our modeling, you see in the blue line, the MBI only case and then with our recent pivot in emphasis. We are talking to two companies that that we intend to merge with later this year. The revenues and earnings are more than doubled. By buy these

were seeking a Series A equity funding of $15 million

to fund the next 12 months of a before we seek a pre IPO Series B of $50 million.

We intend to after that to find an exit to two years later, either an IPO or an acquisition. The series A capital will be used to ramp up marketing and sales to develop more AI software and to acquire. You see six cases here. It should be easy for everyone in the audience to tell that the mammography is hides the cancer, the MBI reveals it. Thank you very much for your attention.