James Hugg, SmartBreast - Spotlight Interview | LSI USA ‘23

Transcription

Nick Talamantes  0:14  
James, thank you so much for joining me in the LSI Studio today. 

James Hugg  0:17  
Thank you. 

Nick Talamantes  0:18  
Tell me a little bit about the work you're doing at Smart breast.

James Hugg  0:21  
We are empowering women who have dense breasts to defeat cancer through early detection and treatment. And what we do that by providing a machine, which can image dense breasts that mammography won't work on. Mammography fails 70% of the time in dense breasts, but we can we can see right through the dense breast tissue.

Nick Talamantes  0:49  
So how are you doing that?

James Hugg  0:50  
We do it with a technique called molecular breast imaging. It's an imaging machine that can see through the dense breast tissue.

Nick Talamantes  1:02  
Is it using any type of technology similar to what we see in PET by any chance? How is What does molecular breast imaging mean?

James Hugg  1:11  
You're correct that PE T PET imaging is a form of molecular imaging. This is a this uses technically is using single photons instead of double photons as PET uses of it's related to pet but it's not. It's a a nuclear medicine technique.

Nick Talamantes  1:35  
Why do dense breasts need to be imaged with MBI? Instead of what I would consider to be industry standard and what most women are familiar with, which is mammography? 

James Hugg  1:44  
Sure. Mammography uses X rays. And the X rays that are useful for mammography are fairly low energy, and they just can't pass through dense breast tissue, they get stopped. And all you see is a shadow on the on the mammogram, which can hide early stage cancers.

Nick Talamantes  2:07  
So it's my understanding that you know, approximately 50% of women actually have dense breasts. So what's sort of the awareness like? And is there any efforts being made currently to tell women Hey, you have a specific breast breast density, you actually need to be imaged with this technology instead, in order to stay on top of your screening. 

James Hugg  2:27  
So you're correct. It's been a secret of radiologists have not been revealing to women that they have dense breasts and that they can't really be sure whether they have cancer or not. But in the last 10 years, there have been several advocacy organizations founded by women with cancer that that was hidden by dense breast tissue. So the awareness has been rising. There's been a lot of effort to, to have a national standard for informing women. And actually, two weeks ago, the FDA announced new rules that apply to all mammography centers, they have to now inform women of what their breast density is. And if they're dense, they have to advise them that they should have additional screening. And then Congress, there's a bill that that called the Find It Early Act. It was introduced by Katie Couric, who has dense breasts and cancer. It looks like it's going to pass and it what it requires, is that insurers will pay for this additional screening.

Nick Talamantes  3:43  
Well, that's great that the awareness is starting to be raised and that women can get the proper care that they need to ensure that they are staying on top of their preventative medicine and early diagnosis. Tell me James, what other technologies are available for women with dense breasts or is MBI the only solution for them?

James Hugg  4:05  
So currently, there are two other choices. One is ultrasound. And the other is MRI. MRI is very limited in who can can actually be scheduled for it. Women have to have what's called a 20% lifetime risk of developing cancer. And this is based on family history, and other other factors. So only a few women say 10% of women qualify for an MRI, the rest would be given today, ultrasound and ultrasound is nonspecific, meaning lots of false positives, lots of biopsies that, that don't turn up anything. And it also misses a number of cancers.

Nick Talamantes  4:57  
So it's my understanding think that women, after they reach a certain age are required to be screened every one to two years. How does that change with women with dense breasts? Do the guidelines change? Are these women at greater risk of developing breast cancer?

James Hugg  5:13  
It's been shown that women with dense breast have five times the risk of developing cancer of women who have fatty breast or it's of no, no real density. So it's it's a big effect. That's as large a risk factor as having us. A mother with with breast cancer

Nick Talamantes  5:37  
May be coming back to the company. What does the name what inspired the name smart breast? Why are you guys called Smart breast?

James Hugg  5:42  
Well, you know, the, you know, a company called PetSmart. It's not because the pets are smart. It's the pet owners who are smart, we're using it. So what we're trying to imply is that women who use our product are smart. 

Nick Talamantes  6:01  
You have a pretty unique company logo as well tell me what's the inspiration behind the logo that you guys use with your company.

James Hugg  6:08  
So our logo is a flying owl. owls can see in the darkest of nights, we can find cancers in the densest of breast. 

Nick Talamantes  6:18  
That's brilliant. Where are you guys at right now as far as your commercialization status? Are you in market already? Are you in clinical trials?

James Hugg  6:26  
We are in the market. We have been for several years. In fact, we bought the product line from GE Healthcare. So we have FDA clearance, we have reimbursement and registration in 12 foreign countries. So we're we're well into the commercialization. We're at a stage of needing to now to accelerate the commercialization recover from the COVID, shutdowns and, and launch into to making this a bit more available for women. So

Nick Talamantes  7:03  
in order to get the fuel you need to accelerate and recover. Is that what brings you to LSI this year?

James Hugg  7:08  
Absolutely. We're here with a series a request for $10 million.

Nick Talamantes  7:14  
What's sort of the next step for you guys, once you scale up? Is there other applications for this technology that you're looking at developing, or other indications you're looking at?

James Hugg  7:26  
We are looking at adding AI powered software tools to this, for instance, assessing an individual woman's risk rather than, than these questionnaires that that that really paint a broad brush, picture of risk. So we believe that using imaging information, we can assess a woman's risk and then prescribe for her what the best imaging path would be. It might be alternating mammography and NBI in alternate years. 

Nick Talamantes  8:04  
What is the potential market opportunity look like for MBI technology?

James Hugg  8:07  
Well, it's actually quite large, because as you mentioned, 50% of Western women have dense breasts, and 70% of Asian women have dense breasts. So mammography is not the ideal tool for them. NBI we think is the best tool. So the market opportunity is very large to serve more than half of women. We, we believe that we can reach $250 million in sales in five years, if we're properly capitalized.

Nick Talamantes  8:42  
Are there other competitors developing similar MBI technologies for imaging dense breasts, we

James Hugg  8:48  
have one competitor in MBI. And I think the market is more than big enough for both of us to succeed.

Nick Talamantes  8:57  
What distinguishes you from your competitor? 

James Hugg  8:59  
The leadership of our company has over 20 years experience with NBI I was working at GE leading the technical team that developed this technology. We my partners have experience with a prior company and with distributing the software. So we think that our leadership experience is probably the biggest differentiator. 

Nick Talamantes  9:27  
You know, you mentioned that you're looking at implementing AI to further assist those doing the imaging scan. Are you looking at developing that internally? Or are you seeking a strategic partner who already has expertise in building AI and analyzing images? 

James Hugg  9:43  
We're looking for partners and we've been talking to two startup companies that are doing AI and women's dense breast imaging. One is working with MRI and one is working with with ultrasound.

Nick Talamantes  9:59  
Well James, thanks for stopping by the studio and telling me about all the things you guys are doing at Smart breast it's great to see what you're the hope you are bringing to women out there.

James Hugg  10:08  
Thank you