James Hugg Presents SmartBreast at LSI USA ‘23

Molecular breast imaging (MBI) technology to more accurately diagnose early-stage breast cancer in women with dense breast tissue.
Speakers
James Hugg
James Hugg
CEO, SmartBreast

Transcription

Hello, I am James Hugg CEO of SmartBreast. You probably know that early detection and treatment are the keys to defeating cancer. And 50% of women have breast tissue that is too dense for mammography to work and to help them with early detection. Our technology which is pictured here, is capable of finding four times as many early stage cancers as as mammography and dense breast. And to date we've saved over 900 lives. X ray mammography uses X rays that cannot pass through dense breast tissue. And the tissue is appears white on mammograms, as does tumors. And so it's easy for tumors to be hidden in dense breasts. In fact, 70% of tumors can be missed in dense breast tissue. Also, there's a five times greater cancer risk for women with dense breasts. It's a big problem because 50% of Western women and 70% of Asian women have dense breasts. Another problem is that mammography requires that the breasts be flattened, which leads to painful compression. Our solution is called molecular Breast Imaging, or NBI. Gamma rays are used by this technique, gamma rays pass through safely through dense tissue. We also use a tracer, which is avidly taken up by by tumors. You see an example here of the same breast. The mammogram on the left was classified as being normal, whereas the MBI image on the right clearly shows the evidence of a tumor. Not only that NBI is painless. I have a news game changing news to tell you two weeks ago, the FDA announced that they would be requiring all 1821 mammography clinics to notify women what their breast density is. And if they were dense to two, recommend to them supplemental imaging. Also in Congress at this time is a find it early Act, which has bipartisan support that would require insurance companies to pay for that additional screening. We think this will have a profound impact on the demand for NBI. Now SmartBreast is an impact investment, you see that we have the potential of saving over 500,000 Wasted lives every year. But we're also a value investment because there's so much money wasted on late stage cancers that could be saved. In fact, only six cancers detected early would save enough money to buy one of the MBI scanners. We currently manufacture sell and service NBI hardware. There are two different units and they're both FDA cleared reimbursed and registered in 12 foreign countries next year, we're going to be adding AI software by working well we will work with to startup companies that that deal with AI software. The global breast imaging market is growing at 10% per year. And our bottom up calculation including the FDA announcement predicts $250 million in five years as attainable. We have early market penetration. We have 217 customers in 12 countries. Over 80,000 patients have been studied, and over 600 lives saved over 60 Publications show the efficacy of MBI. We have a number of partners who have published and who are joining with us in writing grant applications. We sell directly to hospitals and our digital marketing addresses As the users of NBI, who are the breast radiologists, surgeons and oncologists. Now, these are not the people who make the final decision. So they help us in the hospitals with the decision process to convince the decision makers. The unit price is to $400,000.10 years of service is also 400,000. The cost of acquisition of a customer is 5%. Of that we will add a sales team this year, and we will continue to use distributors in the rest of the world. Our competition is mainly indirect mammography, ultrasound and MRI. And each of these cases MBI has advantages even over MRI where it's MBI is 1/4 of the cost. We have deep IP moat with 18 granted patents. These first two column families covering our current product, but also we've taken care of the future. The Next Generation NBI product I've been involved in in dense breast imaging for over 20 years as has my partner Brad Pat. In fact, I was I led the team at GE that designed the current scanner that we're using. Each one of these leaders has 30 years or more experience in medical devices and imaging. And we've worked together before we've got a number of acquisitions and exits under our belts. We also have a team of international advisors both medical and business. In 2021, we purchased the the technology from GE and Dylan, we expect to be profitable by 2025. And we you can see the extra revenues that are added by this FDA announcement. We plan to exit by IPO on an Asian market or by acquisition. The m&a market in this area has been quite active, giving us confidence that we could be acquired. We raised 2.4 million under a seed collateral seed to buy the the technology. We're currently raising $10 million in our series A and we have a lead investor doing due diligence. The main use of funds is for marketing and sales. Next year, we intend to have a price round to continue the marketing and sales acceleration and to acquire the the artificial intelligence software. So we have a strong leadership team with traction that's been established. We have we're adept have adaptable tap to tactics that are showing traction in the market. We have a competitive edge over our competition for 21 patents and this new FDA regulation will magnify the demand. Thank you. This is the time to invest in saving lives of our mothers wives, sisters and daughters. Thank you.

LSI Europe ‘24 is filling fast. Secure your spot today to join Medtech and Healthtech leaders.

September 16-20, 2024 The Ritz-Carlton - Sintra, Portugal Register arrow