Cody Simmons Presents DermaSensor at LSI USA '23

Transcription

Cody Simmons  0:04  

Hi everyone. My name is Cody Simmons, I'm the co founder and CEO of Dermasensor. We've commercialized the world's first point and click skin cancer detection device. We equipped the most common provider PCPs to detect the most common cancer skin cancer. The main problem with skin cancer is that there's so much of it. There's 5.5 million skin cancers diagnosed just in the US each year. And melanoma is expected the second most common by 2040. Melanoma is also the number one cancer killer of young women. Fortunately, while there's a lot of skin cancer, 99% of it is curable if detected early. Unfortunately, many skin cancers are detected late due to a combination of poor access to dermatology, and low skin cancer detection rates or sensitivity by PCPs. So our goal has been to develop a low cost high performance and easy to use device for the US is 300,000 primary care providers so that they can assess lesions more like our 10,000 dermatologist. I'm excited to share that we've recently received an Edison award or submission to FDA is currently pending review. And we're already we already received FDA breakthrough device designation a couple of years ago, our device equips frontline providers with a non invasive handheld tool to more effectively assess skin cancer, we're effectively putting the eyes of a dermatologist in the hands of hundreds of 1000s of frontline providers so that they can catch more skin cancer and decrease unnecessary referrals. And the device use process from capturing the data to receiving the results takes under 30 seconds, which is critical in primary care where the average console time is just 10 minutes. Not only is this data capture process much faster and more consistent than using photography for telemedicine like take taking a picture of a mole sending it to a dermatologist. But we also give an immediate point of care response instead of receiving an assessment days later. Coupled with that high product efficiency and utility. Our small smartphone like pricing model is lower costs and using telemedicine and negates any need for new software any it integrations. So bit about the technology, we use a type of optical spectroscopy called elastic scattering spectroscopy or ESS which we have protected with three issued patent families, two of which are licensed from our collaborator Boston University, as well as a machine learning database of 1000s of biopsied pathology confirmed lesions. So technology uses light to analyze cellular and sub cellular features to distinguish malignant tissue from benign. So it's capturing and processing data from beneath the surface of the skin, so in a sense serving as an optical non invasive biopsy. Accordingly, the device performance is unaffected by patient's skin color, since we're not taking surface level photos, which is really important in the AI community. And for this this topic specifically, there's over 20 published studies from various researchers on using ESS to assess different types of skin cancer, sorry, different types of cancer, skin, colon, esophageal, and they repeatedly show that ESS captures clear spectral signatures for effectively differentiating malignant from benign tissue. So, there's a fair amount of coverage in the popular media about using photos and smartphone apps for skin cancer. To be clear, there's not a single image or optical based product of any kind for skin cancer that's FDA approved and available in the market right now that provides any kind of risk assessment. The only AI skin cancer imaging based system that's ever been approved by the FDA was a large one you can see here called Melo find that was approved only for dermatologists use only for use with melanoma. And it was discontinued a couple years after launch due to its poor performance clinically and its high price tag of $120,000. And the US government has shut down a couple apps. Again, one is pictured here that we're marketing claims to help consumers detect melanoma. Two we expect to be the first first one on the market. As I mentioned, we have completed six clinical validation studies. And this clinical evidence is under review right now by FDA. The two validation studies in dermatology showed that the device performance both sensitivity and area under the curve is comparable to an in person expert dermatologist assessment. One study was for melanoma, the other study for all common skin cancer types. The two validation studies in primary care showed that the device performance is superior to in person primary care physicians performance and a head to head comparison. One of these was the FDA pivotal study which involved 22 study sites globally in over 1000 patients. A press release was widely covered on this study results just a few days ago. Go when we presented the data at American Academy of Dermatology, the two clinical utility studies in primary care, one of which involved over 100 physicians. Both showed that PCPs miss half as much skin cancer using our device compared to using just their standard of care visual assessment, and also their overall accuracy or area under the curve improved, with dozens of top names in dermatology and also primary care leaders as advisors, study sites and authors on the forthcoming manuscripts, including Mayo Clinic and Harvard. Our clinical evidence and medical community support really position as well for success once we're commercial. So our products really enabling a new distribution model for effective skin cancer checks, right? It's not just the 10,000 dermatologist anymore, it's now 300,000 frontline providers, like family doctors, clinicians have read telehealth. similar products like butterfly cue their ultrasound, and echo health AI stethoscope have shown that a combination of direct sales to large heart health systems with broad digital marketing efforts can effectively sell in a scalable way to primary care. And our commercial plan now has been refined with our new commercial advisors who just joined in the last couple of months. Steve Mayer, ZX CEO of wall Shaolin and Jason Bella, the co founder of Echo health, who's AI stethoscope is in use by 350,000 clinicians, most of which are in the US. using existing reimbursement codes, the estimated average Medicare reimbursement will be $27 per patient, resulting in estimated 2.5 to 3.6 million in additional revenue for every 100 PCPs. And of course, many health systems employ hundreds or even 1000s of PCPs. There's also very clear value propositions for value based systems. As you can imagine, in market research with PCPs that our practice owners 85% report that they would purchase a device and the average practice would actually purchase two devices. Given these upfront financial benefits and the clinical benefits I covered earlier, and that there's no similar product on the market. There's no upfront device costs, nor it integration, adoption barriers or operating team board and advisors really think the adoption shoni here's a realistic base case, we forecast just over 1000 units sales in our first full year of sales next year, reaching 11,000 units in year three, which would equate to about 2 million in year one, and 14 point 5 million in revenue year three. And the large majority of this as you can see is recurring revenue given our SAS or a house like business model. Our goal is to achieve these sales with 15% market penetration in five states. And then to exit or scale ourselves or scale ourselves nationally after that. Note that the sales do not include large health systems outside of those target five states such as CVS optim Kaiser, each of which employed 1000s to 10s of 1000s optimizing 30,000 PCs. To continue with executing on our vision we have a great team with a track record of building and exiting med tech companies. Most notable is not me is my co founder and our chairman Dr. Murray's furay, who sold Mako surgical to Stryker for 1.6 billion and is currently the CEO of another Miami based CT med tech company called Insight Tech. My backgrounds in bioengineering and business at Brown and Stanford. I worked at Genentech for several years, and this is a third early stage inception stage startup that I've been a part of launching are other leadership team members also have impressive track records. For example, our CCO has been the commercial lead for two exits of similar devices. Following our long product manager miniaturization process and clinical development work over the last decade, we closed in 11 Point 5 million series A in early 2020, a 10 million bridge early last year to fund completion of the pivotal studies. In our preparation for us launch, we plan to raise another 15 to 20 million upon FDA clearance in q3. Last couple slides here. We also have some very interesting partnership and growth opportunities relating to patient referrals. Work with other dermatology products and telemedicine which I'm purposely not sure much detail on here. And with that, thank you for your time and hopefully you like the many other reputable organizations here think that our work will have a major impact on patient lives. I look forward to hearing from an interested investors or partners after this. And if we can't connect here, you can reach the company and our contact email there or email me on message me on LinkedIn. Thank you