Nelson Patterson Presents Anavasi Diagnostics at LSI USA '23

Transcription

Nelson Patterson  0:05  

Thank you. Many of us during the pandemic experience the delays that are encountered when you have to get a PCR test that reverse transcriptase technology enabled us to have more precise, specific and sound treatment. As a result, on about SU was founded in 2020. With a specific game to bring point of care RT lamp molecular diagnostics to the point of care for rapid, precise, easy to use and cost effective molecular diagnostic treatment. Right now we're seeking to raise a Series A of 20 million, and I'll share more about the amount that we've already raised to date. So what is the need, there are three precision, speed and reliability. clinicians and patients don't trust antigen tests. Patients don't want to wait for a long time for a molecular results. And frankly, physicians are sick and tired of having devices at the point of care that have a 20 or percent or higher unreliability rate meaning a malfunction or an inconclusive result. So the solution is simple. This is the Anavasi Diagnostics Ascencio DX moleculer detector has an FDA EUA already, we're already commercial and generating revenue we bring to the market simplicity of use precision and speed and our clinical trial. Positive results came up in 16.8 minutes on average, negative is a little bit longer because our internal control is targeted to the negative simplicity. It's a simple, easy to use reusable device with a separate test that is also available containing our assay and buffer. The precision is there. We had an 89% PPA and a 96 MPa. We already have our EUA and we're part of the NIH radix program, which brought us 15 million in non dilutive funding. So what makes this platform compelling and differentiated. Again, it goes back to speed to molecular result, not speed to an antigen results 17 minutes under 17 minutes to a positive in our clinical trial, the size, I'm holding it in the palm of my hand, it weighs less than five ounces. Compare that to high complexity laboratory machines that take up whole rooms, the cost, this detector is $250. The kit between 25 and $30. And right now, there's very little waste. The only thing that you have inside of this is pipette a reaction to a swap. The nice thing is our accuracy is there significantly better than competition, significantly better than antigen tests, and our dependability. We have a very low malfunction rate compared to the rest of the industry. The market size is large according to Evercore just this year, the global point of care diagnostics market is almost a $50 billion market. COVID alone is 10 billion of that we're just trying to address initially $1 billion. We're currently focusing on a few key segments of the market with both direct sales as well as distributor partners. Senior Living Centers, urgent care, mobile testing clinics, and workplace on site screening are our prime initial targets. We also have a government and state and local government distributor that is working with us. Our management team is quite experienced together we have 11 successful exits with greater than $1.2 billion. We have over 125 years of combined medical experience. Our co founders are a faculty member at the University of Washington, Microsoft 20 year veteran and the founder of a medical device design and commercialization firm. We bring collectively a very significant and experience I'd like to call it a complimentary with an E competency team. We have our outside directors, senior researcher at Illumina, a an experienced investment banker and the global sector leader for medical devices for Korn Ferry, our sciences what differentiates us this is a reusable detector. Unlike other molecular detectors that are available today. We're not disposing of plastic batteries and electronics after every use. Importantly, there's no wife fi or Bluetooth on here. So cybersecurity is not a concern. We use a dynamic QR code to communicate results in a proprietary portal that we have developed an assay that has target redundancy we multiplex right now. We are the first product that went through review at Rosalind, which is the NIH is testing center for variant escape and detection. To demonstrate that we had 100% Target against all known variations and mutations of COVID. We have multiplex capability, which will enable us to go into other fields with respiratory with multiple targets, as I'll share in a moment. And importantly, as part of our assay, we developed a buffer that has superior artifact minimization that enables us to get very good results even in the presence of blood, viscous Muse mucus or hair. And our clinical trial, we were perfect against our comparator, which was a high complexity PCR assay, up to 34.7. Their limit of detection was 36. Our development pipeline is quite robust. We will seek initially to fill out our respiratory pipeline, building on a multiplex flu a flu B and COVID. Putting that into a clinical trial this year, and having that available for the end of the flu season. We intend to expand that into strep a RSV, other multiplex combinations they're in to target specific segments of the market. Additionally, sexual health we have a researcher who is using our product and platform right now under a CDC grant, and also in veterinary health where we think there are markets for development. Our IP is strong. We have five patents already in process, we have filed international claims. Each additional test or assay brings two additional filings. So we build our IP moat. And we've identified in our second generation detector already an opportunity for two to five more patterns. As I said, the NIH is back this technology. They like this product, we've received over $15 million in non dilutive funding. Our manufacturing strategy is very capital light. We depend upon outside manufacturers but NIH has also bought us the ability to have an in house production capability that we will turn on with market demand. That lean capital structure enables us to produce almost to demand based upon current trends in testing. That means we're not tying up valuable capital in inventory. Our financial projections are that we expect to do $8.1 million this year, we're operating at a loss only because we are investing in our r&d pipeline and running clinical trials. We expect that growth next year to continue a significant growth and we have very attractive margins and will be EBIT a positive going forward. We expect our Series A to be the only raise that we will need our fundraising timeline. As I mentioned, we were founded in 2020. Through friends and family as well as high net worth individuals and family office we have raised close to $15 million to date in both direct equity as well as convertible notes. The NIH gave us $15 million, approximately a non dilutive equity funding. And we've used that. So again, the investment opportunity here is to participate in the next generation of molecular diagnostics. We see this as a obviously expandable market and a global market on top of that, and we are looking for both strategics as well as venture funding to participate in this. Thank you very much