Will Mauldin Presents Rivanna Medical at LSI USA '23


Will Mauldin

Will Mauldin

Chairman & CEO, Rivanna Medical
Read Biography
Rivanna Medical are the makers of Accuro, and FDA-cleared device for epidural guidance.


Will Mauldin  0:00  

It's awesome to be here. I'm the CEO and co founder of Rivanna Medical and happy to share with you more about the company and how we're elevating standards of care with world first imaging technology. So at Red Banner, we're really focused on addressing this unmet need that exists in medicine and impacts millions of patients each year and it involves blind needle placement, and in particular blind neuraxial guidance. So neuraxial That's epidurals and spinal anesthesia. Most folks are familiar with epidurals in the context of labor and delivery, but also lumbar punctures, which is a similar procedure to a spinal, but you're extracting fluid to run a test for diagnosis of a neurological disease or disorder. All of these procedures involve placing a needle around sensitive spinal anatomy, namely the spinal cord. And instead of using advanced technology, or advanced imaging technology, these procedures are currently performed based on experience and are done blind. So if you talk to an anesthesiologist, they'll tell you about drawing this like imaginary line up and down the patient that will kind of palpate the hips feel try and feel the bones and then insert the needle and some of them call this poking hope. So this technique, the standard practice that has existed for a long time is really insufficient, you can imagine an obese patient or patient with spinal rotation, which is very common, just palpating the back is not going to give you an accurate placement location. Studies bear this out most of the needle attempts fail. This results in re attempts of the needle sticks and increases complications which range from debilitating post Dural puncture headaches to chronic back pain paraesthesia. And although very rare, they're always a small number of spinal cord injuries. Just a couple of months ago, in the New York, New York Times there was an article about a patient that died from a failed epidural placement where the catheter was actually placed in the spinal canal in dosed. So this current standard practice is just completely inadequate. It's existed for a long time, but it's ripe for something new. So why don't they just use conventional ultrasound This is widely available, anesthesiologist already use this to make their central lines safer. Well, there's some particularities about neuraxial procedures that preclude its use here. One is that you really need three hands if you're going to introduce ultrasound, so you need one hand on the needle, one on the syringe to do something called wasa resistance. And then you need another hand for the probe. These are usually single clinician procedures. So this is not possible. Also, the position of the probe, if you're going to image the spine is the same location that you need the needle and those can occupy the same space. So this is in addition to a steep learning curve with conventional ultrasound, these are the reasons ultrasound just not used currently for bedside neuraxial. So Rivanna, we've developed a platform of technologies to give sight to these blind bedside procedures. This revolves around our unique set of ultrasound bone imaging technologies. So ultrasound is usually used for soft tissue imaging. So we've developed ultrasound technology, image bone with high quality, and then combine that with AI decision support to really reduce the learning curve as well as other technological innovations. And this platform is not only applicable to blind neuraxial procedures, but really millions of additional procedures like bone marrow biopsies, intrathecal, chemo and other similar procedures that are currently done blind. We've leveraged this technology into an initial product that's on the market, which is a handheld device called an Accuro. It's a nice little device, very portable, easy to use for the clinician, it has AI decision, support software on it to automatically interpret the image and show you where the epidural space is how deep to go. So this is like a stud finder for the spine, low cost device. And surprise, surprise in the clinical trials. This device if you use it to take a look at the spine and plan out where you're gonna go with the needle and knowing the depth. This does better than doing nothing. Right. So typically, in the latest study that was published 40% first attempt success rates and we raised that to 72.5%. Reduced a complication called paraesthesia by quite a lot from 45% to seven and a half percent. We sold over $5 million of this device. We're partner with B. Braun and this has really allowed very robust engagement with the early market But the real key to mass adoption here is not only to, you know, locate the spot on the back to insert the needle and get to that 72% level, but to get to 95 99%. And what's needed here is to not only see where to go, but to watch the needle go to the target anatomy, just to see it go to the epidural space. And I mentioned kind of two limitations there that are precluding this the three handed problem and the midline problem. And we have addressed that with this system. So you can see we've built in a lot of value into the consumable here, which is, of course advantageous commercially, and solve the 3 handed problem by securing the probe onto the spine. And then we have a gap in a two array set up there so that we can see the needle with a midline approach. You can also see we have some advanced AI enabled decision support, we have a CT like image rendering that that overlays the ultrasound image to reduce that image interpretation, learning curve that's involved. So unlike standard ultrasound, Accuro 3s is able to deliver first tip success. And this is by way of introducing a new real time safety standard for neuraxial procedures. And unlike X ray, we can bring that to the bedside. So our approach to the market here is to really focus on a beachhead market, the nation's top birthing centers, we will leverage our existing install base that there were 250 hospitals with our handheld accurate, as well as a commercial strategic that will be joining this investment round that I'll mention again later. This will naturally be leveraged into the overall acute pain neuraxial market, there's 4.6 million procedures per year. And then there's additional very significant sources of growth by adding new probes like a high frequency probe for pediatric LPs, customized probes and also new AI modules to go after bone marrow biopsies. intrathecal chemo chronic pain is a huge one as well to be able to bring those bedside instead of having to go to a pain clinic and do that under fluoro. An additional very significant source of value for the business is in this additional platform that leverages our ultrasound bone imaging technology into a device that can eliminate non essential radiography in the emergency department. So this is a device that provides 3d comprehensive musculoskeletal diagnosis at the point of care. And the value proposition here is to accelerate patients and not make them go through that lengthy X ray kind of standard practice with radiology into fast track them out of the IDI. Most of these patients don't have fractures, 80% of them don't. This development is supported by a $65 million contract that BARDA awarded to Dr. Anna and there's additional significant procurement opportunity at the end of that contract through Project bioshield. So with these two major product platforms, launching over the next few years, there's significant short term revenue growth opportunity for the business and also to build build more value behind that right vana bone imaging IP platform. We also manufacture these devices so we enjoy attractive gross margins that will expand with volume. Have an amazing team. Adam Dixon is our executive VP of engineering, he's attracted over $78 million in non dilutive r&d funding, which is really astounding. Jacob Katz leads our commercial team. He comes to us from midline, very talented commercial individual. Also want to point out Nikki Gagne, she has had VP level positions at GE and Siemens. And then we have centers of excellence at Yale UVA, our partnership with BARDA and B Braun, were seeking a lead financial investor to join our commercial strategics in a $10 million Series B two round for us that will launch Accuro 3s. And we have a lot of interest in this and expect to be able to close by June. So with that, thank you very much and would be very excited to talk with anybody that would be interested in joining us to elevate standards of care with our world first imaging technology at Rivanna. Thank you


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