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Novuson | Stuart Mitchell, Founder & CEO

Speakers

Stuart Mitchell

Stuart Mitchell

Founder/CEO, Novuson
Read Biography
Novuson’s patented DTU technology will represent the first substantive innovation in over 25 years for targeting vessel sealing / dividing, and hemostasis (bleeding control) in surgical and trauma applications.

(Transcription)

Stuart Mitchell  0:05  

Thank you. As I indicated, I'm Stu Mitchell. I'm the founder and CEO of Novuson. Novuson has developed the next generation of Advanced Energy surgical devices that are safer and more precise than current technologies on the market. Advanced Energy devices are ubiquitous in the surgical arena. They're used in about 90% of all surgical procedures. They are intended to make surgeries faster and more efficient. But they do so at the risk to the health and safety of the patients and the surgical team. This is what surgeons see when they use the devices in a laparoscopic procedure smoke. This carcinogenic smoke occurs because the devices burn and char tissue. These smoke particles are so small that the protective equipment that the surgeons use don't protect them from the viruses, the bacteria and toxic gases that are contained within the smoke. This has been a problem since these devices were developed. And research shows that even last year, it is a significant problem with the current technologies. The CDC actually recommends not using these devices. The device rat manufacturers recommending recommend using smoke evacuated. Unfortunately, compliance of smoke evacuated or use is rather low. This affects over 90 million patients per year in North America. Not only a surgical smoker problem, but one out of every 200 uses of the electricity based devices or RF devices result in severe burns are operating priors. This again affects significant number of patients and the surgical teams. At Novuson on we do things a little different. Our direct therapeutic ultrasound is a disruptive novel technology that does not burn or char tissue. We don't put electricity through the patients and we don't cause carcinogenic smoke. What differentiates Nova science technology from the other technologies is that we use ultrasound energy to weld the tissue together and then we use another mode of ultrasound energy to cut the tissue. Ultrasound is the most efficient way of putting energy into tissue as opposed to radiofrequency are the electricity based devices which use electricity to cauterize the tissue and the mechanical knife to cut it or the harmonic devices which basically use mechanical friction to burn through the tissue. We embed transducers ultrasound transducers in the end effectors of our device, we will be producing the first three millimeter in diameter sealer divider on the market, which will make a smaller, more precise and current technology. Our technology addresses a significant amount of the pain points that clinicians have with current technologies. This is our technology in use and an FDA required test. This is sealing and dividing isolated arteries. These are poor sign arteries a three millimeter one and six millimeter one. FDA regulation is 240 millimeters of burst pressure we exceed that. But also important is that we have less than a half a million millimeter of thermal spread which will be the lowest thermal spread in the industry. Here's an example of our technology being used in a porcine animal model. This is a gastro perchloric bundle that contains an artery or vein a lot of connective tissue so a lot of tissue in a three millimeter device. And as you can see we cauterize right through it. We cut it, there's no bleeding, the more important there's no charring, there's no burning, and there is no surgical smoke. Notice on three millimeter device does everything that the current technologies on the market do that are five millimeters in diameter. We have less thermal damage and we are safer than those technologies though. Our management team has experience in technology, business, finance, and product commercialization. Our medical advisors are in specialties where a three millimeter device is desired. We're currently working on our regulatory filing for our three millimeter device which is going to be the disposable handset and the generator. Once we get regulatory clearance, we're launched with our key opinion leaders in a few local ambulatory surgical centers. In 2023, we'll expand our product portfolio to our five millimeter device which will allow us to introduce it into urology and additional centers. And 2024 we will release our 10 millimeter device which will increase the number of procedures that we can perform. So that was phase one of our go to market strategy. Phase two will actually engage a contract manufacturer and go with direct sales into ambulatory surgical centers will follow that with distribution partnerships into the hospital systems and around the rest of the world. And the final phase is actually licensing agreements in robotic and endoscopy space. So Novusan on will have two revenue streams. The first is direct sales, which uses a razor razor blade business model. Our handset is Disposable single use single patient use, the sales of which are predicated on how many surgical procedures are performed. The generator is capital equipment. The sales of this are predicated on how many surgical suites they can be placed in. The second revenue stream will be through the licensing agreements, which will be in robotics and endoscopic space Combined, these will give notice on the $6.4 billion total addressable market. Using this go to market strategy, we project the capturing just less than one half of 1% of the US surgical procedures and 1% of us surgical suites that will reach 62 million in revenue by 2026. When all of a sudden was founded in 2014, we launched the University of Washington licensed technology from then we raised $3.2 million in NIH grants, we ran our Series A for 2.63 million to 2020, we conducted our pre meeting with the FDA, we signed our first strategic partner, we demonstrated that we meet FDA requirements. We raised 3 million in convertible notes, and we demonstrated our commercial value proposition. Just last year, we were awarded three patents, we built our first run of production validation devices, these are the devices used to do the regulatory validation studies with we're currently working on closing our $10 million Series B. Nova has a complete IP portfolio, we licensed four patents from the University of Washington, we received the three last year and I actually filed a new patent last week. Our patents cover all aspects of our technology from the devices how we build them to the feedback algorithms that we use. We're currently in diligence for $2 million, Series B, we have term sheets from two strategic partners and one VC out of New York. While we were doing this diligence, we do have a bridge round open to finish our validation studies for regulatory filing. Once we get regulatory clearance, we think that we'll have a 2x increase in our value, which will be about a 6x return for our investors if we exit. This is an example of devices in this space or companies in this space that have built their products and exited via acquisition, we think notice on will be acquired in about two years for 50 to $100 million by these companies listed on the bottom, all of which we have ongoing discussions with Novuson is a novel first in class disruptive technology, technology. We're safer, we're more precise. We have a very clear regulatory path straightforward 510 K. We have experienced executive team. We have one strategic investor already. We're in discussions with two others. We have the sign term sheets, we're in discussion with a VC we have signed a term sheet on that. So please join me in improving the safety and efficacy of surgeries.

 

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