Gustavo De Greiff, KneeVoice - Audio Based Orthopedic Diagnostic Device | LSI USA '24

Gustavo De Greiff  0:11  
That represented the noise of a damaged knee cartilage. Cartilage is one of the most important parts of our bodies, but actually is usually overlooked. It acts like a shock absorber, preventing painful joint bone to bone friction in the joints without proper diagnosis. Today, more than 75 million Americans suffer from excruciating pain, experience reduced mobility or need intrusive surgeries. That is why we have developed a device that is very easy to use. Let me show you how it works by placing a patent audio sensor in the center of the kneecap and a position center to the right of the patient with we ask the patient to do eight flexion and extensions, and our device will capture the sounds, vibrations and position, analyze them through our enhanced machine learning algorithm and generate a precise diagnosis in less than five minutes. How do we compare with the present options, images like MRIs CT scans are not designed to detect soft tissue or cartilage damage, therefore they are not precise. Microscopy is very precise, but it's also expensive and invasive. However, until now, is the only way to detect for certainly the cartilage damage. Nivoist has arthroscopic level accuracy for cartilage damage in a fraction of the cost and obviously, with very little or no inconvenience. Nivoist is a new to work device. We are not invasive. We can perform and examine less than five minutes, we have developed proprietary software and hardware to capture audio position data from the joints. We develop machine learning algorithms, in essence, with all the different sounds from from cartilage and from joints. We what we have developed is the shasam of joint sounds. Let me dive into the details a little bit more. We are using the ICRS scale grading system that is used to assess the severity of cartilage damage in joints, which has been used and trusted by clinicians for decades. An ICRS of one is a perfect, healthy cartilage, and an ICRS of four is a worn out cartilage, actually, with bone to bone friction generating a lot of pain. Our system provides the ICRS score to the doctors and also a more granular, granular knee voice score, also therapeutical recommendations to be considered by the doctors and the patients. We have done a lot to validate the science behind our technology. We listened and recorded the noise from more than 9000 needs. We conducted clinical trials in six different centers where we compared our results with the images of from arthroscopy of 120 patients, and our precision was 90.3% compared with arthroscopic images. Nivs brings benefit to all the stakeholders. Patients will have a quick diagnosis, allowing them to make informed decisions. Providers will have a clear therapeutical pathway and the ability to get reimbursed. Healthcare payers will save millions and doctors as doctors won't prescribe unnecessary MRIs or surgical interventions. We are currently running pilots, and we are thrilled to be conducting clinical trials at the kirland job Institute at Cedars Sinai, one of the world's most renowned Institute in orthopedics and sports medicine. We are pursuing FDA clearance as a class two medical device, and we are well on our way for FDA approval, which we expect to receive either in the latter part of the third quarter of 2024 or early fourth quarter. Our go to market strategy is based on a three pronged approach, first harnessing the key opinion leaders to champion and propel our products and capitalizing on the close relationship with the interested health system. Second, we are committed to showcase our devices in the most important trade shows and symposiums. Reinforcing our presence both of these initiatives will lead to the third. Which is capturing the attention of the major players who potentially become our distributors. The orthopedic device market presents a great opportunity for our target is to reach 34 million in revenue by the third year. And these projectors, these projections are conservative, but they indicate a potential EBITDA of 19 million by the end of 2027 nivoist technology will revolutionize diagnosis throughout the whole body. Our sights are set on the potential next steps with this the hip, the ankle and the jaw. All of these could not be possible without a fantastic team. My co founders, Dr Carlos Leal, an orthopedic surgeon from Harvard Medical School, Felipe Rigby that holds a Master's in systems engineer and with high we have I share a successful exit. I am Gustavo de grave, a tax executive with more than 20 years experience in finance and entrepreneur entrepreneurship, and I hold two successful exits, and of course, a inspired team of advisors, engineers, products, designers and clinicians that believe on what we are doing. Our world class advisory board is comprised with executives from FIFA, cedar, Sinai, Seymour, Biomet Smith and Nephew and Stryker, to recap, we are a company that has already done the heavy lifting. We have raised 2.1 million in previous rounds. We carried out successful clinical trials. We have a clear path to regulatory clearance. We have certified commercial devices. Our manufacturing and design studios are located here in California, and we have great IP already granted in the US, UK and Europe and other countries. We recently started a funding seed round of $1 million and today we have confirmed 825,400 from our lead investor, which is newfound venture group, and 425 from previous investors, angels and, more importantly, from doctors that use our products as agreed with our lead investor, we are using a convertible note at the cap of 10 million 10 million with 20% discount and an 8% interest, the primary use of the fund is to secure FDA clearance manufacture a new batch of devices to put in the hands of doctors that have expressed interest. Now allow me to show a small video. I

Video Playing  8:05  
So finally, here it is the knee voice, a telephemeral cartilage auscultation device that provides precise information of cartilage damage. As simple and easy as it looks is really a sophisticated device, not a toy for physicians. It fills the void of a dynamic test that provides previously unknown information and adds a lot toward practice and toward decisions different from CT scans or MRI that can be used repeatedly in the office and provides the highest customer satisfaction as doctors and patients can interact when doing the test and listening live to the sound from the Need It does require physician interpretation to validate our own clinical perception and diagnosis, but nivoist is the perfect device for continuous monitoring of interventions osteoarthritis progression and in the future as a wearable and easy use of plans in sports performance and prevention. So welcome nivoist.

Gustavo De Greiff  9:01  
Thank you very much. We are obviously looking for the right partners to join us in capturing our share of this $34 billion market. Thank you. Thank.