Sparta Biomedical | Dushyanth Surakanti, CEO

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Dushyanth Surakanti  0:05  

Almost weekly, we get emails from folks in their 20s 30s 50s and even the late 80s, asking if they could be the first patient enrolled. In a clinical study using our device, we'd be been hard at work trying to get one step closer to the clinic. Since last May, we've had several notable wins, we completed an oversubscribed financing round. We've achieved design freeze, successfully scaled up the process and transferred it to a commercial partner. In multiple discussions with the agency, we've confirmed our preclinical strategy. And we've developed a custom tool set that accompanies our medical device. We expanded our team to help us with quality and manufacturing workstreams. And we've expanded our IP portfolio to cover the critical aspects of our technology. Our team is made up of technologists and operators with long histories in MedTech and pharma. We have a nationally recognized Scientific Advisory Board of clinicians, researchers and educators. So we know this problem of cartilage degeneration in the knee is significant. But the unfortunate reality is that the standard of care is far from optimal. There are hundreds of 1000s of procedures happening every year, and up to 30% require reoperation within two years. In addition, there are many millions living with total knee replacements. And it's been found that one in three are deemed inappropriate candidates for such an intervention. So we asked ourselves with this as the backdrop is how can we fill this gap in the treatment paradigm? What does that ideal solution need to be? We looked at it as a biological problem, not a chronological one. Can we develop a solution that mimics native cartilage and brings down the pain which can be so debilitating for so many? We created that technology. It mimics hyaline cartilage be it tribology, compression tensile or shear. It comes in multiple shapes, so that it can approximate very closely the femoral condyle radius of curvature. It's highly Aussie integrative, where it anchors into the bone where the pain arises. And it's low profile will ensure that minimal cartilage and bone will be removed during prep. This gives surgeons the confidence as they go in to treat their patients. These features also result in a patient centric profile, patients will see a drastic reduction in pain, meaning that they'll be back on their feet immediately. They'll also be getting to do what they enjoy most. And they'll be doing that for many, many years down the road. Our technology is backed by several patent families. And we're prosecuting many applications with broad claims. We're excited about where we are, but we have a lot ahead of us. 2022 is going to be a big year, we have a number of activities to ladder up to the IND submission. Next month, we'll be kicking off a large animal study. Shortly thereafter, we'll be working on mechanical testing. Both will be under GLP conditions. In the background, we'll be working on our clinical development strategy. And then in the latter half of this year, we'll be looking to raise capital to support that clinical study where we'll have sites in the US and overseas. The capital will also help us expand our management team, as well as cover things such as clinical trial manufacturing, supply, and IP prosecution. All these activities will lead to an ID filing towards the end of the year. With the agency's buy in with our preclinical strategy, we're bullish about our prospects. We've established the key partnerships across a multitude of partners and entities. We have an experienced team that's backed by even more experienced team of regulatory and quality consultants. We plan to expand our capabilities over time. But with this as the foundation, we're really looking forward to submitting a robust IDE and ultimately getting that Clinical Study initiated before the second half of 2023 Thank you