Vyasaraj Manakari Presents Magloy Tech at LSI USA '24

Vyasaraj Manakari  0:00  
My name is Vyasaraj Manakari, and I am CEO and co founder of Magloy Tech, wherein we strive towards revolutionizing the material of care in orthopedic and trauma fixation sector with bioresorbable implants. So my journey with orthopedic implants began back in 2011 when I met with a motorbike accident, I had a near joint fracture and I needed a PCL reconstruction, which left me behind with a titanium implant. Over the past decade, this titanium implant has not just reminded me of my accident, but I have to endure lasting pain as well as restricted movements, especially with strenuous activities, and as you can see from the second image, there is a noticeable shift in the posture of my knee as well. And the easy solution to avoid all of this is an additional implant removal surgery, but it comes with complications such as nerve damage, refracture of the bone after removal post operative infections and again suffer pain after the removal surgery, and especially in some cases, like pediatric patients, the removal itself may not be possible because the bone overgrows around the implant. And this story is not just unique to me, but 5 million trauma fixation surgeries happen where people suffer with discomfort and pain, and more than 20% have complications associated with it, and a looming uncertainty of removal surgery that may be needed, and these additional metal implant removal surgeries cause a burden of more than ten billion across the healthcare system, and more often than not, these complications are material related permanent implants like stainless steel and titanium stay in the body forever, which can lead to implant related infections at the point of implantation. Also, titanium and stainless steel have higher elastic modulus than the bone, so it may cause stress shielding and implant loosening in the long run, to alleviate the concerns associated with permanent implants, there are biodegradable polymer implants, however, they do not have necessary mechanical strength and cannot be used in load bearing areas, which can lead to premature implant failure. So this is where our solution comes in, where when we believe no patient who has a metal implant in his body has to endure long, lasting pain. And our solution is reso mag, an implant which is made up of magnesium that naturally and seamlessly transforms into bone once the fractures are healed, we have ensured that reso mag has higher strength retention during the bone healing phase, then a control degradation and gas pocket formation, which is commonly associated with magnesium implants, and then resorbed naturally over a period of 18 to 24 months. Our USP is two patents. One is a specialized green magnesium production technology, which is unique to us in the whole world, and we combine that with an AI based materials design and property customization that helps us to tailor the properties of our implants such that they are four times stronger than polymers and provide a stability of the metal. They are made up of non toxic natural elements such as magnesium, zinc, calcium, and their strength performance is tailored to match that the bone healing phase. Our preclinical trials are proven to be safe and effective and also promote enhanced bone growth and commonly associated problems with the permanent implants, as I was explaining before we were able to overcome with tailoring our implants so where magnesium finds its application in the temporary implant sector, we are focusing our product portfolio in the pediatrics, foot and ankle, cranio, maxillofacial and trauma, which accounts to more than ten billion market by 2028 and our first product is a cranial plating system. As you can see from here, it's world's first of its kind, fully dissolvable solution. So what we are doing with this product is we are combining a biodegradable polymer tissue scaffold along with magnesium screws and plates, which is provided by us. So currently, if you see the cranial and maxillofacial scaffolds are always coupled with titanium screws and plates. So even the scaffolds, though, they dissolve the plates and screws are left behind and need a removal surgery. So this is a first of its kind, wherein we provide material resorption in tandem with tissue regeneration, and especially in case of Pediatrics, it helps in unhindered skull growth. And in our design, we have ensured that there can be no changes to the existing clinical and surgical workflow we are planning our FDA breakthroughs. Submission by q2 this year, and we have partnered with a company called osteopor to develop this technology together and resume will be ready for market. Latch in 2026 we have completed our pre clinical trials. We are going with our FDA breakthrough device classification in the next quarter, and start with an idea ID submission as soon as we hear back from the FDA by the end of this year, and either go for 510, K or de novo approval. Also, we are having our manufacturing scale up and getting the necessary ISO certifications, and we expect to launch in the US market by 2026, so this is our current product portfolio with reso mag implant technology, the first one is the cranial plating system. We are also subsequently developing trauma screws, and we are planning for both of them to be simultaneously submitted to FDA as well as Health Sciences Authority of Singapore, which also gives us market access to whole of Southeast Asia, we have a technology development agreement with one of the universities in Singapore to develop dental tax and also we are focusing on 3d printing of magnesium so that we can have patient specific scaffolds and implants by 2028 Our team consists of world leading material scientists in the field of developing magnesium alloys. As you can see, Prof Manoj Gupta has been consistently ranked as top 2% of the scientists worldwide in development of magnesium alloys. Overall, we have more than 30 years of experience in material science, and our clinical board has more than 20 years of experience in craniofacial as well as orthopedic trauma overall. We have a very defensible patent portfolio a manufacturing process which is unique to us. We have proven our preclinical trials, which have shown the implants to be safe and effective. We would be going for our clinical trials soon, and expect both FDA and HSA approval by 2026 with the current partnerships and distribution agreements we have, we are expecting a revenue potential of 20 million when targeting 15,000 trauma procedures in the first two years of Our product launch, we are looking to raise $4 million which would help us in completing the clinical studies and also get the market approval and manufacturing scale up and ISO certifications. And most importantly, we are looking to create awareness in the US markets, with having more KOLs and access to hospital networks on board, and maglotech is well positioned to disrupt the temporary implant industry, and we continue to seek introductions to more clinical partners and KOLs regulatory and commercial advisors that can help us to gain access to the US market and also investors who are Interested in orthopedics. Thank you very much, and we ask you to join us in eliminating the need for additional implant removal surgeries associated with orthopedics and trauma fixation sector. Thank you. Thank.