Steven Lin Presents BioGend Therapeutics at LSI USA '23

Transcription

Steven Lin  0:05  

Good afternoon. Thank you for coming to my talk. A BioGend is Taiwan based company. It was founded in 2016 and currently is listed in the Taipei exchange. The company has two regenerative technology platforms for bone and cartilage repair and regeneration. The first partner is called a RevoCart. It's a one step. A toggle is called a G repeater system that is commercially available in Taiwan. And the second technology is all I F. TCP, a composite material. It's an Oslo inductive upon graph based on recombinant human BNB to currently under several clinical trials. We know arthritis is a major disease worldwide. In this country alone, there are over 60 million US adults suffer from this disease and the annual economic loss is over 300 billion. We don't know the cause of arthritis but we do know that you have the cartilage damage your knee it loads damage is not repair and cartridge does not heal that eventually you will have also arthritis that you might become a candidate for artificial joint replacements down the road. So how big is the cardiology market in this country there are over a million arthroscopic procedures performed every year. And among those over million procedures, the doctor will find out there are over 100,000 those knees will show some degree of cartridges damages and among those over 100,000 Knees, there are over 100,000 knees have a severe cutters damage. That means you have the full thickness cartilage damage you can see that the underlying bone and loss damage you will not hear by yourself or your they are not treated the knee with just deteriorate with tie a very quickly so based on those the over 100,000 Severe cartilage damage. The market potential is over a billion dollars just in this country alone.  originally formed a company called Genzyme and the other Boston is based on autologous Chondrocyte Implantation and that means surgeon when patient comes in surgeon with tech a small amount of biopsy tissue is around about 200 milligram then the tissue will go back to the competence laboratory, then sales we get separate then put into a bioreactor for four weeks and after you have several million of conscious come to psi, then pitching comes back through reserves surgery so we call this a two step surgery. And the current generation product is called a Macey which is much easier for surgeon to do the surgery and I may say is the treatment of choice by many sports medicine surgeon to treat a large defect. It generates about 120 million in sales a year. But measure has several major drawbacks that really limits its broader applications. The first one is that because to surgery so it's a very cumbersome and inconvenience. No one wants to go through two surgeries they have to wait you know at least four weeks you know for sales to get ready. So mesh is very expensive. It costs like over $40,000 Okay for surgeries. And our company's river card we call it a one step call to repair it based on the sin countryside co therapy just like a messy but it's a one step and when patient comes into the or surgeon takes a small piece of tissue and this tissue, never leave the or it goes Through the two treatment, the first treatment is a mechanical mission to reduce the tissue into very fine particles are less than one millimeter in size. If you look at this particle on the SEM your part don't see any countryside. So, the second step is use enzyme to briefly to treat those particles for 20 minutes. Now, you pull those particle back to the SEM and look at now you can see the counter sigh expose and a particle surface. So, now imagine that you put us particle back to your knee which is the best bio reactor much better than the power reactor you can design in a lab, the cell have no problem receiving nutrients. So, they will respond right away they will start to migrate and reproduce that's how this technology works. So, well you know clinically, then we combine this particle with a scaffold power biodegradable porous scaffold. So, you have students go in plan and surgeon just through the whole you know to the to the bone defect sign and pull the product okay to a defect depends on the size of the defect, surgeon can use the 1234 product to cover the different areas and entire surgery takes less than one hour. So comparing okay the Macy has to go through to surgery and four weeks cell expansion and this less than hour surgery is done. So, so this technology over several competitive advantage over Macy, what is it they use a stem cell therapy principle as a one step surgery, so it's a quick and convenient and the cost is much, much less. And so Ribcor has gone through a human clinical trial in Taiwan and it has been commercially available for for for two years, last two years and close to 200 patients after receiving the treatment. And this is this data is from a pivotal study. As you can see this this patient has lost Elysian so it received the three implants. And one year follow up when a surgeon goes into the knee you know to look at the repair tissue. And you can see the defect is fully covered with a repair tissue beautifully. And the chart on the bar chart is is called the tender activities in a score that's major, how well the patient can perform the competitive sport. And five years you can see the bar Archer, the control patient, almost no control patient can play computer sport like basketball or baseball. But the treatment patient okay can still play computer sports. So clinically, this terminal is a very effective and so rivercourt is commercially available in Taiwan and it will still be available in the special medical zone in Highland Island, China, in some South Asian countries. And in the US. We are in the process of applying for ID study. And also we have submitted CMR applications. Now want to talk about second Richard if technology is a bar graph. The Bhangra market again worldwide is very big as the over 5 billion is jected to grow to between five and 7 billion okay by 2030. And there are so many different types of Bulworth and bone substitutes, but they all fall into three different category either osteoconductive are also inductive, or osteogenic. But only our own bowl has all the three property so so our bowl is considered as the gold standard when it comes to a bowl grab to infuse you know for me, Tarik is the market leader. And it's been around for 20 years you know since FDA first approved it in 2002. It generated I think around roughly between 400 to 500 million in sales a year and he use collagen POA and collagen as a carrier, you know for a protein and to deliver and but it has a couple of kind of major drawbacks one is that because the dose you know, is very high. So there's always safety concerns and because the high dose important is provided by a drug company so the cost is very high so it's very expensive Yeah. And our companies Why have TCP bone graft is also based on recombinant human BMP two, but it's produced from a bacterial cell. Okay, it's different manufacturing process and it's formulated for spinal fusion and also a spambot a feeler you know for different for various types of bone defect and it has a several competitive advantage one is the guarantee the quality because we produce BMP to ourselves. So, we have full control on the quality and the costs of the proteins and because the way we deliver the protein is using beta TCP ceramic. So, it has some it has a much better profile, yeah, is it profile and this is the animal evidence is showing that it works much better than the views Okay, a lower dose Okay, based on the critical rabbit bonk defend model and sheep spring fugi model, and this product has gone through phase two. Now urine study in Japan for three study is going to start later this year. And also there's an open tibia fracture clinical study ongoing in Taiwan and the US and as a dental study in Japan, and the spine fusion, the idea we submitted as far as we have a complete should study. Thank you.