East Meets West | LSI Asia '25

Yuval Binur  0:03  
Good morning, everybody. I'm venture capitalist and company founders for the last 40 years. So I have lot of scars on my back, a lot of experiences in the last 15 years. I got myself very involved with a Asia Pacific activities and opportunities, with a big focus on China potential. So I try to practice East me twist, because I believe that meeting the people, talking to them, being there, give one the opportunity to learn the potential, which is, at the moment, not fully exposed, of the Asia, Asia Pacific zone, or region with, you know, nearly 2 billion people, 2 billion potential patient, 2 billion potential customers, etc. During my 40 years of experience. I went through several financial crisis the last one, big one was 2008 for those of you who remember it. But these financial crisises were nothing in comparison, at least to my judgment, the crisis that we are facing nowadays, the post covid crisis, I would say that there are five major problems that we are facing, and I would love to discuss it in a minute with my colleagues in the panel. And if I try to listen just as headlines, I would say number one problem that I face is the anti globalization, or you can call it de globalization, trends in politics. Here you go to America. They say, Make America Great. What is make America great is mean, I don't care about the world. I care about America only you go to Europe. And Europe just issued the EU just issued a notice that they want to restrict imports of medical products and maybe other products from China to the EU. Why we want to build the EU self sustain. You go to China, they are hiding behind the big China wall and also restricting and encouraging China made products we use only in China and make difficulties on imports into China and so on. So anti globalization become a major, major problem for us, and we'll discuss it more in the panel in one second. The other problem I face is instabilities of the financial markets. At the moment, the financial global financial markets are instable, and depends on what President Trump will say every morning, which is different than the previous morning. Of course, people try to avoid risks, and putting money into innovation, into early stage involve certain risk. So the instability actually affect our ability to push forward the envelope of innovation. The The third issue, and that's great, by the way, they the fact that startups are really collapsing because they cannot raise the necessary money to bring themselves into the first immense level, or into or into the pivotal study and commercialization of the product. The increased cost of clinical studies are also one big obstacle, because today to get a pro a complex product, for example, half valve into the market. You speak about total cost from idea to commercialization, maybe 80 million US dollars, and that's beyond a typical venture capital capabilities, because the time also it takes to get this product to the market is long because of the increase requirements by the regulator, by the regulators. And finally, there's some point which has pluses and minuses, and this is the introduction of AI into medicine. This has lot of advantages, but it's a problem too, because from reimbursement point of view, from corporate ability to cope with software. But while before that, there were only hardware experience in these corporations becoming becoming a very long process and difficult. So these are the issue. These are the issues that we are facing in I would like to to my panel here, first of all, to introduce themselves. Maybe start with Helen and continue. Just say one word who you are and what you

Helen Yang  4:50  
do. Okay, so, good morning everyone. This is Helen Yang from FOS Medtech. Foson Medtech is the medical device and diagnostic. Unit that belongs to Folsom farmer, which is at least the company in both Hong Kong and Shanghai Stock Exchange. So during the past few years, we did a lot of cross border deals with minority investment, merger and acquisition and also like the joint venture model that I will elaborate more in the next questions. 

Yuval Binur  5:22  
Thank you. Please. Can you

Julia Yuan  5:25  
okay? This is thanks. This I'm Julia Yuan. I'm from the CC RC Medtech, and also the abhida Medtech, which is China company and also Taiwan company. So actually, the our company is doing many focus on medical device. We are CIO to helping the start company for the Medtech stop company, or the MNC company, global company, to accelerate their device, to launch, to commercialize into not just only Asia, also globalization, for example, the European company, European region, and also the US. So thank you. Nice meeting you all

Yuval Binur  6:08  
and Cynthia. Go ahead. 

Cynthia Chen  6:11  
Hi everybody. This is Cynthia Chen, representing pornovo Medical today. We are a pioneer medical device company focusing on two indications, pulmonary hypertension and heart failure. FDA breaks through designated devices, and currently we have five robust global clinical programs ongoing with two FDA ID studies, one European pilot study, and our core product, the padn, which stands for pulmonary artery hyper innovation, has already been commercialized in China, Europe and the Middle East. Thank you.

Yuval Binur  6:46  
Thank you very much. I would like to put the following question to the panel, because you represent the three of you represent, actually different aspect of the cross border activities. So maybe Helen, I think that your operation has to do mostly with the importing to China ideas and products through joint ventures, through licensing, through other moderns. Can you and you do it, it for many years, I presume. Can you tell us a little bit about the difficulties that you face nowadays, with the changing environment, with the financial pressures, both in China and out of China, how you cope? And do you think that this model is still valid for what you do and for the for the global health care if you will? Please?

Helen Yang  7:35  
Okay, thank you. Yuval, so it's just like I just mentioned that in the field in the past few years, as folsen is working actively in introducing unit, the breakthrough med tech technologies, into the China market through investment and the joint venture model. And the joint venture model is very successful, and which including the joint venture between fossil and Intuitive Surgical from the United States, the joint venture between Folsom and inset tech from Israel, and also a joint venture with a Swiss based startup company in a sports medicine area. However, we do find that it's more challenging making the steels in in in the recent years because of the geopolitical tensions and the potential trade war among the major economies and the tariff issues. So but we still see that there is opportunity. So first I would like to go to the challenges. There are three major challenges I found, and we have encountered, the first is the financial stability and the challenge of the fundraising of the partners, because some of the partners that we are going to collaborate was pre profit or and many of them is the startup companies, and they face a lot of challenging in getting their self well funded. So that also put some pressure from our side to make more comprehensive analysis of their stability from from the financial perspective and the capability of their leadership in a in the, you know, in the fundraising so that was set up, you know, more barrier for us to make make the determination to collaborate with these companies, and the second is from China itself. So the central government now have published many policies that encourage the procurement of domestic manufactured product, which include consumable devices and capital equipment. So in this regard, when we start to do the financial project, is projections on certain deals, we start to became very conservative because of the uncertainties that also will influence the future of. ROI of this investment, and sometimes that our partners cannot, you know, understand why we are so conservative, because they always have a high expectation in the China market. So sometimes this will be a deal breaker. And third thing is that just you love you mentioned about the registration pathway. So we all take the FDA, you know, registration pathway, as a standard. But the currently situation is that the China and FDA, we call it an MPA, they have to set like, like, higher bars than FDA in certain medical devices. So it took, like, more cost and more time to get this product approved in a chat in the China market, and also that triggers us more investment from our side to get this product commercialized. So those are the challenges we have encountered. But you know, we always a big believer in China and its development, and and the China market is too big to be ignored, and with our solid skills in the deal making and the you know, the financial and the government relations of Folsom, we sure have the confidence to make more deals and to benefit our patient. Thank you.

Yuval Binur  11:19  
Thank you very much, Cynthia, I want to give you the microphone now. You represent a very different model, because you have a China innovation which is very exciting, and you try to globalize it by raising fund and moving towards big clinical studies out of China, say, in the US or EU, whatever. Can you tell us a little bit about the different difficulties you face in raising the funds for active, for expanding the activities out of China?

Cynthia Chen  11:51  
Sure. So I wouldn't really think those challenges as difficulties, but it's just another one, another obstacles that we are facing going global. The journey of PA DN, which is our blockbuster products, started from 2009 so at a very early stage, we recognize the difficulties on three perspective from IP to data to data reproducibility and also the culture and transparency. To address the early IP for site challenges that we, that we have been encountered, we began to partner up with Wilson socini For the past past decade to build a strong IP portfolio, only you involve only evolving pa DN. We have, we have got over 100 patents in more than 65 countries over the past 12 years, so that when we go out and talk to strategic talk to investors, you know, they have been doing FTO analysis during each round, and I think they were pretty satisfied with the IP barriers, the IP portfolio that we were building, and the second part is data reproducibility. So after today, pono has published over 1000 clinical cases, including 700 to 800 clinical cases add up with more than 300 commercial cases in China and Europe last year, what we were being doing is that we actually conducted another European pilot study, working with sites from Portugal, Italy, Serbia, Georgia, Switzerland and many other European countries to replicate what we have been seeing in China for the past decade on all those Caucasian patients data, and because we were busy preparing for the two FDA studies that going to be launched this year, per FDA request, we actually conducted another, around 100 animal studies, 100 pigs, animal studies last year in us, working with us based cars and animal labs which replica, which again replicate, what we've been saying on all perspective on our safety data on animals. So from a ponova perspective, we believe, you know, combined with clinical rigor and all the transparency and represent reproducibility of the data, the validation show travels both way, not only from east to west, but also west to east, grounded in data, IP and global patient impact.

Yuval Binur  14:33  
Thank you very much. Last but not least, to you. You know the big component, the cost component in new companies trying to become commercialized, are clinical studies. Of course. Clinical studies are getting super expensive everywhere. More so in the United States, of course. And if you speak about complex product, it's even costlier because of the long follow. Up required. How do you cope with how you Cooper situation like this? And I want to pose a complimentary question to you. You know, we, I mentioned before that we are entering the AI, going into clinical, into supporting physicians, etc. So set aside other issues like reimbursement and so on that don't exist yet. AI is built on big database. You have to have a huge database in order to allow the mechanism of AI to make smart and correct decision, not mistakes. So the collection database, in my view, need to be global. We cannot just do AI in China and then different argue, different algorithms in the US. Can you talk a little bit about all this issue how you overcome and how you envision young companies like Cynthia represent and Helen represent, how they can cope with it?

Julia Yuan  16:00  
Okay, sure. So, you know, in China, the you know, the past years is more heavily rely, especially on the clinical data. Is heavily rely on the European or FDA study clinical data to approve the medical device. But since the 2013 the situation has totally changed. The FDA that at the NPA, the China FDA, the MPA, has, you know, established and launched the new policies that means for the you know, more restrict on the clinical data, clinical evidence to for the further has been, you know, can be clear or granted the approval from the MTA. So having said that these Meg, most of the business companies, has need to be rethink how to establish their the clinical data, not just, you know, always running the clinical trials in European and in the FDA in the western culture or Caucasian datas. So nowadays, more, more voice and more you know, strategy lies make company to think to run the global trials. So the China also launched like other like other countries, for example, FDA and European countries, they are accepting the oversee clinical datas. So same as China, also accept the clinical the oversee, we call oversee clinical datas. But there is a certain requirements for accepting that data for China registration. Having said that, that means, if we can pay ahead, that probably can reduce most of the, you know, the cost, for example, just like probably most of the audience were running a trial in the FDA in the US and in the European is really costly, and then we can, as a company wise, to think whether the global like pharmaceutical size, they already introduced through the global data can support most of the participant country registration purpose, so sensing for the medical device. They are also introduced global trial or Regional Trial, the pan Asia trial to support the multi country registration purpose, so that will be dramatically reduce the cost of having running the clinical trial evidence to fulfill multi countries, you know, expectation, for example, but the challenge is different, especially for medical technologies. There is not just like a pharmaceutical size, there is a different patient population, for example. There is a difference between the practitioner clinical practice, between the Caucasian country versus to the Asian country. So we have to come to come to the consensus and the balance in the protocol design to ensure is a feasible not just only for the Western practitioner, Western doctors, also for the Eastern doctors. So this is also the challenging piece to come out with, a visible protocol, the investigation plan to ensure the trial execution part can be smoothly running, and then we can generating, not just only the Caucasian data, also the Asian data, to ensure to meet all the, you know, target country agencies, expectation. So, having said that, that will be dramatically reduce the cost, and also, you know, to accelerate the. The country approval as well. Thanks. Thank

Yuval Binur  20:02  
you very much. I want to focus a little bit the discussion for the few minutes left to us about this problem of globalization. And just to illustrate to you, something you know in the United States, President Trump is giving away hats and on the heads say, Make America Great Again. So I got one, I open it from the inside. It's a made in China, the heads made in China. So that's kind of issue of globalization. But of course, I say it in humor. I would like to ask the panel to suggest how we can move forward globalization. How, and remember, when we speak about is met mid west or West eight? Doesn't matter. It's not only China. It's only coincident. On the panel, I have only China people, and I address the minister from Australia. Maybe next year, you bring somebody to join this panel from Australia, because we don't know what happened there, too far away. So we have to open, open up to the other. You know this Vietnam, there is a Cambodia, there is so many other important sites where patients need help here and how, and this is not, I don't want to make it only a China session. So China, of course, happened to lead for variety of reason, but going, going, going back to the panel, how you convince people that you know that what you do in in the Pacific Rim, let's call it is, in your case, specifically in China, is good, is acceptable. It's meet the standard. Did you face issues like this, to get both a collaboration, clinical collaboration, but also to get joint funding? So Helen, maybe with all your years of experience, can you share with us how these things are today?

Helen Yang  21:59  
Okay, so I would like to start from several cases that you know we are now and negotiating, or we have just completed. So one of the cases, actually is from Australia. We are now in negotiation with the image based company from Australia, but with their core team, the algorithm team, from United States. So when we discuss about the collaboration that the Alvarez team has a lot of concerns about the data security and how can we adopt the cloud based database in China, and a lot of issues. So with this, you know, in front of us, we have to first to erase their the their concerns, with the with the with the with the proof of the, you know, is a strong proof that what we do is that we invite these people into China to for on site visit, because they have never been to China before. What they think the China is like, what the the city is like the 1980s So, but when they come to those to the to Shanghai and Beijing, well, they find that everything's fantastic, the construction, the transportation, and also the manufacture. So we bring them to one of our manufacture facility in Beijing, where we use the AI technology to speed up the scaling of the production, to lower the down cost of the of the production process. That they kind of feel astonished because they have in their in their current facility, they are still like rely on majorly, on the manual side. So, so we, we just a week. We just say, okay, so if you collaborate with us, we can adopt this, AI, this automatic, you know, production in China. Maybe we can help you to build a pallet in China that you can leverage the experience, you know, in the United States and in Australia. So you have to always think from your counterparty set and how you can create benefit with them, not only in China, but you have to always be proactively to support them and with the with the experience that you gain in China among you know in the business that you collaborate. So in this regard and the after the return to their country, they became very supportive about this, this future collaboration. So we hopefully that we can close the deal within no two or three next two or three months. So speak about the joint funding side. So we have different models, you know, because fossil is currently well funded group, and sometimes if we see an importance about the and also the company. The opportunities of this of certain unique technologies that we may, we may accept some intangible investment from the IP side, instead of cash investment from our partners, so that will solve a big issues in their concerns, into, you know, making best the investment, like in the in the form of cash injections that can help us to foster the deals so so to be always be open up and review, not you not try to erase the different, but to Find a way to bridge the gaps and also try to design the very flexible deal structure for both parties.

Yuval Binur  25:50  
Thanks, Cynthia, you. You have raised money, I presume, from within China and also out of China, sources about the out of China sources for the fund, for the money you raise. Can you tell us some of reaction of the people? Were they trusting the product, trusting the data you saw them, or question in it? How was it? How you managed to track investors from out of China for your innovation?

Cynthia Chen  26:21  
So what I have been telling my investor and all the potential investors that we are meeting today is that if you are looking for the best of Asian innovation, then it's ponovo and it's padn. Padn is a flagship example of China original origin and innovation. We build upon our clinical success over the past 12 years, over 1000 clinical cases with three we achieve three FDA breakthrough, designation, device indication within two weeks. And we are the first and the only China origin technique being mentioned on the 2020 22 ESC and ers guidelines. Canadian success is not only built upon itself, it's actually built upon proven legacy. So our Technology Co founder Dr Xiao Liang Chen, who is one of the top intervention cardiologists in Asia, he has invented a bifurcation lesion standing technique called DK crash, back to 2017, decade crash was again written and being recommended by ESC guidelines as as level to be. Technique, treating treating bifurcation lesion patients. So our pathway and PID passwords actually followed what Dick crash has been through, we are proving to the world that Chinese physicians and Chinese doctors, we are not only one of the clinical sites that you guys are doing globally, we can eventually define one of the industries and eventually move the treatment paradigm. So I think, combined with the right talents, with the right clinical validation, IP foresight and cultural adaptability, eventually, we can spread ahead and lead and lead at least one of the industry and the treatment paradigm around the world.

Yuval Binur  28:15  
Thank you very much. We are left only with two minutes. So I want to give you my opinion on this, my opinion is that it's extremely important that companies out of the Asia Pacific that want to go global should actually incorporate key opinion leaders and a board of board Members from out of China. These people will come to China. My resistance from these people was always, oh, we don't know. We don't trust China. We don't trust the India so and so on, Australia into the rest of the countries. But if we bring them and incorporate them in what we do, they are part of it. And by this, we can, in our little limited space, can break the barriers of distrust between between the countries, leaving aside the big the big politics. This is one step, and I think the second step is a com, is meetings like LSI, which is in the Pacific Rim here, which is amazing meeting. I would bring few, also of the clinicians, the key clinician to come here, not to talk about clinical aspect, to talk about how we build trust between the continents. That's critical, in my view, and I want to thank and to bless, actually, Scott and the team here for doing this, this amazing work. So as a conclusion we have only half a minute, I want to say that we have to Leech the the potential exist in the Pacific. Ray. A huge potential. It's not listed. It didn't it's only we see the tip of the iceberg. The iceberg is deep and comprehensive. Lot of opportunities, financial, clinical and mostly helping patient. Because at the end of the day, while we do all this, we want our patients globally to be healthy and better in in the Singapore, heart China, heart Australian, heart us heart in Israel. Yeah, they are all the same, the same diseases. No difference, if you for who study anatomy. So, so your help to do this globalization to do, to push the recognition that the Pacific Rim, in the main countries, in the Pacific Rim, can definitely contribute, and leveraging each of these countries with what they can contribute. So if you speak about Singapore production, is, to me, is first thing that they can contribute. If we speak about Australia, I would say early stage, maybe clinical studies, for example, and how we incorporate the whole piece in order to get faster, cheaper, better products, is the big challenge. So we just make the time. And thank you very much for your attention. And thank you the panel. And I would suggest that anybody among the audience who want to talk to the panelists, you find the opportunity to the amazing software system that Teresa created. And thank you, Scott and goodbye.