Turning Clinical Ideas into Market Opportunities Howard Levin: Goals of Presentation

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1 Turning Clinical Ideas into Market Opportunities presented April 4, 2018 by Dr. Howard Levin, President and CSO, Coridea at MDTX, the Medical Device Technology Exchange Howard Levin: I'm going to talk to you today about my feeling about how to turn clinical ideas into market opportunities and why people come to your companies in order to use it. And actually, some of our companies use Greenlight Guru. Some of our companies use a bunch of the stuff that's out here. So, we're really happy to be here. We appreciate Joe allowing us to come here today and talk about this. We have 25 minutes. I'm told that if I'm not done in 25 minutes, I get thrown off. I will go through this reasonably quick. So, if I do that and there are questions that you want, the easiest thing to do is, while I have to run today, I'm going to try and be back tomorrow, but also you can me at Feel free to do that. Goals of Presentation So what I'm going to do is explain how ideas move from academics to industry; explore some of the problems with doing that; give a pathway that we've used to do that; and talk to you a little bit, if we have time, about what's patent; and, for those people in the audience who want to be inventors, how to handle that. Serial Entrepreneurs with a Long Track Record of Successful Innovation So, we founded six companies, all were acquired. Mark Gelfand and I started out at Hopkins together, in academics, and moved through into industry. We've been working in our incubator, called Coridea, for the past 15 years, 120+ patents issued in the US, 150 pending, raised $100 million in venture funding in our company and returned over $1.4 billion to our investors.

2 We've done everything from functioning as a CEO, CMO, CTO to sweeping the floors. And in a startup, that's just the things you ve got to do. We now focus primarily on doing things from back-of-the-napkin to first-in-human proof-of concept and that's where a lot of the companies that are here today, come in helping us. These are some of the companies that we've started and have been sold. Worked both in Academics and Industry So, I started off as an undergraduate biomedical engineer, except there was no biomedical engineering when I started. It was Electrical Engineering and Computer Science. Masters, then did my medical school, did Cardiology at Johns Hopkins, Random Mechanical Cardiac Assist Program or Artificial Heart at Columbia for a while. And while I really liked clinical medicine, I also like the early stage stuff. So, I moved from there into startups. So, I left academics and joined my first company in So, what I want to do is talk to you about the relationship between physicians and engineers. It's been a very long and close relationship. It has changed somewhat over time. I just want to go through the history of it a little bit and tell you how we as clinicians think of it and how you as engineers and companies should think about how you could add value and how we can add value to you. Relationship of Physicians and Engineers The relationship started a long time ago with a number of things. Initially, as you see on the top right, that was one of the first pacemakers. That's actually a true pacemaker that was implanted in the human. And there's a bunch of watch batteries and a timing circuit from Popular Mechanics embedded in epoxy. Literally. Built in a garage by guy named Earl Bakken who founded it, and now is the $5 billion or $10 billion company called Medtronic. So, physicians work very closely with engineers, even the early stuff like heart valves. It was based on a bottle stopper from an idea from the late 1800s. And at the time, device manufacturers considered physicians to be really into it or necessary. But then, physicians found that if they wanted to move things forward, they needed to work closer with engineers. They needed to understand more about how engineers did things. That was because in 1976, the Safe Medical Device Act, essentially 510(k)s and PMAs came in. So, the FDA started to regulate things. And that was when physicians and engineers figured out, they have to really work together to figure out how they did it. Common Example of a Today s Physician Invention So, how does a physician, in a clinic or in academics, et cetera, come up with an idea and then end up coming to you for help? Well, the problem is, they have this idea, but they have no access in the academic environment, essentially, to engineering, real engineering. They have academic engineering but no real engineering. So, the inventor wants to publish the early results because that's what you do in academics. That's the currency of academics, it is publications.

3 They filed a US or PCT or European EU application. They describe it in great detail, except, they have very little engineering enablement of that design. So, the university gets a really nice patent with very narrow claims. They feel that they've got a billion-dollar thing on their hands. But, when they try to get licensed, they get really surprised. The problem is, especially in Europe, that the seminal patent discloses some really unworkable problems. The recent heart valve, a called the Transaortic Valve Replacement TAVR, which is the hottest thing in medicine, was actually invented by a guy who filed the initial patent in 1995ish. And then, there was work done in Europe. The original one said, OK, we're going to replace the valve, but we're going to have little hooks hooking into the side of the aorta where the valve is supposed to sit. Well, it turns out that that sucked. You know, it just wasn t implementable from an engineering point of view. There were much better ways. The problem is, that inventor prevented anybody from owning the field, because of the way it works in academics, they didn't file follow-on applications and the ones that they filed don't protect the entire field, just their one way. So, everybody else then says, OK, we're going to come up with our own ways of doing it. All the intellectual heavy lifting was done in academia. The industry generates lots of patents with sophisticated, better ideas, and the inventor has to say, Well, I'm not going to make any money in the academics, the university s not going to get any money, but we were first. So that's a problem and it doesn't help anybody. Let s say you could raise enough money to start a company So, what's the right way to do it? This is where you guys come in, in terms of the different services that you provide here. So, academic scientists, clinicians, come up with an idea and start a company, but they found they couldn't do all this stuff to commercializing their idea in humans. Originally, they hired an execution team, which then were supposed to make this commercial device through clinical trials, start sales, et cetera. The problem is that they failed in this gap, in transitioning things from the research, sort of clinical concept idea, to an actual commercial device. So, that led to the development of incubators and the whole industry of medical device companies, that helped both provide the information, clinical research opportunities, design control, et cetera, to help incubators to bridge the gap, move into the execution, and then lead to the sales and marketing. The standard device idea assessment process The problem with physicians is that when you have a hammer everything looks like a nail. So, how do we figure out if an idea is good or not? Well, they've been working on an idea for years that's been NIH funded. Looks like it works well on animals, may have some clinical benefit. Or while placing a stent, they notice if the catheter had a specific curve, some of your harder cases will become faster or

4 easier. They notice that if pacemakers implemented their new stimulation algorithm, it would improve cardiac output in their most difficult patients. So, are these good ideas? Yes? No? Yes? The answer is for mankind. Yes. For a business. Maybe. Why? Mankind vs. business Things that make a business, and this is when you take on a client, as the companies that are here, when you take on a client, are they a viable client for you or can you add value to the people that are actually doing this stuff? So, being a business means there are enough patients to use it in, it's simple enough to use widely in those patients, that it can be developed in an appropriate amount of time and money, for the investor, that means to venture capitalists, usually, or the strategic, to make a return on their investment. Fundable doesn't mean that it works great clinically, and I personally need it frequently, which a lot of people that may come to your booth, if you were in a place where there are a lot of clinicians that would come to your booth and say, I need you to help me. I'm going to give you a big piece of the pie. This is really great. I need you to spend your time on it. Fundable does mean that your device is better than existing ones. It's in a really hot area. You found the one-in-10 VCs who believe in your concept, how good a job you do presenting that plan and how lucky you are to be at the right place at the right time. So, good-for-mankind are funded by NIH/Foundation/other not-for-profits. Things that are businesses are funded by VCs or strategics. So, when I give this talk to physicians, it's a question of, how do you choose which of those ideas that you've come up with or other people have come up with, should you spend your time on? And, for you guys it means, which physicians, companies, startups should I spend my time on or take part of my payment in equity or other things, in terms of my reimbursement. How doctors approach development So, this is where you guys come in. It's very hard for a clinician or scientist to competently evaluate all of the marketing, clinical engineering, IP, reimbursement, regulatory, et cetera on their own. Not trained, don't have experience. They need to partner with somebody like yourselves, somebody who's been through it, and consider doing things like license to incubator, taking royalties, or starting a company with the people they partner with. So, what areas should these people be focused on and what should you look at when people come to you and say, You know, this is my great idea. I'd like you to help me with it?

5 Breakthrough therapies tend to start in academics; better tools developed by industry or clinicians So, breakthrough therapies tend to start in academics. Better tools are usually developed by industry or by clinicians in the trenches. So, you want to start at the top where there's a large clinical need and you can make a better tool, which is not commonly, again, what physicians do. Some clinicians can make suggestions to you and come to you and ask you, Can you make this catheter for me? Can you do this, et cetera. But what the big ones are, are those things where you make a new device opportunity in the pharma space and renal denervation, others for hypertension, things for diabetes, et cetera. Those are where the really big money is right now: COPD, pulmonary valves, things like that. Or, you could have a disruptive opportunity in existing device space. So, you take something that's surgical and make an interventional, valves. You take an implant to procedure. So, if you could take a pacemaker and turn that pacemaker into a simple one-time procedure that you don't need an implant for. Or, what people really pay a lot of money for, if you can increase the number of procedures by turning over things faster or making it procedure faster. The monorail guidewire was a great example that. Decreasing costs, or if you threaten their franchise. So, if you have a surgical valve, if somebody comes with a percutaneous valve, you're likely going to high acquisition price or get a lot of money for developing it because you're threatening their cash cow, their franchise. And in the end, what you have to understand is they're coming to you to help them. And this is a very important point. They're coming to you to help them get clinical data and develop IP. You have to separate out when the people coming to you when a startup coming to you is asking to help them develop clinical data and generate IP that they can sell and be acquired by a larger company versus they're asking you, for a manufacturing contract, to make a device that you're going to make money on them selling. And it makes a big difference to our vendors, for some of our different companies, when you come to them, you have to explain because sometimes, then, they're going to end up dealing with you on a costplus basis. And sometimes, if it ends up with manufacturing contract, you know, for us it's good because we can back load some of the costs, et cetera. So that, if you're dealing with startups, I would truly suggest that you understand where they are in their development cycle. What they want to do and, how do you want to interact with them to make sure that they're going to get what they want, and you're going to be able to make money. What you should know before deciding to move ahead with a company So, how do you find an idea?

6 And these are questions that you can ask them to make sure it's actually worth your time. They should have asked these questions to figure out whether it's worth their time, but you don't want to commit engineers, project managers, resources to projects that you don't feel are going to get you somewhere. So it has to be a big enough unmet clinical need. Are the indications good? Do they believe they're going to have an overall clinical benefit that's better than something else that people will pay for their device? Do they have an initial device design and some other ideas about which way to go? Can you help them with that? Are they developing a totally new approach? Can you help them by re-purposing some existing technologies? If you can do that, it helps them a lot. One of the biggest problems is stacking risk. So the more you can do, for example, if you can take an accelerometer from an iphone or the aerospace industry and put it into a pacemaker, you save, you know, a million or $2,000,000 in development for that particular company because you don't have to start from scratch and that's where you can save a lot of money and helping people to do that. Clinical and regulatory risks So, the clinical and regulatory people here, you need to help the physicians understand, or these startups understand: What are number of patients required, money inclusion/exclusion, should they have? Are their short-term endpoints believable, that are going to get them to be able to raise more money and be able to pay you? What's the required duration of follow-up? What's the IP risk? Do they have freedom to practice? Are you doing something that's going to be a dead end? Because it was a great engineering idea, but somebody did it five years ago and the guy just never looked to check. Is their device novel? In today's world, reimbursement is big. If it's going to take 10 years from idea to approval, that's much different than two years from idea to approval. So, you have to look at it and figure out is this something that you can help get through the process quickly? Or is this something that's going to take a long time and a lot of money and you may be retired before they get through. Sales and marketing risks Is it a normal referral pathway? Who owns the patient in terms of physicians? Does it fit into your existing skill sets, et cetera? Is there an exit strategy? Is there only one acquirer that is going to acquire it, that could potentially acquire it? That could drag things out for years because they're going to force the company to show sales?

7 Or are there multiple potential acquirers in that space? And they're going to be able to bid one against the other. Did they need a sales ramp? The physicians and the startups should have gone through a matrix similar to this, to determine whether it's worthwhile to do it. And 90 percent of this can be done on paper. You don't even have to set foot in the lab for one day in order to get rid of most of the projects. So, I would encourage you, if this is the type of area that you're in and you want to make sure that the people coming to you are actually going to be around a year from then and be able to pay you, to think a little bit about asking them this. Important Take Away Points So what are the important points? It's really comparatively easy to come up with an idea that if it works, it s going to have a significant impact on patients. Is it going to work on one percent of patients or is it going to work on 90 percent of patients? That's why it's very hard to find a commercially viable project that fits all those criteria for success. The synergy and places like this (MDTX) with more interaction between startups, physicians, and companies synergy is essential, and your experience is what's going to help drive the benefit for them. Use for physicians. It reduces both physiological and clinical risk. But don't let physicians tell you how to drive your engineering. You've got to stand up and tell them what the answer is. I have three minutes left, so I'm going to give you guys a choice. I can either go through and explain to you what patents are in a high level and who's an inventor, stuff like that, because a lot of physicians like to see that. Or I can answer questions. So, it's your guys choice. Joe Hage: Show of hands for patent. Show of hands for question. Patent wins. What is a patent? Howard Levin: Okay. This actually, even as far back as ancient Greece, there was this idea: You have to protect inventors from things. But actually, patents came out of the plague. So, when the plague came in Europe, most things were trade secrets. It was passed down from family and family member to family member, generation to generation, and during the plague, a lot of these things were lost because people got wiped out. So, the king, I forget what country, Italy, Republic of Florence, said that we're going to give you a protection if you tell us exactly how to do everything and you enable it. So, you explain what you did and somebody can pick up this patent to do exactly what you did. We're going to give you a monopoly on it for certain amount of time, which in the US now is 20 years, but after that it's available to everybody. And that's how patent law came about.

8 And in order to do it, it's like real estate, right? So, you own this piece of land. You know where the borders are. If you want to come in and trespass on my land, you got to buy it from me. You got to pay me something called the license or royalties to do that. So, the fundamentals haven't changed. What a patent does and doesn t do What it doesn't do, it does not give the inventors right to manufacturer or sell the covered product. What it does is it allows you to exclude other people from stepping on your turf. So, if you look at this, what you want to find out is, when somebody comes to you and says, I want you to build this and we're going to sell this and we're going to make a lot of money and we're going to give you part of the money that we make, that s called a license. What do you do? What does that mean? Well, there's community stuff which is called the public domain stuff, there s stuff that belongs to other people and there s stuff that belongs to you or the manufacturer. So, if, on the right side, that product straddles what belongs to the manufacturer and what belongs to others. The stuff about the product, in the circle that belongs to other, is infringing. And the people who own that intellectual property can stop you from selling that. Which means you don't make money when you produce it. The product that the manufacturer owns exclusively, means that they can sell it and they get all the money for that. You can license or co-license the stuff that's in the infringed area, and able to make money on it, but, it's all a deal. So, also, inventorship is very specific. It is a legal definition. It's contractual. So if you as the manufacturer have an employee who is an inventor, you actually have rights to that patent. This is one of the big, big problems that startups deal with, and I deal with on a daily basis, in terms of going to contract manufacturers, is that will they assign their intellectual property rights to me or do I have to license it from them? And that makes a big difference in how you make a contract with the place that you're working with. There's basically, to go through quickly, it has to be novel and non-obvious. And non-obvious is some ordinary people skilled in the art. Imagine a fresh biomedical engineering graduate with a library card, but not inventive. Would it be obvious that all of the elements that make up that patent are obvious to him?

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