Communicating Product Value—The Foundation of Market Success

Hello and welcome. My name is Shawn Smith from Medtech, leading voice, and I am here with Ed Ed Doherty and Tatiana Staneva today, and we are going to be talking about the unwritten rules of medtech success. This webinar is intended for companies wanting to understand their value proposition, and how to communicate it to stakeholders more effectively. I'm gonna start with a few housekeeping announcements while we while we warm up and a couple of advertisements. I know that you'll appreciate that. So the housekeeping announcements number one, this webinar will be recorded and will be made available to all registrants tomorrow. It will arrive via email along with the link

to the slide deck. Special note. When downloading the slide deck, you got to hover over the download button in the upper left hand corner on Linkedin. Please know that you can download the slides. It's just that Linkedin hides the download button from you because they're fun like that next thing that you need to know is that there will be a poll question. There will be a survey afterwards. We really appreciate your feedback. It really helps us understand what you want more of and what you want less of, and guides us in content creation. So I hope you take time to participate in both of them. Hopefully, I won't mess up the poll question the way I did earlier this week.

Technical glitch. Then the next part is use the Q. And a button. Ask your questions at any point during the thing. When we get to the Q. And A at the end, we will get through as many of those as we possibly can use the chat button to communicate with me and feel free to use it vigorously. I think we're going to do a certificate of attendance. So if you would like a certificate of attendance, please put your name as you would like it to appear on the certificate in the chat, not the Qa. In the chat along with your email address, so that we know where to send it, and in 2 or 3 days we will get those out. Those are done manually, so please be patient with us now.

I'm going to put in the chat part 2 of this which is getting paid for your product. Is, you know, this is part one about the value proposition part 2 is about getting paid for your products about reimbursement. It's about commercialization strategy. And you want to make sure to attend both parts of this or at least watch it in replay, because it's totally worth it. This is an amazing session on a related note. There's also going to be a guest speaker talking about commercialization pitfalls on the Mdg premium call tomorrow. That's a live zoom call where you can dial in last announcement is those of you who are unaware. I'm co-hosting the 10 x 2025,

Humanizing Medtech Conference on May 7th and 8th in Newport Beach, California. This is a 2 day in-person event with tons of interactive workshops. I'm going to put a note and a link in there. But if you want more details, just ping me in the chat, hey? Tell me more about 10 x. It's gonna be awesome with all those announcements out of the way. I want to introduce Tatiana and Ed, and let them say a word or 2 about themselves before we jump into the today's presentations. Tatiana, why don't you start

Thank you, Sean, and so nice to meet everyone, even though I cannot see you. But I'm super happy and excited to be here and talk about what I personally care about most which is creating clarity for action. So who am I? I am originally Bulgarian, but I also say that I'm German because I have lived in Germany for many, many years, and I kind of think like a German, not only like a Bulgarian. and my background is in a combination of strategy, finance, and innovation. And most of my career, which is about, I don't know. 25 years or so I've actually spent in life, sciences and pharma, digital, health and medic, and all of these kind of related fields that I kind of tend to describe as healthcare, and I founded my company last year.

the goal being that I just wanted to. I, what I really care about is helping individuals realize their business visions, and I do that by helping them clarify what it is that they want to focus on? How do they get speed into figuring out their value proposition, their business model ideas that they may want to innovate on if they're a bigger business. Because I work with both startups and and established companies. And it's basically my, I guess curiosity and my ability to listen very carefully and not forget everything or anything. Actually, I'm writing down everything. And this is what helps me to kind of help. You crystallize your thoughts and define a roadmap for action, and just do it. So I'm based in London, and like, I said, very excited to be talking.

Talking to you today

Glad to have you and Ed

Good morning, everybody, or good afternoon. Depending on where you are. I am based in Washington, DC. And really happy to have the opportunity to talk about some of the things that I think about every day. And, as Tatiana said, I'm very passionate about. I noticed in looking at the register that there are a number of colleagues and friends who have joined today, and thank you very much for taking the time to do that. I look forward to continuing the conversation. I've been doing this work for about 30 years. A lot of focus on helping startup companies come into the Us market and be successful. And so that's really the focus that I take as I'm doing this work. I was delighted to have the opportunity to meet Tatiana 6 or 8 months ago, as we were both working with mass challenge, Uk

advising a number of the companies in this year's cohort. So if there's anybody on today from Masschallenge shout out, and really pleased to have the chance to work with you, but also to to meet great colleagues who have become friends. So I'm hoping you'll feel some of that synergy in the work that we do with you today.

Wonderful do you want to share your presentation now.

Yes, I will go ahead and do that. Please bear with me for a second, because it's always telling me what is. Gonna go on this screen. And what is gonna go on that screen? So one second. okay, can you guys see? I guess? Maybe Shawn, you can confirm. that this is this is

Hit the share button again at the bottom

Yeah, very good. Let's do that again

There we go!

There you go! Perfect. excellent! Well, without further ado. Let us take you through this. Webinar. I'm just gonna create a oh, no, you can see my point, that's great. So we have prepared a nice agenda for you and We have already introduced each other. So I'm just gonna take a few moments to walk you through the agenda. You know, this is a 2 part webinar. Today, we're going to focus on Neurovida medical, which is a company that you will learn about, and how they are approaching, or what their plans are for entering the Us. Market.

In the next session, which is next week, we will basically expand on what we talk about today. And with that, I'll just, I would just say, we go on with it.

Yes. so let me take a couple of minutes just to give you a little bit of context for what we're hoping to do. We had a lot of fun in putting this together. And we're proposing today to take a case study approach to the webinar we're hoping that in taking that approach, that you'll hear questions and see issues that are very familiar with you, that perhaps you have been thinking about or talking about with your colleagues as well. So what we've done is we created a Med Tech Company, and we'll present the details of that company in just a minute. And what we are going to do over the course of the next hour and again next week is really kind of show you how we work with companies to sort of tease out the real value and to identify areas where companies can be better, can be clearer about what their value is and can help attract investors

and business partners who will participate in the work that they do. So what we're really going to focus on is a pitch deck that our fictitious company put together, and is preparing to use in speaking to a 1st round of investors, and so we'll go through that, make some comments, and then hopefully, at the end of the discussion, open it up for some questions, and have you ask us, or comment on some of the material that we've identified. So why don't I turn it over to you, Tatiana, to introduce Noravida Medical. You're on. You're on mute, not Tatiana.

Absolutely. Thank you. So this is a company neurovida medical that we Ed and I created. And because I'm partial to Germany, it was founded in Germany by 2 great founders, Dr. Anna Fisher and Dr. Lars Becker. And it's a Med tech startup which focuses on non-invasive neurosimulation which is coupled with AI for adaptive treatment. They are at 1st targeting the migraine market, but they plan to open it up to more indications within chronic pain. It's a wearable headband. It has an accompanying smartphone app, and also it offers physician connectivity for remote monitoring, and all parameters can be adjusted. So just a little bit about the founders. So Dr. Anna Fisher is a very accomplished academic neurosurgeon and neurologist. She's specializing in pain neuromodulation and brain machine interfaces. She was basically very frustrated at the clinic where she was working by the lack

of non-drug options for migraine patients, and she saw way, too many side effects, and you know, all linked to the pharma solutions in her clinics. So she wanted to basically create medically validated, non-invasive and accessible solutions that neurologists could you know confidently prescribe and so that's why she founded co-founded Neurovida with Dr. Lars Becker. who in himself is a biomedical engineer. He's the CTO. And his focus is on non-invasive neurosimulation, and he also has previous startup experience. Even in this space he's an expert in wearable. He's super passionate about hardware. He loves miniaturization. He wants all the products that he helps create to be super usable and accessible to patients. So he's basically a tech visionary.

He himself was disillusioned with the existing neuromodulation devices. He wanted something much less bulky, much less expensive, and something much more intelligent, if you wish. So he saw an opportunity there in this AI powered by electronic medicine, and he co-founded the company in Eurovidia Medical with Dr. Anna Fisher. They also have their 1st employee on board Jonas Muller. and he is the brilliant AI architect. He is just an amazing data scientist. He specializes in AI driven by electronic therapies. And he's absolutely fully 200% committed to creating a super awesome cutting edge. AI enabled solution for

migraine patients. So that's the company. And now we are going to go into well, their vision

So their vision is a really interesting one. Where they have or they want to position themselves as the premier provider of what they call intelligent neuromodulation. and they're confident that their solution is good because they've gotten some good signals, some good trends in early early data that they've collected. And so they're they're moving forward very strongly in this direction. Now, what they think is unique about their solution is that, in fact, in their review of the market. There are not any other companies that have similar products where the migraine neuromodulated treatment is actually responding to, where the patient is in real time. What they found is that frequently there's a sort of a time lag between when a patient begins therapy with a neuromodulation device and when they begin to experience

therapeutic benefit. What they found is that during that time many times patients get discouraged because they're not feeling the immediate impact that they're looking for. And as a result, many just stop using the product. And that ends up being detrimental for them. And so their insight is that in using this responsive neuromodulation. They're able to actually get to therapeutic benefit sooner because of the interaction with the AI, and that that will benefit patients improve outcomes and get to therapeutic relief earlier than they can with other devices.

And so I think it's really on that when they've begun to go out and talk to some investors. And I think, Tatiana, you've you've pulled together some investor comments

Yeah. So yes, I'm not on mute again. Very good. So yes, they have decided that they now want to enter the Us. Market, because it is the bigger market, and they believe that they can be more attractive to investors. Actually, as a matter of this. So they started their investor conversations already last year, basically, in the second half of 2024. And the problem is that investors so far are not committing they're getting this what I would call. And this is really, from my experience, various and confusing feedback. And this feedback is also ranging from quite general to super specific. And we have selected some examples here, just to give you a sense of what specific means like. So, for example, this is, I actually start with the general feedback investors might say something like, Oh, well, the migraine market is a tough one for you to win, and there are so many well funded competitors already. How are you going to break through? So that's

broad. And they, they, you know, Neurovida is also receiving some feedback like, well, you know, nowadays every device contains. AI. So you know. what's your you know, cutting edge here. or the feedback is like super specific. On the other hand, where they're asking like, what is your plan for the FDA? Have you talked to them? How long do you expect review time to take, or what is your evidence? Strategy? And it's you only have a few small studies in the EU. But how is this going to translate to the Us. So it's basically tons and tons of feedback, which is like, I said. very confusing, and very on the one hand, general, but, on the other hand, super specific. And the question here is

What do you do with this as neurovita? And what what neurvita needs to do here is basically check. If they have the answers to these questions that the investors have thrown at them. If they do, if they have the answers, that's great. Your readers should then just rework the storyline to preclude these comments and get to the real discussion which is about funding and not about why they should be funded. But they should be talking terms, and they should be getting the deals with investors, however, and this is. you know what we do see. On an ongoing basis. If if the company, if neurbita cannot answer these questions satisfactorily off the bat, and by that I mean satisfactorily answer satisfactorily means that investors will accept the answer, even if they're not

committing yet to investing, but they will accept what they're being told. They will say, Okay, this is a good enough answer. So if if new bit cannot give these answers, then they must go out and find the answers to help them refine the strategy and the execution approach that they're taking. and we're going to. We are going to talk about this later today. There's also another clue here which I just want to cover very quickly, and we'll come back to it later, and also in the in the second session. And it has to do with the diversity of the feedback, because this kind of gives clues to the to the investor outreach strategy that this company has.

It's you would wonder, why is it so different? Why, why are somebody some investors asking general questions, while others asking more specific questions. This gives clues about how new Vita might be approaching them, and what homework they might be able to do to kind of make the feedback more yeah, more. Not coherent. But what I'm looking for is focused. So before we go there. However, let's look now into a few slides and excerpts from your Vita's pitch deck to understand where this feedback might be coming from and here. I just want to comment. This is obviously their their cover. Page and like, I said, this is only an excerpt, so it only contains the slides that we want to talk about. There are the issues that we want to cover. This is the cover page, and already here they are

setting up this treatment. This device that they have is an AI treatment. And because they have developed, they have developed this tagline for the product. your Vita, your migraine, your AI treatment. And this is something that it's a very minor detail, and most investors or more readers, viewers of this presentation might not even notice, but some will. And it's a very it's a very specific remark, your AI treatment, which might come across as a bit of flippant remark, if you wish. And the point here is that basically every single detail matters. And if we, when creating even the cover pages, the 1st impression that that counts. Remember, you have to be absolutely well serious, professional, and knowing the audience, knowing cool greeting the software, some investors, it might make sense to remove the AI, for example.

for others, it might make sense to to keep it. yeah. So that's that's just here on their cover page. And now we can go into the actual pitch

So if you take a look at this 1st slide, there are a number of things about it that I think are potentially really effective. So, for example, they very clearly state the problem that they intend to solve, and they set that forth immediately and clearly, and speak to some of the key features of their product that we're going to help address the problem and come to a solution. And the artificial intelligence component of the product is really an important part of that solution, important, not just in the functionality of their device.

but important because they identify that right up front as a differentiator for them in the marketplace. Again, note that to their knowledge, based on the research, they've done no other company in this. The chronic migraine treatment space has this type of functionality, and so they've identified their differentiator and are presenting it immediately upfront. Now let me tag that on the flip side, and note that the fact that there is an AI functionality in the device becomes very important in the company's plans for interacting with FDA. And I'll mention that later on in the presentation today

And actually, I would like to add something here from the perspective of anyone who might be familiar with the migraine market. If that is the case, they will immediately ask themselves, What's different about the solution, because the market is so well supplied with 1st of all pharma solutions, and then now also a number of devices that treat migraine. And so some investors might actually even discount the whole investment proposition here, because they don't necessarily see an answer right away. And, as you know, investors get hundreds of decks every week, so it's important to catch their attention very early to capture their attention. And so

how can how can Neurovita do this? And clearly here they are. They are already talking about the AI, and they talked about the AI on the on the previous on the title page. But they're not really saying much about it yet. If they are presenting this, and they don't have an extra slide on the AI element of the device. They need to actually talk about it. Say what data it has been trained on. If it's open source. If it's biobanks, they need to talk more about the algorithm. They basically need to provide details on how they select the trading data and how it reflects how it applies to the Us. Population, because otherwise it just looks like they're just missing a chance to position themselves as different and better than the competition

which might lead to disengagement on the investor side quite quickly. So we will cover the specific recommendations of how to solve things like this later. But the bolder statement here, like. we revolutionized the migrate market with an AI enabled individual patient response and a superior device. Something like this is better in terms of capturing attention and also leading the investors to the point they need to focus on than telling telling something like this is the problem. This is the solution, which is the traditional way that well, startup decks are structured again. Here on this page they are showing the product called neurovita stim. But again, there's nothing about AI and how it stacks up against the competitors. And I want to point out here that though I see this quite often, especially with scientific and tech founders.

because they have amazing innovations and ideas in their startups, which are quite complex, and many, many founders who are very familiar with all the complex, and they can actually explain it and understand it very well. Decide not to include it, not to include this much more complex view of their products. because they're afraid of overwhelming the audience, and because maybe they're even trying to adhere to this 10 page limit of a pitch deck. And you know, all these guidelines that we get. But in my experience the reality is that actually hiding the complexity is guaranteed to, to basically deprive you of the chance to show the beauty and the compelling features and the compelling strengths of your product. And that's why the way to actually show this is storytelling, and I know that a lot of people talk about storytelling, but it's not clear exactly what it is. We will make an effort to explain what we mean here.

The essence of it. And that's why I am so passionate about clarity is that the story shouldn't be less full or less complete. It should just be simpler. So do not omit something because it's complex, simplify it, and weave it into a story which give gives a more or less full picture of the venture. And this is what sticks with the audience. It's it's the stories they actually stay with with investors, with customers, with anyone, really, any stakeholders, even the employees of this company when they have more. So so yeah, so they need to needs to talk about this, explain the beauty of this AI, and and if this is the differentiating feature which looks like it is, they should really talk about it. And again, I will come back to this later. To explain how a story is different from just the presentation of facts. But for now we can move on

So if we take a look about where the company is now, as they begin to approach investors in the United States to continue on with their product development plan. Let me take a look at some of the details that they present about themselves. I have to say, in looking at this, I find them to be in a pretty strong position as an early phase company beginning to communicate with investors. Why do I say that? Well, clearly, if you look to the right in that box on the right hand side of the slide, you see that they've already taken some pretty significant steps forward in launching their evidence development strategy. So they've got

feasibility studies. And they've already initiated and are waiting for feedback on a long term. Follow up study. So what I really like about that is that they're they're kind of, you know, to use Tatiana's language. They're building an evidence story here that they're going to add, add to over time to demonstrate the effectiveness and the benefit of their product in different ways over time. So it's almost like each study contributes the next chapter in a book, if you will. each chapter of which talks about another facet of the product and its value, those of you that I've had the chance to work with before, have probably heard me talk about what I like to refer to as an evidence cascade.

meaning that evidence development is not a 1 and done kind of thing that you need to present evidence to FDA to get regulatory clearance, or you need evidence for payers to get reimbursement. But you should really think about your evidence plan as an ongoing development of the story about your product. Why is that important? Well, hard to to demonstrate all of the value of your product in one or in several studies. You know, studies have to be very well articulated and focused in order to be effective in communicating their message. So a series of studies, a series of publications on what you're doing to develop supporting evidence for the product is a valuable tool

it provides you with multiple opportunities to reach out to the stakeholders that you want to communicate with. So every time an article or a journal piece comes out, you have a chance to send that as a courtesy to a lead opinion leader in the migraine area in this case, or to a payer as a courtesy to let them know about the development of the product and the evidence that is beginning to emerge. So that's really valuable. And it allows you the opportunity to communicate with these audiences before the product comes to market, and to do that in a way that is fully compliant with all of the regulations about promotional activity of a product that has not yet been cleared or approved by FDA. So I think it's a strategy worth considering.

and let me go on and and notice something else here on this slide, and that is that the company has already had an initial meeting with FDA here in June of 2024. Their pre-meeting or pre-submission meeting with FDA referred to as A. Q. Sub meeting. If that terminology isn't familiar to you. Once FDA begins communication with companies that intend to submit applications for regulatory clearance or approval, they assign the company a number, and the number starts with a Q. And so that's how we have come up with that terminology Qsep. Meeting. So they had an early meeting. Every company should think about the value of having that type of meeting what the right timing is to do, that what the value of the interaction with FDA can be

for the company at that early stage in the development now, importantly, for Nurevida. They had gone into this Q. Sub meeting with FDA, hoping to get confirmation that the 510 K. Marketing clearance pathway was appropriate for them. That pathway relies on a company being able to identify a so-called predicate device. Another device that's already been cleared or approved and is on market in the Us. And they're being able to demonstrate that their product is substantially equivalent to the other product. Now, what's attractive from the company perspective is that that pathway does not typically require presenting any clinical evidence. And so it's a shorter, more discrete pathway to come to market and attractive for that reason. But in this case FDA didn't agree that the 510 K. Was the appropriate path

for this particular product. FDA was not persuaded that the predicate devices that Neuravida proposed for their product were actually going to fit within the framework of substantial equivalence for Neuravida. And so Neuravida left the meeting with a clear sense from FDA that 510 K. Was not going to work for them, and that they were going to need to pursue a de novo pathway. Now the challenge for them there is that the de novo pathway will require some type of prospectively collected clinical evidence to demonstrate the effectiveness of the product when it comes to market. Now

that evidence collection takes time, and it takes resources that the company hadn't been planning on contributing to this particular part of the product development cycle. So they have a an issue that they need to work through as they continue to digest their interaction with FDA, you know, to perhaps competing approaches that they could take with FDA one would be to try to identify other predicate devices that might better fit their technology, and they could try to persuade FDA that, in fact.

other devices would be appropriate predicates, and hope that FDA would be persuaded and agreed to pursue that you can be successful if you do that, but it's a heavy lift and requires real, thoughtful planning and research to be able to get to that place. The other thing that the company could do would be to adjust their their go to Market Timeline, and you'll see in a minute that there's some real impact on that timeline, especially when they're thinking about their messaging with investors. So I'll say more about that later on. But let me turn it back to you, Tatiana

Quick!

Have a question. I think

Before before you move on let me launch the poll. hopefully. I can do this right this time. Are you able to

I can see

Yes, yes.

Okay. It seems to be working yesterday or the day before I accidentally stopped it. So thank you. Go ahead. Keep talking. You can just talk over the poll

Is that? Okay, yeah.

Please, do.

Okay, very good. So I just wanted to make 2 side comments on this slide, on the product status here. And these comments are not central to this webinar, because neither Ed nor I are experts on it. But we see this, and we just want to alert you to this. And the 1st thing is that you can see here. Neurovida has raised quite substantial, almost 2 million really euros from grants in in Europe and from university funds, and and so on. And this is amazing. and they probably are confident that they can fundraise, which is, which is a good thing to be confident. However, fundraising is a completely different skill, and then grant writing more or less, and especially when it comes to fundraising from Vcs. And what I mean by this is that you can only learn the fundraising job by doing it. And it's a full time job, and it's the job of the CEO. And

most of the time. Also one of you know their whoever their co-founders, but usually is the CEO's job to do the fundraising, and what I see for scientific and and tech founders especially is that they need to commit extra resources and In other words, they need to get someone with the right skills to help them, or they need to get someone to do it for them, or they need to really invest a lot of time in in doing this fundraising and doing doing it like they need to be doing like a basic, very commercially savvy. So that's that's 1 thing to to basically keep in the back of your mind. The other point is that you grant money specifically for those companies that are

based in the EU and may have received money from there. They can have implications on the IP strategy when entering the Us. Because of competition issues. Usually grant money is linked to enhancing the competitiveness of the EU, and when you raise money from us investors, those investors in turn want the IP to sometimes be transferred to local entities in the Us. And this can create all sorts of issues. So I just wanted to highlight this, and, you know, give you something to think about. In addition to all the other things that we're covering today. Sean, the poll is going. I don't need to

Yeah, I'm just gonna give it a couple more minutes while you talk

Okay, very good. I can just continue talking excellent. So now we get to the migraine market. And basically the potential which is a must have slide, as all of you know. But sadly, it's possible that by the time you get there investors may have lost interest in talking about the product. And this kind of is a bit of a danger with neurovita here, because so far, they're talking. The picture that is presenting to an investor is okay, this is a super highly competitive market. All the other competitors are super well funded. They've been around for 5, 6, 7 years, and I don't see how this neurovita is going to be better, and how they're going to beat them. So they might not even care about how large the market is, and that this is why Neurbita needs to really capture their attention early. However, if they're still engaging, because Neurovita has done a great job talking about the AI, even though they didn't have a slide on it earlier.

And they've managed to weave in something about how they're better than the competition already. then, what investors will want to know. Here is how will Neurovita capture the 5, 10% of the neuromodulation and digital therapeutics market which they're estimating at 300 million Us. Dollars. Now this is another issue, because, as we said, Neurovita is a very early stage company, and if they were more advanced in terms of sales traction, they might point to that to support their claims of capturing 5 to 10% of the of the market. However, given how early stage they are, they cannot do that which means that they lose this potential to generate excitement because they're showing a big market sizes. If you recall, this is actually one of the reasons why they think they will be more interesting to investors. So there's something. So there's another reason why they need to come up with something to compensate this kind of lost opportunity to to sell themselves as a good investment. Opportunity

The next slide in the Neurovita pitch deck is a slide. That kind of sets forth the competitive market that they expect that they will enter in the Us. When they come to market. And so you know just a couple of comments about the way that they have presented this. On the one hand, it's very, very good for a company like neuravit to be pretty clear eyed about what the competitive market looks like, and in this case it would appear that they've done a good job of identifying a really tight marketplace. What's good about that for them is that the investor looks at this type of information and says, Okay, I think they understand the challenging market environment that they're going to be entering. So that's good. So as an investor, I'm going to be looking for what their actionable concrete steps

have been, or will be to be able to address the marketplace that they're going to enter. So that's really something interesting. Let me go back to the interaction that the company's having with FDA, though for just a moment so recall that the company is is incentivized to see if they can find a predicate device that would work for their technology. Well, one of the things that they could do if they haven't already done. This would be to look at the other products that are currently on market to see if there is, in fact, a good fit for choosing one of the other products for a predicate for their own product.

Now that is is something that is potential. If you those of you who know a lot, or or have been working a lot in the 5, 10 K. Space. Though if you look at these competitor products, you will know that none of them would be a good predicate, principally because they have different mechanisms of action that would not be consistent with what neuravit is proposing, but it's a good strategy to think about, anyway. So if they don't want to invest the time and the money in preparing for prospective clinical data collection for a de novo application.

They could think of some other opportunities that might help accelerate their time to market and their time to generate some revenue, which, again, is an important component in the way that investors will evaluate the opportunity that this company presents to them. Now one way that some companies have try to accelerate their regulatory pathways by taking a so-called two-step process to get to marketing clearance, the 1st step being an earlier product with a much narrower label that can fit into a simpler regulatory pathway a 510 k. In this case that they can use to piggyback onto for a second approval

that could potentially happen in a shorter time period. This has worked for some companies, not for all, but it's worth considering a range of options that might work for you. The second approach that companies consider is the extent to which they can commercialize some of the data that they've been using. So a company with an AI solution has already been engaged in certain data purchases and used to train the artificial intelligence that they are developing. Perhaps there's a way for them to commercialize, that for use in research that other companies would conduct, for example. And so it's worth, perhaps, considering those alternatives to strengthen their position in interacting with investors.

But I know, Tatiana, you had some comments about this slide as well

Yeah, I have a just a few comments. Basically, this is a really good slide, because it's starting to get to the core of the problem at least one half of it. I because I, in my opinion, this and we'll talk about this. The problems with their storyline are that they are not highlighting their competitive advantage, and they're not dissecting the competition and showing how they're better. But it is good because it's starting to get into this direction. It's a bit late in the deck, almost, for my taste. I would like to address challenges head on first, st but I'll talk about this in a little bit,

it when presenting the competition and talking about it. It is of utmost importance to identify the correct criteria to compare against, and of course, there has to be a balance between where neurovita is good versus which criteria they must be better at to beat the competition, because there are objective criteria. And you can see here some of them are listed technology, personalization, efficacy cost and so on. But they but but neurovita and any company that is talking about its competitors, needs to have thought about all the potential criteria and selected some to focus on. And here, in this case, for example, what I'm missing when I look at it is the safety aspect. I also don't see the adherence aspect. I don't see a usability, aspect, quality of life, improvement.

and so on. So there are many more factors that are an investor or anyone who knows the market would want to see. And it's also possible that neurbita just hasn't presented them again because of lack of space, and they're missing a chance to position themselves in a stronger way. So they also what one thing that that comes to mind here is that they always must consider substitutes. So not direct competitors only like these product, a product B and products here actually based on real companies that Ed and I researched for this study. But there are also a number of visual therapeutics companies which are not a device, but they are collecting data, and they are offering a similar solution to alleviate migraine symptoms. And the substitutes are not listed anywhere here. So

If if it could be, it could be a a sign of an unknown unknown to an investor that basically in Europe is not aware they should be also looking at this market, and in that case it might be some a bit of a missed homework that they still need to go back and cover. So that's on the competitors. And then the other thing that I would. Highlight here is that they're actually mixing up the competitor evaluation with something that is a prerequisite for their market access. And that's the Ftf pool and the insurance coverage. These are not things that that are that are gonna make them better from than competitors. I mean, I know it sounds like this. If they have FDA approval and the others don't. Yes, that's great. But it's not the case. 1st of all. And second, it's a prerequisite for becoming a competitor. In the 1st place. So this requires it's it basically needs a

a deep dive. The FDA approval and the insurance coverage. So the the market access strategy needs to be discussed separately, which they are not seem to be doing here

All in favor of keeping the number of slides in their deck to a minimum. This slide sets forth their timeline and also identifies the specific funding that they are looking for from investors in this round. So if we just kind of look briefly across the steps in the process that they set forth. What do I notice? They had an early meeting with FDA, and that's really good. They didn't get the answers that they were hoping that they would get. But getting other answers early on is actually good news, because it gives you time to think through and talk through the alternatives that you will have to look at.

So you know, thinking about then the process that they're likely going to have to go through to get to commercialization in the Us. An investor is going to look at a timeline like this and ask if it's realistic now, hard to say at this early stage in development for the company. But as I look at this, it appears that it could be pretty aggressive, meaning that the company is not really accounting for any problems, any delays that end up presenting themselves. So, for example, if they have to go forward and collect prospective clinical data, how much time is that going to take realistically the time to interact with Irbs and with investigators and recruiting patients, and so forth, that can be challenging and missing your timeline as a company asking for funding

is really problematic. So how do you present a timeline that is both aggressive if you will, but also achievable. And don't put yourself into a position where you're trying to essentially sell a story that you know you're not going to be able, or it's very unlikely that you'll be able to achieve. So that would be something worth considering. Just as an aside, I'll also comment that one of the issues that companies now should be thinking about, particularly with regard to interacting with FDA, but also with other Federal agencies in the Us. Government is that, as I'm sure you're all aware, there's been a ton of disruption here in Washington and around the country. With regard to Federal employees.

large numbers of employees either have or will be let go over the coming months to achieve the goal of slimming down the overhead in the Us. Federal government. What we know, or what appears to be, what's the impact is going to be for FDA, but also for Cms. And for other government payers, is insufficient staffing, meaning that although the traditional 510 k. Timeline from submission to clearance is supposed to be 90 days or around that time. We expect to see those timelines extend potentially significantly.

and that's going to affect your ability to get to market as quickly as possible. Now the good news is that the device associations in the Us. Advimed, and Mdma and others are being pretty straightforward in communicating. That's a problem to Congress and to others who may have some influence over that. But I would definitely try to monitor where things are there as they progress, because it could have a real impact on your ability to get to market in an efficient manner. The other thing, I guess, would be to to look at exactly what the funding is that they have set forth here.

and if I may add something because we it is a super important point, but seeing that we only have

A few minutes left. I'm wondering if we should cover the how to how to estimate the funding in the next session, and we just present the quick recommendations now

Okay.

Take some questions, maybe. And then we covered this very important bit in the next session. What do you think

I think that's great. I mean, what we'd like to address is exactly how you get to the number that you want to ask for in this funding round, and we can provide some ideas about how to do that. But great idea, Tatiana, please let's go to that section. Then

Let's let's do that. So as you can see, guys, this is a lot of content. And we're really trying to to highlight, the the details and the important thing. So this is just a snapshot of what I would recommend for the how to improve the investment story and what we're going to do next week is there will be more detail about this with examples how to actually implement it. So for the investment story, they really need to open the pitch with the strongest point, which in case seem to be the AI. They need to explain everything. They can explain about it without overwhelming the audience. And this is why this is a big task. So writing a pitch deck, even though it's 10 pages, it's actually a much, much bigger exercise, and when I work with clients I advise them to prepare a very layered playbook which they have at the ready, and can pull individual slides to answer specific questions.

but the goal is that they initially tell A. They initially grab the attention with the strongest point and keep that attention as they move on through the presentation. So in this case for Nirovida, it also means to address the weaknesses head on which is, they need to pick apart the competition, because that's the elephant in the room. And like I said, they need to tell a story. They need to integrate this sort of like a digestible complexity into the pitch, something that again, it doesn't limit the scope, but it simplifies. It makes it easier to understand. So yeah. And of course, if they can bring the product and demonstrate it, or do a demo of the app version of the app part of it. That's what they should do. And I'm gonna hand over to add to add, for this

So from my perspective, a couple of things that they might pay closer attention to would be a number of things. First, st to make sure that they understand the clinical practice flow. Oftentimes, when companies bring new products to market in a particular therapeutic area, they don't situate the product in the practice flow in a way that will help clinicians optimize their practice to make it streamlined more successful, and so forth, and so almost like plotting out what the practice flow is from step to step. Who does a patient with migraine headaches?

See 1st among clinicians, and then how do they advance through the treatment path gives you a good idea of where and when this innovative product would best be entered into the flow, and would be used most effectively and most broadly. The second piece is really to take a look at the demographics of the target patient population. In this case individuals who have chronic migraine who feel that they're not getting the treatment benefit that they want from drug therapy alone. So they're looking for another step in their therapy understanding who those patients are, as clearly as you possibly can is important because it helps to identify who the payers are that you're going to have to be interacting with. To ensure that your product gets covered

and gets paid for at an amount that is consistent with the value that you're able to demonstrate about the product. I'm going to say more about that next week. But it's something to really think about. The 3rd thing is relationship development in the marketplace. Many clients come to us and indicate that they really don't have many relationships among clinicians and thought leaders in the clinical area where they are working. Some companies will focus particularly on the key opinion leaders and really focus all of their energy on demonstrating or building relationships with Kols. But if they do that and exclude relationships with clinicians in routine clinical practice, they've really lost an important piece. My sense is that the best strategy is to balance an interaction or relationship development with both of these.

It's the clinicians and clinical practice who can help appeal? Denied claims for payment for the use of your device. It's they. They are the ones who understand how the practice flows and where the device can best be introduced, and they are the ones who understand the business. So things like whether you should enter into a relationship with a distributor in the Us. Or or use the clinicians themselves to distribute the product to their patients. These are important decisions that they can help inform as you come to. Continue to move toward the Us. Market. All right, let me stop. Hopefully. We have some questions

and we'll pick up on a number of these things next week. If you have questions that don't get answered today, then please give us the opportunity to address them next week. Come back, and we'll be able to do it. At that point. Sean, let me turn it back to you.

Yes, so I have put the link for next week's session in the chat somewhere near the top. Please take advantage of that, please. Also complete the survey. We did maybe have one time for one question before we sign off, and the question that stuck out for me was that for startups. It's often difficult for them to get figures of the competition, efficacy, real costs, profitability, etc. Any suggestions before we sign off on where to look for intelligence, competitive intelligence.

You want to take that one

Yeah, I would say, anywhere. And that's basically the hustling bit. Right? It's kind of like selling as well. We basically look in your network. And you look for anyone who can give you any clues. And obviously, people who work for those companies cannot talk about it, and others who may have worked will not be able. So it's all confidential and all that. So it's so if it's not possible, it's not possible. But because these are, you know drugs or treatments that have been launched already. Hopefully, there will be some information somewhere. So this, for me, is a kind of like a diligence exercise which takes a long time, and it has to be done meticulously. So it's again I would approach because I'm very structured. I would approach with a plan of like, where to look, whom to ask, and to dig in deeper and deeper and deeper. And nowadays, of course, with my favorite, my favorite AI engine is complexity, so I'll ask it, for you know, to help me structure the search, so to speak, and then go and dig in.

dig and dig. So that's my kind of yeah. Approach.

You can purchase a lot of data that will give you some insight into where companies are. That is an expensive approach. I think it makes sense when you get really close to market. But I agree with Tatiana that it takes a lot of time and hard work to get that information I find sometimes looking at blogs or looking at things not so much in the sort of technical press, but in more public press types of information, you can begin to piece together a story that can be instructive about where your competitors really are.

Fantastic. Thank you so much, both of you and everyone who attended today. I put the link in again for getting paid for your product, a medtech commercialization roadmap taking place next week. Please join us for Part 2. We loved having you here today. All of this information will be sent by follow up so you can access it there as well. Thank you again. And shall we sign off? Say goodbye to everyone

Thank you all

Thank you, everyone. It was a pleasure to talk to you. Thank you. Please complete the survey. Okay, take care

Bye.

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