Leonara vidal, Global Clinical Affairs Lead at Gentell

Jesus Moreno (00:02.892)
Welcome back to Global Trials Accelerators, the podcast where we dismantle the barriers to clinical innovation and explore the strategies driving the next generation of life-saving therapies. Every year, MedTech developers pour millions of dollars into highly controlled, rigid design pivotal trials. We build perfect testing environments, outline hyperspecific protocols, and establish narrow parameters for a device intended use.

But the moment that device enters a hospital, the real world takes over. Clinical professionals drived by the patient needs inevitably find innovative ways to handle, adapt, and apply these technologies outside those narrow boxes. For years, the industry has treated that gap as a compliance headache. Our guest today is a pioneer at strategic shift.

That flips the traditional clinical trial model entirely on its head. A concept she calls researching in reverse. 

Jesus Moreno (00:02.900)
Leonora Leite Vidal is the global clinical affair leader at Gentel. Her trajectory is nothing short of extraordinary. Beginning her career as a nurse in Brazil, she secured her first international research award during her undergraduate studies, followed by a second award in 2024 for a landmark project with John Hopkins University and USAID that established a new national treatment model in Brazil.

After twenty two years of excellence as a clinical professional, she transitioned to global clinical operations, moving through Spain, Ireland, and the UK, training healthcare professionals on class two and three implanted devices studies, and winning a third international research award along the way. Now is a published author of three books and a leading scientific voice in Europe.

She is here to challenge the way we think about data generation. Join us on today's conversation as we discuss the topics of usability blindness in traditional protocols, how to turn retrospective observational post market clinical follow-ups or PMCFs into a massive efficiency gain, and how resource constrained companies can bypass high cost.

Multi-year pivotal trials by looking at how devices are actually handled in practice. Leonora, welcome to Global Trials Accelerators. It's a true privilege to have you with us today.

Nara (01:40.558)
Thank you, Jesus. I'm very happy to be here with you guys today. And it's a pleasure talking about a subject that I'm passionate about, that are actually the post market follow-up studies that are so useful for industry at the moment, rather than very long and strong clinical trials in the industry field.

Jesus Moreno (02:06.164)
Excellent. I'm so excited to explore that topic with you. But before we do, I wanted to start in Brazil. Early in your career, you were pulled into a large collaboration project with John Hopkins and USAAID. On that end, you reshaped national treatment protocols. Most people don't get a project with that kind of reach until decades into their research career.

What did carrying that responsibility so early on teach you about how clinical evidence actually moves the needle on public health versus how it's talked about in the lab?

Nara (02:51.618)
Yeah, like that was a very amazing experience that I had when I was actually a student. a professor at the university actually saw my passion through infection diseases and like publications and things like that. And she started to invite me to be part of some trials at the university until I got like a contest.

In between the students, and I passed in first place to start an initiation product project with her in clinical studies in infection diseases. So she actually chose as a subject the tuberculosis cases in Brazil. We had very high rates of tuberculosis by then. It was like on the 90s. I'm not gonna say like my age to you.

But it was very long ago. So she wanted to shape another kind of treatment in Brazil to avoid the patients to abandon the treatment. Because once the the patients actually got better in terms of the symptoms, they you would abandon the treatment. And if you don't take the medication for entire six months, the symptoms they come back and you become like

multi-drug resistant patient through tuberculosis treatment. So that was very important to the country. And Johns Hopkins University had a bunch of doctors and nurses there. And they wanted together with that my professor to establish a clinical study that I was part of as a student. I I must remember that. And we started to develop a lot of different

clinical trials into the same big study. So we tried to let's say make an a new treatment that was supposed to be efficient and safe for the patients. So she developed 20 days first dose attack treatment with everyday medication and after that more 44 doses.

Nara (05:15.808)
of the same medication but not daily basis, which were like causing several different symptoms on the patients. The treatments is like a chemotherapy, so it's very strong. A lot of patients they had autoimmune hepatites, medication hepatitis, and a lot of other problems because of the medication. And then after that

Jesus Moreno (05:36.478)
Yeah.

Nara (05:44.692)
Making the medication be taken with a lot of more pills and less in in less days during the week was a must. All the patients they had less symptoms post medication, they were feeling very well the majority of the days in the week, they didn't have all the adverse events provoked by the medication.

And they could complete six to four doses. That was actually the whole treatment during six months. And we actually, unbelievable, in that situation, we resolved the problem of abandonment in Brazil. That study we tried we treated 4,800 patients at the at this point.

And zero point zero thirteen percent abandoned the treatment, which was like the lowest yeah, lowest rate in the history of the country. So until now, the same model of treatment is taken in Brazil as a official treatment for tuberculosis.

Jesus Moreno (06:43.242)
Unheard of.

Jesus Moreno (06:49.059)
Mm-hmm.

Jesus Moreno (06:58.946)
Wonderful. Translating evidence into practice is is the main goal of of any s any project along those lines of researching, you know, a new medication that can have national level impact. And it's so interesting how yeah that that translation between the initial protocol and how things played out was effective and

And there was yeah, flexibility and and it allow you guys to shift the implementation of the trial and have such great results. And after those formative years where you learned about the stakes of of clinical research, you moved from Brazil

And you took your experience internationally into Spain, Ur Ireland, and UK.

And you started training healthcare professionals on class two and class three implantable device studies. I'm curious to learn, moving across that many regulatory cultures in such a short span, how did that difference in setting help you learn about how to write a protocol?

Nara (08:13.678)
Yes.

Jesus Moreno (08:31.85)
in a way that that you might not have learned if you had stayed in headquarters or more local setting? How did that shift in in culture allow you to see what's a must in a protocol assign? and how how is the different from someone that follows a more traditional route staying

only in their regulatory environment.

Nara (09:03.894)
I think as a healthcare professional we need to think about the patient in first place, isn't it? And the patient is not a medical just a medical condition that you see clinically with your like healthcare professional eyes. The patient is also the environment where he is inserted. So the culture is actually very important for any clinical treatment and any clinical trial or

Post market activities that you must develop over time. Because where the patient is inserted, it's going to give you the idea where you can actually identify like the basis, the roots of the problems, or conditions that can actually be minimized by understanding the environment where he's living at the moment. For example,

Each country they have different diet patterns, right? They have different weather, they have different habits in terms of like that can impact a lot, like their clinical condition, their diseases, their cure treatments, their involvement on the therapeutic process. So I think that is where the healthcare professionals

They don't understand how it's important to you to understand how the patient is inserted in the culture. Because, for example, right now I'm working in Gentel, and Gentel is a great vertical company. Since long ago, we are trying to treat patients like with different kinds of wound care products and ostomy products. And to that to happen.

I do need to know in terms of culture how the patient is like developing his eating habits. So I do need to understand what they eat, how many times they eat, if they drink enough water, their age, their ethnicity, and a lot of other variants that actually can impact the result of our dressings on them.

Nara (11:25.208)
So if a patient is, for example, eating fat, fat, fat all the time, not eating proper protein, carbs, and vitamins according to all the groups of foods that we actu we actually have in the world. So these patients it's not gonna have like the best outcome in terms of treatment. The wound is not gonna heal like really fast. It's not gonna heal like even on the

normal conditions because the diet it's very bad. So we need to understand in terms of culture where the patient is located, how the culture like impacts his healthcare conditions and the therapeutic treatments we are offering to them.

Jesus Moreno (12:17.27)
I see it's all about the context. after you've built your research career, you decided to become a published author. Three books along with your academic publishings. with this explicit stated ambition to to keep growing as a leading scientific voice in Europe and specifically the UK.

Nara (12:34.574)
Yeah.

Jesus Moreno (12:47.064)
How does having one foot in the classroom and one in the industry change the way you approach clinical strat strategies for Gentile? And does teaching have an impact in as to how you think about questions to ask?

Nara (13:10.126)
Actually, it was the the opposite because since I was a child, I started to writing books when I I was just like eight years old. I had a little brother and I used to write like little stories to him, like to sleep. I always I always was like passionate about this brother and I started to write books because my family didn't have condition to buy me a book every week.

So I wrote to him 68 little books. But by the age of 12, I was already a writer. But was just like a play between family members, do you understand? But then when I started to be interested in research, my professor actually taught me how to write an article with scientific basis. And because I always loved like writing.

Jesus Moreno (13:55.212)
You

Nara (14:09.088)
in everything. I have until now I still have my diaries and I write them every every night. So I think that was just a natural context of my life. After having contact with science, that was actually my second passion. And writing was first passion. I do shape right now my career between the academical field that I was

a professor before in Brazil. And because I always loved like to study, to write, to read, to publish articles and everything, I started to develop this passion inside of my environment with my students at the university. And today I have a group of ex-colleagues, ex-students. we have a research group in Brazil still working online.

We publish a lot still and we are part of the directory of one of the biggest universities in Brazil, that is University of São Paulo. So our group is being recognized recognized by this university and I'm really happy because I think science is the way we're gonna get the the world like a better place for us.

Jesus Moreno (15:37.131)
And has that experience of working with different levels of let's say expertise or colleagues at different levels of expertise, both peers as well as undergrads or postgrads maybe, has that helped you see what others might be missing because they're so used to working at a certain level and they're

just, you know, set in their ways when they're writing a protocol and they might be missing missing out on that genuine curiosity the undergrads might have because they're just starting to open their eyes to to this world of research. Has that at all changed the way you think about how you structure a protocol and what the what the endpoints are?

Nara (16:36.962)
Yeah, I think it's very important that we cannot ignore that in every time of our lives we have knowledge that can be exchanged at any time. So my graduate students, they were like something that I'm not at the moment. They were they were like updated with the technologies that they know. TikTok and a lot of digital tools and other things that are so rich.

that we can explore to make like better clinical studies in the future and to add into the science field that we cannot ignore that is very important. So if you have a student that practices everything that other teenagers, young people practice, they they can give you like amazing feedback about some subjects. For example,

Nowadays, when we treat when we try to do like clinical studies that are related to Seasight, they say to us, Professor, we need to add a question on the protocol that is related to how many hours per day you have access to your social media or how many hours per day you can actually be.

with your eyes close to the same screen or something related to it. So things that I would never think because my generation didn't have like mobile phones or laptops or screens all the time. Right? So they have actually a lot of knowledge to exchange with us and no knowledge from any age can be ignored in if you are actually trying to

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Jesus Moreno (18:38.4)
I see. It that's that instinct of noticing what the protocol's missing is really the seed of the biggest idea I want to explore with you today. You've coined a term that's very interesting. It's called correct me if I'm wrong, but I think it's usability blindness. Can you walk us through it? Why why do rigid design protocols?

Nara (19:01.026)
Yes.

Jesus Moreno (19:06.174)
so reliably fail to anticipate how clinical how clinic clinic users are actually going to handle a device after the trial is done, after it's out in the real world.

Nara (19:29.358)
Can you repeat? I think the internet is not collaborating with me today.

Jesus Moreno (19:33.813)
that's fine. Let me let me restate that. that instinct, noticing what the protocol's missing is really the seed of the big idea I wanted to get into with you. you've coined a term for it, it's usability blindness. Can you walk us through it? Why do rigidly designed protocols

so reliably fail to anticipate how a clinic clinician is actually going to handle a device once it's out of the trial environment and into the real world.

Nara (20:14.21)
Yeah, so that is actually the biggest difference in between a proper clinical trial and a post market activity follow-up. And it's actually very interesting. And it I that's why I'm passionate about post market PMCF, because post market gives you freedom that clinical trials doesn't give to you. And I'm going to explain why. Clinical trials are always seeking like high

high technological or specialized centers of study to put study to to be developed there. So a clinical trial to be developed in like in the high knowledge center of research in a big hospital in Europe, for example. We have in Gintel one that is about to start. But what I want to do, I want to talk about today, it's like

How the limits of a clinical trial make you blind to the new usability of every medical device. Because clinical trials, you need to have a proper clinical protocol and you cannot have any deviations of this kind of clinical protocol, right? So you need to apply the product in exactly the same population that is like

precognized you g you need to apply the same technique you need to apply inside of the indications correctly and you cannot you cannot have any mistakes on that. And you of course you are worried with the safety of the the patient. And that is always first place that we think as healthcare professionals. But in terms of PMCF,

Because the product is already certified and you are sure that the product is not gonna cause any harm on the patient, you can, with your freedom, use the device in the same classification by the notified bodies regulation, of course. You can use the device in the same classification in different intended uses.

Nara (22:35.392)
And this is like the most rich impact that you can cause in the industry with a medical device. Because you also, apart from guaranteeing the safety of the patient, you are creating another possibility to the patient's treatment if you use in another indication. And the PMCF can bring you that because it's not like so let's say rigid.

and flexible as a clinical trial because the product is already certified, isn't it? So it's safe to be used. For example, I have a product here that's my new passion. This product is a C-section dressing. It's not being certified being certified at the moment. It's in the process to be certified. So we're going to start to do a PMCF post-market clinical activity with this product.

And I took this product to a conference some time ago. And in this conference, the nurses they were like so happy to see the product. Because apart that product being capable to be applied in C-section incisions, in surgery, and in abdominal incisions, they said the product has the same perfect shape to be applied also in neck.

And had surgery because the shape is exactly the same size and the same format of the incisions they do. And I didn't know that because I'm not a head and neck nurse. So, but I had this inside. And now a surgeon from Portugal that is working with breasts, he said the same: that is perfect for patients that are actually going under like

surgery to remove the breasts or like breast surgery, plastic surgery, to put on the incision after the after the surgery. So it's a new indication like appearing here. It's a new possibility to be used in a in a person. It's a new product being generated to help the population to have the best care. And the product is safe.

Nara (25:00.694)
And can be and is going to be using the same classification. So I couldn't be happier to listen to it. Another example that we have on the moment is like a cream made by Manuka honey. This cream is actually a new sensation that we have in the company at the moment. Why? First of all, it's pure honey. Second of all, it's antibacterial.

And thirdival can be applied over the skin for almost everything. Every type of wound, every type of burn, every type of situation on the skin, it's safe to be used. But something that was really interesting to hear that the product is not just to be applied as a protect protection, it's a barrier, barrier cream, it's just to protect against like rubbing things, too.

And abrasions, things like that. So it's for protection, but it's also a product that can treat areas. For example, baby rash from diapers. You can apply on a baby, and you can not just protect against a new rash, contrat the rash that is already in the skin of the baby. And

It's made by honey. So the baby accidentally, if he has contact with that, no problem. The baby can smell, the baby can pass on the skin, the baby can eat, because it's pure honey. So it's very safe for pediatric applications. And at the moment it's not used by for pediatrics. So it's a new indication that was like actually taken from PMCF activities. Do you understand?

That's why usability blinds are actually covered with PMCF activities and not with clinical trials.

Jesus Moreno (27:07.266)
Those are two excellent examples. but can you maybe walk us through the particulars of how it looks like for a company to shift from testing of label excuse me, from from treating of label use as a risk category and to treat it as a roadmap for input and and future research. How does that look at a

Nara (27:35.683)
Yeah.

Jesus Moreno (27:36.876)
At a particular practical implementation.

Nara (27:40.834)
Yeah, so we need to take care of the the misuse word because it's very serious to misuse a product trying to make like the good t for patient and actually harming the patient's health. So I take very seriously when we talk about misuse. But what we need to know is like first of all, the person that is going to apply the product is a healthcare professional.

With a lot of training and knowing like all the adverse effects, all the expected effects, all the performance that was supposed to do on this on the patient, and also the safety aspects. The patient is always first place in our lives. But if you can take the chance to use a product that is actually very beneficial.

In another indication, considering first place the safety of the patient. Another very important aspect is the regulatory classification. The product must be in the same regulatory classification. And the new indication must to be the same application, but in another part of the body. So if you use

for in those three aspects you actually can have like you can produce more products that are beneficial for the patients and you can discover also a lot of holes on the market where you can actually cover with new innovative products.

Jesus Moreno (29:33.049)
That's a that's a very sharp reframing of of that off label term, which has for many years been a negative of ha has had a negative connotation to it. so using this strategy of starting from the from the information you can gather through a PM PMCF where

clinicians are creatively using approved devices and technology for other to solve other problems they're facing in in their practice seems to lend itself well in contrast to running a pivotal trial that costs tens of millions if not if not more and it takes two to three years to get ready for and even

longer to implement. So have you been able to capture any metrics as to how this translates into real efficiency gains? and is there a catch? Is there a diminishing return at some point?

Nara (30:53.304)
Yeah, actually we need to be clear in terms of what means that we need when we have a clinical trial and what it means when we can have actually a post market activity. Always a clinical trial is developed on the development phase. The product is not yet classified, is not yet registered, and is not yet like approved to be used in humans.

So we need to be very careful to say no, we don't want to choose like a clinical trial. Also, the clinical trials, they are more expensive because the the prof healthcare professional that is going to develop the clinical trial must be the best in the market. Which means I always like to give my clinical trials to people that are involved in science.

So professors, doctors that are developing studies with other materials, like competitor materials or other materials, people that are specialized in the area that we are actually talking about. So that is one important aspect for the clinical trials. For post market activities, they are non practical and they are very expensive to the industry to hold during

a certain time and they have a lot more steps in terms of regulatory obligations than a PMCF activity. But PMCF activities they can be used like they can be developed with the patients that are currently being attended by the healthcare professional that agrees to participate on them. So they're gonna benefit their patients with an innovative material

that is already certified, already proved, safe, performing, with minimum risk to the health to the health system. So those this difference is actually fundamental to us to explore because the PMCF gives you the freedom and the possibility to find other healthcare professionals that are actually not just

Nara (33:17.974)
specialized in the same in the same part, in the same field of application, but also in other fields. Reminding you that the safety of the patients is first, second is the regulatory classification of the device, and third the similarity of the intended use and the application of the medical device on the patient's body.

So I think that situation can explain to you how important in some way are the clinical trials and how important are the PMCF if they are taken like seriously. And one important thing: PMCF activities usually are taken by the professionals in the industry as a way to feed the regulatory obligatory.

obligations in terms of producing clinical documentation for keeping the registration alive. But that is not true, let's say. You can give a lot more feedback for your industry field, like for the hel the developers, like the R and G team, research and development team.

you can give a lot of feedback to your clinical team, to your commercial team after a post market activity, than with a clinical trial. So both are fundamental in the industry field, but in different scale and in different moments.

Jesus Moreno (35:08.8)
I see. And having established that difference in taking into account the regulatory objectives of both types of of research, have you noticed in in the growing footprint of Gentiles wound clinics across UK, Spain, Brazil, I I believe you're expanding to Paraguay and New Zealand.

recently recently excuse me you have you seen any live regulatory shifts in any of those markets that actually reshape how you can put that PMF data to use right now or is or should there be initiative to reshape that regulatory body perspective

so that that PMF data can be more enriching and be used to solve more problems than just keeping the the product legally usable in their market.

Nara (36:24.926)
I believe people already are aware the importance the importance of like PMCF activities because on those moments, KOL, for example, key opinion leaders activities, we hear a lot of people that is specialized in the all the devices that we are studying, isn't it? So when we have those moments between those valuable like specialists,

You hear so much from them. And during the PMCF activities, I'm passionate about this because I have contact with several other people and I can understand their universe and the holes that the market actually presents to us. There is a funny story that was the first time that I was passionate about usability of devices and PMCF activities.

One patient once was having problems with a device when I was working in another company that was long ago, and the company was producing ostomy bags, and we had a product that was made like with fibers of coal to neutralize the smell of the feces in an ostomy bag, of course. But the patient wasn't.

Happy enough with the product because he wanted more. How he solved the problem? He started to put mints, normal mints, mental sweets, inside of his ostomy bags. But then he created another problem because sweets mixed with the gases, the gases that like the source of the problems of.

ostomy bags, the acidic aspects of like the the feces products and and those kind of things the patient started to have ballooning which is like the the the bag was becoming a little bit like bloated with gas because the sugar reacting with the acids from the gastric

Nara (38:51.244)
system of him. So that was a big hole on the on the market, right? So they he wanted something with nice smell, not just neutralizing the smell, but also neutralizing and adding value to the smell. So he wanted something smelling mint to be more clean, to feel a little bit more hygienic. And I I was thinking like that deserves a PMCF activity.

Let's start to produce a coal material with hydrogel to neutralize the smell also with mint flavor. Then we're going to to solve the problem with the smell and the problem with the ballooning, with the quantity of gases inside of the bag. And then a product was born from this whole of the market.

So we need to identify, we need to observe, we need to like be really passionate about what science can bring to us and what observation and those activities can bring to us. It's not just an activity to fulfill the regulatory obligations. It's also something that can bring value to your company, value to your community, value to the patients.

Because a lot of people they need a lot of more medical devices that are not still invented, that are not still being s being sold, and we we have the obligation to produce them, to produce those products to them, in my opinion, as healthcare professionals and scientists and people from research, development.

Jesus Moreno (40:47.032)
That's that's wonderful. It's a wonderful source of innovation and that brings it back to to startup realities. do you think there's a place for a PMCF in the context of a startup where there's limited runway, no appetite or budget for a multi year pivotal trial? how can a PMF drive insight?

Nara (40:58.318)
Mm-hmm.

Jesus Moreno (41:16.844)
realistically in the context of a company that's resource constrained and just at market entry or close to market entry, is this a full s suitable strategy early on? And can it provide valuable information when when the company is at that

point in time in in their development process?

Nara (41:50.05)
That is actually the best question you made me today. Because then I need to come back to the time that I was a professor. The healthcare professionals working in the companies, they forget where they were born, on the university, on the academic field. And like me, a lot of other students they are like very thirsty to experience a clinical trial.

A healthcare activity, a PMCF activity, they are very eager to participate in any of experimental research that you give to them. And that is actually the cheapest way that you can actually develop anything. You go back to your university, you talk with the leaders, the professors, the specialists, they indicate to you.

other hospitals they have been working in the past, or colleagues that you can relate to talk to them. And you can develop PMCF activities completely for free.

I'm going to Italy in two weeks time to talk with a professor that is actually developing independent study with our products because he just talked like the product is amazing.

He wanted to try, he he wants to be like someone interested in the area of producing science through the medical field with proper medical devices. And some people they have like the patience, the time, the opportunity, the environment for that, but they don't have like the knowledge. What I'm gonna do with the the results of it.

Nara (43:46.69)
How I'm going to publish it, how I'm going to become someone that is like contributing with the science field and with my patients.

So they need to find someone that is also passionate about publications and interested in the industry, like on the communications team, to develop a work with them, just to put on on a format of publication and to check like if all the steps of a clinical study or all the steps of a PMCF were respected during the development of the clinical the the clinical experience, let's say.

And if it's possible, we should publish that because it's science as well. So I think people always forget where they came from. And I came from the university. I had my first award in research as a graduating graduating student. I had the second one as a professor in the university.

Still linked with the same professor from the graduation. And the third one was already in UK, in Europe, linked with a lot of nice prof prof professionals inside of the industry. So I think we need to remember our friends, our colleagues, people that worked with you in the company before. My ex-manager.

And also my ex-colleagues from other companies, when I have KOL activities to develop, I invite them. Because they are specialists. I know their quality of work. I know their strong opinion about medical devices. And I know the value they can bring to my products here. So it's all about remembering remembering your friends, your colleagues, your university. You have

Nara (45:50.152)
so many other ways to develop PMCF activities apart from paying like millions to a company to develop for them.

Jesus Moreno (46:01.986)
That's a perfect way to bring this conversation home. Leonora, my takeaway is that research in reverse is in a shortcut. It's letting real world clinical usage dictate your regulatory roadmap instead of building it in isolation. to the medTech executives and founders starting staring down at a massive cost of conventional pivotal trials, take a hard look.

Nara (46:19.646)
Yeah. I agree.

Jesus Moreno (46:32.178)
At what your device already tells what your devices are already telling you in the wild before. Excuse me, I'm gonna start that again because there's some noise in the background. this is the the outro by the way. I'm I'm closing the interview. so so Deonora, that's the perfect way to bring this conversation

Nara (46:45.154)
Mm-hmm.

Jesus Moreno (46:58.456)
home and my takeaway is that research in reverse isn't a shortcut. It's letting real world clinical usage dictate the regulatory roadmap instead of building it in isolation. And to the medtech executives and founders staring down a massive cost of conventional pivotal trials, take a hard look at what your device is already telling you.

about how to move forward in instead of starting from zero. Leonora, thank you for your time, for your dedication to science excellence and for sharing your blueprint with us today. And to our audience, go go ahead.

Nara (47:45.006)
Thanks to you, Jesus. Mm-hmm.

Jesus Moreno (47:51.224)
Go ahead.

Nara (47:53.198)
Thanks to you, Jesus. It was actually a pleasure to be here with you today. And I hope I could pa pass like my passion ahead to other healthcare professionals involved in industry. And if anybody wants like to con to contact me and exchange experiences, exchange like feedback or anything, I'll be more than happy. And

Was a pleasure, really.

Jesus Moreno (48:25.25)
Thank you and thank you for being so open to spreading the information and growing the network of professionals that are interested in promoting new usages for previously approved technologies. And to our audience, if this challenged how you think about your regulatory pipeline, send it to a colleague who needs to hear that. don't forget to subscribe to our podcast and we'll see you next time.

Until then, keep accelerating.

Nara (48:58.614)
Yes. Keep excelling.