First in Human Episode #24 featuring Gun-ho Kim 

For episode 24, we speak with Gun-ho Kim, CEO & Founder of Recens Medical. Find out about the Ocu-Cool system: a painless intravitreal injection alternative to chemical anesthesia. First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder & guest host Co-Founder, Andrew Brackin. Episodes launch weekly on Tuesdays & Thursdays.

Andrew Brackin: Hi, I’m Andrew Brackin, the co-founder of Vial and this is First In Human, a podcast where we speak to biotech leaders about the challenges of running clinical trials. Vial is a next-generation CRO built for biotech, focused on delivering faster, and more efficient trials. 

Today, we’re here with an amazing guest, a new partner of Vial’s, in a sense, in that we’re working together on a trial, an innovator. We’ve got, Gun-Ho Kim, the founder and CEO of Recens Medical. Hey, Gun-Ho, why don’t you tell us a little bit about yourself and the company?

Gun-ho Kim: Hello, Andrew. Thanks for your introduction. I’m Gun-Ho Kim, CEO and founder of Recens Medical. Recens Medical focuses on precision cooling for a variety of clinical applications. One of our top products is OCU-COOL which empowers a patient getting monthly injections and let them have a better experience. And, for physicians, a better workflow. 

Andrew Brackin: It’s an incredibly exciting technology. Why don’t we start by you telling us a bit about your background because it’s pretty impressive. I’m excited to speak about what OCU-COOL is and what you do. But why don’t you tell us a bit more about how you got here and, how you started the company.

Gun-ho Kim: I am an engineer. My background is in science and engineering. From 2008 to 2013, my research focus was understanding heat transfer in organic materials, including polymers, and also tissue and cells. I also focus on the very high-profile technology, thermoelectric cooling. Thermoelectric cooling is an expensive technology. But it could be very high-performing and precise, which is ideal for medical purpose cooling.

When I did some research about that, I had the opportunity to collaborate with a biologist and a retina specialist. I realized this cooling technology, especially the precision cooling, could be very helpful for the medical community. I talked with medical doctors in different disciplines like, dermatology and also internal medicine. I realized medical cooling had not been very well explored. Even with its huge impact on these communities. 

Andrew Brackin: The company is based in South Korea, right? 

Gun-ho Kim: I studied at the University of Michigan, where I finished a PhD. I worked with some US biologists, a global community, actually. I published some interesting papers in the heat transfer community, getting a lot of attention. That’s how I got some attention from different disciplines like biology, and the medical world. I had an opportunity to collaborate with them. 

After that, I had the opportunity to found a company in the USA. My former advisor, at the time, strongly recommended me to continue my academic research, given it’s potential. At the same time, he had graduated from MIT. He was a top student there. But, like many of his colleagues, who were students at the time had start-ups. It was not always an ideal outcome. [laughs]

So, I got a good offer from a research university in South Korea. They allowed me to start my company immediately. I’m very satisfied, because the South Koreans work really hard and their infrastructure is fantastic for manufacturing, high-tech, and high semiconductor technology.

ThermalTek is a solid state refrigerator. So semiconductor technology infrastructure is quite helpful to develop precision cooling based on ThermoTek cooling. So I’m very satisfied with working in Korea, having some R&D centers and a manufacturing facility in South Korea.

Andrew Brackin: So many devices have come out of South Korea. Obviously it’s very exciting that you took the risky path and started the company rather than continuing with academia. So far, it seems to be paying off. I know we’ve spoken a little bit about the technology, but talked about precision cooling for ophthalmology. It’s a new option for patients. Can you describe the current methods of anesthesia used for intravitreal injections? The limitations, like, why do you exist?

Gun-ho Kim: When I had the opportunity to work for an integrated specialist back in 2015, the first thing I realized was there are various methods of anesthesia. So for example, some kind of lidocaine, like lidocaine pre-injection, or lidocaine gel, or a topical drug using prilocaine. So they are different in terms of how they are instilled on the ocular surface.

However, they are identical in some sense that they all use a pharmacological agent. The principle and the basic science behind the pharmacological [00:05:00] anesthetic is the lidocaine molecules. They need to diffuse a neuron single transmission channel. They need to block it. It takes time to diffuse through a tissue cell. And usually, for organ tissue and the skin also, ranging anywhere between 5 to 10 minutes.

For sufficient anesthesia, or IVT, they are always similar in several minutes. From an IVT perspective, it’s a very busy clinic. Doctors need to do 30 to 100 injections in a single day. They cannot wait beside patient during that several minute onset of anesthesia. They need to do anesthesia, and then leave their patient alone, and come back later after several minutes and do the injection.

That causes some problems because they need to visit twice. And between that, they do other things. Visiting a patient a second time does not perfectly align with the onset of anesthesia. So, it’s complicated, logistically. The staff needs to manage their time sheet, like, every other room. For the patient, they need to wait in a operation room alone. There are papers that talk about the anxiety waiting for IVT, the level will be much higher.

Andrew Brackin: … It must be somewhat scary, waiting in a sense-

Gun-ho Kim: Yes, totally. [laughs] Of course. 

Andrew Brackin: … to give out, to get an injection in your eye.

Gun-ho Kim: Yeah, right.

Andrew Brackin: So yeah, that makes sense.

Gun-ho Kim: They know the injection’s coming [laughs] now. At the same time, if you have a long exposure time to anesthetic agent, like lidocaine, it has an acidic nature. So it’s obviously not as comfortable as our tears. A long exposure time to an anesthetic chemical, it’s not very ideal. So they can have an irritation. So minimizing that exposure time to all the chemicals is key to having a better post-IVT patient experience. .

Andrew Brackin: And obviously, we’ve spoke about this, but your alternative is precision cooling. Using your device to cool the eye prior to an injection. So, there’s not that waiting period, it’s very fast and efficient. Can you speak more to the device. It’s also a beautiful device, right? I’ve seen it. It’s-

Gun-ho Kim: Yeah, yeah, yeah.

Andrew Brackin: -It’s a really cool designed device. [laughing] 

Gun-ho Kim: I tried my best to make it as small as possible to maximize the view a physician has toward a patient’s eye. The cooling anesthesia, this OCU-COOL, the basic principle is the same. How to block that eye and channel pain receptor, by what means? In chemical anesthesia, they use a chemical molecule to block it. But ion conduction in some ocular solutions can be slowed down at low core temperatures.

 At the same time, the biomolecule, the protein, cannot function below certain temperatures. So not a chemical, but physical method of anesthesia. The question is how much time to take to reach that core temperature that blocks the stop circuit of the protein function that closes and opens the eye channel. For ocular tissue, it’s just several seconds up to 10 seconds. Which is quite significantly faster than the chemical anesthetic agent used for diffusing the eye channel. 

Andrew Brackin: And how long does it last? 

Gun-ho Kim: About 15 seconds.

Andrew Brackin: Yeah.

Gun-ho Kim: A 15-second time window. I’ve found from many retinal specialists that this is more than sufficient to injection. 

Andrew Brackin: Mm-hmm. You don’t have that six or seven minutes, the patient sitting there. The doctor’s off…

Gun-ho Kim: That’s a great question because it has one limitation. You need to inject as soon as possible, which actually aligns with what a retinal specialist wants.

Andrew Brackin: Right.

Gun-ho Kim: Because they have other injections they want to inject as soon as possible. At the same time, it gives some benefit to the patient because they don’t need to suffer from an awkward numbness after IVT. Your eye will feel normal, immediately after the physical anesthesia, within one minute.

That’s one benefit. That 10 seconds is far below the threshold a retina specialist can wait or not. A retina specialist can do anesthesia without leaving patient alone. They can do the injection right away. They can perform an injection and anesthesia at the same time during a single visit, removing the logistical headache.

It also makes the patient’s time in the operation room more minimal. From a practice viewpoint, we save space as a result having more patient purging time.

Andrew Brackin: These patients are obviously coming in pretty regularly, every few weeks, right? I’m not sure of the exact time frame. It’s obviously very challenging because retina specialists are incredibly busy, huge demand from patients with limited time that they have to do these injections. It sounds like your technology is really Going to both speed up the time frame for the retina specialist and offer a better experience to the patient.

Gun-ho Kim: Yeah, right. So interestingly, the number of IVTs is increasing. So, increasing number of aging population also diabetic patients. There are different medical conditions that could be treated by a potential drug pipeline under the surface. There are various drugs, like injectable drugs under the surface. We will have more injections coming in for several features. Having some options which can be much [00:10:00] faster than other standard pharmacology anesthetics could be really helpful for that busy retina practice.

Andrew Brackin: Absolutely. We’re incredibly excited to partner with Recens on the OCU-COOL Phase 3 clinical trial. It’s obviously a first of its kind. Can you talk about the potential impact on the industry from this trial?

Gun-ho Kim: If we are successful with this particular trial, many patients and the doctors can enjoy the benefits I just talked about. A better patient experience and also a fast workflow and less complicated logistics. As a matter of fact, this core temperature cryogenic substance has been very popular in the retina space. Cryosurgery is standard care to remove cancer cells.

 It will change the conception or impression for the cooling dramatically. Cooling is no longer dangerous for surgical purposes. It can be precise, and used for different purposes. 

Andrew Brackin: You are obviously working with some of the most prolific names in retina. I’ve been incredibly impressed by that. You were introduced to us by Arshad Khanani, who’s Dr. Arshad Khanani? He’s one of the biggest names in clinical research in retina. How did you convince these guys to work with you? It’s obviously hard. These people have a lot of projects going on.

Gun-ho Kim: I would say I was lucky. But, obviously, luck is not sufficient. I had a faculty position at a South Korean research university. They happened to have a collaborative relationship with UCSD. After founding my company, I was ready for clinical trials. Through their collaborative programs between two universities, I traveled to UCSD in San Diego.

Staying there, I interacted with a lot of professors. One of them was, Daniel Chow. He was a former professor at UCSD, a retina specialist. After talking and some meetings about a regulatory pathway, he was very genuinely excited with the technology.

 Because universities are not always a very ideal place to run the clinical trial in a speedy manner, he decided to connect me with some very prominent retina specialists in the country. Arshad Khanani and Charles Wykoff. I traveled to Reno, a beautiful city, of course, [laughs] and brought them my first prototype. That was not very pretty, actually.

You’re seeing the final version. At the time, it was a little bulky. But, the function and technology was identical. Arshad, an experienced retina specialist, immediately got the potential value of this technology. After a few weeks of him trying this device on actual patients, he got some great feedback. And, that’s how he convinced me we could finish a clinical trial within a few months.

And as a matter of fact at that time I had also great feedback from the chairman of a big center founded by Novartis in Basel, Switzerland. They said they were very interested and could introduce the technology to Europe. 

However, it would take one year to finish a Phase 1 clinical trial. I decided to start working with Arshad. Arshad was impressed. He opened his network, and introduced me to the other doctors. They saw the potential. I have been trying to be as genuine as possible with them. 

Andrew Brackin: Yeah, and I’m sure that, these are the kinds of folks you need giving you feedback, right? Given that, getting doctors on board with this device is going to be the most important question because at the end of the day, they’re the gatekeeper, and they’re going to decide whether or not they use your product.

Gun-ho Kim: What I realized from interacting with those retina specialists was, their top priority is to bring the best treatment option to patients. How I connected with very good doctors like Arshad Khanani, I believed I had something very meaningful to bring to our patients. The doctors also recognize that. That’s how I got a lot of interest and collaborative relationships with the retina specialists.

Andrew Brackin: Speaking about patients, you’ve obviously proven a great use case with your technology. We’re looking forward to seeing what the results look like from the Phase 3 trial that you’re running, and hopeful that will bring that new option and better experience to patients. What are you thinking in terms of expanding the applications of this technology? Maybe let’s start there, and then I’d love to understand a little more on the commercialization side. 

Gun-ho Kim: That actually connects to our first question. If I see only one possibility for OCU-COOL, or this cooling technology being used for only one single product, then I would choose to be on some a scientific advisory board for some other company and a director of research. But what I realize is it was not unique to only the ocular or thermic space, but also other medical disciplines.

They actually have been using cold temperatures for decades. Primarily for surgical purposes to remove a lesion or cancer from skin or an internal organ. Some doctors, who are very familiar and skilled with the cryogenic substance, cryosurgery, they’ll adjust the distance from the skin judging from an ice flake [00:15:00] formation at the surface and, from their experience, control qualitatively the temperature, so it does not destroy cells.

But, I’m generating other effects. One is a nerve suppressing transmission anesthesia, and the other is suppressing unnecessary immunoresponse in autoimmune diseases and also, inflammatory treatment.

After many papers, I realized, “Oh, this could have a broad impact.” At the same time, those papers didn’t provide a quantitative cooling condition. What temperature is needed to produce a reliable clinical effect? And that’s the moment. Okay, so this is more worthwhile enough to, suffer [laughs] running and founding a startup company. So it’s tons of work, but it’s worthwhile.

We already launched a product for the dermatology space called Target Cool for injectable procedures. At first, my focus is anesthetic clinical effect, OCU-COOL and TargetCool. We have great clinical evidence for anti-inflammatory treatment, such as atopic dermatitis and seborrheic dermatitis, and acne. Those are our clinical pipelines under surface is very useful core for temperatures, and expanding to internal organ also. That is my vision for Recens Medical.

Andrew Brackin: That’s awesome. Final question here. It’s obviously incredibly hard to even get to where you are today. You’re running a Phase 3 clinical trial. You’ve developed this device. It’s ready for doctors to use to start helping patients. What do you think the future looks like in terms of commercialization? You’re obviously a startup. How are you thinking about that? How are you going to get this product in the hands of thousands of doctors around the world?

Gun-ho Kim: Because we are already commercialized the target core dermatology product that we know, what the challenges and some barriers are to deliver a good product to actual customers. We have done a direct sales model. We have tried a strategic partnership with our distributor. We have some idea. Target Cool has been launched successfully in other parts of the world. Outside USA, Europe, Italy, England, Germany, and Southern Asia and South Korea.

I have a strong stretch partner, distributor, and delivery of this product to the customer. We expect a similar thing could happen for OCU-COOL in the US market also we have approval and a distributor not only had this dermatology product, but also an authermic product. So they already are showing their interest to distribute OCU-COOL in their territory. So I think there is a very straightforward way to deliver this product to the actual market.

Andrew Brackin: I know you’re making a big splash in the world of retina. We’ve spoken about the benefits of the product, and so I think those benefits really will stand on their own. I imagine there’ll be a lot of demand from doctors once we get more data from this Phase 3 trial.

Gun-ho Kim: Under the possibilities of dermatology and the dual-cycle market is that the number of doctors is really large. It’s tens of thousands. But retina specialists, the communities are a little bit smaller, so maybe we can do a direct sales model. 

Andrew Brackin: Yeah, exactly. No doubt. We’ve spent a lot of time in dermatology, as you know, so there’s a lot of opportunity.

Gun-ho Kim: Obviously, I will love to start another clinical trial with you.

Andrew Brackin: Let’s get that signed up right now. It’s very exciting. I know our team is thrilled to be working on this Phase 3 trial. There are lots of really great sights involved, and so I think it’s going to be, it’s exciting to get it off the ground in the coming weeks.

Gun-ho Kim: Yeah. Essentially, I agree with your vision. I need to see how it is executed in an actual clinical trial, but your vision is right. It’s combining every component of a clinical trial in a single platform and making not only a sponsor, but also they get some side job as easier as possible. So I think I agree with that platform ‘s ideal vision. Let’s execute it in the very best way.

Andrew Brackin: Let’s do it well. Yes, no doubt. Maybe we can have you back on hopefully, when you have a small business update. You can give us a great testimonial and just speak about the amazing experience you had working with our team. 

Gun-ho Kim: Yeah, obviously, that’s how it has happened with me, Arshad, and Charlie, and other doctors and dermatologists in other parts of the world. We are working on something valuable for communities. If we have successful then we all deserve the great feedback.

Andrew Brackin: Absolutely. Well, thanks so much, Gun-Ho. I really enjoyed this conversation. I think, obviously, you got an incredibly innovative product, so congratulations for the work so far.

Gun-ho Kim: Congratulations for you also. [laughs]

Andrew Brackin: Thank you. All right, have a great day.

Gun-ho Kim: Yeah, thank you. Thanks. Bye.

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