Serafina: Hi, I’m Serafina and we’re at Angel MD’s Alpha Conference over in Napa, California, where I’m joined by Mr. Greg King, CEO of Fibralign.  Greg, thank you so much for joining us today. We really appreciate having you on the show.

Greg: Thank you. I appreciate it.

Serafina: Let’s dig right into the technology. Your group has developed a novel technology. Tell me a little more about then the application of it.

Greg: So, the fundamental technology is we have a way of developing a bioscaffold using collagen, a purified collagen, and actually putting it back into native structure forms. We get a liquid form and work in liquid crystal properties we can create a tissue structure that precisely mimic human tissue down to the nanostructure level.  So, as a platform technology it’s actually taking tissue engineering that’s been around for decades and doing a new twist to that. From that, we started looking at applications where we could apply that, and we’re really focused on treating major medical needs, and that brought us to lymphedema.

Serafina: So, tell me a little about where this technology emerges from. Has this been around in different kinds of industries? Who else is leveraging this unique mechanism?

Greg: So, some of the work comes out of liquid crystal science, or liquid crystal materials development from the LCD industry, and some of the co-founders and I were actually involved in an earlier LCD business that was working with optical materials. The co-founders, actually the one that went to Stanford and started working on some biomaterials applications and found that this actually was translatable to that. So, it actually kind of spun out of Stanford into a startup focused on biomaterials.

Serafina: And you guys have been around since…?

Greg: Since 2007, but the first five or six years have really been just deep research work. This is a whole new pivot from going from LCD to another field, so because of that it was important to get the IP and get some of the proof of concepts worked out first. It was really a lean team, and still is a lean team, but was an extremely lean team just working with collaborators and getting the IP in place. We got more of a commercial focus about three years ago.

Serafina: So, from what I understand, you guys have a pretty robust IP pipeline. Is that true? What are we up to by now?

Greg: Seventeen or eighteen patents now. We have another thirteen or fourteen in the pipeline, as well, too.

Serafina: And it’s not just the IP pipeline. You guys also have a pretty novel manufacturing process. Can we hear a little bit more about that?

Greg: Yeah, so it’s, again, it’s taking advantage of the liquid crystal properties but it’s analogous to 3D printing. It’s not exactly 3D printing but it has this kind of repeatability and scalability as a 3D printer does. So, it’s a computer-controlled process for essentially printing very precise membranes from liquid collagen. All of the equipment and tools were developed by our team. We have an end to end process in place to get to 510(k), to get to CE Marking which we are applying for. We had to get all the production process and all the documentation down to the nitty gritty.

Serafina: Everything that comes with the territory of—

Greg: So, all that stuff has been documented. We are getting ready now to submit for a CE Mark now, but we just finished up the ISO 13485 review, so we are waiting on the certification for that.

Serafina: So, you’ve got safety and efficacy studies out of the way and we’re moving towards—

Greg: We’re now doing clinical phase for lymphedema where we did an initial pilot study in the Dominican Republic with a cancer hospital located there with eight women who had breast cancer, lymphedema, and that went really well. The safety data from that is being used for our CE Mark application. Importantly, we started a study at Stanford that is going to be a multi-site study of women who have breast cancer related lymphedema. There’s a surgical procedure that’s done right now that’s called lymph node transfer that is a way of taking an autologous lymph node and transplanting it to the region—

Serafina: Right, you were talking about current treatment and the standard of care for lymphedema, so let’s circle back around that. There’s one that’s a really antiquated way of therapy, which you’re describing right now which is pretty extreme.

Greg: Yeah, so most of the treatment that has been historically instilled today is really just doing compression, or what they consider conservative management.  So, wearing compression sleeves, or wraps; using the physical therapy to try to physically push the fluid out of the affected limb and hope that it gets collected by another lymphatic region. It does a pretty good job of minimizing the complications that occur with that, but it doesn’t actually treat the disease itself. It can take a couple hours, or a few hours a day to manage that process for some patients. It has kind of a diminishing return over time. The problem is you can get fibrosis and other issues if you don’t really tend to it well. So, there are some surgical approaches that have been developed.

Greg: One that I mentioned in the presentation was a lymph node transfer, and I was just talking about where it’s taking an autologous lymph node and transplanting it into the region, reattaching it vascularly.  And that’s gotten very popular in the last five or six years.  Microsurgeons are doing that, and it can get some pretty dramatic results for them, but also there’s a lot of ones that don’t have a very strong response to it, too. So, what we’re doing in the clinical studies, we’re taking that as the gold standard lymph node transfer. One group is getting that done by itself and then another group that we’re doing will have that with BioBridge, and we’re going to see whether we can help with this kind of missing link.  We can attach the blood vessel; the lymphatic vessels are so small that they can’t attach to those. Hopefully with this new lymph node (Serafina: The scaffolding device is what’s going to—) that it’s going to bridge across it. So, that’s the idea behind it.

Serafina: Hence the name, BioBridge.

Greg: So, we just recently received an NIH grant of three million dollars that is a three-year grant. We are going to use half of that to actually fund the clinical studies.

Serafina: Execute the study that you just described. That’s awesome.

Greg: We’re talking to additional sites now, so we’re going to have probably three total sites going forward, but Stanford is the lead site on that.

Serafina: You just described the NIH interests in the technology, but there’s also DOD interests.

Greg: That’s right.

Serafina: Tell me about that.

Greg: DOD has funded a number of development projects. Lymphedema funding originally started from the DOD before we moved over to NIH for the clinical stage.  They’ve also been very interested in using it for war fighters that have issues with muscle loss and muscle trauma. We actually have a phase II SBIR grant that we did with the VA and with Stanford on using it with modified Messenger RNA and actually seeing the scaffold with that and using it as a localized delivery for this. So, It’s a combination device. The scaffold helps with vessel formation and it’s also delivering a drug therapy to essentially encourage the formation of new vessels too. We just finished up the phase II grant, we just did a large animal study that we just completed so we are still in the process of reviewing the data from that. Already the DOD is asking us to put a proposal together to take it to a GMP phase.

Serafina: Wow, so quite accelerated.

Greg: So, we’re looking for some additional funding for it as well. Yeah, it’s been pretty well received, so that’s pretty exciting. It’s a little more of a involved process because that’s actually a whole drug approval process.

Serafina: Yeah. That would be a different regulatory pathway all together, right?

Greg: Different regulatory pathway, and we—

Serafina: How is it treated? Is it a device?

Greg: It’d be treated as a new drug, so it would have to go through three phases. But in that case, we would work with partners and look at having a partner kind of take it those stages forward.

Serafina: Speaking of partners, who are you interested in partnering with, or what kinds of partners are you keen on?

Greg: Because it’s a platform, we’re looking for people that can actually help us to take some of these products to the market and take it effectively, and we’re very bullish about that. So, in some cases we’re looking for people that may already be in the market for some of the reasons we’re looking at, like at some of the applications we’re looking at. And we’re looking at potential acquisition opportunities as well.

Serafina: So, throughout our conversation today, I completely neglected to mention that I have the device in my hand right now. So, explain to me what I’m looking at here.

Greg: So, this is BioBridge. I’ll just pick it up. It looks a bit like a suture or dental floss, but it’s really a collagen scaffold that’s made from a very thin membrane that we’ve printed using this technology that we developed for assembling a matrix, and then collapses into a thread. So, what’s inside this is actually a nanostructure that’s been optimized for forming new vessels. That took a few years of optimization of pre-clinical studies with Stanford to kind of tweak and modify that.

Serafina: Many and many iterations later we have this.

Greg: But it’s been optimized specifically for endothelial cells to form new vessels. So, both blood vessels and lymphatic vessels. In the large animal studies we did with histology show that right along the scaffold, new vessels form. If you get even a couple of millimeters away from the scaffold you don’t see these new vessels.  So, it’s very specific toward the scaffold to elicit the cell response that we want. So, it’s not a bypass, but it’s a temporary scaffold these new vessels form on, and then it gets absorbed over time.

Serafina: You say temporary, so from a pharmacokinetic perspective, how long does this stay in the human body?

Greg: So, it kind of depends on the application, and we can tune it for that. In the case of lymphedema, we want it there for about six to nine months so the amount of cross linking we do assures to stay there for that time period. But then it gets totally absorbed after that. So, it’s nice. It’s this one surgery, you put this in subcutaneously, and then the new vessels form across that.

Serafina: Very cool. Well, thank you so much for the explanation and the education. We really enjoyed having you on our show today. Once again, that was Greg King of Fibralign, over at the Alpha Conference in Napa, California.