Lode Debrabandere Presents Amynas at LSI USA '23

Transcription

Lode Debrabandere  0:05  

My name is Lode Debrabandere and I'm the co founder and CEO of Amynas and Amynas, what we try to do is we improve patient outcomes after medical device implementations. So, what is there to improve? picture tells 1000 words, you can see what can go wrong. When you implant a medical device, you have encapsulation, you have device erosion, you have migration, you have infections, biofilm formations, especially the infections and biofilm formation are serious and costly complications in about 6% of cases, have one or more of these complications. infections or like I said, are costly and or difficult to treat, you have to get readmitted to the hospital. You got to get you know, lengthy treatments with antibiotics. Sometimes you get resistance against those antibiotics, so you gotta get another treatment course you get revision surgeries involved. And it's it's life threatening. One out of five patients that comes into the hospital with a hospital acquired infection will die in 12 months. So, you know, there's something that needs to be done about these complications. The market that we are focusing on right now with aminos is especially cardiovascular devices, pacemakers, defibrillators as well as neuro stimulatory devices and later on, we're going to breast implants, pain modulators, etc. The leader in the market today as Medtronic, they have a implantable antibiotic coded envelope, which is called tyre X. And today in the United States, about one out of two of Medtronic says pacemakers is wrapped into such an envelope. This envelope has demonstrated to be anti infective and reduce hospital readmissions, about 300,000 of these envelopes are currently being implanted, bundled together with pacemakers. It's about $1,000 per envelopes about $300 million revenue. Interestingly enough, Medtronic is the only one that has a enveloppe. It's not the only manufacturer you have, you know, able to have Boston, your Biotronic and a couple of other smaller players, none of them has access to such an envelope. So there's definitely an unmet need there. TRX is about seven years on the market. Pretty old technology, what we bring to the table is a brand new technologies called nanofiber electrospinning. And then if I would like to spinnin is perfectly suited to to address this unmet need. And why is that for two reasons. The first reason is that nanofiber electrospinning is a technology that allows you to mimic what we call Healthy micro architecture structure of healthy ECM. ECM is our own kind of tissue structure. So our own kind of scaffold that our endogenous stem cells used to adhere to proliferate, to differentiate to regenerate new tissue. So we mimic that by having the same porosity, same nanometre range, fiber, same densities in thickness, etc. So when you slide a pacemaker into such an envelope, what you basically do is you fool the body, and the body does not recognize this pacemaker as foreign. So you get a lot less scar tissue formation a lot this encapsulation. The second reason why this technology is particularly interesting is, you know, these fibers, because of their nanometer range have a huge surface to volume area. There's millions of fibers, they have a capacity to incorporate drugs, in this case on some microbials. So we can actually incorporate drugs into these biodegradable fibers and we can tweak the speed of biodegradability to whatever purpose whatever desired kinetics release we aim for. So there are two main reasons why this technology is so well suited for developing these anti infective, pro regenerative envelopes. What does the competitive landscape look like? It's pretty straightforward. Like I mentioned, there's only one player and now it's Tyrex, three others are in development. aminos is the only one that besides pro regenerative capabilities, which directs does not have also has the ability to with optimal kinetics to drop basically, antibiotics into that particular micro environment post surgery. We have a technology as the only one that also tackles the biofilm formation around the pacemakers. We'll talk to them about that in a minute. So how are we doing this? We create these electrospun nanofiber envelopes these constructs in multiple layers. And so one layer is the core layer is this protein generative layer, which biodegrades in 14 to 16 weeks, which is perfectly synced, right via the grid by the degradability is perfectly synced with weight of T Shoot engraved, so you create a healthy tissue around the pacemaker. We have also a second layer on top of that core layer that is different in terms of its composition different in terms of its kind of fiber density, fiber diameters, that is tweaked to have optimal kinetics. For the drug release, you know, in this particular case, you want to have all your antibiotics, dumped into that microenvironment in seven days, you don't want to have a tail end. And you want to have a potent efficacy from 30 minutes after surgery. And lastly, you know, we licensed in technology from our academic partner that has been worked for last 15 years on identifying a family of compounds. And it's a two amino imidazole structure, and have been designed to inhibit the gene of bacteria and their capability to make those biofilms. So this inhibition of that particular gene inhibits the bacteria to manufacture to produce polysaccharides, which are the core ingredients of their slime layer, biofilm. And so we inhibit that. Due to this unique mechanism of action, we have already demonstrated that these bacteria cannot develop resistance against this type of treatment. So that's a huge paradigm shift where we not only can kill the bacteria, but also we can prevent them from developing a biofilm which you know, long term can become really dangerous. So, where are we right now with the thing is going to be very interesting next 18 to 24 months. For aminos. What we have accomplished to date is we've finished the prototyping. We have de risked from a safety perspective, the polymers that we use in our electrospun constructs. We have also de risked the efficacy component we have in vivo, animal studies that were mandated by the FDA, we have executed those and have, you know, equivalents to Tigrex, which is what we aim for. We actually have some differentiations against higher legs, including better release kinetics, including being pro regenerative and creating healthy tissue around the pacemaker which starlings cannot do. We have started to collaborate with Namsa to execute the final regulatory experiments. This market is particularly interesting, and it's favorable. Because you have this 800 pound gorilla that has really, you know, set the stage and created this infection protection program that has identified that if you wrap your medical devices into a antibiotic containing releasing envelope, you actually reduce hospital readmissions for hospital acquired infections. And, you know, as a consequence of that, the awareness of the need to wrap your medical devices into these types of envelopes has increased dramatically. Moreover, tire x is actually also included now in the treatment guidelines of certain heart rhythm associations. So it is becoming a kind of must do more and more and a lot of physicians are now using these anti infective envelopes to rapid and medical devices. For us, as we now are done with the engineering and the research on the device that we will use to wrap in pacemakers. It's relatively easy to move into neuro stimulatory devices into other implants as well. The engineering is done, we basically have optimized the composition of it, the polymer selections, etc, etc. And so this allows us now as to use all of that work to expand into other indications. And lastly, I think the market needs a solution for this resistance development. When you get once you get back into the hospital. You know, you've lost so many patients develop resistance and an age predicts that in the next 25 years, people will die more from resistant bugs than from cancer. So it is an increasing nuclear bomb that needs to be addressed and we have a non resistance anti biofilm set of molecules that really are going to become paradigm shifting in that perspective. neuter milestones cassette next 18 months, we plan to submit our 510 K to the FDA with a antibiotic releasing envelope specifically for CI EDS. Shortly thereafter, we'll expand into neuro stimulatory devices and we are further advancing our pipeline and further getting you know further evidence of these anti biofilm capabilities that we will also include into the fibers of our constructs such that we have longer term protection on on biofilm formation. So the company is looking for $5 million. Right now we have raised today $3 million. We're looking at an additional 5 million that will allow us to get all the way to FDA approval and beyond, as well as advancing a pipeline to team. Both sides of the pond. We have engineering manufacturing in the United States. We have Microbiology in Belgium. I co founded the company with Dr. Jorge who is an interventional cardiologist in Belgium, who has helped us a lot with the design and the specific aspects of the target product profile of our envelope. And we have a team of capable engineers and microbiologists Thank you very much.