Join Next LSI Event

Join Now

LSI Europe '24 Summit

Filling Fast

Peter Stebbins, Nurami Medical - Soft Tissue Repair Technologies | LSI Europe '22

Speakers

Peter Stebbins

Executive Chair of the Board, Nurami Medical
Read Biography
The company's flagship product, ArtiFascia, is a synthetic dural graft intended to facilitate the healing of the dura after cranial neurosurgery by creating an effective barrier that prevents harmful CSF leaks in dura repairs.

Transcription

Peter Stebbins  0:06  

Right. So infections, leaks, fistulas sepsis, dehiscence reduce. These are things that keep surgeons up at night. Nurami Medical is here to finally, modernize tissue repair to eliminate the countless complications and eliminate those sleepless nights. I'm Peter Stebbins, I'm thrilled to present on behalf of the Nurami board. And I'm just going to start with a summary for you investors of why this is such a great company based on my experience at j&j, looking hundreds of companies from an m&a perspective in which addc from investors perspective. It's a big market, and it's a still a surgeon decision market. It is a technology which is very much differentiable from others. And also, as you'll see, is very superior to others. The third is the team, the team, the brilliant team actually has the IP and the brainpower to develop not just the first product, but go on and to build a real platform for a long time. The other thing I'd say is it's they're not trying to swim upstream, right? They don't, it's not going to be situation they need new new CPT code, they don't need to do business plan new sales force, it is it isn't in a sweet spot. And the the surgeons, their life's going to be easier. And finally, the economics, the economics work well for everybody, it's fully reimbursed. It's a less expensive and faster time, and the manufacturing costs is low. And then finally, from the perspective, a lot of discussion this week about the the fourth and fifth tee of of timing and terms, the business has made a lot of progress and made it all the way through to make the really the first big breakthrough in this area and 20 years, all the way through essentially us approval and a randomized patient study with 90 patients on about $10 million in equity. So they made a lot of a lot of progress. And this team again, I want to just talk about the team a little bit in Nora and Amir. They had met when they were working on a hemostasis project. And they started Nurami when they talked to neurosurgery said, I don't really have hemostasis problems, I worry about leaks. And so let's talk about leaks. And leaks are you know, if there's failures, it can be a really big issue. And two places in the body their precious liquids that could cause problems. One is CSF. And the other is pancreatic juices. And by targeting those areas, Nurami is able to go after the initial area is going to be at about a billion dollar market. And then overall from their portfolio of tissue engineering expertise. And throughout the body, it's probably more of a eight or $10 billion Tam. So what does surgeons want? So surgeons, they want something's easy to use, they don't want to make it hard. They want to make their job easier. They want to have good tissue in growth. They want the patients to do better in the short term in the long term. And they want to deal with leaks, leaks, especially the leaks like that you get with a with a suture line where every time the needle is always bigger than the sutures, there's always a chance of a leak. So what is Nurami doing in this space, really what Nurami is is bringing from the from the Technion some some cutting edge tissue engineering, technology and brainpower. And I put in two buckets. One is on the novel adhesives and sealant formulations and the other is on the nanofiber it's actually kind of interesting how under under penetrated nanofibers are in the medical device space, I think there's a lot of lot of benefit from going on there. And then the magic that Nurami brings to besides having two great products is how they combine them together. As you can see in our product pipeline. The first product is a self sealing Dural substitute colada fascia. The second is artifacts, which is again self sealing, but adds an adhesive layer to allow for easier attachment and especially interesting in areas like the spine where you really don't want to be suturing and the neural fiber acts which has been developed to to handle whatever the pancreas has to can can can consent our way. And so let's start with the first area. So dura mater means tough mater. So the dura mater working with CSF protects your brain, you have trauma or surgery, you need to replace that. And how it's been replaced in the past is basic and Allah graft basically a surgeon will have to take a bit out of the leg and place it there. And then the first wave of commercial products coming into the space, whereas even collagen and synthetic graphs, and they had some advantages and disadvantages and some leading surgeons still do autographs. But then they had one of the issues of those graphs is they still had leakage problems because they were very porous. So liquid sealants came in spray sealants on top of that. And so what Nurami is looking to do is say let's, let's take the best of the learnings from that and come up with a portfolio of products that address that. And so the first product is Artafacia. And what they've done here is combining you really sent you this really nice matrix of nanofibers with a sealant. I like to think about it as a as a jam sandwich. So basically, you have two thin slices of nanofibers that look just like dura so grows into it. And then the gym is this gel like sealant that is in every single patient. So the benefit of every patient getting a sealant and then also, it activates, like a gasket around those rumbo suture holes. So one of the biggest areas of leaks and perception of leaks is around those needle holes. And that is automatically dealt with by this by this product on the company's. As you can see, it looks like the native structure and ACN histology does quite well and much more rapidly than the than the standard of care. It has good growth. And based on that we were able to do a 90 patient study, which was randomized two to one, very quickly enrolled during COVID. And very successfully did that. And also got very good feedback from from the surgeons, here's an example of one of the surgeons like hey, once it's available, we'll go and again, having been has been for a long time, it's important for surgeons to feel like oh, it's gonna be better for my patient. But also, this is something that's going to make my life just better and I want to go to it. I'll give you a quick sneak peek at the studies, we just, we're still in the middle of putting together our FDA filing for the first 510 K this study was a non inferiority trial, but we're still very excited about it. As you can see, there was you know, more issues on the control side than the arta fascia. And I would note that the the two things which are the primary endpoints for this trial was CSF, fistula and pseudo manager seal. And the other thing I'd note on this is the fact that the again, statistically, the doctor really liked the product compared to using this these bovine collagen sponges, which are about six times as thick, and then you have to wet them, and they're really hard, hard to handle and you suit you remember, it becomes a mess. So happy about that bottom line, it's a better product for the surgeons, better for the hospital and better for the patients. But as we learned this week, and we always know being better, doesn't mean you can get to get sold can't get it approved. So market access is important, we feel really good about what we're what's going on here, we've got Artafascia, which is pretty far down the path we have next two products will both be PMAs. But both breakthrough devices, because there really is nothing else for that space. And it's reimburse, hardily reimbursed. So we have a lot of pricing flexibility and a good GP. So you think about you know, coming into this market with a platform or products with high GP and the BioSurgery space records are a lot of players in this space. And they liked BioSurgery because it allows them to, again, sell to surgeons, they get to choose things, these are things where, you know, it's one of the rare things where they actually get to choose like, hey, I want that particular product. And as you can see here, they have a number of good exits in this space. So, you know, we feel really happy about all the progress that the team has made. You know, on the left hand side, you'll see they've they've done an awful lot on you know, very capital efficient arrays, but 10 million of equity and, and some funding from Israeli government. And we'll be able to start commercializing next year. And but at the same time, we're looking now we're starting to fundraise. So we're looking for about $15 million. Erie two I think was here before from Amanda was our, our primary elite investor and in the series A and we're excited about taking that. And really taking that next step because we're going to be out in the market working at Johns Hopkins Brigham and Women's then Northwell is already kind of lined up for for sites in the US to go and we'll ramp up from there and then also move along and the rest of our pipeline. We have a pre pre ind meeting with the with the FDA on our artifix product next week or two weeks from now. And if you want to come on a journey, we'd love to have you. It's going to be a lot of fun and it's really going to be a great opportunity to invest with us and to help patients for a long time. Thank you

 

LSI USA '24 is filling fast. Secure your spot today to join Medtech and Healthtech leaders in Dana Point.

JOIN US TODAY

Share this video

Companies We Work With