Kevin McGann, Accelus - Expandable Spinal Implant Technology | LSI USA '24

Kevin McGann  0:03  
Good afternoon, everyone, Kevin McGann, I'm the president and CEO of Accelus. We are a spinal implant company with differentiated technology. We're headquartered in Palm Beach Gardens, Florida, with an office right down the road as well in Carlsbad. So, our company, we're about six year old company. Our investment thesis serve really under underserved marketplace and spinal implants, superior technology, differentiated technology, we have a full pipeline of disruptive other technology as well that are going to be getting into. Right now we're about $30 million in annual revenue with a high growth rate and a very high margin product as well and led by a very experienced spinal leadership team. Really, again, for us spirit clinical outcomes, we have great data. We focus on a mis segment of the marketplace as well. So any of the data will show a minimally invasive, less tissue retraction, faster or time, faster recovery for the patients. And we are globally adopted as well. We are doing business in 23 international countries. And we see a greater increase adoption across the platform as well. We service the lumbar spinal fusion market, mostly degenerative we don't have anything for really deformity work, a very large market $5.3 billion in the US and a $3 billion opportunity for us again, internationally tailwinds for our company. Mis procedures. I mentioned endoscopic surgery, which is becoming more and more prevalent here in the US and is well advanced in some international countries, expandable cages, which is a very hot technology, globalist, for example, built their company initially on a first expandable called rise. In the US here as well. Many of these types of surgeries are moving from the hospital to an ambulatory surgery center. We fit incredibly well in that marketplace. And we're looking to take advantage of that trend. All navigated capability, robotic capability. Our technology is our primary product is called flare hawk. It's a Biplanar expandable implant, a titanium shim, that a titanium shell with a pink shell I'm sorry, pink shell with a titanium shim driven into it. Once it's past all the neural structures it goes in in a very small profile, and then expands both in width and height as well as our data Gangrel. The biggest difference with ours is that with expansion and height expansion, majority of the other expandables on our market are height only. And with a load bearing of the spine, you're putting a lot of stress and pressure on on the adjacent levels. Again, with the wide footprint, you're getting more support and stability and open architecture which allows for between 10 and 12 cc's of biologics or bone backfill, again mostly the competitive offerings in the marketplace that expansion mechanism as a mechanical mechanism located right in the center of the implant and therefore you can't get the backfill the portfolio itself right now for flair Hawk, we have three different sizes LaRock seven, all of these peak shells are through an ionization process bonded with titanium Firehawk. Seven is goes in the size of a number two pencil and let expand out to 11 millimeters which is the standard inner body that the biggest Medtronic Stryker Depew have began with getting past all the neural structures and then creating that expansion within this space. flyrock Nine is a nine millimeter insertion problem because a 14 Firehawk 11 is 11 millimeter insertion profile going out to 17 which again, is the largest posterior implant that you're going to find on the marketplace. And we have surgeons down in Texas actually putting bilateral elevens in and getting a 30 minute 34 millimeter footprint, which is equivalent to an anterior approach implant again, much more support and stability. Very unique about our implant as well. We've We've trademarked adaptive geometry, there's a little bit of play between that peak shell and a titanium shim. And what that allows, again, as load bearing becomes on the spine, you'll see the implant can form to the endplates. So again, based in science, we're getting much more surface contact area from the bone to the implant. You can see the tantalum markers there at the nose, you can see that they're not perfectly parallel. They're they're misaligned. So in essence, we're getting a customized implant per patient. We also have a full line of pedicle screws posterior fixation. We just launched our module of screws in January, which has was great optics so far. We have a cortical Oh Beyond mis screws, so full lineup posterior fixation as well as totally separate portfolio of Biplanar expandable implants is when we have a branded Toro our first offering is a lateral version, you'll see from the illustration here, we have a unique retractor as well, the same plant goes in again, in minimally invasive fashion, 14 millimeters in width will expand up to 24. Once it's in a disk space, we also have some very, very innovative disc prep. And as I mentioned the retractor, this this prep tool, his surgeons are amazed by it, it's almost like a snow angel, it goes into that space, you expand the wings, and then retract back all of that disc material or comes right back into the shaft of the of the instrument. And it's very, very fast, easy way to remove discs for the surgeons. Again, the implant follows the same thesis as our flower hawk. It goes in very small, you get with first so you provide for larger footprint and then the height and then the height and lordotic angle with the Toro brand is controlled by the surgeon. So a very, very simplistic mechanism. And again, with open architecture that allows for a lot of backfill with surgeons are very appreciative that being able to get that that high level rate of fusion. This also we have in the platform as well an anterior approach and a lift version, and a hyper lordotic posterior version, the ayliffe and posterior version, we'll be actually starting kicking off the design work here, beginning of q2, we expect to be able to launch these mid year next year, probably q3 of next year, we'll be launching these. And there's significant advantages for us as a company as well right now we focus in on a posterior approach. But it does get us into have a side here coming up as well to get us into the anterior as well as the lateral and again will make us a full line of spinal implant company. We've got great IP very, very well protected with IP, a long runway, Sony IP, numerous peer reviewed data. Very impressive data. We're in the process right now as well we are MDD CE marked approved. We're halfway through moving up to that the MDR process. And part of that requirement from from the European Union to get the CE mark under MDR. We have a very extensive study undergoing right now. interim data is very very positive relative to Fusion rates, as well as subsidence. Subsidence for spinal surgeon is very bad because for these degenerative procedures, your gets low back pain, your nerves are being compressed, you want to create that height back. And then again with with load bearing, if this if the implant starts to dig into the endplates, you're gonna get this shrinkage back of that neural cavity, which again is going to reduce it will add to more rehab type of procedures. As I mentioned, as as an organization, right now, we are primarily focused in a posterior market, as 58% of the surgeons practice when they're doing a lumbar case is done posteriorly. But the anterior and lateral approach is what we'll be getting into as well with very, very different differentiated technology, our competitors such as NuVasive, which really invented the lateral procedure, it's a static implant as well. So you're just going in and a larger with high profile or again, ours is going past all the normal anatomy and a similar fashion and getting that expansion in the safe space. So great opportunity for us again to expand our entire offering to our surgeons, additional opportunities for us as well. Our cervical size fixation as I mentioned, the ayliffe lateral and I'm going to touch on the endoscopic market as well. It's a rapidly growing marketplace here in the US, again with our flare Hawk seven. Having that ability to go down through a very small cannula with use of an endoscope is very unique in the industry as well. And so we're really taking advantage of that, that opportunity. The endoscopic market, as I mentioned is growing rapidly in the US. procedures have been moved also out to the ambulatory surgery center as I mentioned, and we again we played incredibly well in the fusion segment of endoscopic surgery. Any ASC or surgeon will tell you that that is the moneymaker. You know doing a fusion is actually going to be the word that better reimbursement both for the facility and for the surgeon. As I mentioned earlier as well, from the ambulatory surgery center market, the data shows and the trends are that there's more and more of these procedures will be moved to outpatient ambulatory surgery centers. Patients are there's minimal state or no state all in a hospital. We have some surgeons one out in Vail, Colorado, for example are doing a one EAC fusions, so the patient is an exercise but still conscious, and patients walking into the hospital three or four hours again, just speaking to the uniqueness of our implant, the minimally invasive nature of the implant, and then great great clinical data and post op outcomes. Our leadership team is very experienced in spinal industry, a Tronic. Striker, our chairman of the board is Alex Lukianoff. Alex was the original CEO of NuVasive, and brought that up to a billion dollar organization based down here in San Diego, recently acquired by Globus, which closed at the end of last year. So kind of in summary, we are the leader and expandable implants. really disruptive technology, and again, not only from the posterior space, but in the lateral and the anterior space as well. We have very, very high margins or cogs are very, very favorable, which allow us again to continue to reinvest back into our business. And then again, the segments of the market where the trends are really moving towards, into scopic, outpatient, the MIS procedures, we are play very, very well and in a very attractive in those markets. That's it, I really do appreciate everyone's time. As I mentioned, we're here we're down in the Palm Beach area, please feel free to come by and check us out. We have a cadaver lab, we train, generally about 250 to 275 surgeons a year or in our office. We have all the endo scopic capital equipment companies have donated their equipment to our facility. And so whether it's Dr. Max eloquence, Max more now Arthrex the big sports medicine companies is moving into spine for the first time in the endoscopic ASC setting. And so we're very pleased with that as well because their ability to train and market is is the best in the industry. And we again we compete very, very well in that space. So thank you all