Jeff O'Donnell, Jr. Presents Toetal Solutions at LSI USA ‘23

Transcription

Thank you for coming and I'm excited to tell you about total solutions. Toetal Solutions is the second portfolio company of a med tech accelerator called runway health care of which I'm also a general partner. Runway healthcare is looking to change the way venture capital works and taking idea stage companies. Putting a management team is shared management team and capital to work to take these ideas up into the FDA approval process and then transfer them out into existing commercial entities. So our intent is to not commercialize these products but rather create commercially ready opportunities for the market. Toetal Solutions is runway's second portfolio company, waypoint orthopedics is its first develops a smart pedicle probe for spinal surgery and Toetal Solutions has developed platform technology for joint fusion. Senior Leadership Team at Toetal Solutions includes multiple board members from runway healthcare as well as experienced leaders in orthopedics. We're very proud to have Bill Rhoda, Rich Brigantia, Tiffany Wetware on our on our leadership team, and Bill and I co founded Toetal. We are a surgeon led design team. So we believe that the folks that do the surgeries every day are the folks that should be telling us what they need. And so we're excited to have Dr. Romanski, Dr. Sundar with us as part of the process from inception. So what is hammertoe? I've heard that a couple of times this week. hammertoe is when the third fourth or or I'm sorry, the second third or fourth toe develops a rigid deformity in which it starts to point down. Once it does that, it will become rigid and the only solution at that point is surgery. That surgery. For that surgery, you perform an osteotomy in which you're opening the toe and a implant rigid implant is inserted into the PIPJ. Foot and Ankle has been a long ignored market in large orthopedics. In the last few years we've seen a big push in strategic orthopedics to continue to develop and attack this market. hammertoe is not alone in that market opportunity. So today that market is valued at two 288 million, and it's looking to grow at an impressive CAGR. Current designs in hammertoe and I apologize if if you're a little squeamish, but current designs in hammertoe have not yet met the clinical need. K wire is often used solution. But as you can see here in this picture, it doesn't do what is needed. Often that K wire will drift. It doesn't provide any active compression it doesn't prevent any rotation and there's an inherent infection risk of having that KY are exposed for six to eight weeks following surgery. Traditional nitinol implants which use the shape memory function of nitinol start to immediately expand once they're opened. And this puts an unnecessary amount of pressure and anxiety on the surgeon and the staff in the room as that shot clock starts. So Toetal Solutions we've designed this Ziptoe hammertoes system it's a fully disposable kit it features measured drills with stops on them K wire our implant is cannulated so you can attack the MTPJ after implantation which most implants do not enable. It comes preloaded on a disposable insertion tool. implant itself features anti rotation thins and deployable nitinol which eliminates the shot clock and provides really tremendous compression of the joint following implantation. So that traditional osteotomy is performed. Our drill bits are used or precisely measured for either side of the implant. The implant would be inserted into the proximal phalanx. Those times are deployed. You remove the implant from the inserter. Put your distal failings on top of the implant and then pull the ripcord deploying the other nine all times. So you see there you have those opposing times you get very nice compression of the joint itself so the hammertoes system again, it's a fully disposable kit. Because we are not using that cheap memory property of night No it's shelf stable. The deployable night no now allows from an inventory management standpoint. This to be on any shelf and ASC The most of these cases are performed. Furthermore, the disposable kit eliminates this long turnover time associated with trays and gives the the operating room the ability to do more cases in a day. We do have a zero and 10 degree planner implant. Often these cases, prefer the tend to replan or you can get a more aesthetic approach for those folks that want it. And then again, this is a cannulated implant. There are not any cannulated implants on the market today, so the ability to treat the MTPJ is capable with this. So while we are focused on the PIPJ, our intellectual property has really created a foundational fusion device here. So because of those deployable times and the way that nitinol works, we've sought and gained protection on applications outside of distal extremity, SI joint fusion AC joint fusion, long bone Arthurdesus. And a sports anchor for suture anchor for sports medicine as well. So being a runway health care company, there is not a a six bucket on this that says commercialize. We are approaching here in the second quarter an FDA 510 K submission. Following that submission and approval we'll look to transfer the entity of total solutions out into an existing strategic Foot and Ankle business. For more information on Runway health care what we are doing, we're Toetal Solutions. Please feel free to visit our site or talk to us in the back of the room. Thank you.