Bill Niland Presents ReGelTec at LSI Europe '23

ReGelTec, Inc. is a clinical stage medical device company developing the next generation of interventional spinal implants for chronic lower back pain due to degenerative disc disease.
Bill Niland
Bill Niland
CEO, ReGelTec



Bill Niland  0:05  
ReGelTec is transforming the treatment of chronic low back pain caused by degenerative disc disease, which is a very large market in the United States and around the world. We have an experienced cross functional team. They've been with me on three days, most of them bear with me on three different startups. percutaneous procedure this is we have excellent one and two year outcomes. Our early patients that we did in 2020 are just starting to get it through your outcomes. So we're really good clinical data out out for a long time. We have a broad IP portfolio with perfection protection at 2039. We are a breakthrough device. And we just had our IDE approved our pivotal trial ready to go in the United States. Again, we have a really experienced cross functional team that's been with many of us a lot of exit between the team clinical advisory team, some of the top orthopedic surgeon, Pierce nunley, Doug Beale, interventional radiology, Kazama dolphin interventional pain and Tom Shear was our animal doctor at the University of Pennsylvania's new Bolton center. Hydrophilic is our product tighter fills a hydrogel made of common polymers PVA, PvP and peg. It's very small amounts mixed fairly tight with also a little bit of barrier minutes. So we can watch it you can watch it flow in you can see it as you do follow ups and one year, two year three years, it's always going to be there and you'd be able to see the barrier and when you do Xrays and CAT scans, we heat the gel up in the morning before the procedure using the steam sterilization process. We want to melt the gel so the gel was melted and can flow down 17 gauge needle it's about seven inches long. The job warms up to about 65. See when it goes down the needle about 55 C and for the disc. So it flows in like a glue. We're doing an augmentation so we're not cleaning the nucleolus out first we're just augmenting what's still left in the nucleolus. This will take place in by interventional radiologist or an interventional pain doctor probably in an ambulatory care setting is where most of these will will take place. It's a quick procedure patients usually go home in two or three hours they're walked out. Just getting prepped the procedure itself is probably 15 to 20 minutes by the time the needle was in the longest part about the procedure is getting the needle placed accurately under fluoro. And then once the needle is put in, the gel goes in pretty quickly. wanted to go back in the bottom over there, you'll see grades one through four in the left hand side grade five through six. This is the Fierman scale of degenerative disc disease, the white are well hydrated discs. So those are good discs in grade one and two. As you can see the white starts going away as you come down to grade three and four. Most of our patients we'll see in a little bit, but our sweet spot is four to eight. When you get down to eight, they call them flat black desks, there's really nothing left. Most of those once you get down to grade five and grade grade through eighth, there's not a lot left in the desk anymore. It's just a gray matter material. There's not a lot of vascularization at that point. And these patients are just suffering on a day to day basis. We think right now there's a treatment gap. And you know, other people are working on things too for this because it's such a big market and treatment gap. Most of these patients are doing physical therapy exercise, they're getting a lot of repeat multiple injections into the disk or into the epidural space. Taking pain medications. A lot of opioids though with this patient population. And you know, to the far right is fusion, which really does not have a good success rate of relieving pain in these patients. It's good if there's instability in the spine, but not just for the pain relief in this patient population. Spinal cord stimulators are coming into play, they take the pain away, but they don't really support the spine or do anything. And then disc replacement which is coming very good in the cervical area still is slow to pick up and very expensive in the lumbar area. We believe hydrophilic will fit kind of in the middle between these we don't eliminate going to fusion or any of the things on the right. If ours works, it's great. And hopefully we can fend off every other invasive surgeries along recoveries that go along with it as a very large patient population. 6.8 million patients are treated are out there. worldwide. The total addressable market for our product is probably two to $3 billion. We have great clinical data like I said, we've done we did two cohorts in Colombia during the pandemic. We did 20 Each cohort has 20 patients in it. As you can see the levels treated mainly in the low back l four l five l five s one, L three L for the modified Fairmined scale again, most of the patients are in grade in grade four to grade eight, which was kind of our sweet spot on this, we moved and started a feasibility trial in Canada and Calgary, Canada at a pain center with a interventional radiologist. And we've done 20 patients in our phase three and we've a lot of learnings from our first two cohorts to the second two cohorts, and I'll go over there, but these are patients the white is the is the implant and you can see the 30 day flexion This is the same patient at 30 days in 180 days, you can see when they flex and they bend, how the gel kind of stays and moves with the patient in both of these at the same time. This is a six month follow up this is live X ray I wonder why it didn't move. It's supposed to move, but it's not moving. Alright, as it got again, you can see this is the dual patient, l four l five and o five s one. You can see the white is our implant in that patient. This normally moves but it's not moving right now. Patient satisfaction how satisfied you are with the outcome of your procedure. As you can see the green the dark green and the light green add up in the 90%. For all of these patients, they're either very satisfied or satisfied with the procedure. Id ODI by cohort, ODI is the scale of disability in these patients you can see they start off with a very high disability rate not being able to do much walk sit for any period of time, hour to 24 months with this patient population we have a dramatic result drop. Also NRS is pain score on a one to 10 Patients are starting with over seven on a one to 10 on a daily basis. And you can see how far down they've dropped on this at the same time. This is a patient paid patient so each line is a patient and you can see how much we've had reduction in ODI one year and reduction in our scores at one year to the key learnings combining discographie with MRI. These patients have fissures and they have tears in the annulus the gel comes in like a glue it runs in if they have too large of a terror too large of a fissure their gel is going to run out of the annulus we learn this and the first set of patients in Colombia. So we need to do a discography first, during discography, we inject the dye into the disc. And we want to see if that dye stays in place. So we're looking for an intact annulus for these patients who want the dye to stay in place on that. And then we know usually this procedure is done about a week to two weeks ahead of time. We also learned with our device has three ml's of gel in it, that implanting one to one and a half cc's of gel is just as good as implanting three cc's of gel for pain relief. So we've learned that with those patients and we get less amount of pressure in the desk and less amount of gel kind of moving out and migrating out of the desk. We also learned that we need our patients to stay still, because the gel is still setting up as you get down to body temperatures when the gel sets up and because one becomes one large mass. Remember we're melting it and we're melting it it goes down the needle into the disc. And then it needs time to get down to body temperature and then it sets back into one large mask in the dislike you saw on the Xrays before when we have had problems in the first 20 patients when we weren't doing discographies first we did have some patients that needed some of the gel removed because it came out into the space posterior really was causing me the leg pain but we learned that it can easily be removed within an endoscopy like nn scopic discovery discographie procedure and we can take that out and the patients are all doing great today. We did recently get our pivotal trial approved. It's a single dual level patients with chronic low back pain for six months due to degenerative disc disease with grades four to eight, 225 patients blinded randomizing two to one so two patients every two patients will get HydraFill, one patient won't. It's a needle prick for the end conservative care for the blinded group responder analysis of a composite endpoint including 15% reduction, ODI, which is standard with the FDA freedom from device and procedure SSEs and SSRIs. We don't want any of the group to have a lot of injections or increased opioid medications. We don't have any injections within 45 days on the final endpoint and freedom from Joe extravasation, causing mild stenosis. We've raised $16 million to date, we still have about $3 million in the bank. Our average burn is about $300,000 a month. And to do the trial in the US it's going to run us about $25 million We expect to finish that financing by the end of this year and start the pivotal trial early in q1 of 2024. We'll have the one year follow up on all these patients is the milestone to get the one year follow up on all the patients PMA submitted to the FDA. We expect also to have CE mark and q1 of 2024. We've submitted our dossier it's been in for about six months so far. We've got some clinical questions. We've answered those, but we expect CE mark very soon. Thanks

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