David Constantine, Juniper Biomedical - Precision Neuromodulation Micro-Implant | LSI USA '24

David Constantine  0:00  
Hi I'm David Constantine, CEO of Juniper Biomedical. I'm going to introduce you to a dramatic improvement in the treatment of urinary incontinence with a unique neuromodulation micro implant. 78 million women in the United States have urinary incontinence, you might be familiar with overactive bladder and stress incontinence. But you might not know that about a third of these patients have both. And there is no treatment for both both. The name of this is mixed urinary incontinence. Today, the care journey is actually split. So overactive bladder and stress incontinence are treated in two separate care journeys. And they look a lot alike. There's some similarities, but they're different treatments starts with behavior modification, physical therapy, maybe some medication, over the counter products, there are injections that provide temporary solutions. But really, we're really focused on the Advanced Care Options. So these are moderate to severe cases where for overactive bladder, you're talking about implantable neuromodulation, for stress incontinence, you're talking about mid urethral slings. But for mixed incontinence, a patient will get an initial diagnosis of mixed incontinence, and then the doctor will have to actually tease out, which is the dominant symptom type to then decide which of these major invasive implants they're going to, to offer their patient. These are generally anesthesia procedures. These are big impact and big surprise, most of the patients who are good candidates for these procedures, don't get them there. And one of the reasons is that they are unattractive to these patients as options, so they just accept their lot, which is really, really unfortunate, and we have something better. Our micro implant can treat both stress incontinence and overactive bladder separately, or together as mixed incontinence. So one implant, one procedure to long term battery powered micro implants, but half the size of the US diamond, it's getting smaller, it's coupled directly to a novel target nerve. It's put in under a minimally invasive 15 minute procedure under local anesthesia. In contrast to those other procedures that we described. This is designed to easily age dramatically and securely couple to that target nerve, the doctor will then set the therapy regimen for a personalized therapy. And at that point, the patient doesn't have to do anything on a day to day basis to receive therapy, it's an automatic delivery of energy, stimulating the nerve. And this is not a continuous stimulation. So the way that this works is we're going to a novel nerve target. And we're delivering two therapies. The first therapy you might be familiar with, because it's used in sacral, nerve stimulation, and tibial nerve stimulation, this is an afferent effect, meaning you're going back up toward the brain, you're stimulating a nerve, you're basically telling the brain to tell the bladder, the bladder to calm down, we also deliver a different therapy. And that different therapy different delivered in a different session, during a given day has an efferent effect downstream toward a target closure mechanism. This is actually targeting damage originally from childbirth, that actually breaks down the nerves that innervate the closer muscles of the urethra, we and remodeling those nerves and restoring and maintaining neuromuscular function, and closure mechanisms. So these are novel, these are novel approaches. And so back in 2019, when we began, we recognize we really needed to deeply understand this. So we've done a ton of preclinical work over 20, preclinical studies in large and small animals, establishing both in acute and chronic effects and really understanding how those work. What we've seen is a uniform pronounced really profound effect in both stress incontinence and overactive bladder, we then also developed a procedure to make sure that it was easy learnable and consistent to deliver this implant. So now we're in a clinical feasibility study. And this is the anchor human data that will support a pilot study. This is a PMA regulatory pathway that we'll be pursuing. And that clinical feasibility study is underway now, in market, this will be a highly highly differentiated solution, not just in terms of what we can treat, but also the way that we do this. So this is a this is a very, very small implant relative to what's out there today. It's delivered under local anesthesia and there's no no daily compliance burden that the patient has to endure. But there's more beyond that. This is restoring natural closure mechanisms. So relative to something like a mid urethral sling, where you're putting a foreign body in there to actually prop things up. This is actually restoring normal mechanisms, natural mechanisms and durable effect that lasts a long time. And if you need to, you can easily remove this device by design, the on that the way that we're actually delivering therapy allows us to confirm very clearly that we're on the right nerve target, we're not dealing with any sort of migration of a lead. And that lasts for many, many years is the anticipation for based on this design. Also, in market, we're dealing with a premium price category. So even governed by the lower range of price price points, modeling this out and governed by the existing landscape of overactive bladder therapies, which are not as many, it's still a very, very, very strong business opportunity. But the market is huge, and has the capacity to get a lot bigger, with a patient profile, or with a solution profile that's more attractive to patients. So it's a really elegant solution for urinary incontinence. But this what makes this technology so compelling is actually that it is a platform and we chose pelvic health, specifically, because there is an enormous gap in care in a lot of these spaces. Most of the innovation capacity that we have today has gone toward heart brain cancer, ortho, all for good reasons, understandable, but there's so much opportunity to improve here. And it's not just in women, women and men, there's a lot of opportunity for improvement, one device and treat multiple different conditions. And we have data on a number of these. I have the privilege, excuse me, I have the privilege of leading a spectacular team. deep experience in both large multinational corporate work, as well as startup experience. An army of passionate advisors, medical advisors, business advisors, technology advisors, and collaborators that have helped us get to this point, and have a great plan for evolution. We recently won the neuro mod prize phase two from NIH was a really prestigious win for us very excited about that. We've got a number of other programs that we're into med tech innovator will be speaking at actually next week. We are closing up a seed round actually, we close up a seed round, we'll make make any announcements next week. But really, I'm here to talk about the next evolution. We're gearing up for a rapid development into market will be the launching a series a campaign later this year 15 to $20 million series A that would find us through the end of the pilot study, which is a large, randomized controlled trial that were designed. So this is a high impact, a dramatic impact journey for us. So we are interested in talking with people who are interested in joining a dramatic impact journey. Thank you very much.