Sahil Diwan 0:03
Hi, everyone. My name is Sahil Diwan, and I'm the co founder and CEO of Safkan Help, and today we're going to talk about cleaning your ears. So our OTA set is the world's first automated and FDA 510 K cleared ear cleaning device. So for those who have never had the pleasure this is when earwax removal procedure looks like today. So that is called an Aeron bladder syringe. And it's been the standard of care since 1821, when an otologist decided to clean your ears with a bladder syringe. This is a procedure that's performed more than 20 million times every year in the United States alone. As you can tell, it's not a fun procedure to go through. So why is this such a big issue? It's because impacted earwax is actually the leading cause of conductive hearing loss, and other symptoms such as pain infection, vertigo, and tinnitus. This is a problem that affects one in 10 Children 120 healthy adults, and one in three people over the age of 65. That translates to roughly about 35 million Americans and 700 million people around the world. So our vision for the company is to first start with our clinical device, which is actually already on the market and have that become recognized as the new clinical standard of care for this procedure, we then want to quickly leverage that clinical performance and brand into the consumer market, essentially creating this new category of ear care. So first, starting with the clinical need. So as already mentioned, this is not a fun procedure to go through. It's painful, it's messy, and it's time consuming. It takes about 20 to 30 minutes on average for your primary care physician or audiologist to perform, which could which quite often puts them behind schedule. And on top of that they have a high failure rate about 35%, which means that millions of patients are being referred out to high cost and T surgeons every year. So overall, not a good space. Not a good experience for the patient themselves. But it's certainly not a good experience for the provider. So this is our solution. It's called the autoset ear cleaning system. How it works is uses irrigation and microsuction built into an automated and wearable device. And the story about this and probably you know, you're curious how we got into the earwax business is because my brother growing up just had this problem. And he would have to go to his primary care physician every few months to get his ears syringed out, sometimes it was bad enough and he'd be sent to the ENT surgeon for micro suctioning. So fast forward a bunch of years, he grows up and becomes a biomedical engineer and thinks to himself Why not marry these two methods into an automated and wearable device, and then the AR Otis that was created. So we already are on the market. We're actually already in 100 clinics we our soft launch was in September. What we've learned from our customers so far is that we're reducing this procedure time from 20 minutes down to five minutes from setup to cleanup. We're reducing those high cost end referrals. We're increasing patient satisfaction, but also provider satisfaction with the procedure. And we've had no reported adverse events such as eardrum ruptures or canal lacerations, which are both quite common with the manual procedures. Today, we charge $899 for the device itself $18 per patient and disposables. And there's already a CPT code in place that we fit into, which is $50. On average, it's actually a higher CPT code than what they build out today. Sorry, little bit gross. Here, we're going to show you that this works. So this is from our large study that we finished recently. And what we learned from this is that we average procedure time treating these significant impactions of 1.75 minutes. So just a few quick cycles with our device and an average success rate of 92%. We already have issued patents on the device in the US and beyond. The patents focus of course on the device themselves, but really importantly, the disposables, which are the ear tips, and waste containers per patient. And looking at the clinical opportunity first, so in the United States, plus a few key countries, which would of course expand into there's about 43 million visits for earwax removal every year. So by the $18 that we charge per patient for procedure for the disposables, that creates a $785 million opportunity per year, just from disposables alone in these countries. And then on top of that, you can throw in about a $260 million opportunity from device sales again in those countries. So by far the standard of care simply is just to syringe that is really our competition here, there are a few other options such as spray bottles, there are actually clinicians who will use a dental floss or like a Waterpik to clean your ears, which is obviously not what it was made for. And then there was a well challenge device that came out in the early 2000s, called the ear wash system. And it was good device. But the problem with it, it was just too cumbersome to set up and clean up. So that added more time to the procedure. So our go to market is pretty interesting. So we are obviously focused within the primary care market as our largest opportunity. So health care systems and the urgent care chains around those are we're actually first focusing on audiology as our beachhead market. And the reason for that is that these hearing aid manufacturers all have these retail chains they have these hundreds if not 1000s of locations where they sell their hearing aids through their kind of like clinics. And the biggest problem here is that keep in mind one in three people over the age of 65 have this issue, which is you're mostly you're hearing a population. And if they have too much wax in the ear, they can't move on with the hearing test or hearing aid fitting, they have to refer you out. And a lot of those times those patients don't come back so they lose those hearing aid sales. So we're already piloting with a number of the large hearing aid manufacturers on chains. And again, we're just helping them sell more hearing aids. And then eventually, we'll expand out to the government and military such as the VA. And also this procedures already performed in retail clinics, such as CVS MinuteClinic. So we'll want to get there over time. So as I mentioned, we launched just a few months ago, but we're already in over 100 clinics. This includes large healthcare systems, large hearing aid chains, and also EMTs and private practice, we already have a significant pipeline of of pilots and customers already and really, what we're doing right now is raising our Series A kicking off next month to scale commercialization of our clinical product. So now we're kind of talking about the consumer need. We all know that Q tips are bad. And the real problem here is that there's simply no safe, effective or physician recommended device that clinicians can recommend that their patients use at home to prevent this problem. And another really interesting fact within the audiology industry is that your wax buildup is the main reason why hearing aids are damaged and sent in for repair, which is a significant cost that the hearing aid manufacturers have to cover. The solutions that people have today are not very much different from clinicians. On top of that there are a few gimmicky and kind of unsafe devices that no clinician would recommend that you use. So our plan is to do for ears what Sonicare did for teeth with the first FDA cleared home use device, the first physician recommended device to allow the 35 million Americans like my brother to and beyond that to prevent earwax buildup from home. So we plan to charge about $149 for this device. Again, just looking at the US and a few key countries that 6 point 5 million people who actually have this problem that creates a $9 billion opportunity just from device sales alone, there would be consumables kind of like a Keurig model here with saline pods per use of the device. And again, I think there's a great opportunity to partner with the hearing aid manufacturers essentially bundling this device with the hearing aid sales about 17 million hearing aid sales globally, every year. That would be great go to market for us since we're already doing a lot of the hard work in their clinics today. We then expand beyond that really focused on health care systems and their physicians recommending this device to their patients to use at home. I don't have time to get through our team, but I'll go through our board and advisors. So we have the former CEO of Welch Allen, Steve Meyer on our board and also on as an investor in the company. We have Adam Daikon, the managing director of treatment HealthTech, also an investor personally but DreamIt Ventures is our largest VC and our seed round. And you can see here the clinicians that we actually developed the product with iterated on and tested it with. So we did raise a $4 million seed round. That is what has gotten us to where we are today. These investors include DreamIt ventures, multi Care Health System, pre copy, calm primary Innovation Fund, and also a number of our customers who really believe in the product and what we're doing. So we're kicking off an $8 million series A next month. And the goal here is simply to scale up what we're already doing in the clinical market and to also accelerate the development of our pediatric and consumer versions. So if you're interested in learning more, come find me in the room next door. My name is Sahil Diwan, and we're Safkan health. Thank you, everybody.
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