Dr. Lynne Lim Presents NousQ at LSI USA '23

Transcription 

Dr. Lynne Lim  0:05  

Good afternoon. I'm Lynn, and I'm a CEO at new skill. I'm an EMT surgeon by training and I've been practicing for more than 25 years, I've operated in more than 10 different countries. And really, I see that with clicks, I will be able to help children all over the world. Here again with just one click. Glue here is the condition where the yellow fluid is trapped behind the eardrum in the middle ear space. It's the middle ear infection, very huge public health problem, easily 100 and 20 million surgeries needed each year. But currently, only 10% of these surgeries are being done. This the number one reason for a child's visit to the doctor's number one reason for antibiotic use, number one reason for hearing loss, and why they require general anesthesia during surgery. Without treatment, there is Speech Language Learning delays, your jaw ruptures, tumor formations, brain infections, long term social economic impact. And so when medications fail, surgeons put a very tiny one millimeter tube onto the eardrum to drain this fluid. But the current surgery is complex that requires six seven different multiple instrument changes in the small ear canal. child cannot tolerate this and undergo general anesthesia. But the FDA has warned about neurodevelopmental effects on the brain and parents are fearful. Once GA is needed, you need the operating theatre setup, huge setup huge manpower needs. You also need the big gray structure the non portable hundreds of 1000s of dollars. That's the surgical microscope. All this leads to very poor take up rate in America. out of 100 patients told to go for surgery only 15 Take up the surgery. Waiting time can be up to one year because it's in the operating theater. Age of surgery can be delayed from two years, up to five years up to seven years. It became very clear to me also that those many most need of the surgery can never get the surgery. I was operating in Cambodia I did not have anesthetist with me. I just with a local anesthetic injections, I was able to take out large neck tumors or kids who are awake. But the next day there were hundreds of kids that had actually tracked over the mountains looking for two years surgery. I had no microscope no general anesthesia in the operating theatre, I could do nothing came back I kept thinking about it. And one day I saw my daughter getting a USPS for earrings, you know just click click and that was the aha moment. Working with my engineer, I now have the world's first handheld sensor control robotic tube applicator very safely and precisely with just one click of the blue button. In one second I inserted that one millimeter tube onto a paper thin air drum in my clinic without the microscope without general anesthesia using an existing proven tube. Payton's have been granted in four regions. We've shown great safety in human trials. So with clicks really, it outperforms my human hand and my human eye with a very clever integration of IP protected technology. The proximity indicator sensor feedback software algorithm pre programmed for different angles of eardrums and the precision cutter if you will just focus on that yellow line mimicking the eardrum with one click tube is inserted. Imagine not for the patient a same day in clinic procedure local anesthetic ear drops home in one hour. For the doctor. I mimic exactly the surgery that I'm doing with a very fine slit incision, very precise, proven tool. But I do it in my office I do 10 patients a day. Even if I do not own a microscope, I do not need to reschedule for an operating theatre months away for the payers slashed prices up to five times no more manpower shortage, no operating theatre shortage, no waiting list. We're very clear clicks advantages over competitors and that's why surgeons I've talked to are really excited about this. Competitors to competitors in the US their manual devices they play in the same field. We are the only automated sensor robotic device. Competitors need to put pressure on the eardrum for up to three minutes uncomfortable for an awake job and so surgeons are hesitant to use it. Surgeons are also worried about the competitors device have a puncture hole on the eardrum. Imagine a puncture hole on the eardrum. It may not heal. It's big for the child. But clicks recreates the surgeon slit with a proven tube. Because of the sensor we take away the microscope we need just a portable headlight. huge unmet needs in America. The prevalence in America are very high 13% of your children have authored this media, but only 15% can get to the current surgery in Australia to Eisah numbers in disadvantaged areas, even bigger numbers. But in many of these developing countries, there's a vast and rapidly growing middle class of two 60% of this middle class, who are wanting good health care for their children, they are able to pay. Yeah, but now they have poor infrastructure, not enough end surgeons, the access is difficult, they cannot get to this. Click is so exciting because it expands dramatically, dramatically. The market for this surgery, the current surgery gets to only 18 million of these surgeries. But the real need is 120 million surgeries. With all this advantages of clicks, we're able to get to at least 54 million of these patients, even with a very low adoption rate, and that would be a 43 billion US dollar market. We've completed 5 million in research. grants. These are non dilutive grants from the National University of Singapore and the National Research Foundation. We have a fully functioning device. We founded the company in 2021 raised a small seed round 1.3 million US dollar, non institutional investors. This will end surgeons, doctors or finance people. And we did the pilot clinical trial at the University Hospital showing great safety able to insert the tube. And last year we are very proud winner of the Medtronic AIPAC challenge and also the grand prize winner for the medtech APEC innovator challenge. We are raising series A funds now 5.5 million and this we hope to complete pivotal trials by a we stopped pivotal trials this year. We completed next year. By 2024, we will get FDA approval, and we will launch commercially in America as the beachhead market and 2025. This is a razor blade sales model. So the body 1000s of times you sustainable, the shaft single use disposable the key revenue driver differentiated business models for different markets. For example, the US get FDA approval with HHS data to convert payers and we want to be leveraging actually economic clinical humanistic outcomes, we will set the new standard of care, we will play not only the FFS market, but we will go all the way to the value based healthcare markets which competitors have not really focused on. Okay, we will be playing right in the intersection of all these three circles we go way beyond the CPT code. These are simple revenue projections and the conservative ones we are using only just what you can reach with the current multiple surgery market, not the handheld device clicks advantages. But already 230 million revenue in five years. I've been focusing on the kids, but in adults 20% of these tips are in adults. We need them not just for New Years, but we need them for hyperbaric oxygen therapy. We need them for cancer therapy effects. And as an end surgeon, I'm really excited about the pipeline. I'm already working on this pipeline products end device anywhere with a point click very precise. Surgery, that's the best thing for us, the more difficult, the better. And with the software inbuilt into there we have a potential for artificial intelligence. Very exciting. We have a very experienced team here to really deliver for you, myself. I'm very close as the surgeon to the patient, to the hospitals to reimbursements. We have regulatory experts in our team Ipu experience, product development, intellectual property experience, and corporate finance and a p&l leadership risk mitigation. An international advisory board from Australia, from APEC, from America, for example, many of these people, they are the presidents of the end societies. And we have an international society, otitis media president with us on the board. Very excited and hope to really partner with you. Yeah, we have a potential for an exit early exit two years time after FDA approval acquired by a key strategic way are actually being watched by a couple of them. And why I say this en ti is maybe not your obviously sexy field. But it is a very niche boutique field. And herein lies the huge potential. So our two competitors, they're just manual devices, but they have been acquired immediately after CE mark and after FDA. And we will have FDA in two years. Thank you very much.