Hamed Hanafi Presents NovaResp Technologies at LSI Europe '23

NovaResp has developed a patented software compatible with any positive airway pressure (PAP) machine to dramatically improve comfort and adherence to therapy for obstructive sleep apnea (OSA) patients.
Hamed Hanafi
Hamed Hanafi
President & CEO, NovaResp Technologies



Hamed Hanafi  0:05  
Hello everyone. How many people in the audience have or their family members have used a CPAP machine or have been told to use one who loved the idea of being prescribed with wine and having to use it? Exactly. My father has severe sleep apnea and does not want to use his machine. My name is Hamed Hanafi and I'm the CEO and founder of NovaResp, the company that is revolutionizing the treatment of obstructive sleep apnea through comfort innovation. Obstructive Sleep Apnea is the blockage of airway that happens hundreds of times throughout the night, it could take 10 seconds up to two minutes of breathing pauses, this could lead to three times higher chance of heart attacks four times higher chance of strokes, it could lead to type two diabetes, 15 times more chance of car accidents. It is estimated that 1 billion people globally are suffering are suffering from obstructive sleep apnea. However, 80% of these patients are undiagnosed. And more than 50% of those that are diagnosed and prescribed with CPAP do not want to use it just like my father. But let's see if there's competition to CPAP therapy. There's oral appliances and pills that do not work on severe sleep apnea. There is newer stimulators that are minimally invasive and very expensive to do. And also, there's surgery that you don't want to do it unless you really have to see perhaps remain the first line of therapy. And the only effective solution for any severity of sleep apnea, except that there has been zero innovation in the comfort of these machines in the last decades. And now, why do patients not want to use their machines, number one, you're tethered to your bedside, you can't move around when you plug it in. Number two, you have a mask on your face and a tube that when you're rolling over, you could roll on. Let's say you accept those situations. Now you have to basically tolerate this high amount of pressure on your face throughout the night. There are a lot of patients that wake up ripping off the mask from their face halfway through the night. And reimbursement is defined as if you use your machine for more than four hours at night. Then you're qualifying for reimbursement otherwise, you're a non adherent patient, and your cost of device is not covered. And that's the problem in the market. Now these patients end up with the heart attacks and strokes. manufacturers don't make the revenue from selling the machines and consumables. Same with the Emmys and the amount of hours they have to spend to talk to their patients to convince them to use it. We have the solution for this. We have an AI enabled software called SIMA that predicts apneas before they would happen and removes them. And this enables lowering the pressure of therapy. Now how does this happen? Have you ever blown up a party balloon in the very beginning you have to push really hard and then it gets easier, right? Airway is the same as like a balloon, if you know it's going to collapse, a gentle amount of air pressure could keep it open. Now let's go through the patient journey. In the Western Europe and North America where there are reimbursement markets. 100 Patients are given a CPAP machine are prescribed with a CPAP machine at choose to actually take it home from those who take it home. 50 end up actually meeting that four hours criteria. 13 months down the line, there's only 32 left and five years down the line. There's only 15 patients on CPAP machines. Improving comfort of these machines by just 10% with our software would increase revenues from sales of machines resupply that is reimbursed every quarter in the US. And same thing for the DMV and reduction of labor costs for them. And most importantly, patients end up with a better quality of life. Just to tell you why patient adherence is so important in this market and is the driver of the market. Only 10% increasing in patient adherence in this market is equivalent to $700 million a year more revenue for manufacturers. This is why patient adherence improvement in patient adherence is considered traction in this market. We have designed a comfort and adherence study on current CPAP users and brand new CPAP users to quantify the amount of adherence we improve. And our product vision is firstly, we provide a software that could be installed on any CPAP machine in the market for manufacturers that want to provide the best therapy for their patients. And you can imagine if you actually lower the pressure of therapy, now all of a sudden, devices could be designed mind that our battery battery enabled and it removes the other issues with adherents and comfort for patients which we're working on. We expect that the second part will actually revolutionize the market in terms of comfort of solutions for obstructive sleep apnea. We've already proving the predictability of the software then we installed the software on a commercial machine and did the first demand trial that's published in the highest impact factor journal. The regulatory pathway for this software is actually pretty simple because for the times that we would, for the rare times that we would fail predicting an apnea, there's a fall back on the normal algorithm all the machine called a pap. Therefore, it's a 510 K path for the manufacturers that would install this software. And we've lined up two manufacturers already. Our leadership team is filled with superstars Dr. Neil Smith is the founder of one of North America's largest privately owned sleep clinics. Mr. Rice SoDI was the President of Software at software as a service at resume up until a couple of years ago. Tom Miller was the VP of sales that resume until a couple of years ago. Steve bill and Joel bring over 70 years of experience in med tech to NovaResp. Myself, I have a PhD in Biomedical Engineering and I'm specialized in respiratory mechanics, or clinical advisory board is even more exciting. Dr. Rena Mehra writes the clinical guidelines of sleep apnea therapy for North American doctors through American Thoracic Society. Doctors fietsen Pennzoil. Right these guidelines through the shorter Institute and through the European respiratory society for the European doctors. We have four patents that are already issued in the US and are entering other geographies, we have already put into more provisional patents and planning to put in more regarding the wearable CPAP as well as the personalization of therapy. we're ramping up to start the comfort study. Then we'll start the tearing study in the beginning of 2024. We will be on the partner CPAP machine and commercialized by the end of 2024. And we'll be ramping up in order to develop and commercialize the wearable CPAP in 2026. We expect to reach positive revenues within the two years of product launch, and $100 million of net revenues within four years of product launch. Our last raise was $2 million. That was done last December. This will take us to April 2024, at which point we'll raise a $15 million round in order to partner with more companies install the software on more CPAP machines as well as the launch of our wearable that would be funded by that round. We are addressing the clear driver of this market which is patient adherence and it's a large and undeniably growing market. We have already showed that the predictive and preventative aspects of the software work and we have protected our IP. Thank you very much

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