Hamed Hanafi Presents NovaResp Technologies at LSI USA '23

Transcription

Hamed Hanafi  0:05  

Hello everyone. My name is Hamed Hanafi, the CEO of NovaResp, the company that is revolutionizing the treatment of obstructive sleep apnea through comfort innovation. How many of you in the audience or your family members have been told to use a CPAP machine? How many of you in the beginning love the idea of having to use a CPAP machine? Sorry, I thought my father has severe sleep apnea and he does not use his machine. Obstructive Sleep Apnea is the blockage of airway for periods of 10 seconds up to two minutes, this could happen hundreds of times a night. comorbidities associated with it. Type Two Diabetes, higher chances of heart attack higher chances of stroke 15 times higher chances of car accidents. It is estimated that 1 billion people globally are affected by this disease, 80% of which are undiagnosed, and half of those that are diagnosed and prescribe end up not using the machine just like my father. There is competition to CPAP therapy, there is oral appliances, and there is pills. They're not effective on severe sleep apnea. Neuro stimulators are minimally invasive and very expensive. CPAP are the only solution that do work, except that no one likes using them. There has been no innovation in this market for patients comfort comfort in the last decades. Now let's see why. Number one, there is a lot of pressure applied to your face in order to keep your airway open, then there is the mask and the tube that you could roll over and you're tethered to your bedside, you can't walk around. Now patients end up not using these machines, which is going to affect their health leading to strokes and heart attacks. But this is also an opportunity cost for DMVs and manufacturers. When patients are prescribed with CPAP machines they're sent home for with the CPAP machine for the first three months of use. If they prove that they use the machine for a certain percentage of those nights, then there's reimbursement that covers the cost of the machine and covers the cost of the consumables on a quarterly basis. So this is quite a bit of cost, that that is caused for DMS and manufacturers and revenue that they're not generating by improving patient comfort, this will improve more patients will stick to them with the machine, short term and long term that has made patient adherence, the driver of this market improvement in patient adherence is equivalent to traction in this market. Now, current CPAP machines or reactive apnea still happen throughout the night. But what the machines do is that they either increase the pressure halfway through the apnea to try to open up the airway which wakes up the patient or wait for the patient to wake up on their own and breathe normally. What our patented AI enabled software Sima does is that it predicts happiness before they would happen. And alkalis a gentle amount of pressure to keep the airway open. We have found this software through collecting 10s of 1000s of apnea is from patients and we are now ready to install it on any CPAP machine that is currently in the market with the normal form factor, turning them from reactive machines into intelligent machines. Now let's connect this to patient comfort and adherence. I'm sure you've all tried to blow up a party balloon. airway is like a balloon in the very beginning. If you want to blow up a deflated balloon, you need to apply so much pressure and then it gets easier. Right? So airway is the same. If you know it's going to collapse and it's halfway blown up you need gentle amounts of air pressure to keep it open rather than a lot of pressure that way ourselves or drops the pressure of therapy and improves comfort for patients on normal CPAP machines. But if you can imagine, if we can lower the pressure of therapy dramatically. Now, the size of the machine can shrink, the power consumption has reduced so you can build battery enabled wearable machines. Therefore our product vision is firstly an incremental step where we install our software on partners CPAP machines and generate licensing revenue through that to turn their machines from reactive to intelligent machines and also our completely wearable fully integrated machine that will completely disrupt this market. As mentioned before, we formed a predictive algorithm through collecting 10s of 1000s of apneas from patients and then we install this on a commercially available machine and tested on patients. And we showed that we can Entering the normal form factor machines into intelligent machines. Now we're going into clinical trials in q4 of this year. Now, this is also a regulatory strategy because if the first AI software is approved through a 510 K path, that we've had the priests up with the FDA, it's going to be a 510 K path. If it's approved the first day I software then that becomes a predicate for our gen two device. So we'll do the trials. At the end of this year, we'll be ready to submit our Health Canada and FDA submissions at which point we are raising our Series A. And in the meantime, we're designing and preparing for commercialization of the fully integrated machine into Intune. Six. All of our four patents are now allowed or issued in the US. And we were planning to file more patents this year. Our leadership is myself. I have a PhD in Biomedical Engineering, I'm specialized in respiratory mechanics and commercialization of medical devices. Master's Lederman, and power bring 10s of years of experience in quite successful startups. Mr. Miller was the VP of sales at ResNet for over 10 years. And Dr. Smith is the founder of one of largest North American privately owned North American sleep clinics. Our clinical advisory board is even more exciting Dr. Mayer and Patel write the clinical guidelines of sleep apnea therapy for North American doctors through American Thoracic Society and Dr. fietsen Possehl. Write those for European doctors through European respiratory society. We have multiple recurring revenue imagined with our partner licensing devices, consumables and software as a service which will bring us to a positive cash flow from year two of product launch. We just closed the RC plus round in December, we're starting our activities to raise a $15 million round in order to tackle and bring this dramatic, revolutionary and disruptive technology of a wearable CPAP to market. We address patient adherence which is the acknowledged growth impediment in this large and undeniably growing market. We have demonstrated in pilot trials that we can predict and prevent apneas and we have protected our IP. Thank you very much and happy to answer your questions.