Brian Weeks Presents PacificMD Biotech at LSI USA '23

Transcription

Brian Weeks  0:05  

Good afternoon. Thanks for sticking around. I'm Brian Weeks and I'm the co founder and CEO of PacificMD Biotech. I'm also an active head neck surgeon in San Diego, California. The most prevalent problem that we're dealing with in our specialty today is essentially resulting in minimized airflow whether it's through the via the nose or the upper respiratory tract. As we all are aware, obstructive sleep apnea is one of the largest addressable markets in all of medicine. And currently, there's no way to objectively measure airflow with patients breathing and also measuring the actual objective airway within a patient's nasal pharyngeal airway. We've developed within our company two platforms, one's called VisionAir and one's called FlowAir that can instantly and accurately measure the cross sectional areas and airflow of the upper aerodigestive tract using any Indus scopic platform. And this currently is being done for obstructive sleep apnea diagnosis under general anesthesia and our technology allows immediate airway analysis in an outpatient office setting. Both of our platform software platforms are compatible and agnostic to any third party endoscope, and doesn't require any change within a physician's practice to utilize the technology and this technology was developed via my my own personal practice out of a clear need for simplifying an objective eye objectively analyzing patients air airways and air flows. The unmet need is clear airflow obstruction, and the upper respiratory symptom is obviously associated with sleep apnea. There's a tremendous body of medical literature that's grown massively over the past five years showing how important airflow is to quality of sleep and quality of life within all patients. And obviously, Sleep Apnea again, is one of the largest total addressable markets and serviceable markets in all of medicine. And diagnosing airflow obstruction and patients can obviously prevent the development of other comorbidities and also improve immediately improved quality of life. So our platforms VisionAir and FlowAir instantly and accurately measure the upper respiratory airway with endoscopy without requiring any sedation. Both platforms as I said before agnostic to the endoscope platform. So if a doctor or physician is using Olympus or Stryker's endoscopy systems, these are software can seamlessly be integrated into their existing hardware, minimizing the cost and you can see on the images on the left is a typical endoscopic image that a doctor would see in an evaluation of a patient in the clinic. And on the right shows our algorithm immediately assessing the airway at two locations both the nasal caveum which is the central part of the nasal airway, and the internal nasal valve, which is more anterior and forward in the airway. And I might add that multiple large medical device companies are have actively innovated in the space of nasal airway, including Stryker with the laterra implant as well as air and medical with the ver a treatments. Both of those companies are active within our specialty today. Our product received FDA clearance in October of 2022. And our clinical evaluation evaluations within clinical sites began in December of 2022. Or we will plan our limited clinical launch in July of 2023. And a full commercial launch in October of 23. Our FlowAir technology which is focused on the retropharyngeal and Retrovir, excuse me, retro powered on Retro glosso airway for obstructive sleep apnea, will be submitted to FDA in June of 23. And we expect to have a limited launch in January of 2024. And we filed for patents around our technology. We've already rolled our technology out in some of the more prestigious sites within our field. And the comments and feedback have been quite tremendous. We're actively because we are a software platform. It's very easy for us to update our software and to make changes that have been then recommended within our clinical sites. But we've already had tremendous feedback our most our newest clinical sites going to be Stanford and we've already had tremendous feedback from their directors in the right ology depends obstructive sleep apnea departments. So these are clinical cases that I'll share just how they're already impacting clinical care within our specialty. On the left, you'll see case involving a septoplasty surgery which is improving the nasal airway by straightening the nasal septum and you can see real time and currently there's no objective way to analyze the airway short of an imaging study like a CAT scan or an MRI. So real time within an operating room setting you can we can clearly understand what types of improvements we've made within the nasal airway. And you can see on the far left, the right side nasal valve improved 10% and the nasal Cavan, 14%, and on the left 33 and 34%, respectively. As I said, there's technology made by Stryker corporation called Matera. And in the center of this is a an example of a case where we showed improvement in the airway by 14 to 31%, on the right and 12 and 22% on the left. And lastly, on the right is a technology case made by Johnson and Johnson or a Clarence, called the airway trach balloon, and you can see that we were able to show that on the right side, airway improvement was 12%. And on the left is the nasal caveum was 87%. So a dramatic and effective way objective way to, to show value and to show improvement in a clinical setting. And again, another example of technology with another company's technology called the Vera procedure by Aaron medical. And again, the data on the right shows a tremendous turn a tremendous and objective way to show and quantify improvement real time to the patient. So these procedures are mostly done in the office setting, and the patients can be shown immediately how much their treatment has improved their way. And lastly, Ulterra case as I mentioned, Stryker again showing dramatic real time improvement again, our algorithm takes 300 milliseconds to process the image. It's run off of an existing tower, and it only requires a laptop or tablet system. This is an example of what our FlowAir technology will do. This is an example of endoscopy on an awake patient in the office. One of the largest technologies being utilized in our field today is hypoglossal nerve stimulation therapy for obstructive sleep apnea. And the largest player in the company in the field is inspire medical systems with a market cap of $8 billion. Currently, they require an anesthesia dice procedure or drug induced sleep endoscopy to qualify for their procedure. And we believe based on current literature that our technology will likely allow for complete elimination of that procedure prior to qualifying qualifying for hypoglossal nerve stimulator procedure. Lastly is our real cloud network, which is part of all of our systems that we've installed. It's a real time data collection. As we've heard a lot about data today. This is encrypted and Deacon decrypted from all of our clinical sites. We've currently developed an existing platform interface that allows doctors to access real time data, we've already generated clinical data that's greater than most of the sum of publications for each of these procedures. And this is just an example of how our data can be accessed by our physician partners. Real time just by clicking on the type of procedure that's done, we'll be able to drive treatment decisions and treatment recommendations that are also correlated with symptom scores that are currently used in our field. And I'll again add that as of now there's zero objective data available for these types of procedures. It's solely based on subjective reporting by patients. So you can see we've already accumulated a very large amount of clinical data in a short amount of time. These disease processes have incredibly high prevalence, and yet the diagnostics and the actual diagnosis ease are quite low because of a lack of widespread ability to rapidly and quickly determine what's going on and what would benefit patients. Our team is experienced I have a large amount of medical device parents I've worked with for startups, all of whom have had exits. My co founders, also a physician active Ryan ologists, surgeon in Las Vegas, Nevada, and we have two lead engineers that are both medical device seasoned experts. Our revenue model is built around a vertical SaaS model which is highly attractive because it's very quick traction in our specialty. There is an existing CPT CPT code in place for our technology which pays approximately $62.31 for Medicare. I've been using that CPT code for these analyses for the past three years and have easy reimbursement. a revenue model predicts the second half of this year will generate $630,000 in revenue ramping up to about $90 million in revenue in year five with a gross margin of about 92%. We're looking to raise between four and $5 million of capital investment majority of which will go to Team expansion and continued r&d development as well as clinical publications and some general our software expenses. Our company is based in Irvine, California, and I'm here if anybody has any questions, we can also visit our website. Thank you very much for your time.