Entvantage Diagnostics | Joe Skraba, President & CEO

Joe Skraba  0:02  
Thank you, George. My name is Joe Skraba, I'm president CEO Entvantage diagnostics based in Austin, Texas. And Entvantage is focused around improving antibiotic stewardship for very common upper respiratory illnesses.

The problem we solve is simple. We get too many antibiotics. Antibiotics that are prescribed for common upper respiratory illnesses are prescribed in great quantities. Oftentimes, upper respiratory infections get antibiotics 80% of the time when they're needed only 10% of the time. And this has been recognized by the WHO, CDC and the White House as being a major medical issue. Now, we've all spent the last two years dealing with COVID 19 and the pandemic that associated with that. What if we could have prepared for that pandemic? And what would we have done? Well, the antibiotic resistance pandemic is coming. We have time to respond. And we believe that we can we can help that by eliminating these unnecessary antibiotics. 73 million patients go to the physician each year for very common illnesses like acute sinusitis, acute bronchitis, acute otitis media, and acute pharyngitis and tonsillitis. There are three common pathogens Haemophilus influenzae, moraxella catarrhalis, and Streptococcus pneumoniae, that are the common pathogens of the bacterial form of these illnesses. Our first indication was sinusitis. We selected sinusitis. Because of the largest reason antibiotics are prescribed in the outpatient clinic that affects 73 million patients in the US and Europe annually. And currently, the physicians are making diagnostic decisions based on symptoms in history alone. And this has led to the situation where 80% of patients are getting antibiotics when just 10% need them. We've solved this problem with very simple easy to use products, we have a device to collect a specimen out of the middle meters region of the sinus, a bacterial assay to to identify whether those pathogens are involved in the infection. And the digital reader to provide the results to the physician all in 20 minutes will provide definitive rapid diagnostic information to help avoid help patients avoid getting unnecessary antibiotics and help better target better out to antibiotics for those that need that we have a great competitive position. There is no office based diagnostic product available in the market today. We have the advantage, key patents that have been issued already. And we've received a $1.7 million SBIR phase to be grant that is running to help us with patient enrollment. We've issued patents on all of the major components of our system, our collection device, our lysis buffer, and the Haemophilus Influenza cell surface markers that have been issued in multiple territories. With great preclinical performance data based on anatomical studies, pilot human studies, and assay performance studies that all meet or exceed the FDA requirements for clearance of this class two De Novo device. Reimbursements in place utilizing independent validated and reimbursement consultants, we've been able to identify to utilize utilizing existing CPT codes can pay us $55 a test for this this product. And with an independent health economist, we're able to demonstrate that we can reduce the standard of care treatment costs from $400 a patient to $125 a patient with the use of our product by eliminating unnecessary antibiotic use and the complications that are caused in the small percentage of those patients. Our business model is simple. We sell this product for $30 to the physician office, it costs us about $6 to manufacture it at volume. And from the physician side they utilize our tests and they're able to generate $55 of reimbursement. This $25 Delta is a 35% increase in clinic revenue for the typical primary care office visit. I'm a medical device engineer have spent my whole career in medical product development and I'm helped out by two great colleagues Oriana Hawkins, who's our assay development director, and Eisa Maldonado-Holmertz is our Director of regulatory and quality. I also I have an experienced life science board that's helping us on a daily basis.  And we're greatly assisted by a great medical advisory board made of top otolaryngologist from academic and private practice settings across the US. Right now we're involved in a multicenter clinical trial that started in October of last year, we have six sites that will be expanding to 15 sites in mid to 2022. It's a single visit trial, where we compare endoscopic collected specimens to the sinew test assay, utilizing a composite assay based on bacterial culture and PCR results. The initial results that we have showed 95% overall percentage agreement with the control specimen, when we're now 10% enrolled in that trial, what we're looking for is a lead investor for our $7 million equity round, so that we can continue our multicenter clinical trials, submit for FDA clearance in early 2023 extend our indications to bacterial bronchitis that utilize the same assay as the sinusitis assay and the commence early commercial scale activities. We're also looking for distribution partners in Europe and in Asia to take this product into those markets. So the bottom line is diagnostic testing at the point of care for these upper respiratory illnesses is a $2 billion plus US market opportunity alone, where no rapid test products are available at this point, favorable regulatory environment utilizing a 510 K pathway. We have established in lucrative reimbursement that pays $55 a test for the product, we can demonstrate that we reduced the overall treatment costs from $400 to $125. With the use of our product, we have a strong and growing international IP portfolio that's led by an experienced management team and advisors. So with our product, everybody's going to win. The patient wins by getting individualized personalized care at the point of care. The physician wins by providing better patient care and increasing their clinic revenue. And the insurance payer wins by providing better patient care but reducing their overall treatment cost. Thank you for your attention again, my name is Joe Skraba. I'm president and CEO of Entvantage Diagnostics. Thank you