Deanne McCarthy Presents Swiftsure at LSI USA '23

Transcription

Hi, I'm Dr. McCarthy, CEO of Swiftsure Innovations where our goal is to improve the standard of care and oral health for mechanically ventilated patients worldwide. Sorry, I don't know how to make rebound. Okay, perfect. Awesome. So prior to founding this company, I was a registered nurse in the medical ICU. And in our training, they focused on the importance of oral health due to its direct correlation to pneumonia prevention. But, so that endotracheal tube that connects the mechanical ventilator to the patient's lungs creates a direct pathway for germs in the mouth to enter the oral cavity. And despite my best efforts, I saw across the board the oral health of all my mechanically ventilated patients decline, despite my best efforts, my inability to safely clean far back in the oral cavity made me realize I didn't have the right tools for the job.

So here you see some tools that we commonly use in ICU. So there's a tooth at that sponge on the stick, basically, that we used to wipe the interior of the oral cavity. But it's very difficult for us nurses to reach far back in the oral cavity, these patients are sedated and uncooperative. So it's basically the clinicians are doing a blind jab to try to clean far back in the mouth, and it's impossible to clean behind the tube in the mouth, and access all areas. You also see imaged a suction apparatus. So also these patients aren't able to drink. They have no oral intake. They're also their mouth is propped open by this tube. So everything really dries out. They have a drastic decline in saliva production. So what we see is really cracked dried mucous membranes, and all the secretions and mucus gets so thick that they're impossible to suction. And when we excavate these patients, the tubes are caked with basically, thick mucus that ranges in color from brown to black to gray. It's basically kind of like a biohazard. And it got me thinking really practically about this gap in oral care is, why aren't we able to rinse far back in the oral cavity, and it's something that we do every day. So I left the hospital and began working with a brilliant group of biomechanical engineers. And we have developed a really simple consumable medical device, a mouthpiece that easily fits into the oral cavity of a sedated patient due to its topography and living hinge. And it allows us to safely clean far back in the oral cavity by seeing simultaneously irrigating and sectioning. So it allows us to basically thin thick dehydrated secretions far back on the oral cavity so they can be effectively removed. And it allows us to rinse away everything that's been mechanically dislodged through tooth brushing, and most importantly, it's fast and easy to use and fits within the workflow of ICU. So there are again a number of products out there that allow us to brush suction and wipe and in addition to we should be rinsing the oral cavity, and only this swish or swish kit allows us to safely rinse all of these impossible to reach areas. So ventilator acquired pneumonia requires patients to need extended length of mechanical ventilation, ICU stay increased diagnostics, antibiotic use. And it's inexpensive care environment one day of mechanical ventilation costs $4,000. So by avoiding infection in this very expensive care environment, the cost savings are huge. So there are 2 million long term mechanically ventilated patients in the US each year. So when we look at our beachhead market of the US, this is a $1.2 billion market opportunity and when we expand it globally, it's 3 billion. So with our precede funds, we have completed design transfer to manufacturing completed verification and validation and we are on track to register with the FDA next month. We have completed our clinical use validation study at the Cleveland Clinic, and we've incorporated product enhancements to our commercial device. We have begun early adopter outreach to identify early adopters during our soft market launch. And next step with our seed funds, we are going to conduct a bacterial reduction pilot at the Cleveland Clinic. We've been working with Forsyth, which is an arm of the Harvard School of Dental Medicine. They are world leaders in the oral microbiome and health research, oral health research. So they worked on our protocol. And we're also going to begin our soft commercial launch and find early adopters who are key opinion leaders in oral health and its correlation to pneumonia prevention and during this time, we'll validate our business model and our sales and pricing strategy as well as fine tune our training materials. With our Series A funds we will complete a multicenter bacterial reduction study with one of the sites again being at the Cleveland Clinic and will also They'll transition from our direct sales model to our distribution channel with distribution model with clinical overlay. And at this time, we'll also do cost reduction and manufacturing optimization. Our clinical validation study at the Cleveland Clinic was a huge success. The switch the switch kit is the first device to ever rinse the mouth of a mechanically ventilated patients. The nurses that use the device commented that it would improve their the oral health of their patients, it was easy to use, and that will be very effective for long term mechanically ventilated patients. We also observed a very quick learning curve with the use of the device. So the white paper is being submitted for presentation at the American Society of Anesthesiologists and we have submitted our bacterial reduction pilot to the IRB at Cleveland Clinic. So within a very short amount of time, it's only been 18 months since we closed our pre seed round. And in that time, we've completed our clinical use validation study one of the top hospitals in the nation for this 510 K exempt device. We've transferred to manufacturing fully implemented our quality system and are on track again to register with the FDA next month. We've under undertaken corporate rebranding and we'll launch our new website in May we have two utility patent family applications and to design a family patent applications and continue to expand our patent estate. I have assembled a very experienced and competent team. Glenn Hanner, comes to us with 15 years of industry experience commercializing medical devices in the startup space and he has two successful exits under his belt. Even Moynahan is our Director of Quality and she has 10 years of experience as a quality engineer, and Robert to senior financial lead. He's our CPA with experience budgeting and forecasting for medical device startups. We have an excellent advisory board with industry specific requisite skills and building corporations with the ability to scale. And we have a strong Medical Advisory Board with experience researching ventilator acquired pneumonia and oral health research in the ICU space. So we're actually closing legals for our seed round this, like today. So this will find again, our backdoor reduction pilot our soft commercial launch, and we'll gain our compelling reference customers with repeat orders. And we're here positioning ourselves for our Series A and we are raising 9.5 million US dollars to complete our multicenter bacterial reduction study, and to fuel our full commercial launch and to scale the company. So in terms of our fundraising history, in combination with our pre seed and seed round, we've raised 2.74 US dollars through convertible notes and just over half a million dollars in non dilutive funding from the Canadian government. We are solving a big gap in oral care that's been acknowledged by every critical care nurse that we've interacted with. This is a large and accessible market opportunity, and we are set to begin our commercial efforts in May. This is a 510 K exempt device with strong intellectual property in place. In a very short time, our experienced team has built a validated product with proven clinical utility. And we have positive initial clinical results again at one of the top hospitals in the nation. And we do have a strong business model that's supported by a large gross margin even at low volumes and a strong go to market plan with an experienced team to execute it. So it's our vision to see this wish kit at the bedside and ICUs world brown providing nurses with the increased efficiency and effectiveness to provide comprehensive oral care. And we really truly believe that this will give critically ill patients a better chance of recovery. Thank you.