Rose Monaghan Presents Frond Medical at LSI USA '23

Transcription

Rose Monaghan  0:05  

Good morning, everyone. I'm Rose Monaghan co founder and CEO of Frond Medical. Frond was founded by 2x Boston Scientific r&d engineers in Silicon Valley in 2021. Currently, we are a seed stage company, which has created a breakthrough technology, allowing highly precise positioning of diagnostic and therapeutic devices for interventional procedures percutaneous10 is coronary intervention PCI is non surgical procedure used to treat obstructions inside the heart. It has becoming more prevalent due to the aging population and the lifestyle change. There are 1 million PCI procedures in the US more than five solid understands are placed inside the vessel every single day in this country. PCI has been around for 45 years during PCI contrast is injected into the artery to show the stenosis the locations and our x ray, a guide wire and the body either through the arm or the leg and the to the heart, and then it has a threaded across the stenosis area. International devices such as imaging catheters, pillows or stents, are delivered over the guidewire to the target a location. Frequently, there is a mismatch between that diagnostic sites and therapeutic or treatment sites because of the limitation of the X ray, resulting in geographic miss, which will cause a gelling of the side branch or re clog the vessel later on, just as shown here. Missing the lesion with a stance occurs a half of the PCI procedures due to the location uncertainty, leading to a sub optimal clinical outcomes such as two to three times the increase the risk of restenosis or heart attack, it will also increase the greater dose of the radiation and the contrast along with longer procedures over standing and increase the cost. So it is time for PCI transformation. Frond has delivered fraud has created a revolutionary but intuitively simple GPS like navigation system using guidewire itself as the log positional reference. So thinking about a ruler, we put the distance encoded markers on the guidewire just like a tick marks to turn it into a measurement device inside the coronary artery. We also develop a sensor, a teeny tiny sensor, which can be integrated with interventional devices. So the sensor travels with the device along the guide we're reporting precise locations in the artery with submillimeter accuracy in real time without the use of X ray. Under our guidewire system, therapeutic devices can be delivered precisely based on the diagnostic assessment performed in the previous steps. So basically, it takes the guesswork completely out of the physicians to enable better clinical outcomes with speed, efficiency, ease of use, accuracy, and cost savings. All this can be achieved with a minimize radiation exposure for the doctors and the patient and the minimize contrast induced kidney injuries for the patient. Our device is the only platform bridges that device location sensing tracking and CO restoration across the entire diagnostic and therapeutic interventional tool sets. We do not have interference issues, sensitivity concerns or vessel size limitations and the other emerging technologies currently on the market. We use the existing procedural workflow without introducing expensive or capital equipment or teaching physicians a brand new procedure. Furthermore, this technology basically enables a stance and the balloons with a proprietary intelligence which can be a game changer for the strategics in such a competitive a commodity market. So our current focus is $20 billion coronary intervention market with 8% kegger We plan to receive FDA 510 K approval later next year, followed by the clinical studies at our key Kol sites. Our initial entry of the market will be complex PCIs within the high risk patient population that requires a position and low contrast usage. After us, we're gonna expand it to Japan and Europe and also expand our indication beyond coronary our device can be implemented as standalone platform or can be integrated with existing commercialized interventional devices. So currently, we have gained strong interest from several top notch med tech companies. Collaborations are in discussion in terms of product integration cells in the market into fast track our technologies to the market. We have achieved the straw IP positions acquired, obtained the 510 K regulatory pathways from FDA, our first animal study confirmed that the performance as intended and some strategic partnership discussions in process, I'm determined to transform interventional procedures because my mom's life could have been saved with success for PCI while I was a teenager. I have a mechanical engineering, physics and material science by training as a head of r&d for PCI in the Bay Area at Boston Scientific prior to fraud. I spent 13 years developing and launching multiple intravascular product platforms. I'm so honored and feel so lucky to have such an awesome team here. Our co founder and the CTO Dr. Shing Lu is an expert with 20 plus years of experience, developing laser and ultrasound base a device from concept to product. Our chief medical adviser Dr. Arnold Vedo, is a worldwide recognized interventional cardiologist with close to 200 publications. He is also the chief of interventional cardiology at the VA Long Beach. Our chairman Dr. Homer Pn is a former CTO and the Chief Scientific Officer of Philips. He is one of the world's leading experts in radiology, medical imaging and artificial intelligence. Our board member Corinne Augustine, has extensive executive experience in operation business development, and merger acquisition. She is also an advisor and the Stanford Business School. Our seasoned advisory board include Rob Casella, former CEO of Philips and Dr. Fumi Kino the director of Stanford Biodesign program and also a well known interventional cardiologist. So currently we are see the stage we just closed the upgrade around last month. You were looking for the the and the syndicate investors for a 10 million Series A, the founder will be used to build up the team 510 K submission, clinical studies in the US and the worldwide launch. The founder will also be used to for product development or beyond coronary. Frond the world transform international procedures to a new standard position patient care with better clinical outcomes, safety and cost savings. With your support and the participation in serious a will we'll get there faster together. Thank you very much.