Eric Berreklouw Presents AnchorValve at LSI Europe '23

Transcription

Eric Berreklouw  0:06  
Ladies and gentleman, I'm presenting you AnchorValve, next generation tmvr device that will expand patients access to a life saving treatment. Mitral valve regurgitation is the number one heart valve disease where in the blood leaks from the left ventricle backwards into the left atrium. It affects 24 million people worldwide leads to heart failure and when left untreated the five years mortality rate to 60%. The mitral valve replacement market is predicted to be $6 billion in 2028, the population of the developed countries is becoming older preferrence of mitral valve disease is 2.5 times larger than of aortic valve stenosis, which is currently already $4 billion markets. While the patient population is vastly undertreated due to eligibility requirements. Current mitral valve replacement options limit patients access open heart surgery is still the golden standard, but has high risks and costs and long recovery times. Current first generation transcatheter tmvr devices are less invasive and cheaper but have severe limitations. The most important limitation is that patient inclusion rates remain very very low, mainly due to a high risk for what we call left ventricular outflow tract obstruction LVOTO for adaptation to large valve diameters and large sizes of the tmvr devices themselves. Left ventricular outflow tract obstruction means that the tmvr here by example, a belt standard device is mainly located inside the left ventricle and is limiting the bloodstream towards the aorta. Anchor valves. Patented breakthrough technology consists of a low profile device positioned at the annulus only away from the left ventricle, and so avoiding Alfio T obstruction. The anchoring fingers are adaptable to accommodate the analysts of most sizes. Double flanges ensure a snug fit Minimizing Leakage from both sides. The device alone allows free movement of most of the original valve leaflets without that spaces, potentially reducing the need for long term anticoagulation. It's a versatile technology that can be used as a so called one or two step procedure and in the tricuspid position as well. Of one step procedure means that the combined anchoring ring and Valve stents are implanted together a rapid procedure but enlarger combined products, you can see Full Movies of our products and procedures at our website anchorvalve.com. a two step procedure means that first the anchoring ring with an empty stamp is implanted and thereafter developed stent is deployed within the empty stent I'll show you a short animation.

Video Playing  3:42  
First implanting a docking platform with an empty stent at the mitral valve annulus and then deploying a valid stent inside it. The docking platform made a super elastic nitinol is positioned centrally at the mitral valve annulus and deployed by self expansion. Thanks to the unique properties of its upper and lower flanges. The docking platform is firmly anchored all around the annulus only minimizing the risk of para device leakage and leaving the mitral leaflets free to move position between the left atrium and ventricle risk of left ventricle outflow tract obstruction is minimized. Next, the balloon or self expandable valid stent is deployed into the empty stent of the docking platform and the anchor valve transseptal tmvr procedure is completed.

Eric Berreklouw  4:38  
Here you can see an LV angiogram of an early prototype of anchor fells device in a living pig. You can appreciate the low profile of the device without any LVOT obstruction or leakage since 2014 First generation tmvr device ICERs have been implanted in only a few 100 patients due to very low inclusion rates. With the next generation anchor valve device, it's expected that these low inclusion rates will increase to more than 75% By avoiding left ventricular outflow tract obstruction and accommodating larger annually. With a seed round of 2.5 million we achieve proof of concept in animals and three patents were issued in the US and EU. We have built experienced leadership and engineering teams advisory board, and KOLs, almost all located in the US. With a series a funding of 7 million we can achieve design freeze of the devices and delivery tools complete our clinical and regulatory plans and get to manufacturing arrangements. Our experienced leadership team consists of our CEO Mike Boussard, who has built several venture backed med tech companies and our r&d executive Karina Reyes in western backgrounds at large medical device companies both based in the US and myself as partic, surgeon and researcher with 40 plus years experience in treating heart valve disease. The rest of our team has experienced instance, catheter valve technologies and come from large companies like Medtronic and efforts and are all located in the US. In summary, we offer an opportunity in a growing highly attractive device market there is an unmet needs that we will serve with increased treatment access. The projected market size is large. We offer a breakthrough technology that clearly differentiates from the competition our patents are granted in the US and EU and more are pending proof of concept has been demonstrated in animal studies. We have an experienced team in the US with KOLs from the Mayo Clinic's the regulatory pathway will be like TAVR and other TMVR devices based on a $2.5 billion mark mitral valve deals in the last five to seven years. There is for sure a potential for an early exit please contact me during the meeting or our CEO in the US. Thank you for your attention.