Joanne Rupprecht Presents Flourish Medical at LSI USA ‘23

Transcription

Joanne Rupprecht  0:00  

Hi I'm Joanne Rupprecht. I'm the CEO of Flourish Medical. Flourish has a medical device that offers a solution for stress urinary incontinence, which normally happens in women. Excuse me, how do I advance? Okay, I'm sorry. So what is stress urinary incontinence? Well stress urinary incontinence, which I'll go ahead and refer to as UI from here is the unintentional release of urine when physical activity causes a stress, a stress and a pressure on the urethra in the bladder. And that that stress or that pressure, as simple as it may be, can again cause the sphincter of the urethra open and unintentionally lead to leaks. SUI impacts an estimated 15 million women in the US alone in 150 million women, potentially worldwide. As I said, the pressure can be caused from normal daily activity, exercise coughing, laughing sneezing, in severe instances, it can also be caused just by walking, bending over or standing up. So ordinarily, in women without SUI, you have a pelvic floor, which x is a hammock, it supports both the urethra as well as the bladder. And when pressure is exerted, it provides a solid foundation, which can support the bladder and leaks will not normally occur. But with childbirth, obesity, and of course with age which is a gift. It can also lead to a compromise of that hammock and that pelvic wall. Nearly half of women over the age of 50 do suffer from SUI, and it does impact their quality of life. It limits their activities, it limits what they can wear. And nearly in a recent survey 43% of 50 to 64 year olds said that they suffered from bladder leakage and 51% of those over 64 also suffer from this condition. Even the market leader in absorbent products admits that the major unmet need is a single use disposable device comfortable to insert and remove. So 90% of women who have SUI right now manage the condition with the absorbent products. But 85% wished that they didn't even have to manage it with absorbent products, but that they could prevent the leaks from happening altogether. 73% of these women said they'd be more active if they could prevent leaks. 49% suffer embarrassment when leak episodes do occur. And 40% say that SUI makes them feel prematurely old. So flourish is the solution to all of that. It is a single use disposable product which is self inserted like a tampon. Once in place. It provides sling lakes support to the urethra in the bladder. And it can prevent not just absorb after the fact but it can prevent these leak episodes. This device is intended to be made available to women over the counter is safe enough to use every day and is eligible for reimbursement through health care savings accounts. The device is made of recyclable plastic, and I'll explain soon why that's important. It has the potential to reduce landfill waste up to 200,000 tons annually. It's a one size fits all. It's self adjusting, and it doesn't interfere with normal urination. The competitive landscape right now the two ends of the spectrum are the absorbent pads. Kimberly Clark and p&g currently holds 70% of the market share but these pads are bulky, they're invisible. They don't necessarily keep your own away from the skin. Sometimes that leads to irritation, body odor, it's hard to sometimes get them fitted properly, especially if you are very active. And it's important that we have other options in place. Now there's two over the counter pessaries vaginal pessaries in place, but these require sizing. You have to replace the string every day and you have to reassemble the applicator. In the most effective treatment for SUI is of course pelvic sling surgery. As an attorney and a personal injury attorney of course this is my least favorite option for any woman A flourish though prevents both the leaks from happening it avoids the absorbent products, there is no fitting required no replacement of string because it's a single use disposable, but it does provide sling like support. Without invasive, expensive operations that could lead to a lot of future complications. The traction we have in this market is we currently have 10 patents granted, we have our high volume production mode completed. This is an environment environmentally friendly device. And in an initial clinical trial with 20 women, it was widely accepted and approved. We also have an experienced leadership team to take this to all of the next stages through to commercialization and beyond both here and in the in the in the world. So the average women getting back to the environmentally friendly aspect of the Flourish Medical device. So women with us UI will use an average of four absorbent pads a day that generates about three pounds of waste in our landfill, whereas flourish generates approximately 1.98 grams of recyclable plastic. This medical device has the potential again to you know, reduce waste 200,000 tons per year. In that initial clinical trial that I mentioned, 90% of the women indicated that they were very satisfied over the control they had over incontinence. 90% felt that they were free from fear of having leak episodes, and 95% indicated in an overall positive experience with this medical device. The target market is going to be women ages 30 to 75. Our sales plan is online advertising blogs, social media, female athletes, spokespersons, TV, print advertisements, and of course, word of mouth. I am here today to seek $1.5 million in a seed round. Where would that money go? That money would go to support our quality management system design controls complete verification and validation studies, usability studies biocompatibility studies. And although this is a Class II medical device only requiring a 510 K, I'm still committed to doing clinical studies to make sure that this is safe and effective. As it's claimed. We will proceed with our 510 K submission and by the end of next year hope to achieve clearance. The revenue projections with women spending $44 per month on absorbent pads at $2 per device with an 80% gross margin, flourish will realize $100 million in sales in the US alone within four years. Our exit strategy, the inventor and chief medical officer Dr. Robert Spitz has already declined initial low offers for acquisition of the intellectual property. He is committed to seeing this through the right way at the right time. Flourish has been in discussions with major consumer companies. And within three to four years, we hope to have an exit in the 25 to $100 million range. So why Flourish? Why now? Well, why not? It's long overdue, again affecting 15 million women in the US alone and 150 million women worldwide. The absorbent products, the the pessaries that require reassembly and replacement of strings and then of course the investment surgeries where you have erosion and in migration issues. flourish again is a single use disposable product reimbursed by flex healthcare accounts. We have 10 patents in an $8 billion industry, a clinical study that initially provided very promising results for women who want to maintain activities and to maintain a positive quality of life. It's safe enough to use every day. And that recyclable plastic aspect is also very needed in our world. Our leadership teams comprised of myself, Joanne Rupprecht. I'm an attorney. I've been in FDA regulatory affairs and quality affairs for over 35 years starting my career at Abbott Laboratories. I have seen many medical devices through to commercialization as an advisor. I also teach it at the University of Colorado to so many of our young, promising people and it was very encouraging to see the young women get up here today and also talk about these types of products to improve the lives of women, Dr. Robert Spitz, he's our inventor and Chief Medical Officer, I still rely on him heavily. And would love to see this be brought to market for his sake as well. He put a lot into the design. The design is not done on a cadaver, but on a woman up right where you have all of the blood in the fluids flowing in their body. That's why the design is so effective. Jim Casac is chairman of the board. He has two medical device exits and many patents under his belt. I recently invited Gary Kaiser, the Senior VP of commercialization to join our team. He has many years in the feminine hygiene space, and most recently with the Viveve. And then Larry Blankenship. He's our director of business development. These are trusted people that I've known for years. And I know that we can make this happen with the funding. Please help me bring this product to market with the funding that I'm requesting so that women can now prevent the involuntary loss of bladder control in a discreet way and improve their quality of life. Thank you