Bill Perry Presents Deep Blue Medical Advancements at LSI USA ‘23

Transcription

Bill Perry  0:05  

Good morning. My name is Bill Perry, I'm CEO of Deep Blue Medical Advances and Deep Blue is transforming soft tissue surgery by bringing out a new generation of surgical devices to provide optimal tissue tension, tissue reinforcement and defect closure. Our first focus has been on hernia surgery and the T line mesh is on the market and growing beautifully. But our customers our surgeons bring us guide us into new surgical applicant applications. And today we're introducing the T line tissue control suture. Now the problem that we're solving is failure in soft tissue surgery due to suture pull through of tissue in surgery or tissue in mash in Herning and hernia repair surgery. It's literally called cheese wiring. And this happens because the abdominal pressures overcome the strength of the surgical fixation site or the mesh anchoring in hernia repair. And for example, in hernia repair, it leads to mesh migration contraction and mesh tearing away from tissue, and a shockingly high hernia repair failure rate long term. The clinical manifestations of soft tissue surgery failure are severe, you can see the cheese wire effect photo with these gashes in the abdominal wall, caused by the surface of the suture cutting through the middle photo, the mesh dehiscence photo that was sewn onto the abdominal wall, those anchor points failed and it rolled up and contracted. And on the right you see torn fascia with the suture up above where the arrows are pointing in this perfect U shaped cheese wire cut down below. Now this is because of a lack of fast, reliable reinforcement that should reduce tissue stress at the surgical site. And without that you have soft tissue repair dehiscence and mesh fixation failure optimal tissue tension and reinforcement is critical but also very difficult to achieve. We're solving a mechanical problem. The problem is stress equals force divided by area now think of the snowshoe. The force of the body on the area of a shoe creates stress that pushes you down into the snow. If you increase the area simply by putting on a snowshoe you decrease the stress at that point, and you can walk on top of snow. Our first product that takes advantage of these principles in this technology is the tee line hernia mesh which is out on the market. It has a mesh body and integrally knit extensions and these extensions have 15 times the surface area of sutures and 300% greater fixation strength, we've eliminated a main point of failure which is that interface point. Now the mesh and the suture are one and the mesh lies flat and smooth. It provides a superior surgical experience with optimal mess mesh tension. Today we're introducing the tea line tissue control suture. Now why the TCS it's very simple, it's organic market demand all of our sites that so in the tea line mash also so in the extension and they instantly start telling us all the other applications in areas that they would like to use this technology. It's flat porous design greatly supports tissue quickly and easily. It grips and provides resistance with Two Way flexible tension adjustment. Remember barbed sutures that dominate the market of only one way tension adjustment. It comes in permanent and absorbable materials in a variety of wits, and it has a broad range of surgical soft tissue applications. And remember these gets stronger over time, because there's bio incorporation into the TCS application is fast, simple and advantageous. The first video is our hernia mesh being sewn in the lockstitch is bite through bite through cut. It takes a surgeon about half a mesh to get through the learning curve. And then the other video here is a running suture. running stitch with the same technology providing great tension adjustment, tissue reinforcement and defect closure. Our surgeons love how this technology works. Our portfolio has four products in it. The hernia mesh T line hernia mesh line is out on the market. It's available today and a permanent polypropylene mesh coming right behind that as a biosynthetic absorbable version of that then an umbilical version or robotic mis version of coated anti adhesion version. All these available are being developed now through 2025. The TCS in permanent and absorbable variations is available in 2020 for breast surgery is super important. To us. This was invented by a plastic surgeon so the breast tissue scaffold we have ongoing partnering discussions that will determine the timing of this product. And the anchor clip is an absorbable fixation device that works to secure the extension or the suture. And it'll be available in 2024. Now the first thing we did was go out to a couple dozen key opinion leader sites to get experience and understanding. And all of these sites have become our enthusiastic buying customers with routine use Mayo Clinic, NYU, UCSF Duke University. Remember these are the luminaries in hernia surgery, and soft tissue surgery. Two markets I'd like to focus on today. The first is the abdominal ventral hernia market. It's about an 800 million US market. It's about 400,000 mesh abdominal wall surgeries each year. There's four primary and 10 secondary players in the market. We love that dynamic for partnering or acquisition. And remember all these use the traditional anchoring approaches that contribute to recurrence. Now the TCS operates in the knotless tissue control device market. It's about a half a billion dollar global market and growing quickly dominated by three players Ethicon, Medtronic and Korzo. And the global suture market is of course, multiple billions of dollars. We've had two rounds of financing to date. With that we've achieved three FDA clearances. We did our alpha clinical launch until q3 of last year. Now we're in the second quarter of our pilot sales launch. We've had 12 manuscripts 16 posters. It's been two and a half years since our first implantation. And since then, over 3500 of these novel extensions and lock stitches have been sewn in with excellent results. We have a robust patent estate for product family at prototype stage or later. Now we're having really discussions on our first potential exit point for later this year. But we're also pursuing a B round and with that funding will grow our sales team, bring out six additional products and move into new clinical markets, long term clinical data that's already in process and do an international launch in Europe. And our second exit point is in the second half of 2025. We have an outstanding IP estate 18 patents filed 12 issued to allowed in four areas, T line mesh design, unique knitting approach of how you knit this mesh anchor clip, and the T line suture. We have an experienced proven team I've been doing this for more than 29 years. I've been part of multiple exits or have led multiple exits and an IPO venture fundraisings north of $115 million in 19, medical product introductions many of these from concept through to commercialization. My partner Dr. Howard Levinson is an academic add wall expert from Duke University and Eastern Virginia Medical. He's currently president of the American Society of Plastic Surgery, plastic surgery Foundation, the rest of my team has excellent experience and a proven track record. And we have a highly engaged and supportive board of directors. So we have three FDA clearances achieved to date, growing sales and our clinical and pilot sales launch multiple early manuscripts and long term data that's following behind that multiple medical conference presentations over 3500 of these extensions and lock stitches sewn in with excellent results in over the two and a half years that we've done since our first cases, a robust patent estate with outstanding value creation and protection to what we're doing for product groups with the first product on the market and others and process and ongoing business development discussions. I'd be happy to speak with anyone about our B round or further discussions as we explore that first exit point. Thank you so much.