Chris Richardson Presents SafeHeal at LSI USA ‘23

Transcription

Chris Richardson  0:05  

Good morning everyone, and SafeHeal is reshaping the way that colorectal surgery is being performed for cancer. Each year unfortunately, almost 2 million new patients are diagnosed with colorectal cancer. It's the second most common reoccurring and female and third in males, and post the initial diagnosis of having colorectal cancer. The patient usually goes through chemotherapy or radiation therapy, followed by resection of the disease section of the colon. During this resection, the to clean edges of the colon are reattached in an anastomosis. This anastomosis needs to be protected or kept clean for a five to 10 day period of time while it heals anywhere else in the body that takes place naturally because of the sterile environment. In the colon being a dirty or infected area, the standard of care has to be a diverting colostomy or an ostomy being performed. So immediately after the anastomosis is created, the colorectal surgeon will then divert or exteriorize an upper part of the bowel proximal to the anastomosis, creating an artificial anus on the abdominal wall. This subjects the patient to wearing an ostomy bag for fecal removal for a period of about two to six months while that ostomy heals, then post the ostomy healing, the patient has to undergo a third major procedure to reverse the ostomy. Unfortunately, for 20% of those patients that are not able to have the ostomy reversed, and they're subjected now with wearing an ostomy bag for the rest of their life. If there was an elegantly simple solution that could keep this and asked the anastomosis for the healing process. 85 plus percent of the diverting ostomies could be avoided. Thus, enter colback colback is a non surgical endoluminal temporary fecal bypass device that mimics what a diverting ostomy does. Our device is a nitinol self expanding self expanding stent platform that has an indwelling attached sheath with two sealing rings and a vacuum chamber. After the anastomosis has been created, the surgeon over a pre loaded introducer inserts our device through the anus above the level of the anastomosis and deploys the device. Unlike most self expanding stents that require tensile strength to maintain its position Karlovac uses vacuum or negative pressure, this negative pressure poles the colonic wall against the fenestrations of the stent, creating a circumferential seal. Now all fecal material passes through. The coal evac device exits the sheath through the anus during normal peristalsis protecting the incision from any fecal material through the healing process. Post the five to 10 days that this patient needs to heal. The colon back device remains in place at that time of healing. We decrease or remove the suction. Through an endoscopic grasper, we free up the proximal and distal ends with the ligatures and extract the device through the anus. We prevent not one but two major surgical procedures and the complications associated with for a simple indwelling device that takes five to 10 days. The marketplace we plan is huge. We have about a $10 billion spend being done in right now worldwide in colorectal procedures and if we just took the low hanging fruit, the mid and lower rectum and colon area as our initial marketplace and focused only on the replacement technology that we're going after which is ostomy bags and ostomy reversal. We're looking at entering and seizing a $3.5 billion market day one. Unlike most medical technologies that have to go through clinical and regulatory clearance and then fight for reimbursement. The colo vac device participates in an existing DRG in the United States and Europe already at very high a ISPs were cost a creative to the health care system and cost negative when it comes to avoiding the complications of not one but two major surgical procedures. We haven't rested on this Laurel if you will from associated DRGs and we've already in pre commercialization and filed for the N UB status in Germany. That's the new tech add on payment and received more than 60 sites have already applied and received this. And we're working with CMS on the past through payment as well. Our clinical the data so far has been broken up in three different pilot studies, safe one safe 2019 and safe to. Collectively these studies have shown that we prevent ostomy in more than 70% of the patients, and 93% of the patients have clean colons beneath our device. The learnings from these three pilot studies have led us to an adaptation from the current generation now to the cola vac to device. Instead of having a negative suction source being vacuum bottles that need to be changed a couple times a day. We've gone through an automated smart vac system which is set it and forget it. The physician at the end of the procedure will put in the negative pressure desired and no one's self regulate throughout the healing process for the patient. We've also modified the colback stent design, instead of a dual stent platform. We've now gone to a woven single stamp platform for two reasons. Number one, the colon is a muscle and during Peristaltic contractions, it expands and contracts. This new woven stent platform will allow peristalsis to occur without the risk of any migration upon suction loss. Our third improvement of the device has been a new introducer it is far more flexible and allow us for indication expansion, and more importantly a more controlled deployment of the device. These changes are going to be in part in in our safe three trial, which is going to be the pivotal trial for the company that it will be in Europe and the United States and initiate in the first quarter of next year. We've already received a secured a strategic partner in China with Genesis medtech. Our IP portfolio is robust. We have five different families of patents that are either been issued or are pending. And we've already conducted to freedom to operate searches. The safety leadership team is the who's who of our business. Collectively we average over 24 years of medical device experience. Our board of directors with Antoine and Anne from Sofinnova We have Shawn from Genesis MedTech and in industry veterans like Jay and Michelle round out our board. So why are we here? To date safe fields raised $30 million in equity based funding an additional $18 million in non dilutive capital from Genesis med tech license and distribution agreement in China with a very low ASP. We have a contribution margin or profit margin nearing 90%. We're raising $35 million at this time that will take us through crossover to profitability which will occur late in 2027. Early in 2028 I appreciate LSI time for let us present today and I appreciate your attention. Thank you