Boaz Assaf Presents Colospan at LSI USA '23

Transcription

Boaz Assaf  0:05  

Hi, good morning. My name is Boaz Assaf. I'm the founder and CEO of Colospan. And in the next few minutes, I'm going to share with you how we are changing colorectal surgery. We have offices in Cambridge and in Israel. We've done we've completed two clinical studies with a device I'm going to show you with some great results 91 cases, the product is the mark and ready to be launched in Europe. We've got 14 branded patents and two more applications pending. And so far, we raise just about $20 million from metric VCs and one strategic partner in the surgical domain. And we also been granted blended financing from the European Innovation Council. Let's begin with the story of one of our patients at the age of 29. Mr. Chuka was diagnosed with rectal cancer, she didn't have any family history, and she was diagnosed after suffering from rectal bleeding. Unfortunately, Iran is not alone. Colorectal cancer is a well known disease all over the world. In the last decade, we've seen a huge increase in rectal cancer rate for patients below the age of 50. Like most rectal cancer patients, Irma was scheduled to get the long course of chemo radiation following by surgery with a plan to resect the disease section section and connect the two healthy segment together by colorectal anastomosis. The most devastating complication associated with colorectal surgery is anastomotic leakage of column content into the abdominal cavity. In the best case scenario, we're talking about longer hospitalization, intensive medication, very high rate of free operation and a huge cost. In the worst case scenario, the outcome is death. The gold standard treating today that surgeon are offering their patient to treat the potential of clinical EEG is to create a diverting Bypass also called the stoma. The surgeon excluded the loop of the small bowel outside the abdominal cavity and connect the patient with plastic back to collect his feces for a few months. Besides making life very difficult for patients stoma is associated with high rate of surgical complication. And closing the stoma requires another surgery and of course huge cost. So Emma hated the idea of having a stoma just for a few months, but luckily for her she was found eligible to participate in our clinical study. Here's a short animation describing our solution designed to replace diverting stoma. We have the audio please

Video playing  2:38  

Pass device designed to produce contact of fecal content with the anastomotic site. After the disease segment is resection, the CoLo span device placement begins through the placement of a single silicone ring around the colon. The surgeon completes the anastomosis as planned. The device is then inserted into the rectum using a delivery system. Once deployed, the thin silicone sheath is positioned by inflating the three balloons and the delivery system is extracted from the body. The ring connecting tube is fixed outside the abdominal wall just like a surgical drain on colon content passes through the sheath. Even if there is slight anastomotic the essence there is no spillage into the abdominal cavity after 10 days. When the risk for leakage is produced. The device is extracted with no need for surgical intervention. The ring is opened from the outside and extracted like a surgical drain. The balloons are then deflated and the sheath is pulled out from the rectum.

Boaz Assaf  3:38  

After surgery, Erma posted a comment on YouTube describing her experience and her concern of having a stoma. We are targeting a growing market of $5 billion based on 1 million procedure located in the left lower segment of the column of rectum per year. Obviously, there's been many attempts to solve the problem of clinical leaks. Unfortunately, none of these technologies showed any clinical efficacy nor be able to replace diverting stoma. We also identified two there are competitors, which we believe we have some unique advantages over both of them. But at the same time, we're happy to see some more companies trying to address the same unmet clinical need. Our potential partners list includes worldwide stapling surgical endoscopy and ostomy companies. The product again you see marked on the new MDR in Europe at the ready to be launched. And in the US it's a class three device with a PMA pathway and where do you have the idea proved? Of course, innovation is not enough today and everybody will have to show clinical or economic benefits. Our reimbursement strategy is focused on hospitals as a main stakeholders, and we've developed a model showing that by replacing diverting stoma with our device, hospitals can save up to $25,000 per patient We're looking at our five year plan, we see two inflection points. The first one will be mid 2025, when we will complete patient enrollment for the people who study and the second one at the end of 2026, when we will obtain FDA approval. We're now raising round of $30 million that will allow us to complete the pivotal trial, launch the product in Europe and obtain FDA approval. new devices often improve patient care. But rarely does an innovation change completely the standard of care while answering the needs of every key stakeholders in the game. Correspond is doing exactly that when it's device, we build a strong company answering the number one clinical need in colorectal surgery represents a tremendous economic upside. And we believe that with our assets in people, IP, clinical and regulatory well positioned to be the this strong leader of this domain. Our team includes top professional developments and commercialization of medical devices. And we also been honored to support by top scientific advisors. Just to close the story of Irma. She had a surgery in August 2021. And this was very successful, and three months later, she found that she's pregnant with a third child. If she had a stoma, this would be impossible for her. I've got a few more times. I'm just going to finish with a one message to you guys. March is the awareness month for colorectal cancer. If you're 45 year old or older and never got tested, I urge you go get screened, this test can save life. Thank you very much