Adarsh M. Patil, OUI Medical - Portable & Disposable Micro-Peritoneoscope | LSI USA '24

Dr. Adarsh M. Patil  0:03  
I am Dr. Adarsh M. Patil. I'm a surgeon and I practice minimal access surgery. So I'm introducing P scope, world's first go for abdominal cavity examination. So endoscopes have transformed medical science, and they are used for examination of body cavities. Approximately 250 million procedures are performed every year. And there are 10 major types of scopes, for example, a colonoscopy for a colon a sister scope for a bladder. So we have developed a scope for abdominal cavity examination. Our vision is to make abdominal cavity examination accessible and safe. The problem we are solving is that the present process of abdominal cavity examination is quite complex. Whenever there is a problem in the abdominal patients have to first undergo non invasive tests, like an x ray ultrasound, CT scan and a PET scan which have their own limitations. They have risk of radiation, they are often inaccessible and inconclusive. To those patients in whom these tests are inconclusive. They have to go through a invasive tests like a diagnostic laparoscopy, or a diagnostic laparotomy, which is an inpatient procedure requires anesthesia and surgery, which is painful, inconvenient and expensive. So we have simplified the process of abdominal cavity examination we give local anesthesia on the abdominal wall a tap block, we confirm the needle position if required. This is a completely disposable scope. It has an optical port camera light source, a balloon to insulate atmospheric air, and a screen to visualize inside. So we make a small Nick, we introduce this device inside under vision we go layer by layer without injuring any internal organs. Once we're inside we put some atmospheric air to make some space inside the peritoneal cavity. We introduced the scope inside and we can have a look inside the abdominal cavity. These are the interstates This is the lever. And if required, we can pass a biopsy forceps and take a biopsy. And it has a feature for irrigation suction as well remove all the guests remove the port and the patient is completely awake because this procedure is performed under local anesthesia. So the device is portable single use and it's cost effective. So it's an ambulatory procedure performed under local anesthesia. It's minimally invasive, and it's painless, convenient, and it's cost effective. So it has multiple compelling applications, one of them being patients admitted in ICU with abdominal sepsis. These patients have a very high mortality rate up to 70%. Mainly because at presentation these patients are very sick with multi organ failure. And transporting these patients to radiology or operating room is not safe. So in these patients, we can perform the scopey inside an ICU in the bedside, we can go inside, have a look and come to a definitive diagnosis. So there is evidence available for this. There is a study bedside laparoscopy as a diagnostic tool in critically ill patients review article wherein they bought the laparoscope in an ICU, perform these copies and try to find out if this procedure was really helpful. And they found that there was change in clinical management in 70% of the patients, they could avoid unnecessary laparotomies in 50% of the patients, and they could reduce mortality rate by 20%. So it could become a gold standard for this for this particular application. It has other multiple compelling applications in staging of abdominal cancers to identify peritoneal secondaries in emergency care for blunt trauma, abdominal or military field hospitals. It helps in timely and effective treatment in Golden arc. It has some exciting applications in perioperative care, and some future applications as well. So again, there is evidence peritoneum scopey for surgeons, Dr. Eduardo ah, perform 2000 find its Kopis over 10 years using existing laparoscope under local anesthesia and using atmospheric air and he concluded that it has great value in liver pathology malignancy, it helps in planning surgery and reduce morbidity. So what I'm trying to convey is that the benefits of examining abdominal cavity under local anesthesia have been well studied and well documented. However, there was no device that was portable, that could be used outside the bar that had all the regulatory clearances and reimbursement code. So we are filling that gap. The potential being abdominal has 10 major organs. We have multiple Will compelling applications approximately 30 million diagnostic laparoscopy is performed every year to our manufacturing cost is $100. We sell these devices at $1,000. We intend to generate a million procedures and a billion dollar revenue. To the total market size for laparoscopy is globally is around $15 billion. Approximately 25% of the these laparoscopic procedures are diagnostic in nature. That makes the sum of $4 billion. And the US market share for global metric market is around 30 person that makes the sum of around $1.3 billion. It's a noble device, we have applied for utility patent globally. And we have received our first examination report, which is really positive, the market for disposable endoscopy is growing at 17%. And also the minimally access surgery market is growing very rapidly. So we believe this is an ideal timing for this device. So as of now we have a market ready product with competing contract manufacturers in place. So we have taken an IRB clearance and completed first in humans. So we have had our first meeting with FDA, and they have given us a great feedback on the device. And our fight and key application is ready we have identified a predicate for our device to in we intend to submit our FY 20 application the end of this month, and we expect to get an FDA clearance by quarter three. And beyond that we intend to generate supporting clinical data and also early sales by 2024. And with this data, we would look for an exit by 2025 upward of a billion dollars. And we if we do not get a proper valuation for our product, then we intend to raise the next round and get to an IPO by 2028. So we fit in existing reimbursement codes. So there are approximately 20 OEMs in the market, endoscopy market. Olympus Ambu Stroz, Boston Scientific excetera. We are a good strategic fit for these these companies. And also this device is a platform to access abdominal cavity under local anesthesia, which brings in new opportunities for new procedures and new therapies. And there are products in the pipeline. I'm Dr. Others I'm a minimal access surgeon with 15 years of experience. And Thomas has 30 years of leadership experience in med tech with three exits. Suzy is an healthcare healthcare innovation leader. And Dr. stiffen is a surgeon and a formal former medical officer for FDA and he has been great help with FDA. We look forward for your support. Thank you