Melzi | Reid Rutherford, CEO

Reid Rutherford  0:01  
Thank you. My name is Reid Rutherford, I'm the CEO of Melzi Corporation. This was just mentioned, we are the developer of the Melzi sharps finder.

Our product was initiated. Based on a surgery that occurred in the Philadelphia region several years ago, a robotic prostatectomy was done. And the sixth step, the robotic procedure was successful, the patient received the treatment they need. The end of the process, though, during the wrap up of the surgery, surgical procedure, the needle actually went rogue, it actually flipped away, and wasn't immediately obvious, they had to redirect the cameras being robot, it was being operated through video system, and they went looking for that needle, and actually looked for over an hour and could not find it. surgeons will often describe that process is like it falls into quicksand, the body is blood is pumping, the body is breathing, things are changing. And as a consequence, the needle can get lost and take a while to get lost. In this particular case, the surgery had to be ended because they couldn't keep the patient under. And the end of it that procedure, the medical practice is that the patient needs to be told, your surgery went fine, everything's great. But oh, by the way, we left a needle in you. And of course, that's not something that's necessarily good news. It's not the worst thing in the world scar tissue will form around it. But in essence, nevertheless, it's not something that surgeons like to do, and they will go to great lengths to find those needles. It's not uncommon based on the surveys, we've seen that, at least, there'll be a number of events that take as much as a half an hour to find and another 15-20 minutes even calling for X ray. The event seems to occur based on surveys about 390,000 times a year. In most cases, as I mentioned that the surgeons will actually locate the needle and retrieve it. And as consequence, there's no further need to discuss it or expose it. But in fact, it happens quite a bit costing a lot in terms of wasted time and procedure in terms of the operating room. Our product was designed to find those lost needles to save the trouble of having to leave it there and have the the problem of telling the patient that we left the needle on you. In terms of the investment we're looking for we we tried to target a very large market and every hospital every hospital doing OR surgery, operating room surgery will need a device like this, we trade or suggest that the item is like a fire extinguisher, you don't need it all the time. But when you need it, it's very good to have it available. There's also the savings for the hospital operating room costs are in the hundreds of dollars a minute. And therefore if you can save that time, there's benefits to the to the institution. And finally our product is patent protected. We have two issued patents one allowed patents as well as a design pattern. The product itself is designed in ergonomic fashion, it can be used in right or left hand it's designed to go through a five millimeter trocar. So it's for the modern standard in terms of very small trocars. It's a 45 centimeter shaft useful clearly in laparoscopic and robotic as well as open surgeries. The way it worked functions is that there's our magnetometers in the tip, which you can see here, there's magnetometers, and they're basically sniffing or smelling the magnetism that's in the environment. We live in a soup of magnetism, the Earth's magnetic fields are strong electronic equipment producing electro magnetic signals. The device functions by noticing changes in the magnetic fields into acidity as a consequence, if it's in a patient, it will be able to identify that it's near metal and near surgical items such as the needle or a fragment. Product is fully adjustable and the sensing be up, increased in sensitivity or reduced. It's designed as a one time use. It's battery operated, it's available when needed. And then when it's completed, it can be retired. The management team consists of people from Stanford from MIT, Temple University, Virginia Commonwealth University and it was well as a development team that's been experienced for many many years. The product is FDA registered is already approved for human use. We are actually in hospitals. Current hospitals include the Houston Debakey Medical Center in Texas as well as the Hackensack Meridian Center in New Jersey, Yale University Middlesex Hospital in Connecticut, as well as the hospitals in in temple and finally I mentioned Stanford University in Palo Alto. The problem of losing needles as I mentioned significant about 390,000 sharp objects are lost every year. The cost if there's a medical malpractice claim that results typically will cost around $2 million. There's certainly the big costs and the main thing that surgeons like to avoid is the reputational damage. The patient risk is significance is that was mentioned the number one are by the Joint Commission the number one never do occur happen that comes happen, our last surgical items. And finally, just to mention the timeframe. Typically you might see as much as 70 minutes added to a surgery if there's a lost needle event.

The problem is increasing because as we see the rise of laparoscopic and robotic surgery, the lack of tactile responses going down or the limitation of tactile response. The photograph on the screen shows actually, this is a human surgery, there's robotic graspers, working on a suture needle and suture itself. During this fray of this particular process is the surgeon was trying to disconnect the surgical needle from the suture, the needle flips away. In this particular image, the process actually took 50 minutes to locate the needle. And to get it happened on screen, you can see the needle flying, you would say just go get it. But in fact, as I mentioned, it took 50 minutes. And this was after an x ray, which wasn't able to detect the needle. The other point here to be aware of is that in times past, the significant most significant problem of retained items were the sponges that are used during the surgical process. New technologies, there's an RFID system, there's straps and radioactive radio illumination strips that are part of the sponges have made that problem be reduced significantly. And as well, we're now seeing the problem with the sharps, the needles the metal objects increase. Again, the way that I should mention just some of the features of the product. It detects lost needles with a 95% reliability rate, meaning that if they go hunting, it will detect needles at a 95% reliability is capable for use in laparoscopic robotic and open surgery. It's indicated for use in gastroenterology and urology as well as other activities that surgeons might like to use. It is also being used for miscounts. When a surgeon surgery is performed, they count the number of needles going into the process. And then they count the name of the needles coming out. There's a fairly common event where say 20 needles go in 19 are out. The question is where's that last needle? Is it on the floor or is it in the patient, we're finding that the product reflects a higher reliability than X ray and locating those last needles. And finally, the main point is it's a one time use product, maintain sterility and available for provides for recurring sales. As I mentioned, the way it works is there are magnetometers in the tip. And they're basically measuring the magnetic fields that are present. And when there's a change in that magnetic field that detects and makes a signal both light to light, as well as signals with a buzzer. So the surgeon operating the unit was able to identify that needle is in the vicinity of where the sensor is. In terms of our commercial rollout, we have as mentioned already achieved FDA registration, it's approved for human use. We've done a limited clinical rollout where we're putting the product out in the marketplace to get feedback from surgeons in the operating room staff as to how well it works. We're doing work with conferences and sales to basically alert the markets as to the availability of the product. We're looking to start an aggressive national rollout, expand our distributor network and continue to be presenting the unit to conferences and others. Our plan for exit is that basically, as we have the siglas product, the launch of the product becomes successful. And we increasing sales and demonstrating the market acceptance for the product. We expect that this product really belongs in the catalog of a global mark of a global device supplier. It's with a significant hospital presence. We've had some interest there and we expect that to increase over the next month. And we're also looking at a regional licensing distributor arrangements for that. Thank you very much. If any interest further on this, I'll be available in the conference room next door. Thank you