Patent Attorney and Founder
Physiotherapist hoping to rehabilitate her industry. I’ve been developing Halo for five years now, so what I’d like to see is Halo grow, and that’s what I’m hoping that we’ll have support to do today. My name is Hayley Warren, I’m CEO and founder of Halo Medical Devices. I’m here today to ask for 200,000 for 21% equity in our company.
Halo Medical Devices was formed when I was a physiotherapy student. I saw a need to make sure we’re getting the best tools out there for our therapists. So traditionally in physiotherapy, when we look at how the joints are moving and if we need to do any therapy on them, we’ll use the standard goniometer. So you can get an idea of what is going on with it. I’d like to show you what it does.
So traditionally, we’d hold it over, we try to make the landmarks up, we guess what’s happening here. You have to do it with two hands, so you can’t support the limb, and you’re trying to do that because one assumes there’s been an injury to the arm and the movement has been restricted, is that what we’re looking at?
Exactly. Yes, it’s very difficult to read the three numbers as well, and Harley’s at the state-of-the-art product at the moment, John, that this is the best on the market.
You’ve got to be kidding. I know. So every practice will have from the finger goniometers, the small ones right through to these. I’ve invented a device that does all joints in under five seconds.
With the Halo, the lasers will always go along any length of limb. You can always intersect with landmarks; therefore, it becomes a repeatable measure, and that’s where we get our reliability off. So from here, we just zero it, which is a click of the button, and then we drop it around, and I click through, and I get the range. That’s its huge selling point: the accuracy, the speed of use, amazing. So it’s being used in a rehabilitation environment to measure the angle of improvement, I guess, in the flexibility post-injury. And it’s being used to make decisions on additional care for sure.
Okay, and at that point where they’re asking for money, you know, we didn’t get to listen to the whole thing, but would you assume they’ve already been through some sort of trials before they can go to market? I mean, what are some of the institutions or companies that might be stopping them from going forward if they haven’t done it?
So if they had come to me, I would have recommended that they conduct a regulatory assessment or have a medical device expert conduct a regulatory assessment like we talked about earlier. So the FDA will begin to investigate these products to determine, you know, in fact, what is its intended use. If they determine that it is a medical device, they will then send a warning letter to the manufacturer, saying your device is a medical device regulated by the FDA, and it needs to go through FDA regulatory clearance, approval, or listing depending upon the classification.