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Tony Galliani 2018 Transcript

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Freed: This is Steve Freed with Diabetes in Control and we’re here at AACE 2018 in Boston, and we have a special guest with us from Companion Medical, Tony Galliani, and he’s going to tell us about his product. It is fairly new, an exciting product especially for type 1s but more importantly even for type 2s, for people that are on insulin. And maybe you can kind of go through it as if you walked into a doctor’s office and you were going to explain to them for the first time what your product is all about.


Galliani: So, I’m with Companion Medical. We have InPen which is a Bluetooth connected smart pen. And it takes Novolog or Humalog insulin in pre-filled cartilages, delivers it in half-unit dosing increments, and it’s connected to an app on the user’s phone. And basically what it’s doing is it’s giving the user and the health care provider pump visibility, pump data for their multiple daily injection users. So, let’s say, a patient comes into their physician’s office and they’re on their insulin pump, the physician downloads their pump and they can see how much insulin the patient has taken, when they’re taking the insulin, how much they’re taking, if they’re missing meal-time doses, if they’re using a dose calculator. So, they get a full picture to what the patient is doing, so then they can better help the patient manage their diabetes knowing what they’re doing. But today, if a patient comes in on multiple daily injections, they have no data. They don’t know when the patient has taken insulin, if they’re even taking it, if they’re missing or skipping meal-time doses. So, it’s just makes it a little challenging knowing what the patient is doing without having the data. So, typically what ends up is a conversation with the patient, “Are you taking your insulin? Are you missing doses? Are you taking it as prescribed?” So, what Companion Medical does with InPen is we now fill that void. So, now with their multiple daily injection patients, they can now get complete visibility to what the patient is doing. They can see when they’re given insulin, how much was given, if they’re missing meal-time doses or skipping meal-time doses, so that patient visit with the provider now can be a little more effective because now the doctor actually knows what the patient is doing as far as insulin delivery goes.

The benefit that the patient gets is we’re taking the math away from the patient. So, now without using the connected smart pen, patient is counting their carbs and they have to remember their insulin-to-carb ratio, their insulin sensitivity factor, their blood sugar target, they have to do all the math in their head to figure out, “Based on my current blood sugar and what I’m eating now, how much insulin do I need to take?” And forget the fact that they also should be considering the insulin they took a couple of hours ago, and how much of that insulin is still active in their body, and it’s difficult. It’s difficult math to do. So, we take all that away.

[Galliani demonstrates app interface on mobile device] We have a dose calculator. So, this is the home screen and on the home screen what the patient sees is their last blood glucose, and the last time they gave a dose of insulin, and how much that dose was. This is a timeline. It shows the last 12 hours of activity. The purple circle is blood glucose and the outside circles here are insulin delivery. The reason why they changed colors is blue is a new dose. And since we’re tracking insulin on board here, right now I have five units of active insulin and that’s five units of this last dose. As these doses fall down the timeline here and that active insulin is being used, these doses shade from blue to gray. Here’s the dose calculator. So, to activate that, I would just tap on that, I would enter in a blood glucose. Let’s say my blood glucose is 280 and I’m eating 50 grams of carbohydrates. It’s going to recommend four and a half units, so we’ll just save that. And then dial up to four and a half units and deliver it from the pen, and then you’ll see that four and a half units automatically populate here on the timeline. And then, if I go the log book here, I can see that four and a half unit recommendation, the four and a half unit dose. And here, I’m getting my average daily glucose, total daily insulin, and total daily carbs. And on the graph here, blue is my insulin, green is my carbs, and the individual purple dots are blood glucose, and the line here is my CGM reading. I’m wearing a Dexcom G5 right now to show that. And I can scroll back and I can see my CGM readings from yesterday and I can continue to go back day-by-day to see what my individual readings are. And then to generate a report for the physician, I would just tap here on the reports tab and then I can generate a PDF right here from the app and share that via email or fax right to the provider. And the phone doesn’t have to be on. The phone can be asleep in their pocket or in their purse, but the important thing is every time they dose insulin, we capture it. And it’s connected via Bluetooth radio from the pen to the phone.

Freed: Who’s your target market?

Galliani: Target market is really anyone on intensive insulin therapy. We have talked about insulin pumps market before. The insulin pump market segment really isn’t growing that fast. And you look at maybe about 40% of type 1s are on insulin pumps, so our target would be the 60% that are not using pumps and that gives now patients visibility to what they’re doing and also gives the provider visibility to what the patient is doing. Because I think if you look at a patient on multiple daily injections, I don’t think I’ve met one yet that at some point has not forgotten to give a dose of insulin. So, now what they’re getting is if they don’t remember whether they gave their dose at breakfast, they can now just look at the home screen on their app and they can see not only when they dosed but how much they dosed. So, this gives them now that visibility to what they’re doing with their insulin delivery. And if they tend to forget to dose at meals, we also have reminders there that will remind them if they don’t have a dose.

Freed: Is there an alarm you can set, so that it can warn you not to take a dose or it’s time to take a dose?

Galliani: Yeah. You can set up timed reminders. So, let’s say you have someone that tends to forget to dose at lunch time, you can set a reminder — you set the time parameter. So, let’s say you would set the reminder between 11:45 and 12:15 if they don’t give a dose in that time, then the alarm will go off and remind them to give that dose.

Freed:  So, it’s pretty similar to an insulin pump except you’re not wearing it.

Galliani: Exactly. They’re getting almost all the features of an insulin pump without the cost of a pump; we’re a fraction of the cost of an insulin pump and without having to wear a device. And really we’re doing everything that the pump is doing except we don’t have the ability to vary basal rates, so patients would still be on basal insulin and we don’t extend the bolus. But other than that, I think the most important features of our app being the tracking active insulin, because there’s always that fear of patients have on multiple injections for stacking insulin, so we’re tracking active insulin and we’re deducting that from corrective doses. And then the numeracy part of it, taking the math away. It’s difficult for patients, for most people, to do that math at meal time to figure out how much insulin to give and there’s always that fear that they’re going to give either too much or too little insulin.

Freed: So, someone who’s on basal bolus, they would have two pens?

Galliani: Correct. They would have two pens.

Freed: And does the software take that into account?

Galliani: So, the Connected Pen is only for their bolus insulin, not their basal insulin. They would still use their basal insulin pen, the same way that they’re using it now. But what we did do in here to help track that is we added a basal reminder, so the patient would select what type in the app, select what type of basal insulin they’re using, how many times a day they’re taking it, the time of day they typically take it, and the amount that they take. And then every day at that time, they’ll get a pop-up on their phone, “Did you take your 18 units of basal insulin?” And then, the patient gets the choice to just tap, “Yes,” that they did take it, they can snooze it, or they can change the amount. And what that also is, it’s not only a reminder for the patient to take their basal insulin when they’re supposed to, but it also then tracks that into the log book. So, when the report is downloaded, the provider can see when the patient has taken their basal insulin, if they’re taking it at the time they’re supposed to take it and also to take in the amount that they’re supposed to take.

Freed: And what kind of warranty does it come with?

Galliani: It comes with a one-year warranty, so if it breaks within that year we replace it with a new one. And there’s also no maintenance involved in it. We wanted it to be like a seamless transition from their current pen, so they don’t have to replace the battery, they don’t have to recharge the battery. The battery is warrantied to last at least a year.

Freed: And insurance? Do all the insurance companies or most of them cover them?

Galliani: Most of the insurances do cover it. Yeah, we’re seeing pretty good coverage nationwide on commercial insurance plans. We’re seeing coverage about 60% of the time, it really depends on the patient’s individual pharmacy benefit design on what their coverage is going to be, but we have a couple of mail order pharmacies that we’re working with. They’ll verify the patient’s benefits, call the patient, let them know what they’re co-pay is, and then they ship it directly out to the patient. But we’re seeing an average co-pay between $50 and $60, and that’s just one co-pay for the year that they would pay.

Freed: How long does the pen last? Because you don’t replace the batteries.

Galliani: We don’t replace the battery, right. So, basically when the battery dies is when you would purchase a new pen.

Freed:  And how long is that usually?

Galliani:  Well, we’ve only been on the market a couple of months now but its warrantied to last at least one year, so they’ll get at least a year out of it.

Freed: Okay. And anything else that — any other comments that you’d like to –?

Galliani:  Yeah, one last thing. We also have connectivity with Blood Glucose Meters and also Continuous Glucose Monitoring, so if a patient is using a meter or a CGM, it’s connected into Apple Health. They would just turn on the source sharing in Apple Health and we can display that data automatically also. So, if they’re using a connected meter each time they check their blood glucose, it’ll automatically populate on their home screen, automatically populate in the dose calculator field, and then also on the log book. And if they’re on a Dexcom G5 or a G6,, it will automatically display in the CGM reading on the log book also. So, then when the report is generated for the provider, the provider can not only see insulin dosing information but they can overlay that with CGM or BGM info as well, so they’re getting that complete picture.

Freed: Okay. Well, I want to thank you for your time! I hope that we can inform some medical people all about your product because it is fairly new. I think it’s interesting because I’ve read a number of articles that basically say because of the cost, your product will be more effective or actually cost the insurance companies a lot less money, so they would prefer —

Galliani:  Right.

Freed: So, we may see some changes in the coverage for pumps and for pens. In fact, the concept that you have is so popular, you’re going to have a lot of competition.

Galliani:  Right. And we’ve been — we’re certainly busy here at the conferences. We were standing-room only at our booth here.