Calibra Finesse - Elegant and Easy to useRecently Abi Basu, the Marketing VP at Calibra Medical gave me a detailed run through of their recently approved Finesse Insulin Patch-Pen. I'd been waiting to learn more about it since the FDA announcement on January 20th, because Calibra Medical doesn't have a web site.
In a nutshell the Finesse is a simple to use and elegant insulin dispensing device. It doesn't contain any electronics, so it takes almost no time to learn how to use it. And the Calibra Medical folks have really thought about design and usability carefully in the Finesse.
The design itself is slim enough that it should be invisible under most clothing. It contains a reservoir that holds 200 units of insulin.
To dispense insulin you simply squeeze the two small buttons on both sides of the Finesse, the unit clicks with each press so you can count the number of units delivered. There's an interlocking mechanism, so both buttons must be pressed before any insulin is bolused, this is designed to avoid accidental dispensing of insulin. It's a bolus-only device, so users will still need shots of long-acting insulin.
You fill the Finesse reservoir with a supplied syringe, they've got a window on the back to see any bubbles - you click the buttons several times to get rid of these. Priming the internal tubing takes about 8 units of insulin and then whatever is needed to fill the 6 or 9 mm cannula.
Depending on the Finesse model, each press will bolus 1 unit or 2 units of insulin. They hope to develop a model that will bolus 5 units per press, but that's in the future.
When designing the Finesse, Calibra Medical looked at some unmet needs in the diabetes space. They found that one major barrier to better blood glucose control is the need to carry syringes and insulin, or pens, at all times. The Finesse can be worn for 2-3 days and ensures that you'll always have the needed insulin with you. Currently Calibra estimates that only 6% of insulin users are on pumps, leaving a whopping 94% of folks with diabetes who might benefit from their product.
They've tested it under extreme cold conditions ("Minnesota-like") and determined that the dispensing mechanism continues to work well. The buttons lock when the reservoir is empty or the cannula is occluded. Currently there's no way to determine how close to empty you might be, they're hoping to have a window in a future version. They're also planning a pediatric version that dispenses 0.5 units with each click.
Calibra has developed a simple sticker system to remind you when you've been wearing the Finesse for 2-3 days. This was in response to the FDA's concern that people wouldn't know when to change it. Each box of 10 Finesse patch pumps comes with a sheet of stickers to remind you which day to change it on, and whether to do this in the morning or evening. And they've made sure that those stickers don't come off, once they're in place.
I was on a conference call with Ellen Ullman of Kids R Pumping and she asked about teenagers and the 200 unit limitation, because some teenagers might go through that much insulin in less than 3 days. (They eat a lot!) Here's the neat thing, you can load another Finesse and put it on but not start using it until the first is empty, so you already have a replacement ready to go.
Calibra Medical has talked with most of the major insurance companies and believe that they'll get coverage for this almost immediately and it won't be counted as durable medical equipment. Costs will be 'more expensive' than an insulin pen, they'll probably have a Tier 3 copay.
The gauge of the Finesse inserter needle for the cannula is 27 gauge, which is on the chunky side. But Calibra Medical claims that the design is such that it's almost painless.
Calibra Medical didn't give a definite date when the Finesse patch-pen would be available, they're currently finalizing some design and supply issues.
Why no website? Abi Basu points out that if they had a website (it appears they currently own the domain CalibraMedical.com) most of his time would have been spent responding to inquiries and demands from potential customers.
My opinion? Calibra Medical has addressed a real need in the marketplace. Their patch-pen is really easy to use, extremely discreet and ensures that the wearer always has insulin for boluses with them. It's one less thing to carry around. The design is as elegant as it can be, and it's something that will probably have an off-label use for Symlin and other drugs. I'm looking forward to trying one out!