TANDEM DIABETES CARE ANNOUNCES FDA CLEARANCE OF THE T:SLIM™ INSULIN DELIVERY SYSTEM

Smallest Insulin Pump System and First-Ever with a Touch Screen

SAN DIEGO, November 16, 2011—Tandem Diabetes Care, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:slim™ Insulin Delivery System (t:slim). This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.

“With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy,” said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.’ The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.”

Of approximately 1.5 million people in the U.S. with type 1 diabetes, industry estimates indicate that only 20 to 30 percent use an insulin pump, despite clinical evidence that pump use can improve glycemic control and quality of life. Tandem Diabetes Care believes that enhanced ease of use and attractive design will encourage more patients to consider the clinical benefits of insulin pump therapy.

“Medical devices are often designed for the hospital setting, not for everyday life. Things like size, look, and feel are often overlooked,” said Dr. Timothy Bailey, director of the Advanced Metabolic Care and Research Institute. “Patients need an insulin pump designed to easily integrate into their daily lives. The device needs to be unobtrusive and look more like the consumer electronics they already use every day.”

The t:slim has a vivid color touch screen and was designed to make diabetes management easier to teach and easier to learn. Additional user-oriented features of this insulin pump include an eco-friendly rechargeable battery and USB connectivity to a web-based therapy management software.

As part of Tandem Diabetes Care’s commitment to excellence, the Company will be building its customer support, sales, clinical, and business operations in preparation for U.S. launch during the first half of 2012.

For broadcast quality B-roll footage, please visit: http://videostorage.prnewswire.com/storage2/download/53296HD.zip

About the t:slim Insulin Delivery System

The t:slim is a modern, programmable insulin infusion pump for people with diabetes mellitus age 12 and greater who require insulin. The pump’s streamlined interface provides users with quick and easy access to all the device’s functions. The t:slim features Tandem’s proprietary micro-delivery technology, which provides safe and accurate insulin delivery from a 300-unit cartridge, and allows for the device’s slimmest-in-class form factor.

About Tandem Diabetes Care, Inc.

Dedicated to advancing the management of diabetes, Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a privately held company with novel technology and a comprehensive, user-centric and integrated approach to product development and customer care. Tandem is based in San Diego, Calif.

Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslim

Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetesCorp

Tags: news, pumps, technology

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It would be nice to see Animas follow suite with something like this and has built in CGM. That's a package I would buy in a hearbeat.

Check it out Timmy-D... Animas/Dexcom CGM hybrid, approved in the U.K. ..Hard to say when the FDA will approve it here in the U.S. (no touch screen)

http://animascorp.co.uk/animasVibe

Virginia Valentine, Dr. Edelman, Gloria Yee and John Walsh...all well known in Diabetes care etc. I know Virginia, it doesnt get much better than her! I think at least the company has a great team in them!

This was a very popular topic in some of the diabetes groups on Facebook. There was a concern there that it would be easy to touch screen and cause an unwanted bolus. One of my friends posted that she had attended a conference/expo where the Tandem pump was being shown. She asked about accidental boluses. The rep told her there are built-in features that would prevent this happening.

Here is what Amy Tenderich thinks about the Tandem pump:

http://www.diabetesmine.com/2011/11/newsflash-tandems-sleek-new-tsl...

Thanks Richard. Does anyone know if it has CGM communication/compatability?

It is compatible with several glucose meters, but not a CGM at this time. I read somewhere it will be upgraded for CGMs later on. The Animas and Omnipod are supposed to combine with the Dexcom CGM very soon.

It is a handsome looking piece of kit I have to admit, I bet cellnovo aren't too happy ha.

As others have said, it doesn't look particularly durable and unless they have used gorilla glass on that screen it would be scratched or cracked in no time and whilst it may fulfill Steve Jobs design mantra of being thin and pretty, it still has a large surface area overall footprint and doesn't look that solid to me.

The thing that makes an iphone is the slick OS and software experience, people try to emulate it all over the place but always get it wrong, I have used many a dodgy touch screen product that is trying to rip off the ipad/ipod.. Just because it looks like an apple product it doesn't mean it would function like one.

Also nobody is going to want to mug me for my pump in Brixton in London, but I bet that thing would look alot more interesting to thieves.

Also rechargeable batteries of this type as you see with mobile phones and laptop deteriorate rapidly, not holding as much charge as they used to, behaving unpredictably and generally being unreliable. Unless the battery is removable and comes with a back up I would not be interested.

Normal pumps you can just carry a AAA battery with your kit, I get 7 weeks out of a AAA battery on my pump which is great. It is also solid and durable..

I would not buy the first iteration of any product, especially an insulin pump from a start up company. Mistakes are always made in the early days (even with Apple ha) and an insulin pump is not something I want mistakes happening with.

Seems like form over function to me, so no doubt it will appeal to the masses ha :)

I want to see the full specs on this pump before I can say for sure. It may be slimmer but also be longer and wider. Just too hard to tell. They say it is shaped "like" a credit card but the term like could mean a whole lot of things.

I also wonder about the sensitivity of the touch screen. That is one place even many phones struggle and are frustrating to use. Would be terrible if the touch screen wasn't very responsive.

The biggest drawback for me is the recharging issue. I am an apocalyptic kind of guy and do not want to rely upon modern conveniences (power) 100% when it comes to insulin delivery. I can always stock batteries.

In the end I am happy to see new insulin pump technology come out and hope it can spur some of the other companies who have been using the same platforms for a long time to innovate a bit.

It recharges via usb, which gives you a lot of options including recharging from your car. What I don't understand is why what they say is all aimed at Type 1, it is if they do not know that there are also type 2 on a pump? With the 300 U cartridge, it would also be fine for T2 pumpers. With 3 x as many T2 as T1 on insulin, why limit the market?
-Lloyd

The guy with the cash behind Tandem, is the Grandfather of a type 1.

I just saw this. Awesome. The only thingI have not found out about is the rechargeable battery. I do not want to have to recharge on a daily basis. Its about time they got with the program and developed a better interface. Most pump interface's rival a TI-82 graphing calculator. Old, clunky and ugly.

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