Solo™ MicroPump Approved by FDA
According to a press release issued today “Elron Electronic Industries Ltd. (NASDAQ & TASE: ELRN) announced today, that further to it previous announcement on July 28, 2009, Medingo Ltd., a group company held 92% by Elron and its subsidiary, RDC – Rafael Development Corporation Ltd., has received formal clearance from the Food and Drug Administration ("FDA"), to market its Solo™ MicroPump Insulin Delivery System in the United States.
Medingo intends to introduce the Solo™ MicroPump at the American Association of Diabetes Educators Meeting which will take place in August 2009 in Atlanta, U.S.A.”
According to the Medingo web site the “The Solo Insulin Dispensing Patch is the smallest, thinnest, lightest, most discreet insulin pump without cumbersome tubing.
The Solo System has two parts: a miniature insulin dispensing patch and a remote control, which allows you to completely personalize and guide your patch for your body’s insulin needs.”
Diabetic Investor plans on meeting with the company at the AADE to gain some perspective on the Solo and learn more about how the company plans on marketing the product. As we have reporting for some it’s one thing to get an insulin pump approved by the FDA, it’s a quite another to have the ability to market and support an insulin pump and their patients.
The Solo joins the OmniPod from Insulet (NASDAQ:PODD) as the only FDA approved “patch pump” and puts insulin pump market leader Medtronic (NYSE:MDT) on the hot seat to get their “patch pump” before the FDA.
From our perspective it will be interesting to see what Johnson and Johnson (NYSE:JNJ) does in the patch pump area as their Animas division has made strong inroads into Medtronic’s user base. Using history as a guide Diabetic Investor believes the company will eventually buy their way into the business rather than build their patch pump. Frankly they will need such a product if there are to have any hopes of sustaining their momentum. Just as the company has partnered with Dexcom (NASDAQ:DXCM) to integrate Dexcom’s continuous glucose monitor with an Animas insulin pump, they will need a patch pump to have a complete insulin pump portfolio.
It’s well known that while Insulet has done a fine job of validating the need for a wireless insulin pump the company has had issues with costs of goods. Looking at the Medtronic patch pump and based on what we’ve seen regarding the Solo, both systems are designed to offer a lower cost of goods. The major advantage Insulet brings to the table is an installed user base of over 10,000 patients and years of experience as the only patch pump player. Insulet also has a second generation pod under development which should help lower costs. With a market cap of under $200 million, JNJ go easily acquire Insulet and use their considerable resources to bring costs under control.
Stay tuned, this could get very interesting.