Today’s BIEL Announcement – Why It’s Important
by Joe on April 27, 2010
WOW!!!! – Today’s BIEL Announcement – Why It’s Important – I am Seriously Impressed by This and Upcoming Introductions
This is really simple. BIEL is announcing a new version of its device. It has higher power (10X) and operates at a different frequency. Most of the time companies want to have their new devices be very similar to the old devices so that the FDA will rubber stamp them into the existing clearance. BIEL does not want this because its current Class III clearance is an issue. It wants the new version to be viewed by the FDA as a different type of device – not another Class III device. The strategy is to have the device have the same attributes as an electric stimulator device, which is a Class II device. This new device does.
If you have been following BIEL for any length of time you should be having an Ahh-Ha moment!!! The main issue with FDA clearance is that ActiPatch and Allay are considered Class III devices. FDA does not seem to want to clear such devices for OTC use even though there is clear evidence of safety. The new device will be a Class II device, but will do much the same thing as the current devices – and maybe even do it better. Having that Ahh-Ha moment yet? You should be. Therefore, the new device should be a Class II with a MUCH easier clearance path. Ahh-Ha!!!!!
This weekend I met with Andy Whelan during my trip to New York. I was very impressed with the significant amount of work they have done on the Class III versus Class II issue. They may have this issue solved shortly. Not making a guarantee, but this new strategy is really strong in my opinion.
I am also very impressed with the other new products in the pipeline. The back pain belt is nearing introduction. In my talks with distributors in Hong Kong and Japan last week, they were very excited about this upcoming product. Also, here’s a hit at a fantastic new product on the near term horizon. Take the current technology – shrink it – install it into a gel insole that fits into a shoe. Could any of the footcare manufacturers avoid carrying this product considering the strong heel and foot pain relief study released last year by Dr. Genecov? I say the new higher powered (which is 10X more powerful) product, the back pain belt and the integration into gel insoles are potential game changers for BIEL. Congrats to the managment team on these new and upcoming introductions. Very strong! I am impressed! Should you be calling your broker? Joe Noel
AI
