GG&G

[walker_429]

The University of Oxford Back Pain study is still recruiting as per my e-mail correspondence with Laurie Pycroft last week ( April 26 ). Andy has told me to get the Indication for back pain they will need to do a study here in the US.

If Biel wants to market a version of the Actipatch for "Back Pain" ( which is the same device as Knee with a different way to hold it in place ) then they will probably need a clinical trial specific to just back pain to claim that indication.

In my opinion, it is not needed as I feel once real world data is accepted and final with the FDA (within a month or so) it will allow the General clearance of pain for Actipatch.

If you do a search for let's say " does back pain have a specific medical term" , the result is back pain or lower back pain....pretty general description. But if you do a search for Heal pain , you get Plantar Fasciitis ... an actual medical term and for Knee pain Osteoarthritis. So those two specific clearances for Actipatch which address a medical term are huge in my opinion.