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$Biel’s FDA Meeting on May 9 for US Market Clearance

We are in the process of expanding the US market clearance from relief of osteoarthritis of the knee pain and plantar fasciitis. Our goal is to obtain general clearance for musculoskeletal pain. To achieve this, we have submitted a chronic back pain clinical study to the US FDA as a formal Pre-Sub. The initial meeting with the FDA is tentatively scheduled for May 9th. Prior guidance from the FDA indicated that a third clinical study was required before expanding the current market indications to cover all musculoskeletal pain. We are hopeful that the process will be completed rapidly, however we will not have a good estimate of this market clearance date until the completion of the May 9th meeting.