It is my understanding from Andy that tomorrows meeting with the FDA is to discuss Biel's request to obtain an Indication of use for “Relief of Musculoskeletal Pain”, which will allow Biel to advertise for any muscle condition, including the back in the OTC SWT Category PQY .
Biel is using the Lower Back Trial data as the 3rd body part to obtain the Full body clearance/ Relief of Musculoskeletal Pain relief as requested by the FDA. It is also my understanding that the Category PQY for OTC SWT will be amended to reflect this indication of use without the need of a new 510(k) application.
The current two clearances for OTC
1. Osteoarthritis of the knee and
2. Plantar fasciitis of the knee
will remain and actually be a bonus medical term Biel will have clearance to advertise their product for such as the Smart Insole that can advertise it's FDA cleared Indication of use to help relieve pain associated with Plantar Fasciitis. ( Hint...Dr Scholls )
Another note of importance in my opinion is the words used in Biels PR April 26th:
" BioElectronics is with B. Braun Medical, Ltd.UK to initiate the "Total Pathways Program" program into B. Braun's 26 geographic markets. The program is for pre-habilitation (treatment that happens prior to surgery) and post-operative recovery. This new program will benefit the majority of the 160,000 UK annual knee, hip, or joint replacements patients. According to Keith, BioElectronics is not just trying establishing a brand, but "to establish the process to a standardize care for pre and post-operative pain."
With the additional May 29th meeting with the FDA, it is my belief that Biel is also looking to establish a Standard of Care option here in the US in combating this countries Opioid crises. If an Actipatch becomes a Standard of Care after every surgical procedure, that would be huge.
GLTA
