Bioelectronics Corp (BIEL)

[Investor100]

Todays Update @ BIEL

The goal of yesterdays meeting with the FDA was achieved as per the press release several weeks back.

The goal was to get positive feedback from the FDA which was accomplished thus they can move forward with the next step in the process with its 510K. This is a big step forward for Biel and I applaud the management team and scientist for a great job! I look forward to more positive news in the weeks, months and years ahead!


Upon reviewing pre-submission information on the ActiPatch® back-pain study (https://clinicaltrials.gov/ct2/show/NCT03240146), the FDA provided positive feedback on the clinical results, and guidance on a 510(k) submission to obtain expanded market clearance for over-the-counter (OTC) treatment of musculoskeletal pain. This would make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are suffering with some form of musculoskeletal pain. While ActiPatch is already FDA cleared for treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (1 million annually), expanded market clearance would allow additional products for the back (42 million), neck (19 million), hip (9 million), shoulder (11 million), carpal tunnel (12 million) and many other musculoskeletal complaints.

No luck needed just some patience - been here since 2009.