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Tuesday, May 08, 2018 6:50:56 PM
Been around this company since 2009 and without a doubt I have seen lots of changes with the management team and its products. The products work for me ( lower back and shoulder) thus I continue to own and add shares when possible ( 12M ). As we know Rome was not built over-night and BIEL is just getting started to a much bigger and brighter future.
https://www.marketwatch.com/story/bioelectronics-to-meet-with-fda-to-seek-expanded-otc-clearances-2018-05-02
May 9th, 2018.
The first meeting will take place on May 9th, 2018 to seek expanded indications for OTC treatment of all musculoskeletal pain for its ActiPatch(R) medical device. BioElectronics currently has OTC clearances for adjunctive treatment of two types of musculoskeletal pain: 1) Knee osteoarthritis 2) Plantar Fasciitis. Per the FDA's requirement to obtain clearance for all musculoskeletal pain, the company submitted the results of a low back pain clinical study, via a Pre-Submission in April 2018. Full details about the study can be found at the NIH's clinical trials listing page.
May 29th, 208
The second meeting will take place on May 29th, 2018 to seek expanded indications for OTC treatment of pain and edema following surgical procedures for its RecoveryRx(R) medical device. BioElectronics currently has a prescription-only clearance for the treatment of edema following blepharoplasty (eye-lid corrective surgery). The company has submitted clinical evidence to the FDA from a breast augmentation study and C-section study, via a Pre-Submission in April 2018.
https://clinicaltrials.gov/ct2/show/record/NCT03240146?term=actipatch&rank=10
Sree Koneru, Ph.D., VP of Product Development at BioElectronics
expressed confidence in the upcoming meetings and in the strength of the clinical evidence. "The clinical studies that were submitted have been conducted in an independent and rigorous manner, so we are looking forward to working with the FDA and seek their guidance to obtain expanded market clearances in a timely manner," Mr. Whelan said.
No luck needed just some patience!
Investor 100
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