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Thursday, May 03, 2018 11:28:26 PM
I noticed a high level of websites promoting the FDA Meetings story, several dozen. Money being spent to get eyes on BIEL, IMO PR coming.
Here is a sample:
Pharmacy Choice - Pharmaceutical News - BioElectronics to Meet with ...
https://www.pharmacychoice.com/news/article.cfm?Article_ID=1999096
BioElectronics Meeting with FDA to Expand Indications for ... - WVUE
www.fox8live.com/.../bioelectronics-meeting-with-fda-to-expand-indications-for-produ...
BioElectronics Meeting with FDA to Expand Indications for ... - KHQ.com
www.khq.com/.../bioelectronics-meeting-with-fda-to-expand-indications-for-products-c...
BioElectronics Meeting with FDA to Expand Indications for ... - NBC12
www.nbc12.com/.../bioelectronics-meeting-with-fda-to-expand-indications-for-products...
BioElectronics Meeting with FDA to Expand Indications for ... - KTRE.com
www.ktre.com/.../bioelectronics-meeting-with-fda-to-expand-indications-for-products-c...
BioElectronics Meeting with FDA to Expand Indications for ... - WAND-tv
www.wandtv.com/.../bioelectronics-meeting-with-fda-to-expand-indications-for-product...
BioElectronics Meeting with FDA to Expand Indications for Produc ...
www.nbcrightnow.com/.../bioelectronics-meeting-with-fda-to-expand-indications-for-pr...
BioElectronics Meeting with FDA to Expand Indications for ... - WRCB
www.wrcbtv.com/.../bioelectronics-meeting-with-fda-to-expand-indications-for-product...
BioElectronics Meeting with FDA to Expand ... - KWES NewsWest 9
www.newswest9.com/.../bioelectronics-meeting-with-fda-to-expand-indications-for-prod...
BioElectronics Meeting with FDA to Expand Indications for Produc ...
www.newschannel6now.com/.../bioelectronics-meeting-with-fda-to-expand-indications-f...
BioElectronics Meeting with FDA to Expand Indications ... - KSWO.com
www.kswo.com/.../bioelectronics-meeting-with-fda-to-expand-indications-for-products-...
BioElectronics : to Meet with FDA To Seek Expanded OTC Clearances
05/03/2018 | 06:44am EDT
(GlobeNewswire) - BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that two meetings have been scheduled with the US Food and Drug Administration (FDA) to seek expanded over-the-counter (OTC) clearances for their drug-free, wearable medical devices.
The first meeting will take place on May 9th, 2018 to seek expanded indications for OTC treatment of all musculoskeletal pain for its ActiPatch medical device. BioElectronics currently has OTC clearances for adjunctive treatment of two types of musculoskeletal pain: 1) Knee osteoarthritis 2) Plantar Fasciitis. Per the FDAs 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 NIHs clinical trials listing page.
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 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.
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.
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