I’m posting this for my own reference and as an addenendum to the charts I posted yesterday. Thanks to whoever wrote this.

Here is a link to the original

An opinion is what you have when you don’t have any facts. When you have the facts, you don’t need an opinion.

Facts – The final order for Reclassification and Renaming of Shortwave Diathermy for All Other Uses is over due and could be published at any time.

– A new 510k was filed for the ActiPatch on 8/6. The FDA suggested this course of action while waiting on the final order. BIEL was advised on this filing by the law firm of Goodwin Procter, whose lead FDA attorney Mark Heller has 10 years experience working with the FDA’s Device Division. The FDA has a commitment to process 510ks within a 90 day period.
http://www.accessdata.fda.gov/cdrh_docs/pdf14/K142209.pdf
http://www.accessdata.fda.gov/cdrh_docs/pdf13/K132194.pdf
http://www.accessdata.fda.gov/cdrh_docs/pdf14/K141286.pdf

– As of 6/30/2015 BIEL had sales of $1,178,796 for fiscal 2015. This is a $732,516 increase over the same period in 2014.

– There are 585 Boots Pharmacy Stores selling BIEL products in the UK.

– B. Braun, a 175 year old company that sells $6 billion a year in medical products, signed on as the exclusive UK distributor for Recoveryrx after clinical evaluation.

– In his 8/2014 interview BIEL EVP Dr. Kotak said ” I joined Bioelectroincs in March (2014) with a roll to drive the European and Rest of World roll out of the current product line as well as bring on the development of the deep and diverse pipeline that Bioelectronics has.” ” We are the leaders in non invasive electrocuticals and we have new devices for chronic pain that are more powerful and we are going to be entering the field of Neuromodulation. Wherever there is nerve that is accessible to our technology we can stimulate it, and that gives us access to some very large markets.”

– Neuromodulation is technology that acts directly upon nerves. It is the alteration—or modulation—of nerve activity by delivering electrical or pharmaceutical agents directly to a target area.Neuromodulation devices and treatments are life changing. They affect every area of the body and treat nearly every disease or symptom from headaches to tremors to spinal cord damage to urinary incontinence. With such a broad therapeutic scope, and significant ongoing improvements in biotechnology, it is not surprising that neuromodulation is poised as a major growth industry for the next decade.

– In his 8/2015 interview AW said ” We have 5 on going clinical trials that we are doing for new products. We clearly see that we can solve and use the product for things like Migraine Headaches, Diabetic Neuropathy, and Post Operative Chronic Wounds.”

– Hundreds of testimonials are available on the WWW with real people telling their story of how the ActiPatch has changed their life by eliminating or reducing their chronic pain.

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