Tuesday, October 06, 2015 9:28:56 AM
- A new 510k was filed for the ActiPatch on 8/6/2015. 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.
- 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.
-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...
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