Replies to post #66410 on Bioelectronics Corp (BIEL)

[seven-up]

ROFLMAO what a post related to Biel, no upside are you aware of what the NHS is? Are you aware of the cost of chronic back pain?

Chronic low back pain is a major health problem and has significant associated healthcare costs, accounting for more than £12 billion in direct and indirect costs every year in the United Kingdom

.

Low back pain is a major health problem and if effective this has major economic implications as the device is cheap and safe.

The upside would be about $250 million to $500 million in revenue for Biel just a opinion could be more or less.

[Lufrance]

Omg , the ignorance here is amazing. Oxford doesn't do expensive clinical studies on just any old product and neither do the huge companies that are now selling the products sell just anything.

BIEL

[ddls]

Yes, Andy CEO has created this glorious company with condition specific PEMF low watt (73 microwatt) products that will NEVER be proved works.
No company or university has the money or would want to spend the money necessary to do a complete competent study to even come close to verifying this has a "positive effect" for pain and or heeling.
It requires too many necessary criteria as in age, health, eating habits, any genetic issues. All this comes into play here. You're looking at million of dollars here... MILLIONS! Quite possibly 10 Million dollars or more for a "complete competent" study.

Sorry Folks, this company has snowed it's investors laterally for a living.

[edbi46]

$$$$ ATTENTION $$$$ ........-The final order for Reclassification and Renaming of Shortwave Diathermy for All Other Uses is OUT and PUBLISHED!!!
- 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...

[GetSeriousOK]

The Oxford study is good for BIEL because:

After the FDA rejects the latest 510(k) they will probably come to the realization that they need to do a PMA, not a 510(k), because there are no predicate devices cleared for OTC pain.

For a PMA, more clinical data will be necessary because most of BIEL's current "clinical data" consists of surveys and testimonials which do NOT impress the FDA. A placebo-controlled double-blind clinical study would do a LOT towards getting this gizmo cleared by the FDA.

The CEO promised the FDA decision by 12/31/2015. I laughed at that "guidance" then and I'm laughing now. This CEO is pretty funny, really.

Regarding the R/S we all know is coming eventually: When a legitimate company does a R/S they also reduce the A/S. When a pinkie scam does a R/S they don't reduce the A/S. Guess which one describes BIEL.