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A couple of months ago, someone asked what Kelly was doing to prepare for the NOPAIN Act. I suggested that she wasn't doing anything other than sitting on her hands waiting for Ilfeld to publish his Opioid Pilot Study.
For which I was, of course, mocked and ridiculed, as I am mocked and ridiculed every time I try to offer an idea or analysis.
Yesterday, Kelly proved me right. A FB poster asked "Kelly thanks for responding I understand your point, can you at least tell us if BIEL is taking any steps in favor of NOPAIN Act that's coming in few months?"
Here's Kelly's reply:
Too little too late. The gizmo is finished.
STOP PRETENDING
From a true BIEL long:
PEMF – Effective Non-surgical Therapy for Degenerative Disc Disease Sufferers
Jonathan Vellinga, MD -
"PEMF therapy is extremely versatile...."
https://www.google.com/amp/s/www.tcimedicine....-sufferers
Intervertebral disc degeneration has few effective treatments that target the underlying mechanisms of the condition. Many non-invasive approaches such as acupuncture, physical therapy, chiropractic care, or medications can help manage symptoms. However, surgery is often the only option offered to more definitively address the underlying problem. This may be due to the complex nature of disc degeneration, which is heavily intertwined with inflammation and the aging of the disc. Yet Pulsed Electromagnetic Field (PEMF) therapy, a technology that has been used successfully to treat other health issues in the past, is now being applied to effectively address the underlying mechanisms of intervertebral disc degeneration in a pain-free and non-invasive manner. What is PEMF, and how can it possibly treat or attempt to resolve disc degeneration?
The “Normal” Spinal Disc
In the spinal column, the discs provide a cushion between the individual bones of the spine, called the vertebra. When we’re young, our discs are plump and moist, providing shock absorption between 33 vertebrae for the up and down motions of walking, running, and other movements. Largely made up of water inside layers of different types of tissues, discs are subject to dehydration, injury, inflammation, and aging among other things.
The inner tissue in a disc is the nucleus pulposus (NP), a jelly-like material that fills the interior space and provides shock absorption. It is surrounded by a tough, dense tissue that is a cross between fibrous connective tissue and cartilage, or “fibrocartilage,” called the annulus fibrosis (AF). The AF layer transitions to the cartilage that is attached to the vertebra both above and below the disc. This helps keep the vertebrae of the spine cohesive as a unit.
The cells of the disc secrete and are surrounded by the extracellular matrix (ECM), which is comprised of a lattice of proteins that provide structural and biochemical support. As with other cell lifecycles in the body, intracellular debris is consumed by a process called “autophagy,” where the debris is broken down and recycled if possible.
As we age, there is a natural tendency for discs to lose their plumpness. This degradation, or desiccation, can allow the disc to become misshapen. The misshapen disc can shrink so that it doesn’t properly cushion, or perhaps causes a bulge in places, allowing it to be pinched by the vertebra above and below it. This situation can be quite painful. At times, a disc can bulge into and compress nerves that are exiting the spine, resulting in nerve pain and/or compromised nerve function.
Understanding the Nature of Intervertebral Disc Degeneration
Although it is still used frequently as a generic term, “degenerative disc disease” is a little misleading. It causes people to assume that there is a disease that is degenerative, meaning an illness that continues to get worse. The “degenerative” part refers to the breakdown of physical structures in the spinal discs rather than an illness that continues to degenerate (1). Some people prefer using the term “Intervertebral Disc Degeneration,” since it leaves out the potentially misleading word “disease.” Regardless, “disc degeneration” is a general term that encompasses the natural, age-related processes that lead to the breakdown of the disc such as drying out, thinning, or cracking (1, 2) which, in turn, can cause pain.
Closer scrutiny of disc degeneration in various studies shows that some of the underlying processes involved are (3):
dysregulation in the extracellular matrix, (breakdown of the proteins or lack of creation of ECM)
changes in the process of cellular death and aging
an increase in the breakdown of tissue
Two big contributors to disc degeneration are extracellular matrix dysregulation, and changes in the aging of the cell. These are important because PEMF therapy acts on both of these. Before we get into the nitty-gritty details of how PEMF therapy acts on these underlying mechanisms of intervertebral disc degeneration, let’s review what PEMF therapy is.
What is PEMF therapy?
The acronym “PEMF” stands for “Pulsed Electromagnetic Field.” PEMF devices can deliver bursts of low-level electromagnetic energy through the skin, with the ability to reach the underlying muscles, tendons, bones, intervertebral discs, and even organs. Different devices have different ways to deliver electromagnetic pulses to a specific body part, such as paddles or pads. Previous studies had shown that these invisible PEMF waves successfully treated such conditions as chronic wounds and broken bones that were not growing back together (4) and PEMF devices have been in use since the 1970s.
What is notable about electromagnetic energy is that it can be directed into human tissue in a non-invasive way, without generating heat or negatively affecting muscle function. Indeed, there are very few, rare side effects, while study after study shows positive outcomes for a variety of conditions, including pain and inflammation (4).
The sensations generated by the PEMF devices can differ amongst people. However, if something can be felt during a session, it might be interpreted as tingling or buzzing. Considering the pain-free treatments, positive outcomes, and low level of risk for negative outcomes, over time PEMF has been studied as a remedy for more and more conditions. Not only that but studies have been directed at understanding the mechanisms of action the PEMF employed to achieve positive results.
PEMF Repairs the Extracellular Matrix (ECM) of the Disc and Prevents Further Degeneration
One mechanism of action discovered was the ability of PEMF to increase the creation of ECM. Remember the extracellular matrix of protein that gets broken down in intervertebral disc degeneration? PEMF encourages ECM creation! This directly reverses a physiological mechanism that underlies disc degeneration. Studies outside of the body (in vitro) and inside mammal bodies (in vivo) both reflected this amazing ability (3). Not only that, there is evidence that short-term treatments can arrest or inhibit the degeneration of a disc (3).
PEMF Positively Impacts Cell Aging
As cells age, parts of the cell can begin to malfunction. That’s when a process called “autophagy” kicks in. Autophagy means “self-eating,” which describes how the cell destroys the failing part of the cell and recycles or consumes (eats) the failing part if it can. Sessions of PEMF encourage cells to address their failing parts through increased autophagy (3), allowing a renewal to occur. This can prolong the life of the cell, making it healthier and allowing it to live longer. Some might even say it reverses or slows the aging of the cell.
Dynamic Duo
You can see that combining a repair of the ECM with prolonging the health of cells is a powerful combination for addressing two of the hallmarks of intervertebral disc degeneration. However, that’s not all PEMF therapy can do!
There are numerous documented positive effects of PEMF therapy, such as (4):
reducing post-operative pain and swelling
reducing the pain of whiplash
increasing range of motion
increasing blood flow (in both diabetic and non-diabetic people)
reducing lymphedema (reduces a build-up of lymph fluid)
reducing inflammation (5)
PEMF therapy is extremely versatile, unlikely to cause pain, and non-invasive. When applied to intervertebral disc degeneration, it can alleviate pain and address the mechanisms of disc degeneration in a very direct way. For some, it may make the difference between being bedridden from pain and leading an active life. If you have suffered from back pain that you think may be disc degeneration, please do not hesitate to make an appointment for an evaluation. PEMF may be the healing alternative you’ve been looking for.
BUY $BIEL$
This stock is awesome, watch you don't step in the doggie dooooooo. Peeeeeee youuuuuuu on your shoe. They are trying to sell their silly trinkets but not having any luck according to the financials. Its been way to long here with little sales of trinket.
Too bad you choose to ignore the facts. You do know BIEL is cooking the books now that they are OTC limited. The reality is if they want to uplist again they'll need to do another audit like in 2010, that they failed by the way, and which lead to the SEC coming in to investigate them. I'm sure you should remember all that. So, STOP PRETENDING. Plus, you should try doing a little more due diligence once in a while.
"ME? LMAO ------ Oh YES, PLEASE keep posting!!!"
Yup. YOU.
And you don't have to worry. I will keep posting. Someone with your lack of credibility deserves every letter.
Arthur = ZERO credibility.
So sad.
And I hope YOU keep posting gems like phantom limb pain is fake. It makes things SO easy.
.
>>>Your showing your struggles with numbers and how financials work.<<<
ME? LMAO ------ Oh YES, PLEASE keep posting!!!
"Maybe when we get the ANNUAL financials, we will find out how those promotions have done."
There is no "maybe" Arthur you will find out how the promotion has done. See? Your showing your struggles with numbers and how financials work. BTW, your showing your ignorance again by posting "promotions". There's only one promotion right now, unless you care to share another.
Also, your constant bloviation about ANNUAL financials has resulted in (drum roll please!) BILLIONS and BILLIONS of shares still being held and not traded. Since you CLAIM to be so good at numbers, give us the total number of shares that have traded since those financials were released relative to total number of shares available.
Regrettably this all just reinforces the fact that you have ZERO credibility on here. Another post of yours that is moot at its core.
Arthur = ZERO credibilty.
So sad.
Shill.
By the way, how ARE those 'promotions' doing? Not too good, as sales have still not resulted in a profit. Did you see the financial report? Can you ‘comprehend’ how BAD it is? Did you see that asset/liability ratio? Pretty ugly -- NO? Have you taken that accounting 101 course yet?
Maybe when we get the ANNUAL financials, we will find out how those 'promotions' have done. Because it appears we are no longer getting quarterly reports! —- OH WELL — "GO BIEL - GO KELLY"!
"HEY! ---- BIEL up 50% today!"
You sure about that Arthur? You're known for having a problem with numbers. After all, you can't figure out something as simple as BIEL's current promotion.
So sad.
Arthur = ZERO credibility.
"OK son, you can have the last word."
That's what I thought. When it comes to someone like you, I ALWAYS will have the last word. Pretty easy when the poster has zero cred and extreme geriatric comprehension issues.
Arthur = ZERO credibility.
So sad.
"OK son, you can have the last word."
That's what I thought. When it comes to someone like you, I ALWAYS will have the last word. Pretty easy when the poster has zero cred.
Arthur = ZERO credibility.
So sad.
OK son, you can have the last word. Now go to your room!
How is this NOT fun?
"YES, MM's are the reason this is trading at ROCK BOTTOM and NOT because of the laughable financial numbers this company has been reporting for over twenty years. ------ YEAH, that's the ticket!"
Glad you agree old man!
Regrettably, your acquiescence doesn't change the fact that you have ZERO credibility on here.
So sad.
Shill.
YES, MM's are the reason this is trading at ROCK BOTTOM and NOT because of the laughable financial numbers this company has been reporting for over twenty years. Or for the concerning reason of why they have stopped reporting those financials quarterly anymore and that all stockholders will have to wait a whole year to see if this improves ------ YEAH, that's the ticket, IT must be the MM's!!!
You cannot make this stuff up!! --- Keep 'em coming!
Yours truly,
MR. FUN GUY ------------ because reading such posts as THIS ONE ----- IS!
Are you leaving this board, because someone said your leaving this week.
If that’s the case I can understand. You been BASHING BIEL FOR 15 YEARS. Because everything you post has been a lie about the company.
Yeah Right, you are here 24/7 Bashing because you 'don't give a rats ass' about BIEL
The best example of 'Gas Lighting' on this Board is your invention of a Fantasy company, Sales Track, to state false data about BIEL.
How much longer are you going to gas light investors on BIEL?
STOP PRETENDING! no one gives a rats ass about this junk company anymore, except maybe you.
"LMAO (really)! Nobody has to listen to me whatsoever, as it seems like the dropping of stock price to ROCK BOTTOM by itself, pretty much says it ALL of what the investors and the market feel about this company."
Oh, poor little old Arthur. Wrong AGAIN. Much like your belief that phantom limb pain is fake, this stock didn't end up at these levels "by itself".
MM's have manipulated this stock to the current levels with six digit trades and trades where broker's fees cost more than the shares traded. It's all there in the trading history for all to see. The fact remains that BILLIONS and BILLIONS of shares are currently being held and not traded.
But I think your little old myopic brain already knew that. Then again, you couldn't even understand the current promotion being offered on Actipatch, so I wonder. Regardless, NO ONE is listening to your posts anyway. So "Nobody has to listen to me whatsoever" is as impotent as anything you have ever posted.
Arthur = no credibility. Oh well.
Shill.
Newbies:
BioElectronics Corporation is an electroceutical company. The Company develops wearables, neuromodulation devices to mitigate neurological diseases. Its pulsed shortwave therapy technology (PSWT) that uses low power pulsed electromagnetic fields regulate electrical activity of the nervous system. Its product line includes ActiPatch Musculoskeletal Pain Therapy, and RecoveryRx Post-operative and Chronic Wounds Therapy, which are sold by or on the order of medical professionals. Its flagship product, the ActiPatch Musculoskeletal Pain Therapy, is developed to relieve chronic pain. ActiPatch is a drug-free, wearable nonprescription medical device that provides 720-hours of on/off therapy. The Company is also focused on international customers to expand its distributions and sales. The neuromodulation basis of PSWT presents significant opportunities for it to develop optimized technology for diabetic neuropathy, postoperative surgery, chronic wounds, and other applications.
https://www.bielcorp.com/
I stand corrected..
Let's keep the posts down, investors might get the wrong impression this junk is maybe worth something.
The reason BIEL's 510(k) attempts failed.......
Pretty much the only reason the FDA ever gives for rejecting a 510(k).....
"Failure to prove substantial equivalence to a predicate device."
Because that's all a 510(k) has to do.
How can you not know this?
BIEL chose a predicate device cleared for blepharasty. They needed to choose a predicate device cleared for musculoskeletal pain if they wanted clearance for musculoskeletal pain.
In my J&J example, J&J would choose a predicate device -- the ActiPatch -- that was cleared for musculoskeletal pain. In my example, I'm asking you to imagine if BIEL had that advantage "way back then."
I tire of this. Never mind, you go Slap That Ask now.
“The 510(k) process was very messy for BIEL "way back then" but the reason for that messiness was that BIEL had trouble proving substantial equivalence to a predicate device.”
BIEL had trouble proving substantial equivalence given the predicate device? Oh, for sure!
Here’s the point you’re missing. Better to ask, why was it troublesome for the company? That “troublesome” was like BIEL living a nightmare for seemingly endless years given their predicate device was deemed to be A-ok for safety, efficacy, and for use post-blepharoplasty surgery!
Imagine that…Yes, cleared for use over the eye after eyelid surgery. Over the eye near the BRAIN. How far way is that BRAIN from the eyelid? Should have been a “slam dunk” inclusive of use for anywhere on the body.
That anticipated “slam dunk” for use with other indications given the cleared predicate device actually turned into a nightmare for BIEL…like a MOAB dropping on this small company. And now those MOAB’s keep raining down on a still small company with the crappy PPS at triple a 1-2.
Cui bono?
All imo.
KT-Recovery+Wave is currently number154 on Amazon.
ActiPatch number 267 currently on Amazon homeopathic pain remedies.
Completely out of consumers sights.
https://www.amazon.com/Actipatch-Muscle-Joint-Therapy-Device/dp/B07PTC6RNH/ref=sr_1_1?crid=3CPQG5ZO0X2FZ&dib=eyJ2IjoiMSJ9._cx5Xt5mLS1AMzl4bwm4reUqWAiNlNhKwmnvmjcAxKj6XwNMCIKzhckcI_scc-E362p08Xt_KOP2LIlsNdiIwigzB-Zg6DU-cLaxJnUXd1la-997ZPrrnfN7lbetEvd4.lsOqvhn6cU4t8-afP6qm2UhjNCbIBC6A-ZIJRRstUyM&dib_tag=se&keywords=ActiPatch&qid=1720014802&s=hpc&sprefix=actipatch%2Chpc%2C215&sr=1-1
https://www.amazon.com/KT-Tape-Recovery-Electromagnetic-Relief/dp/B08WTN6V2Y/ref=sr_1_3?dchild=1&keywords=KT%2BWave&qid=1634565422&s=hpc&sr=1-3&th=1
In this case their patent is worthless, even if they still had it.
This company doesn't have a pot to pee in or a window to throw it out of.
Investors are screwed, and the NO GAIN PAIN ACT isn't going to help either.
STOP PRETENDING
not understanding your argument -- now you are providing the link to the one reseller, and if you click on "ActiPatch Store" you see this:
Sold by Scharf Industries LLC and Fulfilled by Amazon.
so what is not accurate?
And under "Age Range" this reseller typed "Kid." WTF?
your link is broken
search for just the word "ActiPatch" on Amazon. That's how customers would search.
Only one reseller comes up.
https://www.amazon.com/s?k=actipatch&crid=3AGD90G69CRTD&sprefix=actipatch%2Caps%2C93&ref=nb_sb_noss_1
I'm not counting the KT Tape Wave because that is still the 250-hour device. Nobody wants that.
Not sure that is accurate
ActiPatch Store
Whelan, file your annual report in Maryland.
The Corporation is "Not in Good Standing" in Maryland. Also, the Resident Agent is wrong.
https://egov.maryland.gov/businessexpress/entitysearch
Ask Staelin for the money and do your job. Let's not have a repeat of the REVOKED debacle.
There's only one reseller on Amazon selling the ActiPatch. Some entity named "Scharf Industries LLC." Doesn't Whelan realize she'd sell ten times as many devices on Amazon? Instead she's relying on customers to find and trust her actipatch.com website. This is stupid. EVERYONE with money trusts, and shops on, Amazon. Yes, Amazon would charge BIEL a commission, but let's talk volume: how many units do they sell on their actipatch.com website with its blurry low-res graphics?
We all agree with almost everything you say here, but you're missing the point.
Yes, BIEL had a hard time getting FDA clearance. They took baby steps, getting clearance for one small indication, then another, finally ending up with full body OTC for pain.
But imagine J&J wanting to sell the ActiPatch now. Imagine J&J partnering with Shenzhen CICD in China and submitting the 510(k) for full body OTC for pain. They name the ActiPatch as the predicate device. They prove that the device they want to sell is the EXACT SAME DEVICE AS THE ACTIPATCH, MADE BY THE EXACT SAME MANUFACTURER (Shenzhen CICD), MADE AT THE EXACT SAME FACILITY. The only difference is the logo.
The 510(k) process was very messy for BIEL "way back then" but the reason for that messiness was that BIEL had trouble proving substantial equivalence to a predicate device. J&J would not have this trouble proving substantial equivalence of their new device to the ActiPatch BECAUSE IT IS THE ACTIPATCH with a different logo.
You understand that generic drugs are not as difficult to get approved by the FDA as the original drug? The generic drug manufacturer doesn't have to repeat all that clinical testing -- they just have to prove that their active formulation is identical to the original drug.
Ahhh but really, never mind, J&J won't do this. Nobody will, IMO. It's academic because nobody thinks they can profit from selling the ActiPatch. BIEL is safe.
By the way, that "works better in females" problem was the result of BIEL trying to do their own clinical testing. BIEL was unskilled and inept at clinical testing (especially the Koneru Brothers). BIEL got lucky when a couple of skilled independent researchers decided to test the ActiPatch -- otherwise BIEL would STILL be chasing FDA OTC clearance, IMO.
>>>You lost your credibility a long time ago. NO ONE is listening.<<<
LMAO (really)! Nobody has to listen to me whatsoever, as it seems like the dropping of stock price to ROCK BOTTOM by itself, pretty much says it ALL of what the investors and the market feel about this company. So I guess THAT (.0001/.0002) really doesn't need my help, as this cannot go any lower --------- Maybe that is why this is so: (your quote): "Seems there are a lot of people still holding BILLIONS and BILLIONS of shares". -------- ya think?
Please keep posting, this IS fun!
Yours truly.
Mr. FUN GUY ------------ cause it IS!
Want to clear up a few things in getting to your question…
When a company’s FDA - cleared product patent expires…
1. Another company cannot use BIEL’s clearance(s) by simply replicating the product.
2. They must submit via 510(k) process, Premarket Approval (PMA), De Novo classification, or other regulatory pathway via new application(s) for FDA clearance to market.
3. An expired patent for BIEL does not “expire/cancel“ the 5 FDA clearances for BIEL, nor are they transferable to another owner.
BIEL can still sell product as they do now, and with any FDA registered and inspected assembler (currently Chenzen). Again, BIEL owns the 5 clearances; they don’t automatically transfer to another owner.
So, BIEL would not have to do anything different if they choose to pair with a different FDA registered assembler.
That #2 above was a very messy process for BIEL way back when . Another time it was an initial pending clearance for females but not males. Attorneys with FDA specialty cleared things up for BIEL So it could be a messy process, or maybe not, for a new owner.
Flip a coin.
A different approach:
Here’s a hypothetical. What if BIEL decided to change manufacturers. Maybe make the device here in the states for example.
Now the new manufacturer would need to be registered with and inspected by the FDA.
Ok, so what would BIEL have to do in order to sell the devices made at the new facility?
That’s essentially all that the new company would have to do as well, if they are going to sell the exact same device.
"Nice job of saying nothing while trying to sound important."
You do every time you post!
Cognitive Dissonance much?
My reply was well thought out so I would not trigger a Psychopathic Narcissist Tantrum.
You're Welcome!
prus, good post. I repeat and repeat:
My BIEL shares are not for sale.
‘Nuff said!
BUY $BIEL$
Nice job of saying nothing while trying to sound important.
You are good at SOMETHING, anyway. Run with it.
"Thank you for providing me the opportunity to post these numbers again, here on this message board. They are a 'LITTLE' concerning, aren't they?"
Poor little old Arthur. Living under the delusion that his continued posting of financials is going to make a difference. You lost your credibility a long time ago. NO ONE is listening.
In regards to the numbers being concerning, I guess not. Seems there are a lot of people still holding BILLIONS and BILLIONS of shares.
Hey. I've got an idea. Why don't you post the financials again and we'll see if anyone panics and sells all their shares. Oh, that's right. You claim to not care if anyone sells their shares.
Yeah, right.
That's just Nuckin Futs. What an ignorant long winded post designed to deceive filled with fabricated BS.
Do some research... or do you solely depend on Copilot ?
Nothing is as what it seems today. There's a new world coming. Think outside the box.
Go Biel
Maybe this will help you understand.
Imagine a company named Bob's Electronics developing and patenting a PEMF device, going through the same trials and tribulations that BIEL went through to get five FDA clearances, the most recent in 2019. Poor Bob. What an ordeal. All the clinical testing was done with a certain device manufactured by Shenzhen CICD Technologies in China. Bob named this device "the ActivePatch."
Then imagine Bob's Electronics letting the patents expire in 2021.
Now imagine a little biotech named BIEL buying that same device from Shenzhen CICD with a different name and logo printed on it -- "the ActiPatch." They submit one 510(k) to the FDA in 2024 for full body OTC clearance, naming "Bob's ActivePatch" as the predicate device and including proof that this device is the EXACT SAME DEVICE MANUFACTURED BY SHENZHEN CICD TECHNOLOGIES AT THE EXACT SAME FACILITY, the only difference being the name and logo change.
The applicant could append all the independent research done with that same Chinese device, although it wouldn't be necessary. Forget all of BIEL's home-cooked studies and surveys because those were all BS, which is one of the reasons BIEL had so much trouble with the FDA over the years. (Other reasons: Andy's belligerent defiance, and his 2012 episode of selling the ActiPatch online without FDA clearance.)
You seem to think that BIEL would have as much trouble getting that generic device cleared by the FDA in 2024 as Bob had getting the original device cleared. You must think other generics suffer this fate.
And that is absurd. Getting a generic device cleared by the FDA is nowhere near as complicated, costly, or time consuming as getting the original device cleared. Surely you must realize that.
If Bob hadn't allowed the patents to expire, BIEL could not market a generic device in 2024. But Bob screwed up.
And if you still don't understand -- if you come back with some more head-scratching nonsense like the following -- then.... never mind.
>>>Stick to the financials.<<<
LOL, thank you I will. Because they are the most important reason that all stockholders who are holding long and strong, are sitting at the lowest of their investment history. Yes. all the cheerleaders that feebly mocked all the negative posters that point out the dire state financially, this company is in. All that cheerleading and mocking that makes for quite the entertainment. In case you missed the financials and/or incapable of understanding them, here are some facts for you to ponder:
-The company has reported another year of NET LOSS. That is continuing the streak of NEVER showing a profit in the over twenty years in existence.
-The 'cash on hand' was $6,871.
-Assets were $170,320, while liabilities were $16,135,330. What is that laughable ratio? (you see, assets are what you 'own' and liabilities' are what you 'owe'). OUCH!
-Note/loans total over $12,000,000. ALL have matures but unable to be paid off (see 'cash on hand' of $6871). OUCH!
-Many of those note/loans that are family, convert to 50% discounted priced common stock.
-There is 24,705,066,971 (that's BILLIONS) of outstanding shares with 25,000,000,000 authorized. So those conversions will need more shares authorized. OUCH!
-Due to never showing a profit, they have an 'accumulated deficit' of $39,300,441. OUCH!
Thank you for providing me the opportunity to post these numbers again, here on this message board. They are a 'LITTLE' concerning, aren't they?
You are being obtuse. Fine, slap that ask then. .0002 is a bargain of you believe what you are pretending to believe.
“ The new company's device WOULD BE THE ACTIPATCH with a different name so substantial equivalence is a slam dunk”
You mean “slam dunk”….like the subsequent BS BIEL had to go through for all those additional clearances, for how many grueling years?
All those many years after BIEL’s first “device”, you know, the one allowed to be used for post-blepharoplasty surgery. Yes, the device allowed to be used after surgical repair or reconstruction of the eyelid. Last I checked, the eye and brain are in the same area, no?
Yes, all bureaucratic crap putting the company on a hamster wheel for a crapload of years! Treatment of ActiPatch for your back? Sorry, only cleared for the eyelid…near the brain. Try another day. That “slam dunk”?
Want to market your ActiPatch? Sorry, only approved for females and not males. Remember that? Another “slam dunk”! Only eye near the brain use was the menu
You want to go by 501k process BIEL? Ah, yeah, hmm, ah…Let’s see…umm maybe DeNovo, maybe this, maybe that process…. till that crap got put to rest. That “slam dunk”?
Slam dunk my ass! Bureaucracy, politics, lobbying.
Nothing is as it seems, nothing is easy.
If you think it is, why don’t you and your buddies call Chenzen today and make the product and see what the FDA tells you about safety and efficacy and marketing. Or better yet, maybe ask the FDA first. Or maybe you think the product stinks too, so don’t bother.
A. “Hey, I ordered the “slam dunk” and got a “hamster wheel” instead.”
B. “Story, no returns”
Junk, pure junk.
What we have here is, failure to communicate.
STOP PRETENDING.
It seems my original post upset our special snowflake moderator. Poor Mr. " I know the company inside and out."
Here we go again.
"The entity that wants to sell the Shenzhen CICD device in the USA does NOT have to prove safety or efficacy in a 510(k) because that's not required in a 510(k)."
"A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device."
Are you serious?
One guess where that quote comes from. You claim not to lie, yet here we are. But, by all means keep up with these incredibly and increasingly ridiculous posts.
OMG.
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Moderators misanthrope Capsule JustGoDeep toohot JNdouble1 gimmee greenbacks |
PHOENIX, June 13, 2018 (GLOBE NEWSWIRE) -- Uptick Newswire welcomed Andy Whelan, President of BioElectronics Corporation (OTC Pink:BIEL) ("the Company") back onto the "Stock Day" podcast. Andy spoke with Everett about their progress in the US market, UK market, the new product, the US FDA, and new distributors and potential partnership opportunities.
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch(R) Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx(R) Devices for chronic and post-operative wound care; Allay(R) Menstrual Pain Therapy. For more information, please visit http://www.bielcorp.com/
The Company is currently pursuing multiple US partnership opportunities that are partially contingent on additional FDA clearance for the treatment of musculoskeletal pain, back pain, knee pain, muscle, hip, carpal tunnel, etc. Whelan said,"Patience is key throughout this process. It's going as well as it can." Additionally, the Company anticipates solidifying deals with two new major distributors in the Asian and Eastern European markets.
The Company's product development and regulatory clearances are going well. Now, with pre-submission clearance, the 510(k) relief of musculoskeletal pain market clearance application will be filed by the end of June.
The US FDA has recently implemented an Innovation Program seeking "Breakthrough Devices" to Prevent and Treat Opioid Use Disorder. Opioids are routinely used for post-operative pain. Our United Kingdom ActiPatch User Registry accounts that 71% of opioid customers report a moderate (50%) to complete (100%) elimination in opioid medication use. The Company plans to submit its post-operative pain relief market clearance application into this program. The FDA's assistance, participation, and approval will provide credence and accelerate product market acceptance.
The Company has begun shipments of its new single box kinesiology tape product to be used for back, knee, hip, and muscles and joints in lieu of the back wrap, knee wrap and muscle and joint adhesives. The kinesiology tape is easier to use, reduces product costs, and retail shelf space requirements.
The Company is transitioning its United Kingdom over-the-counter sales and marketing from the front of the store to behind the counter to expand product availability from a few stores to all 14,000 pharmacies. Most pharmacies obtain daily product deliveries and most people in the UK qualify for free prescriptions.
Whelan is confident in the direction the Company is moving, and cites the unique nature of their products as a factor that helps the Company stand out in the global medical electronics industry. Whelan then said, "This is one busy little Company."
"Stock Day" host Everett Jolly stands by his assessment from his April interview with the company that the stock is very undervalued. BioElectronics Corporation trades on the OTC Pink market under the ticker symbol BIEL. Shares are currently selling at 0.0037, up over 100% since April.
For more details about the Company's recent FDA meetings, potential partnership opportunities, and attempts to combat the ongoing opioid crisis, follow the link below to hear the full interview.
https://upticknewswire.com/featured-interview-ceo-andrew-whelan-of-bioelectronics-corp-otc-pink-biel-3/ ;
About BioElectronics Corporation
BioElectronics develops and manufactures unique nonprescription affordable neuromodulation medical devices. The Company's technology platform is for the treatment of central sensitization, which is now widely accepted as the physiological explanation for many neurological disorders, and specifically chronic pain. Central sensitization is difficult, if not impossible, to address through pharmacotherapy without having a detrimental impact on normal physiologic function. Moreover, pharmacological and masking therapies (creams, heat patches, TENS etc.) have limited effectiveness for chronic pain due to their transient nature. BioElectronics' electromagnetic stimulation therapy has the distinct advantage of being safe, affordable, long lasting, and effective pain relief.
Contact: Paul Knopick, 940.262.3584, pknopick@eandecommunications.com
FREDERICK, MD., May 31, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), maker of advanced medical devices announces that B. Braun Ltd, of Sheffield, UK has recently completed development of its same day surgical TOTAL Pathway program for joint replacements which includes BioElectronics medical devices. The program is being launched by B. Braun’s UK […]
FREDERICK, MD, May 29, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com reports that it has cancelled today’s scheduled US Food and Drug Administration meeting. “The FDA’s response to our questions, suggestions, and instructions are more than adequate for us to proceed with filing of the formal 510(k) Market Clearance Application,” stated Ian […]
FREDERICK, MD , May 11, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to report on the outcome of its Pre-Submission meeting on May 9th, 2018 with the US Food and Drug Administration (US FDA). The FDA’s Pre-Submission Program is designed to organize and give guidance and feedback on clinical data and what […]
FREDERICK, MD, May 02, 2018 (GLOBE NEWSWIRE) — 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 […]
PHOENIX, April 26, 2018 (GLOBE NEWSWIRE) — Uptick Newswire was thrilled to have Keith Nalepka, VP of Marketing & Sales at BioElectronics (OTC Pink:BIEL) (“the Company”), return to the “Stock Day” podcast. The company has been working hard lately to expand the United Kingdom market with B. Braun in the surgical market and the product […]
FREDERICK, MD, March 19, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce the commencement of a clinical study investigating the efficacy of its RecoveryRx® device for postoperative pain management and recovery following total knee arthroplasty surgery. Currently there are 700,000 total knee replacement surgeries in the US alone and are projected to grow 673% to 3.5 million procedures per […]
PHOENIX, Jan. 22, 2018 (GLOBE NEWSWIRE) — The Uptick Newswire “Stock Day” podcast keeps investors up to date on the latest penny stock news by bringing transparency in the micro-cap side of the market. Connect with “Stock Day” and to over 600+ CEO interviews on the OTC, Pink Sheets and micro-cap news from around the world […]
FREDERICK, MD, Jan. 09, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced wearable consumer pain management medical device, ActiPatch, announced today that CARE Pharmacies has committed to introducing ActiPatch, Musculoskeletal Pain Therapy medical device to its patients. “With the current opioid crisis here in the United States, as pharmacists, we […]
FREDERICK, Md., Jan. 04, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com makes wearable, drug-free chronic pain therapy medical devices. It is pleased to announce that the UK’s government funded public health service, National Health System (NHS), has approved our application to cover and pay for ActiPatch® Musculoskeletal Pain Therapy. The NHS estimates that almost half […]
FREDERICK, MD, Dec. 12, 2017 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced wearable consumer pain management medical device, ActiPatch, announced today the launch of ActiPatch for Over-The-Counter, drug-free pain relief as an alternative to Opioids. ActiPatch is approved by the FDA for Over-The-Counter sales for the adjunctive treatment of pain […]
BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application
FREDERICK, MD , May 11, 2018 (GLOBE NEWSWIRE) -- BioElectronics Corporation (BIEL) , www.bielcorp.com is pleased to report on the outcome of its Pre-Submission meeting on May 9th, 2018 with the US Food and Drug Administration (US FDA). The FDA’s Pre-Submission Program is designed to organize and give guidance and feedback on clinical data and what regulatory pathway should be followed to get market clearance. The focus of the May 9 pre-submission meeting was in discussing the FDA’s feedback on the clinical outcomes and statistical techniques used in reporting the back-pain study.
Upon reviewing pre-submission information on the ActiPatch® back-pain study (https://clinicaltrials.gov/ct2/show/NCT03240146), the FDA provided positive feedback on the clinical results, and guidance on a 510(k) submission to obtain expanded market clearance for over-the-counter (OTC) treatment of musculoskeletal pain. This would make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are suffering with some form of musculoskeletal pain. While ActiPatch is already FDA cleared for treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (1 million annually), expanded market clearance would allow additional products for the back (42 million), neck (19 million), hip (9 million), shoulder (11 million), carpal tunnel (12 million) and many other musculoskeletal complaints.
The company was represented by their clinical R&D team comprising: Sree Koneru, Ph.D., VP Product Development, Ian Rawe, Director Clinical Research of BioElectronics (BIEL), Kenneth McLeod, Ph.D. Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D. Professor Duke University. Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.
An additional pre-submission meeting is scheduled with the FDA on May 29th, 2018 to seek expanded indications in a separate application for OTC treatment of pain and edema following surgical procedures for its RecoveryRx® medical device.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy. For more information, please visit www.bielcorp.com
BioElectronics VP of Sales Discusses Pre & Post-operative Pain Relief Surgical Program in "Stock Day" Interview
PHOENIX, April 26, 2018 (GLOBE NEWSWIRE) -- Uptick Newswire was thrilled to have Keith Nalepka, VP of Marketing & Sales at BioElectronics (OTC Pink:BIEL) ("the Company"), return to the "Stock Day" podcast. The company has been working hard lately to expand the United Kingdom market with B. Braun in the surgical market and the product opportunity from the recent National Health Service payment approval for its ActiPatch® medical device.
BioElectronics is with B. Braun Medical, Ltd.UK to initiate the "Total Pathways Program" program into B. Braun's 26 geographic markets. The program is for pre-habilitation (treatment that happens prior to surgery) and post-operative recovery. This new program will benefit the majority of the 160,000 UK annual knee, hip, or joint replacements patients. According to Keith, BioElectronics is not just trying establishing a brand, but "to establish the process to a standardize care for pre and post-operative pain."
The company is immensely proud of their team for getting their concept through to the National Health Service (NHS) in the UK. In addition to successes here, the company is hoping to utilize their overseas success by applying data to their US-based efforts.
There are some great potential partnerships currently being discussed at BioElectronics, with the closing of a significant deal just on the horizon.
BioElectronics Corp is approaching their upcoming FDA meetings with confidence. "We have the data to make a very strong case for both broader musculoskeletal and post-operative pain relief indications," said Nalepka. "It's an exciting time for the company, and a really cool little product."
For more details on the Total Pathways Program, news about a partnerships, and information about the company's upcoming meetings with the FDA, follow the link below to the full interview.
https://upticknewswire.com/featured-interview-vp-of-sales-keith-nalepka-of-bioelectronics-corp-otcpink-biel-3/ ;
About BioElectronics
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.
Contact: Paul Knopick, 940.262.3584, pknopick@eandecommunications.com
Safe Harbor Statement
Certain statements contained herein are "forward-looking statements," (as defined in the Private Securities Litigation Reform Act of 1995). BioElectronics Corp. cautions that statements and assumptions made in this news release constitute forward-looking statements; the company makes no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time statements are made. These statements may address issues that involve significant risks, uncertainties, and other estimates made by management. Actual results could differ from current projections or implied results. BioElectronics Corp. undertakes no obligation to revise these statements following the date of this news release.
About Uptick Newswire
Uptick Newswire is a private company reaching out to the masses keeping investors and shareholders up to date on company news and bringing transparency to the undervalued, undersold, micro-cap stocks of the market and is the sole producer of the Uptick Network "Stock Day" Podcast. The Uptick Network "Stock Day" Podcast is an extension of Uptick Newswire and has recently launched the Video Interview Studio located in Phoenix, Arizona.
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BioElectronics Up-Date |
Dear Fellow Shareholders, This letter is to report on our recent progress in marketing and product development. We have established the following:
We are continuing to solicit new international and domestic sales and marketing partners for distribution and licensing, while strengthening our relationship with existing partners. To aid in this effort we have engaged an accomplished sales and marketing pharmaceutical consultant to assist in introduction and negotiations of sales and marketing partnerships. US Market Clearance ActiPatch®, Musculoskeletal Pain Therapy We are in the process of expanding the US market clearance from relief of osteoarthritis of the knee pain and plantar fasciitis. Our goal is to obtain general clearance for musculoskeletal pain. To achieve this, we have submitted a chronic back pain clinical study to the US FDA as a formal Pre-Sub. The initial meeting with the FDA is tentatively scheduled for May 9th. Prior guidance from the FDA indicated that a third clinical study was required before expanding the current market indications to cover all musculoskeletal pain. We are hopeful that the process will be completed rapidly, however we will not have a good estimate of this market clearance date until the completion of the May 9th meeting. Postoperative Recovery and Pain We have submitted a formal Pre-Sub to the US FDA for guidance in obtaining market clearance for the palliative treatment of postoperative pain and edema. The application is supported by postoperative clinical studies on breast augmentation and caesarean section. Marketing Expansion We believe that expanded market clearance from the FDA will enhance the market value and attractiveness of the ActiPatch product line. Our economic and clinical studies for the National Health Services allowed us to gain a drug tariff listing for reimbursement in England and Wales allowing the following:
The ActiPatch registry studies report that people buy the device because it is effective, drug-free, has no harmful side effects and overall improves quality of life. We are continually working to solve existing minor issues with the use of ActiPatch. To improve the product, we are introducing custom-design kinesiology tape strips to attach the device to the body. Aside from improving user comfort, this allows us to promote a single multi-purpose box with the added benefit of reducing retail shelf space. We believe this will then allow us to sell the 7-day trial devices from pharmacy shelves. B. Braun UK This is an important development for BioElectronics. B Braun has been using RecoveryRx to improve recovery following joint replacement for many years, although in limited surgeries. However, new advances in day surgery for joint replacement have expanded our opportunity. B. Braun has recently completed a pilot program in the UK evaluating day for joint replacement. The United Kingdom's Group day surgery program for knee and hip replacement patients and is now being implemented on a national basis. Currently there are 80,000 procedures per year involving B Braun. The "fast-track" same day hip and knee replacements are being supported by hospital physiotherapy teams visiting the patient at home and communicating using a special wireless technology tablet. Upon hospital discharge, each patient will be given an ActiPatch medical device and a prescription for 6 additional devices to help accelerate recovery and mitigate the postoperative pain. A similar program is in development for spinal surgeries. On an international level, B. Braun's 54,000 employees are in 60 countries and are separated into additional divisions for hospital care, surgical products, outpatient care, and home care services. It is anticipated that B. Braun's German Group will roll out the same day hip and knee replacement program in the next few months.
Smart Insole – Heel Pain Relief We have redesigned the Smart™ Insole plantar fasciitis insole to enhance user comfort. We are awaiting a written License and Supply Agreement for the product. Clinical Research to Expand Market Clearance and Acceptance Allay®, Menstrual Pain Therapy 28% of women are in the menstrual phase of life and 60% have moderate to severe menstrual pain, or 17% of women. Previously our medical devices were classified as high risk class III by the US FDA. While our existing pilot clinical study for menstrual pain reported exceptional results for menstrual pain, to publish a clinical study and obtain US market clearance, we are collaborating with the University Hospital at Birmingham, UK. The researchers here are world renowned thought leaders in women's health and are conducting a double-blind randomized controlled trial to evaluate the efficacy of ActiPatch in reducing menstrual pain (clinicaltrials.gov listing NCT03394547). You can view the existing clinical evidence and our commercials at https://www.myallay.com/ Prevention of Episodic Migraines Headaches Migraines affect 36 million men, women and children in the United States alone. The facts are:
Chronic pain is now widely understood to be due to central sensitization, which leads to exaggerated pain perception. Migraine is no exception; since it is well known that sensitization of the trigeminovascular pain pathway can occur during a migraine attack. There is pilot data that ActiPatch can help mitigate this sensitization, so a study has been completed to determine the efficacy of ActiPatch in preventing chronic, episodic migraines. The data from the study will be analysed in the next few weeks. We believe this data will allow us to work towards developing a product as a migraine therapy and allowing us to obtain market clearance. Postoperative Recovery and Pain Working with our distributor in Lebanon we are conducting a double blind placebo randomized controlled trial on total knee replacement (clinicaltrial.gov NCT03395444). Through our long standing association with B. Braun UK, RecoveryRx has been determined to be a valuable aid in joint replacement surgery. This clinical study will allow us to gain worldwide recognition and allow for expanded marketing and acceptance of the RecoveryRx as a standard of post-operative care following joint replacement. Interstitial Cystitis (Overactive Bladder and Pelvic Pain) This study is a University of Texas, McGovern Medical School sponsored double blind randomized controlled trial. The goal is to determine how well the ActiPatch therapy works in treating patients with interstitial cystitis, bladder pain syndrome and overactive bladder. Interstitial cystitis and bladder pain syndrome are chronic bladder health conditions that greatly affect quality of life. These conditions create intermittent feelings of pain and pressure in the bladder area. The study is expected to recruit 60 women who are urology patients of the University's hospital. At least 35 million Americans have overactive bladder. Lower urinary tract symptoms, urgency, and pelvic pain are common complaints to urologists and primary care physicians. Additional Bioelectronic Product Opportunities As we develop the organizational structure we envision additional opportunities in chronic wounds, neuropathy, hypertensive therapy, etc. Most importantly future growth is not dependent on large capital outlays for research and development. Immediate Sales Growth We anticipate imminent solid sales growth from the following programs:
Thank you for your support. Sincerely,
______________________ |
FREDERICK, MD., May 31, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), maker of advanced medical devices announces that B. Braun Ltd, of Sheffield, UK has recently completed development of its same day surgical TOTAL Pathway program for joint replacements which includes BioElectronics medical devices. The program is being launched by B. Braun’s UK Group to improve care and reduce the UK healthcare cost of its 160,000 annual hip and knee replacement procedures.
The “fast-track” same day hip and knee replacements are being supported by hospital physiotherapy teams visiting the patient at home and communicating using a specialized wireless tablet. Each patient will be given an ActiPatch medical device and a prescription for 6 additional ActiPatch devices. A similar program is being implemented for spinal surgeries.
Phil Cleary, Senior Product Group Manager, stated that “our TOTAL Pathway program enhances our commitment to patient safety, post-operative care, as well as significantly reducing healthcare costs and hospital stays.” Treating post-surgical pain requires a multifaceted approach. In trials, ActiPatch was well received and produced positive outcomes. We look forward to making this program a success, in the UK and other countries where B. Braun operates.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.
About B. Braun Medical Ltd
B. Braun Medical Ltd, UK, https://www.bbraun.co.uk/ is a member of the B. Braun Group, https://www.bbraun.com/en.html one of the world´s leading healthcare companies. On an international level, B. Braun’s 54,000 employees are in 60 countries and are separated into additional divisions for hospital care, surgical products, outpatient care, and home care services.
Keep in mind partners are happening and licensed ones at that.
The back study will not go in as a new submission, it is included in the knee and ankle submission so this will happen quicker than most would believe. Well actually the back study will be added to the prior submission, I don't want to confuse you
Watch how huge the Co-Branding gets. How many names besides Pain Gear?
Increasing shareholder value=7 components of shareholder value.
• Revenue
• Operating Margin
• Cash Tax Rate
• Incremental Capital Expenditure
• Investment in Working Capital
• Cost of Capital
• Competitive Advantage Period
Within the next 120 days BIEL will have in place-
Full body clearance minus the Migraine, anticipated clearance at a later date based upon the fact that this is a preventative study and the patients must have signs of a migraine coming, this study is a little more complicated.
Licensed partners (Major)
Equity partners
At least 2 huge retail chains
Let’s add on a few more distributors. Why not? Lol
NHS-first week of April, keep in mind not the only week, this is lifetime!
There will be other EU States that will duplicate the NHS and this will be coupled with licenses being sold to partners. What price, how much in royalties will soon be determined.
The August financials will and should be the strength of evidence that a certain person has established a supply chain that will be second to none.
I should mention that sales makeup only one component of the revenue stream, this is where my opinion may differ from the good posters on the BIEL board.
Revenue is the total amount taken in by a business in a set period of time.
This can include royalties, license fees and equity from partners and sales.
BIEL cannot have millions in sales without including the other revenue streams mentioned above.
My revenue forecast including sales may be different than others.
Great rewards will follow in due time. Waiting on the FDA protocol. Which means pre-submission. Guidance, rules and timing will be part of the protocol.(Looks like May-June clearance.)
Migraine clinical results will still be the huge one for the FDA protocol.(August-September clearance on positive results.)
NHS is the first of many EU States getting on board. Pretty good health systems across the pond. Sweden next!
The back pain study will obtain US FDA clearance for relief of musculoskeletal pain. Migraine headaches are not musculoskeletal. Migraines and musculoskeletal pain are both neurological disorders. Two FDA clearances!!!!!!!!!!!!!
SEC-much ado about nothing!
Partners-much ado about something!
12/7/2017 - Try and Tell US Launch, gets a 7 Day ActiPatch to US residents for shipping and handling costs of $4.95
12/7/17 - BIEL closes a deal with ANDA for National Distribution, ANDA has 60,000 commercial customers and is owned by TEVA Pharma, TEVA has extensive business dealings with the NHS
1/4/2018 - ActiPatch gains admission to the UK NHS Drug Tariff as a covered medical device, The NHS is the largest single healthcare delivery organization in the world
1/9/2018 - CARE Pharmacies will be handling the ActiPatch, CARE is an organization of 90 pharmacies in 17 states, CARE will be educating patients on the benefits of drug-free pain relief through Pain Consultations
1/16/2018 - Allay Menstrual Clinical Study is fully enrolled, taking place at the prestigious Birmingham Women's Hospital,an NHS Foundation Hospital
1/22/2018 - BIEL signs deal with Performance Health, 120 outside sales reps, 40 inside reps, KN interview
1/22/2018 - BIEL signs deal with MundiPharma in Australia and 8 other countries, Mundi is associated with Purdue Pharma, KN interview
1/22/2018 - Back Pain Study is complete, BIEL has dialogue ongoing with FDA for submission of Study to expand ActiPatch indications, KN interview
1/22/2018 - Migraine Study will get the full attention of staff now that the Back Study has been completed
1/22/2018 - BIEL in talks with Walmart
1/22/2018 - Meeting scheduled with CVS
This is the last 2 months of activity for BIEL. Any other OTC company would be dancing in the Street if they had accomplished this much in the last year.
The NHS Approval has opened new doors for BIEL and will continue to do so for many years.
FREDERICK, Md., Jan. 04, 2018 (GLOBE NEWSWIRE) -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com makes wearable, drug-free chronic pain therapy medical devices. It is pleased to announce that the UK’s government-funded public health service, National Health System (NHS), has approved our application to cover and pay for ActiPatch® Musculoskeletal Pain Therapy. The NHS estimates that almost half of the 50 million UK adults may be living with chronic-pain¹, which is why there are more than 100,000 physician visits every day for musculoskeletal pain alone².
The ActiPatch is a drug-free, wearable medical device that regulates peripheral nerve activity to provide pain relief. The NHS based its decision considering strong clinical evidence and a health economics study, which found that ActiPatch significantly decreased pain and improved quality of life, while reducing overall healthcare costs by 42% (58.5% reduction in physician appointment costs, 35% reduction in prescription medication costs).
“This is a major win for pain sufferers in the UK, since they will now be able to obtain a prescription for ActiPatch, the cost of which will be covered by the government,” stated Ian Rawe, Ph.D., Director of Clinical Research at BioElectronics. “We commend this move by the NHS, as this will open up the doors for reimbursement in the US and other managed care markets. This will likely have a tremendous impact on our sales and marketability of the product in the UK and elsewhere,” said Keith Nalepka, VP of Sales & Marketing at BioElectronics.
With the addition of ActiPatch to list of approved treatments, chronic pain sufferers now have access to paid safe, drug-free chronic pain relief. The ActiPatch will be listed for payment coverage in April.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.
References
1 NHS, "NHS Choices," January 2018. [Online].http://www.actipatch.com/actipatch/wp-content/uploads/2014/11/ActiPatch-3-month-Cost-Study-Final.pdf
Available: https://www.nhs.uk/news/medical-practice/almost-half-of-all-uk-adults-may-be-living-with-chronic-pai....
2 Arthritis Research UK, "Muscloskeletal Matters," Keele University, 2009
ActiPatch Cost Assessment Study Used By UK's NHS
http://www.actipatch.com/actipatch/wp-content/uploads/2014/11/ActiPatch-3-month-Cost-Study-Final.pdf
This improvement translated into reduced utilization of healthcare services, leading to a 36.8% reduction in health care costs to the NHS over a 3-month period, even after accounting for the cost of the ActiPatch device
Conclusion
Utilizing ActiPatch® as a chronic pain therapy treatment improves patient quality of life, while reducing the economic burden to the NHS.
"Almost half the adult population is living with chronic pain," the Daily Mail reports. A major new review suggests that around 28 million adults in the UK are affected by some type of chronic pain (pain that lasts for more than three months). Read More Link
https://www.nhs.uk/news/medical-practice/almost-half-of-all-uk-adults-may-be-living-with-chronic-pain/
February 06, 2017 09:05 ET
FREDERICK, MD--(Marketwired - Feb 6, 2017) - BioElectronics Corporation (OTC PINK: BIEL), the maker of wearable pain therapy devices, announced today that it has received over-the-counter use market clearance from the US FDA for ActiPatch® for the adjunctive treatment of musculoskeletal pain related to (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee.
BioElectronics is an electroceutical company that develops wearable, neuromodulation devices to safely mitigate neurological diseases and improve quality of life. Our innovative pulsed shortwave therapy technology (PSWT) that uses low power pulsed electromagnetic fields regulate electrical activity of the nervous system. The neuromodulation basis of PSWT presents significant opportunities for BioElectronics to develop optimized technology for diabetic neuropathy, postoperative surgery, chronic wounds, and other applications.
Our current OTC product line includes ActiPatch® Musculoskeletal Pain Therapy, Allay® Menstrual Pain Therapy, Smart Insole™ Heel Pain Therapy, and RecoveryRx® Post-operative and Chronic Wounds Therapy. The US FDA clearance is for our flagship product the ActiPatch® Musculoskeletal Pain Therapy, developed to relieve chronic pain. ActiPatch is a drug-free, wearable nonprescription medical device that provides 720-hours (90, 8-hour treatments) of on/off therapy for $30.00 retail. Most users obtain relief with only 8 hours per day of use, so the device will generally last several months, depending on use. ActiPatch Provides:
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.
How to Order an ActiPatch®?
Visit tryactipatch.com to place your order for the ActiPatch® today.
www.tryactipatch.com
BioElectronics Corporation
301-874-4980
info@bielcorp.com
4539 Metropolitan Court
Frederick, MD 21704
ActiPatch Healthcare Utilization Study Link
http://www.harmonyhealth.se/wp-content/uploads/2017/10/ActiPatchHealthcareCostStudy.pdf
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