Archives for posts with tag: #Pain

This blog is about what interests me. What interest me falls into a general pattern.

Lets read the tea leaves for Bioelectronics. I’m doing this for the non-obsessives. I’ve learned that some things I take for granted logically do not always follow naturally for others. So this is for people interested in BIEL.

  1. The last time Keith Nalepka was on the radio, he said he would be back within forty days with news, basically about the Dr. Scholls deal getting finalized.
  2. Premise-the Dr. Scholls deal can’t get finalized until General Clearance for Pain is granted by the FDA, along with with the wound healing application. This will make the deal better, and will be what the ad campaign is based on. So Bayer/Dr. Scholls needs this before this goes live.
  3. Two days ago, Keith Nalepka said he would be on the radio within the next three weeks.
  4. Sum= Keith Nalepka expects to get General Clearance within the next three weeks, and to be on the radio discussing the Dr. Scholls deal, finalized.
  5. So, General Clearance within the next three weeks?

Steps 1-5 make sense to me. If Nalepka committed to the radio talk, read between the lines.

A general comment—I expect wound care to be easier than general muscle pain, data wise. People are wooses. I don’t expect an honest answer about pain from most people. It’s tough to gauge. Given enough cases in a well run study, yes, you can generate valid data, but I innately am suspicious of gripers.

Wound care, however, is a beautiful study. Just take a thousand similar wounds, treat 500 with an ActiPatch and 500 with a placebo, monitor objective criteria like healing time, swelling dissipation, scar formation, rate of infection, there are multitudes of data you can can chart, graph, correlate. Now you’re talking my language. How do you feel doesn’t work for me, especially when half the people in the study might just be whiny crybabies who want an opioid prescription.

Why do you think the German giant medical stock BRAUN like BIEL for it’s wound treatment in that recent major deal? Because you can prove wound healing with data with no debate really.

Anyway, it will be interesting to see how it plays out. I have to thank Keith Nalepka for his transparency on Twitter. Follow him, let’s make him a Blue Check.  Expect a press release next week as yet another European country announced it will pay for the Actipatch. Sweden, which has one of the greatest health care programs in the world, joined the UK in adding Actipatch to their national health care program. I thought Germany would be next in line because of BRAUN, but I will take Sweden, a world leader. It is exciting to see all this finally playing out.  I’m rooting for Andrew Whelan and the team. It’s like the Old Man and The Sea, as  I have said before. He caught the biggest fish in the world, and for all the BIEL shareholder’s sakes I hope he can bring it home. Something tells me the sharks already had their best chance.

 

 

 

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Winding up May 15th, 2018.  Bioelectronics will most likely release a statement about the May 29th FDA meeting by June 1st, 2018.  While BIEL cannot comment on the General Clearance meeting which took place on May 9th (or so) while in process, it might well provide some hints included in the May 29th release on the separate FDA application for wound healing. This would be the tactful way.

Waiting for  the “ink to dry” on the Doctor Scholl’s agreement. I have a pen here at home I could have lent them, usually  dries completely in about thirty seconds. I admit it is not a very special pen, I think I lifted it from a bank, but I would have been happy to donate it, for future reference.

A fairly ideal outcome for this press release-These applications are very template driven, the hard part was the creative effort to invent this and get through all the other hurdles.

IHUB is going to get ugly near term until the recent spate of orchestrated stock shorters throw in the towel. Last FDA approvals, it took several days for the stock to really spike. I think this news needs to sink in, be understood and digested by the investing world.

No new testing required and the previous 510K submission can be used. Approval for the back means full OTC General Clearance. Migraine, Menstrual, Carpal Tunnel, everything can go easier, not to mention post surgery coming up on May 29th.

 

BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application

GlobeNewswire

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 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, 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

First, BIEL and the gang need to bring their lawyers that helped them get the first couple FDA clearances.

Second, BIEL and the gang need to bring their lawyers that helped them get the first couple FDA clearances.

Third, BIEL and the gang need to bring their lawyers that helped them get the first couple FDA clearances.

Sit there stony faced and make the FDA talk themselves into a ditch.

Last couple of clearances were in Feb 2017. The prelim meeting was like 2-3 months earlier, if memory served.

Lots more positive data since then, and the product has gotten beta tested quite a bit also. Nobody died from using it yet. Cellphones are way more dangerous. Never heard of an ActiPatch exploding.

Up 650% so far this year? If BIEL really gets going, that will seem like small potatoes.  I have always valued this at at least a nickel a share (current share structure), but with the NHS deals and current team at BIEL, this could be too conservative. 2 FDA meetings this month? Scuttlebutt and hearsay will push this to a penny.

 

Hello Friends,

I recently spoke with the upper management of Bioelectronics Corporation, who as always have been responsive and informative. I rarely call them. Anyway, they are working behind the scenes, be assured of that. Possible partnerships on the horizon, nothing which has not been publicly discussed, but it was good to hear they are still in the game firsthand.

This post is about two items in particular. As the CIA might put it, I have a limited hangout here, nothing earthshattering. However, I want to present some ideas which, if cultivated by a grassroots of #Actipatch supporters, presence on Social Media, in particular Twitter, will be increased significantly.

Two items are pasted below. I will address each in turn. The first, a post on the I-hub Bioelectronic message board about getting more out of Twitter. DewmBoom posts “Tweet for fighting the Opioids Epidemic, Using Actipatch”

DewmBoom, though well-intentioned, should have phrased this thusly:

“Tweet for fighting the #OpioidsEpidemic, Using #Actipatch”

The difference? Hashtags(#) are what demarcate subjects on Twitter. #s are basically the coding signal Twitter uses to categorize “meta” words. I know this from my sub-career as a book promoter. Without the #, you are mainly invisible on Twitter.

https://ritetag.com/best-hashtags-for/backpain I googled twitter pain relief hashatags: Open source, easy access info, and all that is necessary to get a lot more mileage out of Twitter posting is to add two popular hashtags to your post

Screenshot 2017-08-11 at 11.08.15 AM

 

Screenshot 2017-08-11 at 10.48.47 AM

So, for prospective Twitter users, use #ActiPatch as a central locale on Twitter, but also add another one designed for the topic of the post. Don’t use more than two hashtags, you look like a spammer or a bot.

Case in point. Here is a Tweet from the Bioelectronics Corporation (Actipatch)

It’s a lovely site, a lot going on, but some issues we need to discuss. I will use the post below as an example.

 

Screenshot 2017-08-11 at 10.47.01 AM.png

This post has no hashtags. It uses the word “Paresthesia”, which is from Ancient Greek and basically means that “pins and needles” sensation you get sometimes. Let me play the near perfect score in the verbal section of the SAT card here. If I had to look that up, others had to as well. Problems is you have to get it done in 300 characters. Even #Paresthesia would have been better. Doctors might follow that hashtag.  Also, this is probably about reducing #MenstrualPain using the #Actipatch. Billion dollar industry and I need to say “probably”?

I found this by putting “pins and needles hashtag on Twitter”into Google search

Screenshot 2017-08-11 at 11.23.24 AM.png

 

found this by putting “paresthesia hashtag on Twitter” into Google search. They are out there, but we need to start adding hashtag to the best metawords in the post.

I promised there would be nothing earthshattering, didn’t I?

Screenshot 2017-08-11 at 11.25.30 AM.png

 

People love this product, and there is a lot of interest in reducing opioid addiction, helping people relieve pain safely, and being truly socially responsible. Incrementally, with baby steps, we could get this boulder rolling downhill and let it assume a life of its own through social media.

So whats the first step? At least start using #Actipatch. This will help organize people on Twitter. After that, the best hashtags will reveal themselves. I have been tweeting President Trump and even First Lady Melania whenever either tweets about the opioid crisis, which apparently started the day Trump was inaugurated, testing it. Like, retweet, reply #Actipatch. I will follow anyone who uses #Actipatch in a Tweet, and so should everyone else.

frodo