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"Consider that my parting shot", If Only, Unfortunately more BS
Parting Shot
" a remark that you make when you are leaving, so that it has a stronger effect"
In addition to the Predicate Data BIEL provided 2 Studies to support the RecoveryRx 510k application:
Clinical Data:
The clinical data in this 510(k) includes results two randomized, doubleblinded, placebo-controlled studies:
• A randomized, controlled, double-blinded study that investigated the
effectiveness of RecoveryRx in treating postoperative pain in 18
women who underwent breast augmentation surgery. These women
presented with the following average baseline demographics: 31.6
years of age, weight of 134 lbs and height of 5.52 ft. The primary
outcome was a difference in daily pain, measured on a 0-10 visual
analog pain scale. The results indicate that the effect of active
treatment with RecoveryRx provides a statistically significant
treatment effect (reduction in postoperative pain), when compared to
placebo (p<0.05).
• A randomized, controlled, double-blinded study that investigated the
effectiveness of RecoveryRx in treating postoperative pain in 96
woman who underwent cesarean section surgery. These women
presented with the following average baseline demographics: 27.1
years of age, gestation period of 38.7 weeks and 2 prior cesarean
section surgeries. The primary outcome measure was differences in
postoperative pain as assessed on a 0-10 visual analog scale. The
results indicate that the effect of active treatment with RecoveryRx
provides a statistically significant treatment effect (reduction in
postoperative pain), when compared to placebo (p<0.05).
ActiPatch provided 3 Studies for their Musculoskeletal Clearance:
Clinical Data:
The clinical data in this 510(k) includes results from three IRB approved,
randomized, controlled studies. Additionally, usability testing was
conducted to support the OTC use of the device.
• A randomized, controlled trial on chronic cervical osteoarthritis
(neck pain): This was a randomized, active-treatment controlled
study to evaluate the safety and effectiveness of the ActiPatch
medical device to reduce the pain level of patients diagnosed with
cervical osteoarthritis. The active-treatment control was an NSAID
of the Cox-2inhibitor family. There were 200 intent-to-treat
patients, out of which 197 completed the four-week study. There
were 142 women (71%) and 58 (29%) men in the study, with an
average age of 45 years. The primary endpoint for efficacy was
reduction in pain (VAS score) while at rest and being active, over
four weeks, when compared to the beginning of the study. The
results indicate that ActiPatch significantly reduced pain
(measured by VAS pain) associated with COA in the device
treatment group, and that the treatment differences between
device-treatment and NSAID-treatment groups was significant
(p<0.05).
• A randomized controlled trial on osteoarthritis of the knee: The
osteoarthritis of the knee study was a double-blinded, randomized,
placebo-controlled study to evaluate the safety and effectiveness of
the ActiPatch medical device to reduce the pain level of patients
diagnosed with knee osteoarthritis. The placebo treatment was a
device that was identical to ActiPatch but did not produce an
electromagnetic field when turned on. There were 66 intent-to-treat
patients, out of which 60 patients completed the four-week study.
There were 43 women (71.6%) and 17 (16.4%) men in the study,
with the following average demographics at baseline: 68 years of
age, BMI of 27.4 and disease duration of 12.1 years. The primary
effectiveness endpoints were improvements in pain level over the
four weeks as measured by the before and after VAS score and
WOMAC scores, and the primary safety endpoint was all
treatment-related adverse events during the study. The results
indicate that ActiPatch significantly reduced pain (measured by
VAS pain) associated with KOA in the device treatment group,
and that the treatment differences between active and placebo
treatment groups was significant (p<0.05).
• A randomized controlled trial on plantar fasciitis (heel pain): This
was a randomized, double-blinded, placebo-controlled study to
evaluate the safety and effectiveness of the ActiPatch medical
device to reduce the pain level of patients diagnosed with plantar
fasciitis. The placebo treatment was a device that was identical to
ActiPatch but did not produce an electromagnetic field when
turned on. A total of 70 patients were recruited into the study, and
all 70 completed the study. There were 52 women (74.4%) and 18
(25.6%) men in the study, with the following average
demographics at baseline: 51.5 years of age, BMI of 31.8 and
disease duration of 1.1 years. The primary effectiveness endpoint
was the daily morning (AM) VAS score, and the primary safety
endpoint was all treatment-related adverse events during the 7-day
study. The results indicate that ActiPatch significantly reduced
pain (measured by VAS pain) associated with PF in the device
treatment group, and that the treatment differences between active
and placebo treatment groups was significant (p<0.05).
More arcuately, Conned a lot of investors and did harm to BIEL with My Lies like 'Sales Track', 'Andy Told Me', 'BIEL to Declare BK Any Day', 'No way BIEL Survives This', ect, ect, ect, for last 12 years.
Congrats to the investor who grabbed 5 million shares at 1:37 !!
I would speculate that a new marketing strategy is being implemented. Will make more sense when further information is revealed.
Thanks Hawk, the New ActiPatch.com site is Live
Buy button works, BIEL is Selling ActiPatch in the US Market.
Extensive 'Clinical Evidence' page that proves efficacy.
https://actipatch.com/
Got it, publicly Bearish when wanting to Buy, publicly Bullish when wanting to Sell
I have always wondered what would motivate someone with no financial interest in BIEL to spend their valuable time Posting or Moderating on the BIEL board.
In the past there has been evidence that some bashers felt that AW screwed them and they were thus on a righteous mission to destroy BIEL. I can somewhat understand that state of mind but AW is now gone.
There are those that love to take the opposing side to any argument and the possibility of paid bashers who then would have a financial interest in trashing BIEL.
I am here because I own BIEL stock, I use ActiPatch daily and I would like BIEL to stay in business so that I have continued availability to ActiPatch.
Mopani Pharmacy in SA with 5 stores, 300 employees, Promoting Actipatch
https://mopani.co.za/collections/first-aid-sale
https://mopani.co.za/collections/first-aid
New Actipatch Retailer, Oak Works, $24.53, Free Shipping
Montgomery, Alabama
https://www.clinicequipmentshopofficial.com/actipatch-advanced-24-hour-pain-relief/
That's one Opinion
Another would be that the previous TOS created a basher playground. They had free rein to say anything they wanted about a company and its employees while being shielded from personal responsibility by the TOS.
Apparently 'Snowflake' is in the eye of the beholder .....
<<<<<<< I guess it just always surprises me what snowflakes you guys are. >>>>>>>> 7/17
<<<<<<< Wow!, it was just an article in HBR put in for discussion. I never suggested anything deserving of such a response. >>>>>>> 7/12
Thanks for confirming KW did Not delete her Linkedin account toohot
Turns out this was a Rorschach Test, seeing what one wanted to see in an ambiguous event.
Buys = 4.4 million shares
Sells = 310k shares
Neutral = 869k shares
BIEL Up 11% .
Congratulations, you just explained why an AS increase is not a viable option
There is no Market for billions of new shares with the SP depressed to .0005 and no positive news from BIEL.
Convertible Note holders realize this fact and are rolling their loans over.
Just laying out some facts, you don't have to like them but they are still facts
Buys @ 5 = 5.4 million shares
Sells @ 5 = 3.5 million shares
Sells @ 4 = 56k shares
Neutral @ 4.5 = 100k shares
Only 56k shares transacted at 4 today out of a 9.1 million share Total Volume
And some have a problem with BIEL Closing at 5 .
Buys @ 5 = 5.4 million shares
Sells @ 5 = 3.5 million shares
Sells @ 4 = 56k shares
Neutral @ 4.5 = 100k shares
Yes, 'Non-Opioid Pain Relief Device Market' is a thing and BIEL is front and center
" * February 2020 Bioelectronics Corporation received approval from the US FDA for their groundbreaking product, ActiPatch. As an Over-the-Counter electromagnetic neuromodulation device, ActiPatch introduced a fresh innovative approach to pain management, highlighting the shift in medical paradigms towards non-invasive alternatives."
" * July 2019 Bioelectronics Corporation secured another major accomplishment when it was granted market clearance from the FDA for its RecoveryRx device. This product, designed as a non-invasive strategy for relieving postoperative pain, underscores the increasing acceptance of electroceutical devices in managing pain."
https://www.astuteanalytica.com/industry-report/non-opioid-pain-relief-device-market
EXPLORE THE BENEFITS OF EME PAIN-RELIEF TECHNOLOGY
Enovis currently has the EME Knee Wrap, Powered By ActiPatch, on Sale for $41.99
https://www.djoglobal.com/patient-resources/articles/explore-benefits-eme-pain-relief-technology
LOL, Yes Amgen with only $26 billion in revenue last year is struggling due to their CEO Duality
Medtronic's Geoff Martha is also a CEO/BOD company only producing $31 billion in revenue last year.
Disney's Robert Iger is also a CEO/BOD company only producing $82 billion in revenue last year.
Chevron's Michael Wirth is also a CEO/BOD company only producing $235 billion in revenue last year.
IBM's Arvind Krishna is also a CEO/BOD company only producing $61 billion in revenue last year.
When are all of these floundering companies going wake up and kick their CEO off the BOD so they can make some real money?
What is CEO Duality?
"In nearly all companies, the Chief Executive Officer (CEO), holds a seat on the board of directors. More often than not, the CEO is actually the chairman of the board. This situation is known as CEO Duality."
https://thebusinessprofessor.com/en_US/business-governance/ceo-as-chairman-of-the-board
<<<<<<< Holding the position of CEO and ON THE BOARD is a conflict of interest >>>>>>>
"Robert A. Bradway is Amgen’s chairman and chief executive officer. He became chairman in January 2013 and chief executive officer in May 2012."
https://www.amgen.com/about/leadership/senior-management/robert-a-bradway
********************************************************************************************
<<<<<<<< 3 members on the BOD, Mom Whelan, daughter and RS >>>>>>>>>
The BIEL BOD consists of Chairman Dr. Staelin, CEO Kelly Whelan, Keith Nalepka.
"BOARD OF DIRECTORS
Richard Staelin Chairman, Independent Director
Keith E Nalepka
Kelly A Whelan CEO"
https://www.otcmarkets.com/stock/BIEL/profile
This article might be relevant if the Hindawi Journal, 'Pain Research and Management', in which the ActiPatch Study was Published, had been dropped from the 'Web of Science', it was not dropped. It is still included in the 'Web of Science' along with 201 other Hindawi Journals.
PAIN RESEARCH & MANAGEMENT
ISSN / eISSN 1203-6765 / 1918-1523
Publisher HINDAWI LTD, ADAM HOUSE, 3RD FLR, 1 FITZROY SQ, LONDON, ENGLAND, W1T 5HF
General Information
Journal Website
Publisher Website
1st Year Published - 1996
Frequency - Continuous publication
Country / Region - UNITED STATES OF AMERICA
Primary Language - English
Avg. Number of Weeks from Submission to Publication - 17
Article DOIs - 10.1155/7040
Web of Science Coverage
Collection .................. Index ............................................................ Category
Core Collection Science Citation Index Expanded (SCIE) Clinical Neurology
Other ............... Essential Science Indicators .................. Neuroscience & Behavior
https://mjl.clarivate.com/home
Thanks Probity, this ActiPatch Study was Peer Reviewed by Hindawi, one of the largest Medical Journal Publishers and has been viewed 5,625 times
Materials and Methods
This study is a prospective study and was carried out over 6 months. Subjects provided consent, and data analysis was approved by the Institutional Review Board of Duke University (2019-0285).
Peer Review Process
The following is the editorial workflow that every manuscript submitted to the journal undergoes during the course of the peer review process.
The entire editorial workflow is performed via Phenom, the manuscript submission system for our journals. Once a manuscript is submitted for publication, the manuscript is checked by the journal’s editorial office to ensure the files are complete and that the relevant metadata are in order. The manuscript is then sent to the Chief Editor who assesses the suitability of the manuscript in terms of scope and quality and, if appropriate, assigns it to an Academic Editor.
The Academic Editor then performs an additional, more detailed, analysis before inviting a number of potential reviewers to provide a peer review report – the Academic Editor can reject a manuscript prior to review if they deem it unsuitable for the journal. Based on reports submitted by the reviewers, the Academic Editor makes one of the following recommendations:
· Reject
· Major Revision
· Minor Revision
· Publish
If the Academic Editor recommends “Reject”, the authors are sent any review reports that have been received and are notified that their manuscript will no longer be considered for publication in the journal.
If the Academic Editor recommends “Major Revision”, the authors are notified of the editor's request that they prepare and submit an updated version of their manuscript with the necessary changes suggested by the reviewers and editor. This might require new data to be collected or substantial revision of the text. The manuscript is then reassessed by one or more of the original reviewers before the Academic Editor makes a new recommendation.
If the Academic Editor recommends “Minor Revision”, the authors are notified of the editor's request that they prepare and submit a revised copy of their manuscript with the required minor changes suggested by the reviewers and editor. Once satisfied with the final manuscript, optionally having sought further advice from one or more of the reviewers, the Academic Editor can recommend “Publish”.
If the Academic Editor recommends “Publish”, the manuscript will undergo a final check by the journal’s Chief Editor and editorial office in order to ensure that the manuscript and its review process adhere to the journal’s guidelines and policies. The authors will then be notified of the manuscript’s acceptance.
The Chief Editor remains ultimately responsible for the aims and scope of the title and will be called upon to handle appeals and other editorial issues as and when required.
Time for New Calculator, BIEL Moves UP 13 Places on Amazon Top Sales List
<<<<<<<< KT-Recovery+Wave sinking to #118 on Amazon >>>>>>>> 7/10/2023
<<<<<<<< KT-Recovery+Wave #131 currently on Amazon >>>>>>>>> 7/7/2023
Thanks imklo, BIEL's Corporate status has been reinstated
As of 6/21/2023 BIEL is in good standing with Maryland, Acknowledgment Number: 1000362014102646
Department ID Number:D05750989
Business Name:BIOELECTRONICS CORPORATION
Principal Office:4539 METROPOLITAN COURT FREDERICK MD 21704
Resident Agent: PATRICIA A WHELAN
9134 BEALLS FARM ROAD
FREDERICK MD 21704
Status:REVIVED
Good Standing:THIS BUSINESS IS IN GOOD STANDING
Business Type:CORPORATIONBusiness
Code:03 ORDINARY BUSINESS - STOCK
Date of Formation/ Registration:04/10/2000
State of Formation:MD
Stock Status:STOCK
Close Status:YES
Thanks GG, this study shows a reduction in Opioid use, a requirement for No Pain Act
Percentage of study group using Opioids:
Analgesics Fraction of users (%)
NSAIDS (e.g., ibuprofen) 43
Paracetamol 61
Weak opioids (e.g., codeine) 25
Strong opioids (e.g., hydrocodone) 11
Tramadol or equivalent 8
Pregabalin (e.g., Lyrica) 8
Amitriptyline 17
Topical opioid (e.g., morphine) 8
Topical NSAIDS (e.g., Voltarol) 21
Gabapentin 2
Other 4
No analgesics 5
"Unsurprisingly, pain reduction was accompanied with functional improvements in sleep quality, physical activity, patient global impressions of life changes, and a reduction in medication use—all of which are strong indicators of QoL improvements. This decrease in analgesic medication use over the 6-month period is a significant outcome, since long-term use of many analgesics results in adverse side effects that can impact patient quality of life [23, 31]. These include the highly significant and often multiple adverse side effects from opiate-based analgesics that are correlated with higher doses and long-term use [32]."
https://www.hindawi.com/journals/prm/2019/3154194/
The only definitive source for answering that question is BIEL
<<<<<<<<< Does KT Tape currently have A NO-COMPETE CLAUSE >>>>>>>>>>>
Common sense should tell you that "cease active promotion of the brand name ActiPatch in North America" would come with some conditions. The most obvious one would be minimum yearly device orders from KT.
KT has had 3 direct shipments of ActiPatch devices from BIEL's factory in China to the KT facility in
Utah:
12/21/2020 - 3,770 cartons
04/25/2021 - 4,332 cartons
06/27/2021 - 2,848 cartons
Shipping records and BIEL's Sales Revenue would indicate no orders delivered in 2022 to KT.
Violating a yearly order quota would most likely not void the entire OEM contract but should allow BIEL to resume ActiPatch promotion in North America. The evidence that BIEL may start selling ActiPatch again in the US is found in the new ActiPatch.com website under development with a 'Buy Button'.
The 12/15/2020 PR says,
"As part of this agreement BioElectronics will cease active promotion of the brand name ActiPatch in North America. Existing channel partners in the USA will continue promoting the ActiPatch brand name, while BioElectronics will continue expanding its network of international distributors for ActiPatch."
As BIEL indicated the ActiPatch.com site is testing layouts
When I viewed it 10 days ago it did have a 'Buy' button that was functional. The site also had several more pages, very close to the Adcock Ingram ActiPatch site.
Today it has just one page with no Buy button and "Coming Soon" written across it.
All of the choices on a Bing search have been disabled except the landing page:
https://www.bing.com/search?q=Actipatch.com&form=ANNTH1&refig=c32299c69168447aa5a5a8310ff3da25
ActiPatch
https://actipatch.com
WebAbout ActiPatch®. ActiPatch® is a new and clinically proven drug free technology in the …
Buy Now
ActiPatch News BioElectronics Corporation Chairman Richard Staelin, Ph.D., Updates …
ActiPatch Products
The ActiPatch® product provides advanced long-lasting chronic pain relief using …
Why ActiPatch
In fact, ActiPatch® is completely sensation free, so the only thing you are going to …
Testimonials
“ActiPatch is the best thing since sliced bread. Please try it. I was sceptical and …
FAQs
ActiPatch® is lightweight, discreet and …Contact Us · How ActiPatch Works
Blog
With the latest clearance, ActiPatch remains the only pulsed shortwave …
Support
Email: actipatch@bielcorp.com US Office …For Medical Professionals
ActiPatch® Back Pain Relief
Advantages of ActiPatch® EFFECTIVE: …Clinical Evidence
Yawn, same BS different year
<<<<<<<<< This company is effectively dead >>>>>>>>>
Year after year, "BIEL is Dead", yet BIEL continues to provide drug free, side effect free, non-addictive pan relief to thousands.
BIEL products are being researched by prestigious institutions like the University of California at San Diego for new indications, paid for by UCSD.
New partners like Adcock Ingram want to introduce BIEL products into new markets.
As the disclaimer states, the idea that 'BIEL is Dead', "is my opinion and my opinion only".
A single point in time
<<<<<<<< The snapshot of a single point in time is misleading. >>>>>>>>>
I was discussing yearly figures. After stating, 'a single point in time is misleading', you go on to quote Quarterly figures. Pretty sure a Quarter is 9 months closer to 'a single point in time' than a year.
The OEM business model amplifies the Quarterly swings in revenue.
Q1 2020 - $118k
Q2 2020 - $33k
Q3 2020 - $155k
Q4 2020 - $522k (KT's first direct shipment)
Q1 2021 - $599k
Q2 2021 - $412k
Q3 2021 - $414k
Q4 2021 - $182k
Thanks for agreeing with me
GSO said sales are the only thing that matter, "I'm looking at the only metric that matters: gross sales".
$289k away from "Green" in 2021 is 8x closer to profitability than $2.4 million away from "Green" was in 2015.
Looking at the wrong metric
Was BIEL better off Selling $2.3 million (2015) of product with a Net Loss of $2.4 million or Selling $1.6 million (2021) of product with a Net Loss of $289k?
Sales are important but the 'Bottom Line' is how much you had to spend to generate those Sales.
In regards to the 'Bottom Line' for the period 2015 - 2022, 2015 was the worst year and 2021 was the best year.
Consumer Medical Device Statistics
CMD Category ........... 2019 (in millions) 2020 (in millions) 2021 (in millions) 2022 (in millions)
Pain Relieving Devices .... $43 ..................... $30 ............................ $30 .................. $29
I was thinking more along the line that those who repeatedly claimed that the Covid Worldwide Pandemic was no excuse for a downturn in business are full horse manure, and BIEL has done a great job weathering that storm.
Looks like BIEL is not alone in Health Insurance Coverage issues
Pear Therapeutics, a maker of Apps that help cure medical conditions-Prescription Digital Therapeutics (PDTs) , valued at $1.6 billion 2 years ago, filed for BK last month.
In a LinkedIn post shared the day of the bankruptcy announcement, Pear CEO Corey McCann attributed the difficulties that many digital therapeutics makers are facing to insurers’ reluctance to cover the technology.
“We’ve shown that clinicians will readily prescribe PDTs. We’ve shown that patients will engage with the products. We’ve shown that our products can improve clinical outcomes. We’ve shown that our products can save payors money. Most importantly, we’ve shown that our products can truly help patients and their clinicians,” he wrote.
“But that isn’t enough. Payors have the ability to deny payment for therapies that are clinically necessary, effective and cost-saving,” McCann continued, adding that “market conditions over the last two years have challenged many growth-stage companies, including us.”
Thanks toohot, I noticed something else when putting this post together
The graphics in the BIEL ActiPatch.com site and the Adcock Ingram ActiPatch site share several images. Some identical and some slightly modified.
Wondering if this is a case of sharing promotional material or if there is something deeper going on.
https://actipatch.com/
https://actipatch.co.za/why-actipatch/
KT has already lost its 'No ActiPatch Sales in US' status
<<<<< they need to terminate the KT Tape agreement that prevents them from marketing the device themselves in the USA >>>>>
Early in 2023 new vendors for Actipatch started surfacing in the US market. Today we have BIEL themselves advertising ActiPatch for sale in the US. BIEL wisely placed sales quotas in the KT OEM contract.
https://actipatch.com/
"ACTIPATCH® MEDICAL DEVICE. ACTIPATCH® IS A REGISTERED TRADEMARK OF BIOELECTRONICS CORPORATION. FOR FULL PRESCRIBING INFORMATION
REFER TO THE INSTRUCTIONS FOR USE. TEL: 1-866-757-2284.
HOME CLINICAL EVIDENCE TESTIMONIALS FAQs BUY!
© 2023 BIOELECTRONICS . ALL RIGHTS RESERVED"
"Name ONE thing that he has done"
Am J Case Rep. 2022; 23: e937549-1–e937549-5.
Published online 2022 Aug 17. doi: 10.12659/AJCR.937549
PMCID: PMC9394547
PMID: 35976802
Treating Intractable Postamputation Pain with Noninvasive, Wearable, Nonthermal, Pulsed Shortwave (Radiofrequency) Therapy: A 12-Patient Case Series
"The authors would like to thank Sree Koneru, PhD (BioElectronics Corporation, Frederick, MD, and Meraqui Medical, Fremont, CA) and Kenneth J. McLeod, PhD (Department of Systems Science and Industrial Engineering and the Clinical Science and Engineering Research Laboratory, Binghamton University, Binghamton, NY) for reviewing the introduction, methods, and discussion sections for technical accuracy."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9394547/
Pulling SP down at Market Open to trigger 4 'Stop Loss Orders' and then Selling those 4s at 5 or 6 sounds a lot like "buy low and sell higher"
Do you feel that dumping 3.6 million shares at the Open accurately reflects a day's Trading?
Or does it reflect someone wanting to manipulate the price downward? It could be a Market Maker or it could be shareholder with an agenda.
Wouldn't a legitimate shareholder who decided to Sell 3.6 million shares today want to get as much money as possible from that sale?
Yesterday there was 10 to 12 million shares on the 5 Bid Size. Why dump 3.6 million shares in the Opening seconds when there are only 1.9 million shares on the 5 Bid Size unless your goal is to drop the SP not get the most money out of your sale?
At 10:16 this morning, with a 5 Bid Size of 4.7 million shares & a 6 Ask Size of 11.7 million shares and no transactions since the 9:30 dump, I ran a test to see what would happen to a Buy Order at 6 for 100k shares. It was filled at .00055, so it was classified as a 'Neutral Trade' rather than a Buy.
38 seconds after my Trade filled a Sell for 140k shares at .0005 hit the Tape.
A company's share price does not necessarily reflect its value
<<<<<<<< NO reputable and successful company will even pay $12.5 million >>>>>>>>>
SiriusXM traded at $69 in March of 2000, was it worth that much, probably not but rapid growth had propelled it upward . In February 2009 SIRI traded at 5 cents, was it worth that little, no but financial debt issues had beaten it down.
A company wanting to enter the PEMF/PSWT market can hire knowledgeable engineers and build a product themselves or Acquire or Partner with a company that already has the technology/products.
" The average cost to bring a medical device to market through the 510 (k) pathway is $31 million compared to the PMA pathway with average costs of $94 million."
BIEL has 5 FDA Clearances for PEMF/PSWT Medical Devices and 3 of those expensive FDA Indications are for OTC Medical Device Marketing, something no one else currently has.