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"To the moon zing Zang zippidy do da. Kelly is awesome."
I agree, whole heartedly...
Go Kelly!
Go Biel!
This piece of doggggy do had a whopping $900 in trades today. To the moon zing Zang zippidy do da. Kelly is awesome.
NASA, one of the smallest sales markets there are.
Especially after the Colombia and Challenger episodes.
SIMPLE!
Declining Sales Cheers!~~
Does NASA use PEMF?
by Richard Hoover
NASA began using Pulsed Electromagnetic Field therapy in the 1960s, to support the overall health and wellness of people working in space stations and engaging in other missions that remove them from the earth.
NASA began using PEMF primarily because it was identified and recognized that the loss of the earth’s natural electromagnetic pulses was detrimental to human health.
Pulsed Electromagnetic Frequency therapy exposes the body to the same frequency as the earth’s electromagnetic energy—or frequencies similar to the earth’s—to mitigate the effects of leaving the earth’s atmosphere and losing electromagnetic compatibility for an extended period of time.
NASA was one of the organizations at the forefront of the PEMF research train, so to speak, as they were eager to identify a solution to the myriad issues that arose after astronauts left the earth.
NASA’s study of PEMF therapy proceeded widespread use of the technology for astronauts, and included a four-year study of tissues, evaluating their response to PEMF therapy.
Following the course of the four-year research study, NASA researchers found that virtually all bodily tissues improved after PEMF exposure, including cellular communication and overall function.
Consequently, NASA was among the first organizations to encourage the use of PEMF therapy as a means of improving and maintaining heath.
NASA’s use of PEMF therapy was intended to replace the earth’s natural electrical signature or energy, because being in space eliminated access to that frequency.
While most of us do not recognize the presence of the earth’s electrical signals and their ability to maintain or support health, the electrical signatures found in all living things play a role in how well the body functions and communicates intracellularly and intercellularly.
When exposure to the earth’s frequencies is lost, health suffers in the form of increased inflammation and the cascade of negative effects that come as a consequence of inflammation in the body.
PEMF therapy was introduced as a solution to the loss of earth’s frequency exposure, in order to help NASA worker’s bodies adapt and heal.
Astronauts were found to experience bone deterioration, depression, tissue damage, cardiovascular damage, and more after even short excursions into space, necessitating the development of a therapy to mimic earth’s EMFs.
While PEMF therapy had been developed prior to the 1960s, it was not until NASA began heavily investigating the technology and using that research to support the health and wellness of astronauts that a larger number of people began to express interest in PEMF therapy and the benefits it can provide.
Although plenty of media attention has been paid to bone density loss after astronauts have returned from their posts in orbit, NASA was interested in developing and utilizing technology that prevented issues before they arose, delivering therapeutic intervention to astronauts while they are still in space, rather than waiting until they return.
PEMF is the safest, simplest, and most effective way to do this, and NASA was quick to implement PEMF therapy when sufficient research has been conducted and encouraged the use of PEMF therapy for bone and tissue deterioration, depression, and other issues associated with leaving the earth’s atmosphere.
Richard Hoover is a PEMF expert and content contributor to PEMF Advisor. With a bachelor’s degree in physics and multiple certifications in natural health programs, he is one of the best PEMF experts around.
https://www.pemfadvisor.com/does-nasa-use-pemf/#:~:text=NASA%20began%20using%20Pulsed%20Electromagnetic%20Field%20therapy%20in,other%20missions%20that%20remove%20them%20from%20the%20earth
Where are the 4th Quarter earnings report? We are excitedly waiting! Biel has a strong foothold internationally so the numbers should be good! Go Biel!
Nice post. Interesting read. Thank you.
Yes, that's the same story that I was referring to. NASA has been involved in PEMF research for a long time.
While BIEL's technology came from original work conducted by Richard Bentall in the early eighties, NASA and it's collaborators were basically inventing the same thing on a parallel path.
JND - What do you think about this article on NASA's early research into PEMF?
https://www.pemfadvisor.com/does-nasa-use-pemf/#:~:text=NASA%20began%20using%20Pulsed%20Electromagnetic%20Field%20therapy%20in,other%20missions%20that%20remove%20them%20from%20the%20earth.
Look at the 14 trades, what a joke!
SIMPLE! She's done!
Declining Sales Cheers!~~
Kelly keeps all her shareholders well informed once every few years. So I am hoping to hear in a couple years that maybe we sold a trinket or two to fill the crazy promise she made us 970k order. Please folks do not hold your breath you may suffocate.
Speaking of NASA did you know:
Endonovo’s SofPulse device can be traced back to work done at NASA in the late eighties. NASA was doing some research in collaboration with scientists studying stem cells. They wanted to see what happens when cells were incubated and grown in a microgravity environment. They learned two things, cells grew better in microgravity, (on earth, the cells settled in the dishes under gravity which complicated their growth), and they also learned that the cells experience periodic bursts of growth as they orbited the planet. This was due to changes in the magnetic field that the cells experienced when orbiting the planet.
The technology was developed for terrestrial use in a collaboration with scientists at a company called Synthecon Inc. They developed a bioreactor for growing cells that is still in use today. Another company called Regenetech licensed the technology and continued to pursue research. The head scientist at Regenetech was Donnie Rudd, he was one of the principles at the beginning of Endonovo. Their PEMF/PSWT device was a direct outgrowth of the work done at NASA, Synthecon, and Regenetech. In a very odd twist, Dr. Rudd was arrested in 2015 on suspicion of murder in the death of his wife. He died in prison last year. Needless to say, his influence at Endonovo is no longer discussed.
I was a little surprised that the author of the recent NASA report on electromagnetic pain relief didn’t know about the earlier connections to NASA research. NASA has been aware of the healing properties, and neuromodulation potential of electromagnetic fields for a long time. But I’ve worked in large organizations, and knowledge transfer across generations of employees is not always very effective. I wonder if BIEL is aware of any of this. I think I’ll send a note to Paul.
References and further reading:
https://ntrs.nasa.gov/search?q=pemf
https://ntrs.nasa.gov/search?q=regenetech
https://ntrs.nasa.gov/search?q=synthecon
https://www.nasa.gov/offices/oct/home/feature_hof.html#backtoTop
https://patents.justia.com/search?q=linda+c+shackelford
https://patents.justia.com/search?q=Donnie+Rudd
https://www.globenewswire.com/en/news-release/2014/01/28/969530/0/en/Hanover-Portfolio-Acquisitions-Changes-Its-Name-to-Endonovo-Therapeutics.html
https://www.signalsblog.ca/the-out-of-this-world-story-behind-endonovos-regenerative-medicine-technology/
FDA Opioid Challenge disagrees. Nuff Said!
Someones lying.
Declining Sales Cheers!~~
FDA And NASA Disagree
There's zero investment value in RecoveryRx, NONE!
It's been tried for 10 years everywhere and failed.
Declining Sales Cheers!~~
Hey Todd Charnetski...the symbol is BIEL-OTC, perfect price to buy.
This RecoveryRX presentation (https://recoveryrx.carrd.co/) contains excellent visuals and printed content that thoroughly explains the fundamentals of pain science and how the Pulsed Short-Wave Therapy generated by Actipatch is more effective than any other pain management method, including pain medications. The slide show and video could be packaged with the NASA Review Study article for a most convincing presentation to physicians, hospital administrators, nurses and physical therapists.
Maybe there are some here on this message board who would consider becoming a distributor?
Thanks to the Whelans...no one knows BIEL
look at the volume. Now BIEL is a national secret company, the general public does not know BIEL. Hehehe
Pure scam written all over it. Typical BioElectronics.
Why the SEC hasn't shut this down is amazing.
Kelly hasn't even paid off the fine imposed in 2016.
What does that tell you, maybe the SEC will confiscate this junk?
Declining Sales Cheers!~~
She can't even mention the Synergy deal, which is a private company, because it's confidential. Do you believe you'll get answers about the national secrets related to NASA?
This is a micro-cap stock that's worthless. SIMPLE!
18-years worth of bullshit flowing from this company's mouth.
How much more time should an investor give them, 18 more years?
Over that time it's been headed down many more times than up.
Just think, BIEL once traded for 40 cents on average in 2004 thru Q1 2006
Time for the longs to sell this at any cost, or risk losing it all.
Then the walls came crumbling down.
Time for the long investors to get real and get rid of BioElectronics. SIMPLE!
Declining Sales Cheers!~~
Dr. Ifeld's Does A LOT Of Government Research.
Biel!!
Yup, And This May Be Why It Is Being Tested.
"Dr. Ifeld's interest in RecoveryRx at UCSD, a Top 10 US Research University, the immediate benefit is the exposure BIEL gets in the research community. Thousands of researchers and related medical professionals exposed to the drug free pain relief RecoveryRx provides."
3-y/o news...call Kelly to see what's become of this...
and WHY she didn't mention this to shareholders.
Excerpt from a NASA comprehensive review of pain management options:
https://ntrs.nasa.gov/api/citations/20205008893/downloads/2020ICA_Mullenax_report_24Sep20.pdf
The BioElectronics sales-staff is very disingenuous. DON'T BUY
Declining Sales Cheers!~~
"2. Obtain an ActiPatch device for evaluation and determine whether it could be beneficial and adapted to spaceflight use."
I think Biel was working on a rechargeable version?
That is the #1 modification that NASA would want. It's all about keeping payload weight down.
If they have any rechargeable prototypes, they should talk to NASA.
Early Call!! Biel Post Of The Year Award!!
Linked Post.
See Especially Pages 14 and 15
https://ntrs.nasa.gov/api/citations/20205008893/downloads/2020ICA_Mullenax_report_24Sep20.pdf
Biel!!
MOONSHOT!!
LOL!!
That’s one small loop for NASA
One giant leap for mankind
I believe in NASA and what it says. They have giant communications departments and thousands of staff. Why I bet they have as many NASA research staff working on the loop issue as BIEL has employees. I wonder if the BIEL loop works better in space?
RELAX, WAKE up and think hard!!! BIEL is to the Moon!!! WAAAAAAAAAAAAAAAATCH out all above!!!! And those who are waiting for it to fall or to go bankrupt or to fail or.....could wait till.......HEHEHEHE....https://media.tenor.com/videos/5ae934e996c417ca96207ad373c1bef7/mp4 ...
Accept this FACT!!!!!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Me have NO IDEA what the F you is talking about -- don't like FB, NEVER used it, never will !!!!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Are you using corticosteroids for OA of the knee? Try DRUG-FREE, FDA cleared, non-invasive RecoveryRx. Sensation free! Can use when sleeping! http://recoveryrx.co #osteoarthritisrelief #neuromodulation #electroceuticals #oa #arthritisrelief #painrelief #ZEROsideeffects
Are you using corticosteroids for OA of the knee? Try DRUG-FREE, FDA cleared, non-invasive RecoveryRx. Sensation free! Can use when sleeping! https://t.co/uk178fKXKz #osteoarthritisrelief #neuromodulation #electroceuticals #oa #arthritisrelief #painrelief #ZEROsideeffects pic.twitter.com/TZYFQVcRHg
— BioElectronics Corp (@BielCorp) January 24, 2023
Yep, so huge Kelly said NOTHING to shareholders.
This is huge...great find..!!
Since BioElectronics failed the FDA opioid challenge in 2018 that puts them out of any hopes of being adopted federally or any insurance company's.
The sales staff at BioElectronics needs to go to work for a used car lot.
BIEL is totally a scam and the product that makes it look legit is called "the front".
They brought the gizmo to market and as predicted by Market Research it failed.
Who knows what back door deals there are to this unaudited pink junk.
Declining Sales Cheers!~~
Once again fueling the clotheing controversy on the BIEL FB page.
that has WHAT to do with Astronaut Bob?
Shank you verrrry much for such " HONEST" answer, so now we know where we stand and who should call !!!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Nothing about Synergy was ever publicly disclosed -- it's just a rumor created by the VP of Sales in a private Zoom meeting with one PowerPoint slide -- but you're convinced that Synergy is going to buy $10 million worth of RecoverRx, no confusion there, no questions, no sir.
that's nice. Slap that Ask! Be an Ask Slapper!
Expanding availability around the globe. #kuwait #medicaldevice #painrelief #neuromodulation #expansion #distribution #actipatch #recoveryrx $BIEL
http://mdmedical.co/bio-electronics.html
Expanding availability around the globe. #kuwait #medicaldevice #painrelief #neuromodulation #expansion #distribution #actipatch #recoveryrx $BIELhttps://t.co/SMxENo5362 pic.twitter.com/NTrvFzk7S6
— BioElectronics Corp (@BielCorp) January 24, 2023
NOPAIN Act Basics
What is the NOPAIN Act?
The Non-Opioids Prevent Addiction in the Nation Act (“NOPAIN Act”) (S. 586/H.R. 3259) is a bill designed to prevent opioid addiction before it starts by increasing the use of non-opioid pain management approaches in outpatient surgical settings.
What Would the NOPAIN Act Do?
The NOPAIN Act is designed to increase use of non-opioid pain management approaches
BY CHANGING OUTDATED FEDERAL REIMBURSEMENT POLICIES.
The legislation would:
Expand patient and provider access to FDA approved non-opioid pain management approaches in all outpatient surgical settings for the next five years.
Require a report to Congress on limitations, gaps, barriers to access, or deficits in Medicare coverage or reimbursement for therapeutic services.
Why Do We Need The NOPAIN Act?
This NOPAIN Act would ensure safe, non-addictive therapies are widely available to the tens of millions of Americans who undergo an outpatient surgical procedure every year. Drug-related overdoses and deaths skyrocketed during the pandemic resulting in the highest rates ever recorded. This policy change aims to reduce unnecessary exposure to opioids and the likelihood of opioid abuse or addiction following an acute pain incident.
Who Champions The NOPAIN Act?
Representatives Terri Sewell (D-AL), David McKinley (R-WV), Ann Kuster (D-NH), and Brian Fitzpatrick (R-PA) and Senators Shelley Moore Capito (R-WV), Jeanne Shaheen (D-NH), Rob Portman (R-OH), and Joe Manchin (D-WV) introduced and champion the NOPAIN Act. The NOPAIN Act now has over 160 bipartisan cosponsors across both chambers.
Congress can act now to prevent addiction before it starts and ensure those who need non-addictive pain therapies have access. Please join us to ensure Congress enacts the NOPAIN Act now!
Support the NOPAIN Act
https://nonopioidchoices.org/nopain-act/#:~:t...ve%20years.
let's not be hasty. Let's wait and see what Astronaut Bob thinks of the one ActiPatch that NASA plans to acquire.
If i would be confused, have questions, i would call Kelly !!!!
Call'em, ask'em and REPORT BACK to The Board !!!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Nobodys ever believed any of it.
WARNING !!! BE ADVISED !!!
ATTENTION All the Smart and INTELLIGENT People / Investors!!! BE ADVISED --- " Sales-Track " and/or " Market-Research " IMAGINARY/FRAUDULENT story is an ABSOLUTE BS, don't you, Beautiful People, BIELieve it one bit !!!!!!!!!!!!!!!!!!!!! WARNING !!!!!!!!!!!!
BIEL $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Sales-Track shows steep 2022-YOY sales declines for BioElectronics (BIEL)
2021 sales 1.6M vs 2022 sales 800K est.
Q1 2022 sales down 40% YOY 599,970 vs 360,444
Q1 2023 sales will also be down YOY as they show so far for the 30 days.
There is no investment value in BioElectronics, NONE!
Declining Sales Cheers!~~
More BS... 3-year-old study (not 2023). You got to be kidding.
Why didn't the "all-knowing wizard" Kelly Whelan post ANYTHING regarding this? It would have certainly helped get the stock price out of the crapper and get more exposure to investors.
It is clear to see to most shareholders that Kelly Whelan is an inept pseudo-CEO and is definitely in over her head with BIEL. She needs to go.
Just say it with me ( Recovery Rx ) just the sound of it makes a Cha Ching feeling! Go Biel
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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.
Contact Information
Uptick Newswire LLC
Everett Jolly, CEO/Founder
602-441-3474
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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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