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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 

10000 N. 31st Avenue C307 Phoenix, AZ 85051 

info@upticknewswire.com 

www.upticknewswire.com 

Release #:812-170554-rl-1141231:
 
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:

  • Domestic and international market presence with products that have proven marketability and customer acceptance.
    Unique, patented technology platform of wearable, safe, and cost effective pulsed shortwave neuromodulation devices for neurological disorders, which include:
    • Chronic Musculoskeletal Pain
      Menstrual Pain
      Heel and Foot Pain
      Migraine Headaches
      Postoperative Recovery and Pain
      Interstitial Cystitis (Overactive Bladder and Pelvic Pain)

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:

  • Prescription coverage for the majority of the 56 million populations of England and Wales.
    A drug tariff listing for reimbursement is expected to accelerate reimbursement clearance request in other nations.
    Has the potential to open the US market to the 90 million people with prescription payment coverage in Health Maintenance Organizations (HMO's), Accountable Care Organization, and other third party payers to provide and pay the cost of ActiPatch therapy.

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:

  • In addition to attack-related disability, migraine interferes with a sufferer's ability to function in everyday life, whether that is going to school or work, caring for family or enjoying social activities.
    About 14m people experience chronic daily headache – attacks occur at least 15 days per month.
    For more than 90% of all sufferers, migraine interferes with their education, career and social activities.
    Depression, anxiety, and sleep disturbances are common for those with chronic migraine.
    People with migraine use about twice the medical resources –including prescription medications and office and emergency room visits– as non-sufferers.

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:

  • NHS reimbursement of ActiPatch in the United Kingdom
    B. Braun, UK same day surgery program
    US professional sales to physical therapist, nursing homes, managed care providers
    International geographic market expansion; and,
    Domestic and International License and Supply Agreements for ActiPatch and the Smart Insole products.

 

Thank you for your support.

Sincerely,

 

______________________ 
Andrew Whelan, President

 
4/5/2018 11:27:37 AM 1141231
Gramps Biel Videos Crank Up the Volume!! 

All are Exceptionally well done!! 

Biel 4 Major Partners 

https://www.youtube.com/watch?v=iOiQDPnhvu8 

Why Invest in Biel 

https://www.youtube.com/watch?v=GAFI4mqnIzQ 

User Reviews Actipatch 

https://www.youtube.com/watch?v=FK9cJUWqpZQ 

Breaking Biel News 

https://www.youtube.com/watch?v=sCSHaIxHGsQ 

Super Monster 

https://www.youtube.com/watch?v=z-eb4LOpdCM 

Deep Profitability Video 

https://www.youtube.com/watch?v=Od__Ot6ZYfw 

Biel Express 

https://youtu.be/R6fm0I4a_Qs 

Liftoff 

https://youtu.be/uJrdTBsMo0g 

Gramps Biel Videos Crank Up the Volume!! 

All are Exceptionally well done!! 

Biel 4 Major Partners 

https://www.youtube.com/watch?v=iOiQDPnhvu8 

Why Invest in Biel 

https://www.youtube.com/watch?v=GAFI4mqnIzQ 

User Reviews Actipatch 

https://www.youtube.com/watch?v=FK9cJUWqpZQ 

Breaking Biel News 

https://www.youtube.com/watch?v=sCSHaIxHGsQ 

Super Monster 

https://www.youtube.com/watch?v=z-eb4LOpdCM 

Deep Profitability Video 

https://www.youtube.com/watch?v=Od__Ot6ZYfw 

Biel Express 

https://youtu.be/R6fm0I4a_Qs 

Liftoff 

https://youtu.be/uJrdTBsMo0g 



https://www.youtube.com/watch?v=Od__Ot6ZYfw&feature=youtu.be

Video By Gamps related to Biel



3/27/2018 Approved For Payment On The UK's NHS TARIFF LIST: IXA BioElectronics Corporation Pulsed electromagnetic stimulator ActiPatch device back 1 device 1395 35251411000001101 

IXA BioElectronics Corporation Pulsed electromagnetic stimulator ActiPatch device knee 1 device 1395 35251711000001107 

IXA BioElectronics Corporation Pulsed electromagnetic stimulator ActiPatch device muscle & joint 1 device 1395 35251911000001109
 


Great Video By Gramps About Biel Must Watch

https://www.youtube.com/watch?v=iOiQDPnhvu8

NHS APPROVED  01/04/2018
UK Approves Wearable mHealth Device for Chronic Pain Management

https://mhealthintelligence.com/news/uk-approves-wearable-mhealth-device-for-chronic-pain-management


Must READ https://www.nhs.uk/chq/Pages/1629.aspx?CategoryID=68 

in the UK the pharmacy like LLoyds can prescribe Actipatch,  https://onlinedoctor.lloydspharmacy.com/uk/general-health so you go in they assess your pain write a prescription and you walk out with a almost FREE actipatch... 

So forget about boots lets just talk about LLoyds , 1500 location, 

at least 5 people vist for pain daily , x 1500 locations x $20 x 30 days = $4,500,000 monthly... that is us forgetting everyone other place that sells it .. 
======2.5 people per/day $2,250.000 monthly sales 
======1 person per/day $900K monthly sales 

UPDATED ;:: 03/08/2018 

actipatch now listed 
http://www.lloydspharmacy.com/en/info/pain-management-service 

Looks who is listed :: under NHS health services 
http://www.lloydspharmacy.com/en/info/pharmacy-services 

FDA HAS CLEARED ACTIPATCH A

BIOELECTRONIC CORP PRODUCT FOR

OVER THE COUNTER SALES 2/3/2017.

BIEL IS THE STOCK SYMBOL 


http://www.accessdata.fda.gov/cdrh_docs/pdf15/K152432.pdf

Actipatch for Knee Pain

Actipatch Smart Insole for Heel Pain Relief


ACTIPATCH Question and Answers 

https://www.thegoodbody.com/actipatch-questions-and-answers/



Opinion Section:

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?

 

https://lnkd.in/eWrgGXc?lipi=urn%3Ali%3Apage%3Ad_flagship3_detail_base%3BNv3Us1%2FsQXyilhKfSKcP9Q%3D%3D

 

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. 



 

 

BioElectronics ActiPatch Drug-Free Pain Therapy Receives United Kingdom National Health System Payment Coverage

January 04, 2018 07:00 ET Source: BioElectronics Corporation
 
 

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 of all UK adults may be living with chronic pain

"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

BioElectronics Corporation Announces US FDA OTC Clearances For Drug-free ActiPatch® Musculoskeletal Pain Therapy

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:

  • Impressive Efficacy
    No harmful side effects
    A 50% Reduction in Medication Use, including opioidsExceptional Consumer Acceptance
    Demonstrated Marketability
    An adjunctive or alternative therapy to pain killers, including narcotics

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 

 

CONTACT INFORMATION

 

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

March 2017 Pictures APP Show  from Australia.



ActiPatch UK Distributors Availability Banner 11-1-15-01
 IN THE UK. WALGREEN HAS PURCHASED BOOTS 

http://www.bielcorp.com/technology/ 

 

MUST SEE  http://www.bielcorp.com/biel/wp-content/uploads/2014/01/Bioelectroceuticals-Mechanism-of-Action-Clinical-Evidence-Version-16.pdf


The Company
We are the makers of ActiPatch Therapy, RecoveryRx Devices, HealFast Therapy and the Allay family of inexpensive, disposable drug-free anti-inflammatory devices.

Our revolutionary line of pain treatment products is sold in more than 35 countries, with the simple goal of changing the way people heal.

Patents::::   
https://www.google.com/search?tbo=p&tbm=pts&hl=en&q=inassignee:%22Bioelectronics+Corp.%22

 

 

Retail Products 

What is ActiPatch®?
Recognized by the Wall Street Journal as one of the top medical innovations of 2009, ActiPatch® delivers its patented BioDynamic Therapy to not only relieve your pain, but to HEAL it so it doesn't come back.  Drugs and heat patches don't work to cure your pain - they simply mask it.  It always comes back.  Introducing a breakthrough in pain relief!


How does ActiPatch® work?

When cells are damaged, inflammation sets in resulting in pain, swelling, and reduced cellular energy.  ActiPatch® calms the inflammation and restores cells to their normal energy levels.  The result:  your pain and swelling diminish and your damaged cells actually begin to heal for sustained relief.  For more information visit the Technology section of our website.

Is ActiPatch® Safe?

ActiPatch® is extremely safe and comfortable to wear. The low-level current that is gently pulsed into damaged tissue is undetectable, even though the device is continuously working to help you heal. 

  http://www.allaystore.com

BIEL 
Primary Product — ActiPatch 
USPTO Patents - check 
Up to date - check 
FDA - partially OTC cleared foot and knee - check 
FDA - working with company on back clearance - check 
Trial supporting back clearance - finished - check 
FDA asked for back data pre-submission meet - check 
FDA relationship quality - fine 
Signed deals with large U.S. distributors - check, do DD 
Ongoing discussions with large U.S. retailers - check, do DD 
ActiPatch OTC cleared 50+ countries - check 
UK NHS Tariff approved for reimbursement - check 
NHS support - trial data, efficacy, safety, price 
NHS motives - public safety, efficacy, savings £100’s millions annually 
Launch - Publicly announced April 1, 2018 Post-launch ramp-up, 90 days 
NHS coverage - 100% insured patients with Rx 
Estimated price on NHS Rx launch - $ .009 to $ .02 
Estimated price on FDA OTC Back clearance - $ .04 to $ .06 
Estimated price on FDA OTC General clearance - $ .075 to $ .09 
Estimated price on U.S. retail (CVS, Walgreens) launch - $ .11 to $ .15 

Is most of this factual? You bet 
Is some of it speculative? You bet 
p.s. ActiPatch is the only miniaturized, USPTO patented, drug-free, side-effect free, safe and efficacious (FDA says so), partially FDA OTC cleared, pain management device in the world and it works well. Fact 


 


                                                                                                                                     Distributors
http://www.actipatch.com/distributors/
To order ActiPatch® online from Canada, please visit www.actipatch.ca

To order ActiPatch® online from Europe, please visit www.actipatchrelief.co.uk

 

      ~BioElectronics Corporation Website~
http://bielcorp.com/

State of Incorporation: MD
Year of Incorporation 2000

~BioElectronics Corporate Headquarters~
4539 Metropolitan Ct.
Frederick, MD 21704
Toll Free: 866-757-2284
Phone: 301-874-4890
Fax: 301-644-3937

Office Hours:
9 A.M. - 5 P.M. EST

E- mail:info@actipatch.net


$$$$$==Updates for 2017 / Products / FDA ==$$$$$ 
 

BioElectronics Corporation

 
2014 Oxford Pharmascience Group (OXP) is sponsoring BIELhttp://www.oxfordpharmascience.com/content/investors/share_price.asp 

Park Lane Hotel, Piccadilly, London 
Thursday, 6th March 2014
 

http://www.otc-bulletin.com/awards/pdfs/Nominations-Supplement-2014.pdf 
 


Approved for Olympics:                                                                                LOOK AT DR Oz
 

The UK's leading pharmacy-led health and beauty retailer

Boots UK is a member of Alliance Boots, an international pharmacy-led health and beauty group.

Our purpose is to help our customers look and feel better than they ever thought possible.  We have close to 2,500 stores from local community pharmacies to large destination health and beauty stores.  We offer fantastic products and services and you'll be cared for by expert, friendly people.   http://www.boots-uk.com/   
 

 

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This Un-Official BIEL Message Board was created by shareholders of BIEL for Shareholders of BIEL. The intent of this board is to help shareholders and also bring discussions about BIEL to a central place.
Information above is gathered from either the internet or from other sources that could prove to be unreliable. Please do your own Due Diligence as some information may be out of date. IHub and the Moderators of this board (BIEL) will not claim nor hold any responsibility for a person(s) financial decisions. If any in-valid information is located on the BIEL board, please notify one of the moderators immediately so corrections can be made.
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BIEL News: Traders News Issues Research on Potential Growth Stocks 05/04/2018 08:00:00 AM
PlusOneCoin Top Posts
#138781   $BIEL : CHRONOLOGY OF EVENTS IN 2018..... THIS IS A DewmBoom 05/22/18 06:46:38 AM
#138592   $BIEL LATEST FDA NEWS ....HUGE Multi Billion Dollar Company DewmBoom 05/21/18 07:35:56 AM
#138434   ALLAY was supposed to be approved as far DewmBoom 05/19/18 09:37:37 AM
PostSubject
#138163  Sticky Note ClinicalTrials.gov Identifier: NCT03166046 seven-up 05/17/18 12:19:07 PM
#136486  Sticky Note BioElectronics Receives FDA Pre-Submission Approval for its Relief N_B 05/11/18 09:05:32 AM
#135505  Sticky Note BioElectronics VP of Sales Discusses Pre & Post-operative seven-up 05/08/18 07:52:04 AM
#135317  Sticky Note Looks like...all findings...will go the SECs way...NOT-GOOD...for BIEL. stockdarockk 05/07/18 12:32:22 PM
#128982  Sticky Note Shareholders update !!! G-star 04/05/18 11:42:24 AM
#139060   Not necessarily featured but they are mentioned and da4483 05/23/18 02:12:33 PM
#139059   Towards the bottom: Gramps 05/23/18 02:10:20 PM
#139058   Specifically, where in that article BIEL is being featured? Daytime_Lantern 05/23/18 02:06:35 PM
#139057   BIEL is one of the Major Market Manufacturers Tropicalstocks 05/23/18 02:06:24 PM
#139056   need some ask slappers now REDZONE 05/23/18 02:03:26 PM
#139055   LOOKS LIKE IT HAS BOTTOMED OUT REDZONE 05/23/18 02:03:08 PM
#139054   Slow & Steady Wins the Race !! Livelikenotommorow 05/23/18 01:59:30 PM
#139053   "Expedited" for a New-510K is 60-Days or Less JustGoDeep 05/23/18 01:53:08 PM
#139052   BIEL = Most Popular Research Article in Pain jamesonkh 05/23/18 01:48:00 PM
#139051   BIEL Bioelectronics Corporation Featured in Global Report jamesonkh 05/23/18 01:43:21 PM
#139050   Apples and Oranges. I'm talking about putting out Steve43 05/23/18 01:40:19 PM
#139049   Well, that may be so. JNdouble1 05/23/18 01:37:56 PM
#139048   Umm, IHUB, maybe take a look at all JustGoDeep 05/23/18 01:32:57 PM
#139047   You are free to hold your clock as DewmBoom 05/23/18 01:31:09 PM
#139046   It is just a paperwork exercise for Biel JustGoDeep 05/23/18 01:29:31 PM
#139045   VP of sales scheduling another radio interview......Big News DewmBoom 05/23/18 01:28:28 PM
#139044   I'll answer your question with a question. Don't Blatcherone 05/23/18 01:27:06 PM
#139043   I believe you, but can you show a arizonaminingman 05/23/18 01:25:45 PM
#139042   Has Biel actually submitted the request? JNdouble1 05/23/18 01:23:27 PM
#139041   Gaining exposure https://www.cnbc.com/2018/05/11/globe-newswire-bioelectronics-r doc063 05/23/18 01:19:23 PM
#139040   So if we create Market interest, and boost Steve43 05/23/18 01:19:04 PM
#139039   And why isn't there much public interest? Is Blatcherone 05/23/18 01:13:27 PM
#139038   Negative Posts have NO Influence on Biel Now JustGoDeep 05/23/18 01:12:23 PM
#139037   I don't know, should we just sit and Steve43 05/23/18 01:02:33 PM
#139036   I feel we will do just fine here Cdub3 05/23/18 12:51:47 PM
#139035   Ok Lets get REALLY Stupid with the Numbers JustGoDeep 05/23/18 12:50:41 PM
#139034   Interest can be easily generated, by opening the Steve43 05/23/18 12:49:40 PM
#139033   RecoveryRX by itself is a MEGA---MONSTER !! JustGoDeep 05/23/18 12:46:05 PM
#139032   Not much public interest...And HOD's never hold up. stockdarockk 05/23/18 12:44:58 PM
#139031   Nothing is killing us we are doing okay toomuchwasabi 05/23/18 12:23:55 PM
#139030   A surprise would be adding post surgical use markjohn62 05/23/18 12:20:36 PM
#139029   Biel is the Best-Stock to Buy and Hold JustGoDeep 05/23/18 12:14:50 PM
#139028   Tomorrow Begins My Prediction or Forecast JustGoDeep 05/23/18 12:09:54 PM
#139027   Low Volume & Interest = Killing Us jamesonkh 05/23/18 12:05:48 PM
#139026   The sequel will be Migraine. markjohn62 05/23/18 12:03:08 PM
#139025   BIEL THE MONSTER UNLEASHED JustGoDeep 05/23/18 11:58:01 AM
#139024   "Slap the Ask" "Stops the Slide". Go BIEL, Steve43 05/23/18 11:47:38 AM
#139022   Biel-#8 Most Read Board Today #1 Stock JustGoDeep 05/23/18 11:45:03 AM
#139019   Keith working on dates for new radio interview bankrupt_2009 05/23/18 11:32:41 AM
#139018   BIEL is the BEST!!! That’s why we’re all HERE!! Tropicalstocks 05/23/18 11:28:38 AM
#139017   he-has-charts-u-think-stocks/actipatch-https://twitter.com/keith_nalepka REDZONE 05/23/18 11:27:40 AM
#139016   kith i know ur watching-more-interested-in-stock-than-actipatch??? REDZONE 05/23/18 11:26:53 AM
#139015   COMPANY will not respond to share-increase/RS ??SSS REDZONE 05/23/18 11:22:37 AM
#139013   Yes it is !! FDA meeting next Tuesday !!!! ysung 05/23/18 11:21:48 AM
#139012   RedZone Signaling Followers = Should Bounce jamesonkh 05/23/18 11:20:47 AM
#139011   we wait and a filling hits might hit .0003 REDZONE 05/23/18 11:20:45 AM
#139010   turn $2900 in to $3400 $500 PROFIT=do=that=10x=$5000REAL-CASH REDZONE 05/23/18 11:20:13 AM
#139009   buy area and sell .0032-0035 REDZONE 05/23/18 11:17:31 AM
#139008   Adding Shares @ BIEL Investor100 05/23/18 11:15:06 AM
#139007   Classic before news takedown! Great time to add. josemaria 05/23/18 11:10:02 AM
PostSubject