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16~28.. transfer each other for pps down..
Expand 400 more stores!!!
BioElectronics Update
BioElectronics Company Updates
Monday August 22, 2016
Pending FDA Market Clearance for Over-the-Counter Sales
We had a second status meeting with the FDA on Wednesday, July 20, 2016. Senior Management from the Neurology and Physical Medicine Group, 4 examiners, the Head of the Physical Medicine, and the project statistician were present. The meeting went well and the tenor was very good.
Our knee and plantar fasciitis studies, and our explanation of our unique mechanism of action have been accepted as indicative of musculoskeletal pain relief. The examiners have also agreed to review our UK Registry back pain data to accommodate our broad relief of musculoskeletal pain indication of use request. We have excellent data on approximately 4,500 back pain users, as well as well as observational study data on 100+ subjects demonstrating the durability of the therapy over 6-months.
We believe the data will be acceptable in lieu of a controlled clinical trial for back pain to support an over-the-counter musculoskeletal pain indication through the premarket notification process.
BioElectronics Expands in the UK Market
Leading UK Retailer, Superdrug expands from 186 to 432 stores. Superdrug is a subsidiary of the A.S. Watson Group, the world’s largest international health and beauty retailer with 12,000 stores.
WHSmith, a British retailer founded in 1792, www.whsmithplc.co.uk has agreed to stock and sell our ActiPatch products in their 126 hospital stores. WHSmith currently operates over 1,300 convenience stores
LOOKS LIKE NO MORE DILUTION!!!
The ActiPatch® technology go to the Rio Olympics! WOW!! Thank you 7-up for sharing..
First registration: Friday, July 1, 2016, 18:43
On Friday 24 June, presented at Patras Science Park All 10 finalists Greece and the Balkans for the competition HYPE Global Sport Innovation Competition 2016.
The first award received by Assoc. Professor, Department of Pharmacy, University of Patras Mr. Konstantinos You sell, the proposal «Sports Electroceuticals». The proposal is an innovation of the research team of the Laboratory of Molecular Biology and Immunology of Pharmacy Patron (emvia.upatras.gr), led by Mr. Sells. It concerns technology applied to sports after muscle injury and is achieved by passing microcurrent and electromagnetic fields to the injured State.
The recovery process is accelerated by 25%. The treatment method involves all athletes. Note that already applied with success in football AEK and has presented the medical team of Barcelona. Member of the group is tender and the doctor of the football AEK Alcibiades Kalliakmanis. The final will take place in Rio de Janeiro, Brazil during the Olympic Games, with large prize fund of € 100,000 for the best proposal.
Its products Maralko (ActiPatch®, Allay®, SmartInsole®) are the expression of technology SportsElectroceuticals, in individual packaging. The Maralko expresses its warmest congratulations to Mr. Konstantinos Sells for winning the first prize in the regional competition in Greece and the Balkans and hopes throughout the team every success in the final!
* The contest GlobalStart-up Sport InnovationCompetition organized by EMGI Israel and the HYPE Foundation in Israel, specializing in the development of ecosystems, incubators and business accelerators. The aim of this global contest is to bring together dynamic new entrepreneurs, researchers and students involved in product design and development of technologies that will change in the coming years the sports world than we know today (IoT, Wearables, Swimming, Running Technologies , APP's, MedicalEquipment, etc.). The competition involved 46 countries with the participation of universities, institutes and scientists - researchers from around the world.
In Patras organized one of the eight final on the Balkans. There were 45 entries and after evaluation shortlisted 10 of which emerged the winner. The 10 winning teams participated in a fast-paced training program (international acceleration and training program), having the opportunity to present their innovations to an audience of investors, business accelerators, entrepreneurs and industry executives from many countries.
The company
MARALKO The company is the exclusive representative of Bioelectronics products in Greece and Cyprus. The Bioelectronics Corporation company based in Frederick, Maryland, USA and is listed on the American Stock Exchange. We specialize in manufacturing small disposable devices, specially designed to combat pain and wound healing. The research that has made the company is innovative and focuses on the study of electromagnetic fields for therapeutic use.
The disposable devices developed by Bioelectronics is innovative in design and highly efficient in use. The products are manufactured in a special way to combat back pain, knees, soles and in many other parts of the human body.
The products have won the Innovation Prize for Medicine from the Wall Street Journal newspaper and enjoy honorific references from relevant publications.
Last updated: Friday, July 1, 2016, 18:43
Read also
WOW!! From Actipatch FB..
XXXX XXXXHello actipatch I have had great difficulty in getting my next actipatch boots were empty shelves super drug didn't have any I finally found them on Amazon and it was delivered Sunday I cannot function without it it's amazing I think I would panic if I couldn't find one I don't know if you know why there seems to be a shortage
ActiPatch
ActiPatch We had a huge boom in sales after our article in the DailyMail and stock is running out faster thanks to continued customers. Our products are available direct from us as well, if there continues to be an issue: www.tryactipatch.co.uk
On June 8, an FDA representative notified company counsel that the agency believes that the 510(k) pathway may be available for the ActiPatch device, the agency staff is reviewing the company’s data, and the agency would be back to the company shortly with its pathway determination and advice regarding whether additional information is necessary.
Expect NHS news in this or next week.
B.Barun filed on 02/18/16
39. NHS Prescription Services will acknowledge each application within 5 working days of receipt.
This is an example of the minimum time from receipt to approval and publishing in the Drug Tariff.
Activity Number of working days Example date
Application received N/A 01/05/09
Application acknowledged 5 06/05/09
Application assessed and taken
to a meeting 20 04/06/09
Acceptance letter written 5 11/06/09
Confirmation of detail of entry and
supplies available 35 1/08/09
Month listed in the Drug Tariff N/A September 2009
A number of factors may cause this timeline to be extended e.g. missing
documentation, complexity of information to be evaluated, applicants needing time to
provide further information. An application will not be released for assessment until all
the necessary information has been received. If, after 28 working days, the full
documentation has not been received by NHS Prescription Services, a reminder will be
sent asking for this to be sent within the next 28 days. Failure to send the missing
paperwork/samples will prompt NHS Prescription Services to ask for collection of any
paperwork/samples to be arranged within the next 7 days, after which they will be
destroyed. Any further applications for the product will then have to start anew.
NHS news will be out soon...
FREDERICK, Md., Feb. 18, 2016 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced consumer medical devices, announced today that B. Braun has initiated the application for a listing of RecoveryRx® on the National Health Service (NHS) drug tariff
39. NHS Prescription Services will acknowledge each application within 5 working days of receipt.
This is an example of the minimum time from receipt to approval and publishing in the Drug Tariff.
Activity Number of working days Example date
Application received N/A 01/05/09
Application acknowledged 5 06/05/09
Application assessed and taken
to a meeting 20 04/06/09
Acceptance letter written 5 11/06/09
Confirmation of detail of entry and
supplies available 35 1/08/09
Month listed in the Drug Tariff N/A September 2009
A number of factors may cause this timeline to be extended e.g. missing
documentation, complexity of information to be evaluated, applicants needing time to
provide further information. An application will not be released for assessment until all
the necessary information has been received. If, after 28 working days, the full
documentation has not been received by NHS Prescription Services, a reminder will be
sent asking for this to be sent within the next 28 days. Failure to send the missing
paperwork/samples will prompt NHS Prescription Services to ask for collection of any
paperwork/samples to be arranged within the next 7 days, after which they will be
destroyed. Any further applications for the product will then have to start anew.
BioElectronics Responds to U.S. FDA's Comments on its Market Clearance Application
PR Newswire BioElectronics Corporation
12 minutes ago
????
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FREDERICK, Md., May 10, 2016 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced medical devices, announced that it remains in negotiations with the U.S. Food and Drug Administration ("FDA") regarding its 510(k) premarket notification for the ActiPatch® Musculoskeletal Pain Therapy. Two weeks ago, it submitted detailed responses to the FDA's questions related to the published clinical trials and the Company's Registry Study of the 5,000 UK ActiPatch users. "We responded to all of the FDA's questions from its review of our 510(k) submission and we are hopeful that we satisfied the agency's inquiries," said Ian Rawe, Ph.D., Director of Research for BioElectronics.
Last week the Company, through its lawyers, responded to the FDA's concerns associated with the correct pathway for gaining an OTC status. Currently there are no legally marketed nonthermal shortwave therapy devices indicated for OTC use and thus the Agency believes the 510(k) route is inappropriate. However, it is the Company's position that our submission provides the necessary evidence that the product is both safe and effective and that the FDA has found a number of proposed OTC labeled devices substantially equivalent to prescription devices. Consequently, the Company is scheduling a meeting with the agency regarding its current classification position and is maintaining its pursuit of an OTC indication for use for treatment of musculoskeletal pain.
ITBRA is finalists for the 2016 Edison Awards!!!
http://www.edisonawards.com/finalists2016.php
FDA 127 Calendar day.. almost... IMO
**Radiological and Orthopedic devices tend to take the least amount of time to clear, averaging 135 and 140 days respectively in 2014.
GLTA
plus103 stores in Canada..
From ActiPatch FB
We're excited to announce that ActiPatch® Pain Relief is now available in 103 Showcase - Home Of The Hottest Trends stores across Canada! Visit www.actipatch.ca/stores to find the location nearest to you. Learn more about drug-free, safe, effective, sensation-free, award-winning ActiPatch at www.actipatch.ca
Cisos Malaysia.
“We believe the #InternetofEverything can be a life saver.” @Cisco Malaysia’s Albert Chai on #iTBra: https://t.co/Xf0blFOjGU via @StarOnline
— Cyrcadia Health (@CyrcadiaHealth) November 20, 2015
numberous Bioelectronic clinical trials gov data....
1.https://clinicaltrials.gov/ct2/results?term=bioelectronics&Search=Search
2.https://clinicaltrials.gov/ct2/results?term=actipatch&Search=Search
3.https://clinicaltrials.gov/ct2/results?term=recoveryrx&Search=Search
Singapore will be first????
#Breastcancer incidence in #Singapore is skyrocketing. That’s why we intend to launch #iTBra there early. https://t.co/QTAuL7MaCC via @STcom
— Cyrcadia Health (@CyrcadiaHealth) November 18, 2015
Actipatch FB 30K Likes!! https://www.facebook.com/ActiPatch/?fref=ts
Canada Markets from FB
1. available at Toronto General Hospital's Outpatient located at 585 University Avenue, 1st Floor NU, Rm 2 (416-340-4075)
2. available at Costco.ca
3 available at www.tryactipatch.ca or www.amazon.ca
4. available at Cochrane Foot Care Wellness Centre 140-3rd Street West Cochrane Ontario P0L 1C0 Canada
Leslie Medical Pharmacy at 4800 Leslie Street, Suite 110, North York, Ontario
check 2dls post history..24/7/365 5+ yrs.. LOL
11's wall gone,,,MM screw up!!!! LOL
company updates!!! http://www.bielcorp.com/investors/investor-updates/
WOW..3.25M/0.0023 bid
trade 1share/0.00229 LOL.. come on..
IMO, CISCO will buy out ITBRA.... LOL
LOL trying PPS down...
LOL ITBRA for men???
https://twitter.com/RobRoyea
Actipatch will be on shelves at Canada Walmarts???? WOW
BioElectronics Files FDA Premarket Notification for ActiPatch® Therapy
Yes.. We should spread out news....
Great DD!!! Thank you for sharing info..
Thank you for sharing info...
will hold till end of year,,,
Estimate completion date is Dec 2015...
https://clinicaltrials.gov/ct2/show/record/NCT02511301
tick, tick, tick.......... Boom!!!!
It's coming.....
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-13889.pdf
Cardiopulmonary Bypass Blood Pumps proposed order date = 01/07/2014
FDA reclassified from class 3 into class 2 = 06/05/2015
shortwave diathermy proposed order date = 02/20/2014
FDA reclassfication from class 3 into class 2 = ????
LOL....
Breaking 0.001!!
No MM'S blocking wall..
Ask is thin.
Go BIEL
L2 0.0009/10k ask
That's it..
Let's go BIEL team..
Time to move on..
Thanks
I expect this month..IMO
multiple final rules tend to come out together same day, week, month base on my DD..
check out past final rules dates..
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240318.htm